Octreotide-depot (Octreotide-depo) - malangizo ogwiritsira ntchito

Dzinalo:Octreotide-depo

Kupanga ndi mawonekedwe a kumasulidwa

Lyophilisate pokonzekera kuyimitsidwa kwa kutsekeka kwa makulidwe a nthawi yayitali kapena yoyera ndi kuwala pang'ono kwa chikasu, mu mawonekedwe a ufa kapena ufa wosakanizidwa piritsi, zosungunulira zomwe zimagwiritsidwa ntchito ndizoyimira zopanda mandala, kuyimitsidwa kokhazikitsidwa kumayera koyera kapena koyera ndi tint yoyera yachikasu. kachalandir Botolo 1 ili ndi 10 mg ya octreotide. Othandizira: Copolymer wa DL-lactic ndi glycolic acid - 270 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium mchere - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, jekeseni 0,8% - 2 ml.

Kuchuluka kwa botolo lagalasi lakuda ndi 10 ml. Bokosi limaphatikizapo 1 muloule wa solvent, syringe yotaya, 2 d / ndi singano ndi 2 mowa. Atakwezedwa m'makatoni.

Lyophilisate pokonzekera kuyimitsidwa kwa kutsekeka kwa makulidwe a nthawi yayitali kapena yoyera ndi kuwala pang'ono kwa chikasu, mu mawonekedwe a ufa kapena ufa wosakanizidwa piritsi, zosungunulira zomwe zimagwiritsidwa ntchito ndizoyimira zopanda mandala, kuyimitsidwa kokhazikitsidwa kumayera koyera kapena koyera ndi tint yoyera yachikasu. kachalandir Botolo imodzi ili ndi 20 mg ya octreotide. Othandizira: Copolymer wa DL-lactic ndi glycolic acid - 560 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium mchere - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, jekeseni 0,8% - 2 ml.

Kuchuluka kwa botolo lagalasi lakuda ndi 10 ml. Bokosi limaphatikizapo 1 muloule wa solvent, syringe yotaya, 2 d / ndi singano ndi 2 mowa. Atakwezedwa m'makatoni.

Lyophilisate pokonzekera kuyimitsidwa kwa kukhazikika kwa makulidwe a nthawi yayitali kapena yoyera ndi kuwala pang'ono kwa chikasu, mu mawonekedwe a ufa kapena ufa wosakanikizika piritsi, zosungunulira zomwe zimagwiritsidwa ntchito ndizoyimira zopanda mandala, kuyimitsidwa kokhazikitsidwa kumayera kapena kuyera ndi kutuwa kowoneka kutuwa, kachalandir Botolo imodzi imakhala ndi 30 mg ya octreotide. Othandizira: Copolymer wa DL-lactic ndi glycolic acid - 850 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium mchere - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, jekeseni 0,8% - 2 ml.

Kuchuluka kwa botolo lagalasi lakuda ndi 10 ml. Bokosi limaphatikizapo 1 muloule wa solvent, syringe yotaya, 2 d / ndi singano ndi 2 mowa. Atakwezedwa m'makatoni.

Zachipatala ndi gulu la mankhwala

Gulu la Pharmacotherapeutic

Somatostatin (analogue yopanga)

Pharmacological zochita za mankhwala Octreotide Depot

Octreotide-depot ndi mtundu wa mankhwala octreotide omwe amagwira ntchito kwa nthawi yayitali kwa i / m makonzedwe, kuonetsetsa kuti mankhwala octreotide okhazikika m'magazi kwa milungu 4. Octreotide ndi njira yothandizira pathogenetic ya zotupa zomwe zimafotokozera momatostatin zolandilira.

Octreotide ndi octapeptide yopanga yomwe imachokera ku chilengedwe cha mahomoni somatostatin komanso imabweretsa zotsatira zofananira zamankhwala, koma nthawi yayitali kwambiri.

Mankhwalawa amachepetsa pang'onopang'ono kukula kwa kukula kwa mahomoni (GH), komanso ma peptides ndi serotonin opangidwa mu gastroenteropancreatic endocrine system.

Mwa anthu athanzi, octreotide, ngati somatostatin, imachepetsa kubisala kwa GH chifukwa cha arginine, zolimbitsa thupi ndi insulin hypoglycemia, kubisalira kwa insulin, glucagon, gastrin ndi zina zam'magazi a gastroenteropancreatic endocrine, chifukwa cha kudya, komanso kuchuluka kwa maselo, kuperewera kwa maselo, kuperewera kwa maselo, kuperewera kwa maselo, kusungunuka kwa thupi, kunyezimira kwazinthu. chifukwa cha thyroliberin. Mphamvu yoletsa kuponderezedwa kwa kukula kwa mahomoni mu octreotide, mosiyana ndi somatostatin, imafotokozedwa kwakukulu kwambiri kuposa kubisika kwa insulin.Makonzedwe a octreotide samatsatiridwa ndi chodabwitsa cha hypersecretion cha mahormone ndi makina oyipa amakono.

Odwala omwe ali ndi acromegaly, makonzedwe a Octreotide-depot amapereka muzochitika zambiri kutsika kosalekeza kwa ndende ya GR ndikudziyimira ndende ya insulin ngati kukula kwa chinthu cha 1 / somatomedin C (IGF-1).

Odwala ambiri okhala ndi acomegaly, Octreotide Depot amachepetsa kuopsa kwa zizindikiro monga kupweteka mutu, thukuta kwambiri, paresthesia, kutopa, kupweteka m'mafupa ndi mafupa, zotumphukira neuropathy. Zinanenedwa kuti kulandira chithandizo ndi octreotide mwa odwala omwe amapanga peniteni adenomas yobisa GH kunapangitsa kuchepa kwa kukula kwa chotupa.

Pobisa zotupa za endocrine m'mimba ndi kapamba, kugwiritsa ntchito Octreotide Depot kumawunikira kuwunika kwa zizindikiro zazikuluzikulu za matendawa.

30 mg octreotide depot masabata 4 aliwonse amachepetsa kukula kwa chotupa kwa odwala omwe amatulutsa zobisalira komanso zosabisalira wamba (metastatic) neuroendocrine zotupa za pakhungu, ileamu, akhungu, akukwera m'matumbo, colon yopingasa ndi zowonjezera zowoneka ngati nyongolotsi, kapena metastase ya chotupa cha neuroendocrine. Mankhwalawa adakulitsa nthawi yochulukirapo m'gululi: nthawi yapakatikati yopita patsogolo inali miyezi 14.3 poyerekeza ndi miyezi isanu ndi umodzi ya gulu la placebo. Pambuyo pa chithandizo cha miyezi 6, kukhazikika kunawonedwa mu 66% ya odwala mu gulu la Octreotide-depot ndi 37% ya odwala omwe ali mu gulu la placebo. Mankhwalawa anali othandiza pakuwonjezera nthawi yowonjezereka, onse pobisa komanso osabisala zotupa za neuroendocrine.

Mu zotupa za carcinoid, kugwiritsidwa ntchito kwa octreotide kumapangitsa kuchepa kwa zizindikiro za matendawa, makamaka, monga "kutentha kwa m'mimba" ndi kutsekula m'mimba. Mwambiri, kusintha kwa zamankhwala kumayendetsedwa ndi kuchepa kwa plasma serotonin ndende ndikuwonetsa kwa 5-hydroxyindoleacetic acid mkodzo.

Mu zotupa zodziwika ndi hyperproduction of the vasoactive intestinal peptide (VIPoma), kugwiritsa ntchito octreotide mwa odwala ambiri kumayambitsa kutsika kwam'mimba kwambiri, komwe kumadziwika ndi izi, komwe kumapangitsa kuti wodwalayo akhale ndi moyo wabwino. Nthawi yomweyo, pali kuchepa kwa zosokonezeka zamagetsi zamagetsi, mwachitsanzo, hypokalemia, yomwe imakulolani kuletsa maulamuliro am'madzi ndi ma electrolyte. Malinga ndi compression tomography, mwa odwala ena amayamba kuchepa kapena kuyimitsa kukula kwa chotupacho, ndipo ngakhale kuchepa kwake kukula, makamaka metastases ya chiwindi. Kusintha kwamankhwala nthawi zambiri kumayendetsedwa ndi kuchepa (mpaka pamachitidwe abwinobwino) pamagulu a vasoactive matumbo peptide (VIP) mu plasma.

Ndi glucagonomas, kugwiritsa ntchito octreotide nthawi zambiri kumabweretsa kuchepa kowoneka bwino kwa zotupa zosunthika, zomwe zimadziwika mwanjira imeneyi. Octreotide ilibe gawo lililonse pakukhudzika kwa matenda osokoneza bongo a shuga, omwe nthawi zambiri amawonetsedwa ndi glucagonomas, ndipo nthawi zambiri samachepetsa kufunikira kwa mankhwala a insulin kapena pakamwa a hypoglycemic. Odwala omwe ali ndi matenda am'mimba, octreotide amachititsa kuchepa kwake, komwe kumayendetsedwa ndi kuwonjezeka kwa thupi. Pogwiritsa ntchito octreotide, kuchepa msanga kwa glucagon m'madzi a m'magazi nthawi zambiri kumadziwika, komabe, ndi chithandizo chotere, izi sizipitilira. Nthawi yomweyo, kusintha kwa zindikiritso kumakhazikika nthawi yayitali.

Mu gastrinomas / Zollinger-Ellison syndrome, octreotide, yogwiritsidwa ntchito ngati monotherapy kapena kuphatikiza ndi histamine H 2 receptor blockers ndi proton pump inhibitors, itha kuchepetsa mapangidwe a hydrochloric acid m'mimba ndikuwongolera kusintha kwachipatala, kuphatikizakomanso pokhudzana ndi kutsegula m'mimba. Ndikothekanso kuchepetsa kuuma ndi zizindikiro zina, zomwe mwina zimagwirizanitsidwa ndi kapangidwe ka peptides ndi chotupa, kuphatikiza mafunde. Nthawi zina, pali kuchepa kwa kuchuluka kwa gastrin mu plasma.

Odwala omwe ali ndi insulinomas, octreotide amachepetsa kuchuluka kwa insulin yamagazi m'magazi. Odwala omwe ali ndi zotupa zogwiritsidwa ntchito, octreotide amatha kuonetsetsa kuti kubwezeretsanso ndi kukonzanso kwa syntoglycemia kumayang'anira ntchito. Odwala omwe ali ndi zotupa zosavomerezeka komanso zotupa, ma glycemic control amatha kusintha popanda kuchepa kwa nthawi yayitali mu insulin.

Odwala omwe ali ndi zotupa zosowa, hyperprodizing kukula kwa mahomoni akumasulidwa (somatoliberinomas), octreotide amachepetsa kuuma kwa zizindikiro za acromegaly. Izi, mwachiwonekere, zimagwirizanitsidwa ndi kuponderezedwa kwa katulutsidwe ka kukula kwa mahomoni omasuka ndi GH. M'tsogolo, ndizotheka kuchepetsa kukula kwa pituitary gland, yomwe idakulitsidwa musanalandire chithandizo.

Odwala omwe ali ndi khansa yokhala ndi khansa ya prostate (HGRP), dziwe la maselo a neuroendocrine omwe amafotokozera za kulandirana kwa somatostatin receptors kwa octreotide (mitundu ya SS2 ndi SS5) imawonjezeka, yomwe imapangitsa kudziwa kwa chotupa kuti octreotide. Kugwiritsa ntchito kwa Octreotide-Depot kuphatikiza ndi dexamethasone motsutsana ndi maziko a androgen blockade (mankhwala osokoneza bongo kapena opaleshoni) kwa odwala omwe ali ndi HGRP kumabwezeretsa chidwi cha mankhwala a mahomoni ndipo kumayambitsa kuchepa kwa Prostate antigen (PSA) yoposa 50% ya odwala.

Odwala HGRG okhala ndi mafupa metastases, mankhwalawa amathandizana ndi kutchulidwa kwa nthawi yayitali. Kuphatikiza apo, mwa odwala onse omwe adagwiritsa ntchito kuphatikiza chithandizo cha Octreotide Depot, moyo ndi kupulumuka kwapang'onopang'ono kwapamwamba kwatha bwino.

Pharmacokinetics

Zambiri pa pharmacokinetics ya mankhwala Octreotide-depot siziperekedwa.

Acromegaly (posakhala ndi zotsatira zokwanira kuchokera ku opaleshoni, ma radiation mankhwala ndi chithandizo cha dopamine agonists, odwala osagwiritsidwa ntchito, komanso odwala omwe akukana chithandizo cha opaleshoni), kumasuka kwa zotupa za gastroentero-pancreatic endocrine system (carcinoid chotupa ndi kukhalapo kwa carcinoid syndrome, zotupa, yodziwika ndi hyperproduction ya vasoactive matumbo a peptide - VIP, glucagon, gastrinomas / Zollinger-Ellison syndrome, insulinomas, zotupa zodziwika ndi kupanga kwa somatoliberin - somatoliberinomas, kukananso m'mimba mwa odwala AIDS. Kupewa kwa zovuta pambuyo pancreatic opaleshoni, kuyimitsa magazi komanso kupewa kubwezeretsanso mitsempha ya varicose ya esophagus ndi cirrhosis (kuphatikiza ndi endoscopic sclerotherapy).

Contraindication mankhwala

Hypersensitivity kwa octreotide kapena zigawo zina za mankhwala.

Pafupifupikuyang'anira The mankhwala ayenera kulandira mankhwala a cholelithiasis, shuga, pa mimba ndi mkaka wa m`mawere.

Mlingo komanso njira yogwiritsira ntchito Octreotide Depot

Mankhwala Octreotide-Depot amayenera kuperekedwa kokha mwamphamvu intramuscularly (IM), mu minofu ya gluteus. Ndi jakisoni wobwereza, mbali zamanzere ndi zamanja ziyenera kusinthidwa. Kuyimitsidwa kuyenera kukonzedwa nthawi yomweyo musanalowe. Patsiku la jakisoni, vial yokhala ndi mankhwalawa komanso zochulukirapo ndi zosungunulira zimatha kusungidwa kutentha.

Mankhwalawa acromegaly odwala amene s / c makonzedwe a octreotide amapereka okwanira kuwongolera mawonetseredwe a matendawaMlingo woyambira wa Octreotide Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. Mutha kuyamba kulandira chithandizo ndi Octreotide-Depot tsiku litapita s / c yoperekera octreotide.M'tsogolomu, mlingo umakonzedwa poganizira kuchuluka kwa ma seramu a GR ndi IGF-1, komanso zizindikiro zamatenda. Ngati pambuyo pa miyezi itatu ya chithandizo sikunatheke kukwaniritsa zokwanira zamankhwala komanso zamankhwala am'magazi (makamaka, ngati kuchuluka kwa GR kumakhalabe pamwamba pa 2,5 μg / L), mlingo umatha kupitilizidwa mpaka 30 mg kutumikiridwa pakatha milungu 4 iliyonse.

Mu milandu pamene pambuyo 3 miyezi chithandizo ndi Octreotide-Depot pa 20 mg, kuchepa mosalekeza
seramu GH ndende pansipa 1 μg / l, kusintha kwa ndende ya IGF-1 ndi kutha kwa kusintha kosintha kwa mankhwala a acromegaly, mutha kuchepetsa mlingo wa mankhwala Octreotide-depot mpaka 10 mg. Komabe, mwa odwala awa omwe amalandira mlingo wocheperako wa Octreotide Depot, ma seramu omwe amakhala ndi GR ndi IGF-1, komanso zizindikiro za matendawa, amayenera kuyang'aniridwa mosamala.

Odwala omwe amalandira mlingo wokhazikika wa Octreotide-depot amayenera kuyesedwa miyezi isanu ndi umodzi iliyonse kuti azikhala ndi GH ndi IGF-1.

Odwala omwe chithandizo cha opaleshoni ndi chithandizo chamankhwala a radiation sichothandiza kwenikweni kapena chothandiza, komanso odwala omwe amafunikira chithandizo chanthawi yayitali pakati pa maphunziro a radiation mpaka atakwaniritsidwa, amakulimbikitsidwa kuti ayese mayeso a chithandizo cha jekeseni wa octreotide kuti aziwunika magwiridwe antchito ndi kulolerana kwakukulu, ndipo atatha kugwiritsa ntchito mankhwalawa Octreotide-depot molingana ndi dongosolo lomwe lili pamwambapa.

At mankhwalawa endocrine zotupa zam'mimba ndipo kapamba Odwala amene s / octreotide amapereka mokwanira kuwongolera mawonetseredwe a matendawa, kukonzekera koyamba kwa mankhwala Octreotide-Depot ndi 20 mg milungu 4 iliyonse. The sc makonzedwe a octreotide ayenera kupitiliza kwa masabata awiri pambuyo koyamba mankhwala Octreotide-Depot.

Odwala omwe sanalandirepo kale umuna wa octreotide, tikulimbikitsidwa kuti chithandizo chiyambitsidwe ndi s.c. octreotide pa mlingo wa 0 mg mg katatu kapena tsiku kwa nthawi yochepa (pafupifupi masabata awiri) kuti muwone kuyeserera kwake komanso kulekerera konse. Pambuyo pokhapokha izi, mankhwala Octreotide-Depot amawayika malinga ndi dongosolo pamwambapa.

Panthawi ya chithandizo cha mankhwala ndi Octreotide-Depot kwa miyezi itatu imapereka chiwonetsero chokwanira chazidziwitso zamankhwala komanso zolembera zamatenda, n`zotheka kuchepetsa mlingo wa Octreotide-Depot mpaka 10 mg,
Anasankhidwa masabata anayi aliwonse. Milandu yomwe itatha miyezi itatu ya chithandizo ndi Octreotide-Depot, kusintha pang'ono pang'ono komwe kumachitika, mlingowo ungathe kuchuluka mpaka 30 mg sabata iliyonse 4. Poyerekeza ndi chithandizo cha mankhwala ndi Octreotide-Depot, pamasiku ena ndizotheka kuwonjezera mawonekedwe awonetsedwe a matenda a endocrine chotupa cham'mimba ndi kapamba. Milandu imeneyi, makonzedwe owonjezera a ma octreotide muyezo wogwiritsidwa ntchito musanayambe chithandizo ndi Octreotide-Depot tikulimbikitsidwa. Izi zitha kuchitika makamaka m'miyezi iwiri yoyambirira ya mankhwala mpaka achire octreotide mu plasma atafika.

Kubisa komanso kusabisitsa zotupa wamba (za metastatic) za khungu, ileamu, khungu, kukwera, colon ndi vermiform zowonjezera, kapena metastasis ya zotupa za neuroendocrine popanda chotupa chachikulu. Mlingo wovomerezeka wa Octreotide Depot ndi 30 mg milungu 4 iliyonse. Octreotide-depot mankhwala ayenera kupitilizidwa mpaka zizindikiro za chotupa chikukula.

At Chithandizo cha khansa ya Prostate yotsekemera ya mahomoni Mlingo woyambira wa Octreotide Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. Pambuyo pake, mlingo umakonzedwa poganizira mphamvu za seramu PSA ndende, komanso zizindikiro zamatenda. Ngati pambuyo pa miyezi 3 ya chithandizo sikunatheke
zokwanira matenda ndi zamankhwala amuzolengedwa (PSA kuchepetsa), mlingo akhoza kuchuluka kwa 30 mg kutumikiridwa aliyense 4 milungu.

Chithandizo cha Octreotide Depot chimaphatikizidwa ndi dexamethasone, omwe amalembedwa pakamwa malinga ndi chiwembu chotsatira: 4 mg patsiku kwa mwezi umodzi, ndiye 2 mg patsiku kwa masabata awiri, ndiye 1 mg patsiku (yokonza mlingo).

Octreotide-depot ndi dexamethasone chithandizo cha odwala omwe adachitapo kale mankhwala othandizira antiandrogen amaphatikizidwa ndikugwiritsa ntchito analogi ya gonadotropin-kumasula mahomoni (GnRH). Pankhaniyi, jakisoni wa analogue wa GnRH (fomu yofikira) amachitika nthawi imodzi m'masabata 4.

Odwala omwe amalandila Octreotide Depot amayenera kuyesedwa mwezi uliwonse pozama za PSA.

At odwala omwe ali ndi vuto laimpso, chiwindi, ndi okalamba palibe chifukwa chokonza mtundu wa mankhwala Octreotide-depot.

Chifukwa prophylaxis wa pachimake postoperative pancreatitis The mankhwala Octreotide-Depot muyezo wa 10 kapena 20 mg kutumikiridwa kamodzi osapitirira masiku 5 ndipo pasanathe masiku 10 pamaso pa opaleshoni yomwe akufuna.

Malangizo pokonzekera kuyimitsidwa ndi kuperekedwa kwa mankhwalawo

Mankhwala amaperekedwa kokha mu mafuta. Kuyimitsidwa kwa jakisoni wa mu mnofu kumakonzedwa pogwiritsa ntchito zosungunulira zomwe zimaperekedwa nthawi yomweyo isanachitike. Mankhwalawa ayenera kukonzedwa ndikuthandizira okhawo omwe amaphunzitsidwa bwino.

Asanalowe, jakisoni wokwanira ndi zosungunulira komanso botolo lomwe lili ndi mankhwalawa liyenera kuchotsedwa mufiriji ndikubwera ndi kutentha kwa firiji (mphindi 30-50 zimafunikira). Sungani botolo ndi mankhwala Octreotide-Depot molunjika. Kugunda vial mopepuka, onetsetsani kuti lyophilisate yonse ili m'munsi mwa vial.

Tsegulani phukusi la syringe ndikulowetsa singano ya 1.2 mm x 50 mm ku syringe kuti mutenge zosungunulira. Tsegulani zochulukirapo ndi zosungunulira ndikuyika mu syringe nkhani zonse za ampoule ndi zosungunulira, ikani syringe kuti mupeze 2.0 ml. Chotsani kapu ya pulasitiki mu vial yomwe ili ndi lyophilisate. Tetezani mankhwala opopera pa mphira ndi mowa. Ikani singano mu lyophilisate vial kudutsa pakati pa poyimitsira mphira ndikubowola mosamala zosungunulira pamodzi ndi khoma lamkati la vial osakhudza zomwe zili mu vial ndi singano.

Chotsani syringe kuchokera pambale. Valali imayenera kusunthira pansi mpaka yosungunulira itadzaza kwathunthu ndi ma lyophilisate ndi mafomu oyimitsa (pafupifupi mphindi 3-5). Kenako, osatembenuza botolo, muyenera kuyang'ana ngati pali bokosi louma kumakoma pansi pa botolo. Ngati mapesi owuma a lyophilisate atapezeka, siyani vial mpaka pakhuta bwino.

Mukatsimikizira kuti palibe zotsalira za malo owuma a lyophilisate, zomwe zili mu vial ziyenera kusakanikirana mosamala mozungulira kwa masekondi 30-60 mpaka kuyimitsidwa kopanda pake. Osagwetsa kapena kugwedeza vial, chifukwa izi zitha kutha chifukwa cha kutayika komanso kuyimitsidwa koyenera.

Ikani mwachangu singano kudzera pa cholembera cha mphira mu vial. Kenako gawo lama singano limatsitsidwa ndiku, ndikakongoletsa valoyo pakadutsa madigiri 45, pang'onopang'ono kukoka kuyimitsidwa mu syringe kwathunthu. Osakujambulani botolo ndikulemba. Mankhwala ochepa amatha kukhalabe pamakoma komanso pansi pa vial. Zakumwa zomwe zatsalira pamakoma ndi pansi pa botolo zimaganiziridwa.

Mukangotola kuyimitsidwa, pindani ndi singano ndi piyano yapinki ndi singano yobiriwira (0,8 x 40 mm), ndikutembenuza mosamala syringe ndikuchotsa mpweya ku syringe.

Kuyimitsidwa kwa mankhwala Octreotide-Depot kuyenera kuperekedwa mwachangu mukonzekera. Kuyimitsidwa kwa mankhwala Octreotide-Depot sikuyenera kusakanikirana ndi mankhwala ena alionse mu syringe imodzi.

Gwiritsani ntchito swab ya mowa kuti musambe jekeseni. Ikani singano mozama mu gluteus maximus, kenako ndikoka pang'ono syringe kuti mubwerere kuti muwonetsetse kuti chombocho sichingawonongeke.Fotokozerani kuyimitsidwa pang'onopang'ono ndi kupanikizika kosalekeza pa syringe plunger.

Ngati ilowa m'mtsempha wamagazi, tsamba la jakisoni ndi singano ziyenera kusinthidwa. Mukatseka singano, sinthani ndi singano ina yofanana.

Ndi jakisoni wobwereza, mbali zamanzere ndi zamanja ziyenera kusinthidwa.

Zotsatira zoyipa

Zomwe zimachitika: ndi i / m makonzedwe a Octreotide-depot, ululu ndiwotheka, samakonda kutupa ndi totupa pamalo a jekeseni (nthawi zambiri amakhala ofatsa, afupi).

Kuchokera m'mimba: matenda a anorexia, nseru, kusanza, kupweteka kwam'mimba, kutulutsa, kupangika kwamphamvu kwa mpweya, kutulutsa chimbudzi, kutsegula m'mimba, kusinza. Ngakhale kuchuluka kwa mafuta okhala ndi ndowe kumatha kuchuluka, pakadali pano palibe umboni kuti chithandizo cha nthawi yayitali ndi octreotide chingayambitse kuchepa kwa zinthu zina zomanga thupi chifukwa cha malabsorption (malabsorption). Nthawi zina, zochitika zofanana ndi zotumphukira m'matumbo zimatha kuchitika: kumatulutsa pang'onopang'ono, kupweteka kwambiri epigastric dera, kusokonezeka kwa khoma lam'mimba. Kugwiritsidwa ntchito kwa nthawi yayitali kwa Octreotide Depot kumatha kupangitsa kuti ma gallstones apangidwe.

Kuchokera kapamba: Nthawi zambiri za pachimake kapamba yemwe amapezeka m'maola kapena masiku ogwiritsa ntchito octreotide anenedwapo. Pogwiritsa ntchito nthawi yayitali, pakhala pali milandu yokhudza kapamba chifukwa cha cholelithiasis.

Kuchokera ku chiwindi: Pali malipoti osiyana pa kakulidwe ka kukanika kwa chiwindi (hepatitis yacute popanda cholestasis yokhala ndi matenda a transctase pambuyo pakutha kwa octreotide), kukula kwa pang'onopang'ono kwa hyperbilirubinemia, limodzi ndi kuwonjezeka kwa ALP, GGT komanso, mochepa, ma transaminase ena.

Kuchokera kumbali ya kagayidwe: Popeza Octreotide Depot imakhudzanso kwambiri mapangidwe a GH, glucagon ndi insulin, zimatha kukhudza kagayidwe ka glucose. Kuchepetsa kwa kulolera kwa glucose mutatha kudya. Pogwiritsa ntchito nthawi yayitali ya Octreotide sc nthawi zina, hyperglycemia yosatha imatha. Hypoglycemia imawonedwanso.

Zina: Nthawi zina, kuchepa kwakanthawi tsitsi pambuyo pa octreotide, kupezeka kwa bradycardia, tachycardia, kupuma movutikira, zotupa pakhungu, anaphylaxis akuti. Pali malipoti osiyana pa kakulidwe ka hypersensitivity reaction.

Mimba komanso kuyamwa

Palibe chokuchitikira ndi Octreotide Depot pa nthawi yoyembekezera komanso nthawi yoyamwitsa.

Chifukwa chake, pakubala, mankhwalawa ayenera kuikidwa pokhapokha ngati phindu lomwe lingakhalepo kwa mayi limaposa chiwopsezo cha mwana wosabadwayo.

Kuyamwitsa sikuvomerezedwa mukamagwiritsa ntchito mankhwalawa panthawi yoyamwa.

Kugwiritsa ntchito kuwonongeka kwa chiwindi Kwa odwala omwe ali ndi vuto la chiwindi, palibe chifukwa choyezera kuchuluka kwa mankhwalawa a Octreotide-Depot. Kufunsira kwa vuto la impso Kwa odwala omwe ali ndi vuto la impso, palibe chifukwa chokwanira chokonzera mankhwalawa a Octreotide-depot.

Gwiritsani ntchito odwala okalamba

Mwa odwala okalamba, palibe chifukwa chokonza dongosolo la Octreotide Depot.

Malangizo apadera a kuvomerezedwa Octreotide Depot

Ndi zotupa zapituitary, kuyang'anira odwala ndikofunikira chifukwa chakuwonjezeka kwa kukula kwa zotupa ndikukula kwa kupendekera kwamawonedwe. Muzochitika izi, muyenera kuganizira kufunika kwa njira zina zamankhwala. Mankhwalawa gastroentero-pancreatic endocrine zotupa nthawi zina, kuyambiranso kwa zizindikiro kungachitike. Odwala omwe ali ndi insulinomas pamankhwala, kuonjezera kuopsa ndi kutalika kwa hypoglycemia kungadziwike. Kuopsa kwa mavuto am'mimba kuchokera m'mimba thirakiti kumachepa ndikumayambiriro kwa mankhwalawa pakudya kapena pogona.Ndi chithandizo cha nthawi yayitali (acromegaly), musanalandire chithandizo (miyezi 6 mpaka 6) - ma ultrasound a ndulu.

Miyala mu ndulu, ngakhale atapezeka, nthawi zambiri amakhala asymptomatic. Pamaso pa matenda azachipatala, chithandizo chokhazikika kapena cha opaleshoni chimasonyezedwa. Pewani jakisoni angapo malo amodzi nthawi yomweyo. Asanayambe makonzedwe, konzekerani yankho la kutentha kwa firiji. Gwiritsani ntchito panthawi yoyembekezera komanso mkaka wa m`mawere pokhapokha mukuwonetsa mwamtheradi. Kusintha kwa magazi m'magazi a shuga kumatha kuchepetsedwa ndikuwongolera pafupipafupi kwa Mlingo wotsika. Mankhwalawa, kuwunika mwatsatanetsatane magazi a shuga ndikofunikira, makamaka kwa odwala omwe akutuluka magazi kuchokera ku mitsempha ya varicose ya chiwindi ndi chiwindi cha chiwindi - chiopsezo chokhala ndi hyperglycemia.

Bongo

Pakadali pano milandu ya Octreotide-Depot sinanenedwe.

Kuchita ndi Mankhwala Ena

Octreotide imachepetsa mayamwidwe a cyclosporin m'matumbo ndikuchepetsa kuyamwa kwa cimetidine.

Ndi munthawi yomweyo kugwiritsa ntchito octreotide ndi bromocriptine, bioavailability wa yotsiriza ukuwonjezeka.

Pali umboni wamabuku kuti somatostatin analogues imatha kuchepetsa kutsimikizika kwa zinthu zomwe zimapangidwa ndi isoenzymes ya cytochrome P450, yomwe imayamba chifukwa choponderezedwa ndi GR. Popeza ndizosatheka kupatula zotsatira zofananira za octreotide, mankhwala omwe amapangidwa ndi ma isoenzymes a cytochrome P450 dongosolo ndipo ali ndi malire ochepa othandizira (quinidine ndi terfenadine) ayenera kuyikidwa mosamala.

Mankhwala Okhala Pamalo a Pharmacy

Mankhwala ndi mankhwala.

Migwirizano ndi magwiritsidwe akusungidwa

Mankhwalawa amayenera kusungidwa pamalo owuma, amdima, osatheka ndi ana pa kutentha kwa 2 ° mpaka 8 ° C. Moyo wa alumali ndi zaka zitatu.

Kugwiritsa ntchito mankhwala Oktreotid-depot pokhapokha ngati adokotala adalembera, malangizo ndi omwe amaperekedwa!

Kutulutsa Fomu

Mankhwalawa amapezeka mu mawonekedwe a yankho la jakisoni, woyikidwa mu 1 ml ampoules kapena 5 ml vials.

Octreotide Depot ndi Octreotide Long amapezeka mu mawonekedwe a lyophilized ufa kapena wophatikizika ndi porous misa mu mawonekedwe a piritsi loyera lamitundu yosiyanasiyana. Kuphatikiza apo, kuyimitsidwa kolimba kopanda mawonekedwe ndikuyimitsanso, komwe ndikungoyimitsidwa pang'ono kwa mthunzi wowala, kumalumikizidwa.

Komanso, mitundu iyi ya mankhwala imatha kuperekedwa mwa mawonekedwe a lyophilisate pakukonzekera kuyimitsidwa komwe kumayikidwa mu kupangika kwa intramuscular ndi nthawi yayitali ya 0.01-0.03 g yogwira ntchito muzinthu zamagalasi zakuda. Kuphatikiza apo, 2 ml sol sol ampoule, ma syringe otayika, singano wosabala ndi mowa wambiri umaphatikizidwa. Seti imodzi ndi imodzi jakisoni.

Pharmacodynamics ndi pharmacokinetics

Mankhwala awa ndi analogue opangidwa. somatostatinokhala ndi mankhwala ofanana, koma amakhala nthawi yayitali.

Chithandizo cha octreotide chimachitika pakafunika kupondereza chinsinsi cha kukula kwa timadzi ta m'magazi, kukula kwa matenda am'mimba kapena chifukwa cha arginine, insulin hypoglycemia kapena zolimbitsa thupi. Zotsatira zake zikuchepa katulutsidwe a insulin, gastrin, glucagon ndi serotonin, omwe amathanso kuwonjezereka m'matumbo kapena chifukwa cha zakudya. Kuponderera kwachinsinsi kwadziwika insulinndi glucagonzomwe zimalimbikitsaargininekutsitsa katulutsidwe thyrotropinchifukwa thyroliberin.

Kugwiritsa ntchito mankhwalawa musanachitike kapena pancreatic opaleshoni kungachepetse zovuta zamtundu wa postoperative, mwachitsanzo:fancula kapamba, sepsis, abscesses, pachimake postoperative pancreatitis.

Chithandizo cha magazi ochokera m'mitsempha ya varicose m'matumbo am'mimba mwa odwala omwe ali ndi vuto la chiwindi limodzi ndi mankhwala enaake - sclerosing ndi hemostatic, amathandizira kuti magazi asiye kutuluka komanso kupewa kutaya magazi pafupipafupi.

Mkati mwa thupi mumatuluka zinthu zomwe zimagwira mwachangu komanso mwathunthu. Pankhaniyi, kuchuluka kwa Octreotide m'madzi a m'magazi kumatha kufikira mphindi 30. Gawo limamangidwa ndi mapuloteni a plasma ndi 65%, koma kulumikizidwa ndi zinthu zopangidwa ndimwazi ndizosafunikira kwenikweni. Kuchoka kwa mankhwalawa kumachitika m'magawo angapo kudzera m'matumbo komanso mothandizidwa ndi impso.

Zizindikiro zogwiritsidwa ntchito

Mankhwala okhala ndi octreotide amalembedwa kuti:

acromegalyngati kusakwanira kwadziwikadopamine agonistskomanso ngati sizingatheke kuchitira opareshoni kapena ma radiation,
zotupa za endocrine gastroenteropancreatic system,
glucagonomas, gastrinomas,
insulomas, somatoliberinomas,
chotsutsa kutsegula m'mimba mwa odwala AIDS
opaleshoni yam'mimba, kuphatikizapo kupewa mavuto,
magazi, kupewa kubwezeretsanso matenda a varicose mitsempha ya chiwindi ndi matenda ena a chiwindi ndi zina zotero.

Contraindication

Kuphwanya kwakukulu kogwiritsa ntchito mankhwalawa ndi Hypersensitivity.

Kusamala kumafunikira pochiza odwala. cholelithiasis,matenda ashuga,at kuyamwa ndi mimba.

Zotsatira zoyipa

Pochiza ndi Octreotide, zosokoneza pakugwira ntchito pamimba zimatha kuchitika mwanjira: kusanza, nseru, kukomokakupweteka chisawawa, kutsekula m'mimba,ndiTheorrhea, matumbo kutsekeka, pachimake hepatitis wopanda cholestasis, kuchuluka kwa hepatic transaminases, hyperbilirubinemia, pachimake kapamba ndi ena.

Zingakhalensoalopecia ndi thupi lawo siligwirizana. Mawonetsero akumaloko samachotsedwa: zilonda, kuyabwa, kuyaka, redness kapena kutupa. Kugwiritsa ntchito nthawi yayitali nthawi zambiri kumayendetsedwa ndikupanga ma gallstones, kutsika kwa glucose, komanso kulimbikira hyperglycemia, hypoglycemia.

Octreotide, malangizo ogwiritsira ntchito (Njira ndi Mlingo)

Mankhwala Octreotide adapangidwira mtsempha wamitsempha kapena makina osunthira. Mlingo umayikidwa payekha, poganizira momwe matendawo alili komanso zomwe wodwalayo ali nazo. Mwachitsanzo, acromegaly ndi zotupa za gastroenteropancreatic system zimafuna kuyang'aniridwa kosuntha tsiku lililonse la 1-2 nthawi pa 50-100 mcg. Kuchita kupewetsa zovuta chifukwa chogwirira ntchito kapamba kumakhudzanso njira yoyamba ya ola limodzi asanachitike laparotomy, ndiye kuti imaperekedwa tsiku lililonse katatu pa 100 μg pa sabata. Pamafunika kusiya magazi kuchokera ku mitsempha ya varicose yam'mimba, kupatsirana kosalekeza kwa 25 μg / h kumaperekedwa kwa masiku osachepera asanu.

Malangizo ogwiritsira ntchito Octreotide Depot ndi Octreotide Long FS malipoti omwe adawakonzera jekeseni wozama wamitsempha mu minofu yotsika. Pamene subcutaneous makonzedwe a Octreotide amalola odwala kuti azilamulira mokwanira mawonekedwe a matendawa, mlingo woyambirira wa Depo ndi Long umaperekedwa pa 20 mg milungu 4 iliyonse kwa miyezi itatu. Kenako, mankhwalawa amasinthidwa malingana ndi zolemba zazomera zamatenda ndi zizindikiro zamankhwala.

Ngati odwala kale sanalandire Octreotide subcutaneally, ndiye kuti chithandizo ndi wothandizirayi ndi njira ziyenera kuyambitsidwa kwa masabata awiri. Njirayi idzawunikira kugwira ntchito kwake komanso kulolera, pambuyo pake mutha kuchitira chithandizo ndi Octreotide-Depot kapena Long.

Bongo

Ngati bongo wa Octreotide kapena Octreotide-Long, zotsatirazi zitha kuchitika: kuchepa kwakanthawi kothamanga kwa mtima, kupweteka kwam'mimba zachilengedwe nserukumaso kwa nkhope, kutsegula m'mimba. Pankhaniyi, chithandizo chamankhwala chimachitika.

Milandu ya mankhwala osokoneza bongo a Octreotide-Depot sanafotokozedwe muzochitika zamankhwala.

Kuchita

Kugwiritsa ntchito mankhwala ndi CyclosporineImachepetsa msinkhu wake mu seramu, imachepetsa mayamwidwecimetidine ndi zida zothandiza kuchokera mmimba. Ngati octreotide ndi mankhwala pamodziinsulinpamlomo mankhwala a hypoglycemic, opanga beta, BKK ndi okodzetsa, ndikofunikira kusintha kusintha kwake. Ntchito mogwirizana Bromocriptine achulukitse kuchekekera kwake.

Zinapezeka kuti mankhwalawa amachepetsa kuvomerezeka kwa zinthu zomwe zimapangidwa ndi ma enzymes a cytochrome P450 omwe amayamba chifukwa cha kuponderezana kwa kukula kwa mahomoni. Chifukwa chake, popereka mankhwala otere, tiyenera kusamala.

Zolemba za Octreotide

Mu pharmacology, ma analogues angapo a Octreotide amapezeka, chachikulu kwambiri ndicho Sandostatin.

Zofananazo zimakhala ndi:Somatostatin, Diferelin ndi Sermorelin.

Monga mukudziwa, mowa umaletsa kaphatikizidwe mahomoni, chifukwa chake, kugwiritsidwa ntchito kwake ndi mtundu uliwonse wa Octreotide kumatsutsana.

Ndemanga pa Octreotide

Tiyenera kudziwa kuti kukambirana pa intaneti pankhani yogwiritsa ntchito mankhwalawa komanso kugwira ntchito kwake sikofala. Nthawi zambiri, ogwiritsa amafunsa mafunso kwa akatswiri omwe ali ndi chidwi ndi momwe kuchizira kwamatenda kumathandizira.

Komabe, pochita zamankhwala, fomu ya Depot imagwiritsidwa ntchito kwambiri. Nthawi yomweyo, ndemanga pa Octreotide Depot onetsani kuti imagwiritsidwa ntchito kapamba, komanso mitundu yovuta komanso yovuta yamatendawa. Inde, mankhwalawa amangoikidwa ndi katswiri ndipo amayenera kuyembekezeredwa kuti chithandizo chitha kuchitidwa kwa sabata limodzi.

Mlingo

Lyophilisate pokonzekera kuyimitsidwa kwa mu mnofu makonzedwe a nthawi yayitali ya 10,0 mg, 20,0 mg kapena 30.0 mg kwathunthu ndi zosungunulira za 2 ml (Mannitol, jekeseni yankho 0.8% 2 ml)

Botolo limodzi lili

ntchito yogwira - octreotide 10,0 mg, 20,0 mg, 30.0 mg,

zokopa: Copolymer wa DL-lactic ndi glycolic acid, D-Mannitol, carboxymethyl cellulose sodium mchere, polysorbate-80.

Solvent: D-Mannitol, madzi a jakisoni.

Lyophilized ufa kapena porous, wopangidwa piritsi, unyinji kapena zoyera ndi tint yowoneka ngati chikasu.

Solvent: wopanda mafuta owoneka bwino

Kuyimitsidwanso: Ndi kuphatikiza kwa kusungunuka ndi kusunthika, kuyimitsidwa kwakanthawi koyera kapena koyera ndi mawonekedwe ofooka achikasu. Kuyimitsidwanso kwina sikuyenera kupitilira mphindi zisanu. Poimirira, kuyimitsidwa kumakhala kovuta, koma kumatha kuyambiranso ndi kugwedezeka. Kuyimitsidwa kumadutsa momasuka mu syringe kudzera pa singano No. 0840.

Mankhwala

Pharmacokinetics

Ndi makonzedwe a intramuscular, octreotide amadzaza kwathunthu.

The achire ndende m'magazi amafikira pambuyo 30 mphindi.

Kumanga mapuloteni kuli pafupifupi 65%. Kumangiriza kwa octreotide ku maselo amwazi ndikosavuta. Kuchuluka kwa magawa ndi 0.27 l / kg. Octreotide imapangidwa mu chiwindi.

Chilolezo chonse ndi 160 ml / min. T1 / 2 ndi 100 min. Pafupifupi 32% mu mawonekedwe osasinthika amatsitsidwa ndi impso. Mwa odwala okalamba, chilolezo chimachepa, ndipo T1 / 2 imawonjezeka. Kulephera kwambiri kwa aimpso, chilolezo chimakhazikika.

Farmacodynamics

Octreotide depot ndi octapeptide yopanga yomwe imachokera ku chilengedwe cha mahomoni somatostatin komanso imabweretsa zotsatira zofananira zamankhwala, koma nthawi yayitali. Mankhwalawa amachepetsa pang'onopang'ono kukula kwa mahomoni (GH), komanso ma peptides ndi serotonin opangidwa mu gastro-entero-pancreatic endocrine.

At zam'mimba zotupa Kugwiritsa ntchito Octreotide kumapangitsa kuchepa kwa zizindikiro monga kumva kugontha ndi kutsekula m'mimba, zomwe nthawi zambiri zimayendera limodzi ndi kuchepa kwa kuchuluka kwa serotonin mu plasma ndi excretion ya 5-hydroxyindoleacetic acid ndi mkodzo.

At zotupa zodziwika ndi hyperproduction of the vasoactive matumbo peptide (VIPs), kugwiritsa ntchito Octreotide kumabweretsa kuchepa kwam'mimba kwambiri. Nthawi yomweyo, kuchepa kwa kusakanikirana kwa elekitirodi ya electrolyte kumachitika. Mwa odwala ena, kupita patsogolo kwa chotupacho kumachepetsa kapena kuyimitsidwa ndipo ngakhale kukula kwake kumachepa, makamaka metastases ya chiwindi. Kusintha kwamankhwala nthawi zambiri kumayendetsedwa ndi kuchepa (mpaka pamachitidwe abwinobwino) pamagulu a vasoactive matumbo peptide (VIP) mu plasma.

At glucagonomas Kugwiritsidwa ntchito kwa Octreotide-depot nthawi zambiri kumabweretsa kuchepa kowoneka bwino mu zotupa zotuluka. Octreotide-depot ilibe gawo lililonse pakukhudzika kwa matenda osokoneza bongo a shuga, omwe nthawi zambiri amawonedwa ndi glucagonomas, ndipo nthawi zambiri samachepetsa kufunikira kwa mankhwala a insulin kapena pakamwa a hypoglycemic. Odwala omwe ali ndi matenda am'mimba, Octreotide amachititsa kuchepa kwake, komwe kumayendetsedwa ndi kuwonjezeka kwa thupi. Pogwiritsa ntchito Octreotide, kuchepa msanga kwa glucagon m'madzi a m'magazi nthawi zambiri kumadziwika, komabe, ndimankhwala osakhalitsa, izi sizipitilira. Nthawi yomweyo, kusintha kwa zindikiritso kumakhazikika nthawi yayitali.

At gastrinomas / Zollinger-Ellison Octreotide depot, yogwiritsidwa ntchito ngati monotherapy kapena molumikizana ndi H2-receptor blockers, itha kuchepetsa kupanga kwa asidi m'mimba ndikuwongolera kuwongolera kuchipatala, kuphatikiza pokhudzana ndi kutsegula m'mimba. Kukula kwa zizindikiro zina, kuphatikizanso kutulutsa, kumacheperachepera. Nthawi zina, pali kuchepa kwa kuchuluka kwa gastrin mu plasma.

Odwala insulinomas Octreotide depot imachepetsa kuchuluka kwa insulin yogwiritsira ntchito m'magazi (izi zimatha kukhala zazifupi - pafupifupi maola 2). Odwala omwe ali ndi zotupa zogwira ntchito, Octreotide Depot amatha kuonetsetsa kuti kubwezeretsanso ndi kukonzanso kwa nthawi ya proglycemia kumayang'anira ntchito. Odwala omwe ali ndi chotupa chosaoneka bwino komanso chotupa choopsa, kayendedwe ka glycemic kamatha kusintha popanda kuchepa nthawi yomweyo kwamankhwala a insulin m'magazi.

At kukananso m'mimba mwa odwala omwe ali ndi immunodeficiency syndrome (Edzi) Kugwiritsa ntchito Octreotide kumapangitsa kuti chopondapo chokwanira ngati gawo limodzi mwa pafupifupi 1/3 ya odwala omwe ali ndi matenda otsekula m'mimba, osagwirizana ndi antimicrobial komanso / kapena antidiarrheal.

Odwala omwe akuchitidwa opaleshoni yamapazi, Kugwiritsidwa ntchito kwa Octreotide nthawi ya opaleshoni itatha komanso kumachitika pambuyo pake

At magazi kuchokera ku mitsempha ya varicose yam'mero ndi m'mimba mwa odwala ndi matenda amitsempha kugwiritsa ntchito Octreotide-Depot kuphatikiza chithandizo chamankhwala (mwachitsanzo, sclerotherapy) kumayambitsa kuyimitsidwa kotheka kwa magazi komanso kuyambiranso magazi, kuchepa kwa kuchuluka kwa magazi ndi kusintha kwa kupulumuka kwa masiku 5. Mankhwalawa amachepetsa kuthamanga kwa magazi a magazi mwa kupondereza ma vasoactive mahomoni ngati VIP ndi glucagon.

Mlingo ndi makonzedwe

Octreotide depot iyenera kuperekedwa kokha mozama intramuscularly (IM), mu gluteus maximus. Ndi jakisoni wobwereza, mbali zamanzere ndi zamanja ziyenera kusinthidwa. Kuyimitsidwa kuyenera kukonzedwa nthawi yomweyo musanalowe. Patsiku la jakisoni, vial yokhala ndi mankhwalawa komanso zochulukirapo ndi zosungunulira zimatha kusungidwa kutentha.

Mankhwalawa endocrine zotupa zam'mimba thirakiti ndi kapamba

Odwala omwe s / octreotide amakwaniritsa chiwonetsero chokwanira cha matendawa, mlingo woyambira wa Octreotide-Depot ndi 20 mg pakadutsa milungu 4 iliyonse. Kuwongolera kwa Octreotide kuyenera kupitilizidwa kwa masabata ena awiri pambuyo pa oyang'anira oyamba a Octreotide Depot.

Odwala omwe sanalandirepo kale Octreotide s / c, tikulimbikitsidwa kuti ayambe kulandira chithandizo ndi chithandizo cha Octreotide pa mlingo wa 0 mg mg katatu kapena tsiku kwa nthawi yochepa (pafupifupi masabata awiri) kuti aziyesa momwe amathandizira komanso kulekerera kwathunthu . Pambuyo pokhapokha izi, Octreotide Depot amalembedwa malinga ndi dongosolo pamwambapa.

Mlanduwo pamene mankhwalawa ali ndi Octreotide-Depot kwa miyezi itatu imapereka chiwonetsero chokwanira cha ma matenda a kachipatala komanso zolembera zamatenda, n`zotheka kuchepetsa mlingo wa Octreotide-Depot mpaka 10 mg wodziwika pakapita masabata 4 aliwonse. Milandu yomwe itatha miyezi itatu yolandira chithandizo ndi Octreotide-depot kokha kukatheka, mlingowo ukhoza kupitilizidwa mpaka 30 mg sabata 4 zilizonse. Poyerekeza ndi chithandizo cha mankhwala ndi Octreotide-depot, masiku ena, mawonekedwe amtundu wa endocrine chotupa cha m'mimba ndi kapamba angalimbikitsidwe. Milandu iyi, njira yowonjezera ya s / c ya Octreotide imalimbikitsidwa pa mlingo womwe unagwiritsidwa ntchito mankhwala a Octreotide Depot asanayambe. Izi zitha kuchitika makamaka m'miyezi iwiri yoyambirira ya mankhwala kufikira zochizira zochokera ku octreotide mu plasma zimatheka.

Mankhwala a khansa yokhala ndi khansa ya prostate Mlingo woyambira wa Octreotide Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. Pambuyo pake, mlingo umakonzedwa poganizira mphamvu za seramu PSA ndende, komanso zizindikiro zamatenda. Ngati atalandira chithandizo chamankhwala kwa miyezi 3 sizinatheke kukwaniritsa kuchuluka kwa mankhwalawa komanso zamankhwala am'magazi (kuchepa kwa PSA), mankhwalawa amatha kuchuluka mpaka 30 mg kutumikiridwa pakatha milungu 4 iliyonse.

Chithandizo cha Octreotide-depot chimaphatikizidwa ndi ntchito ya dexamethasone, yomwe imalembedwa pakamwa malinga ndi chiwembu chotsatira: 4 mg patsiku kwa mwezi umodzi, ndiye 2 mg patsiku kwa masabata awiri, ndiye 1 mg patsiku (yokonza mlingo).

Chithandizo cha octreotide-depot ndi dexamethasone mwa odwala omwe adachitapo kale mankhwala othandizira antiandrogen amaphatikizidwa ndikugwiritsa ntchito analogue ya gonadotropin-kumasula mahomoni (GnRH). Pankhaniyi, jakisoni wa analogue wa GnRH (fomu yofikira) amachitika nthawi imodzi m'masabata 4.

Odwala omwe amalandila Octreotide Depot amayenera kuyesedwa mwezi uliwonse pozama za PSA.

Odwala omwe ali ndi vuto laimpso, a hepatic, ndi okalamba, palibe chifukwa chokonza dongosolo la Octreotide Depot.

Pofuna kupewa pachimake postoperative pancreatitis

The mankhwala Octreotide-Depot muyezo wa 10 kapena 20 mg kutumikiridwa kamodzi osapitirira masiku 5 ndipo pasanathe masiku 10 pamaso pa opaleshoni.

Malangizo pokonzekera kuyimitsidwa ndi kuperekedwa kwa mankhwalawo

Mankhwalawa amaperekedwa kokha mu intramuscularly.

Kuyimitsidwa kwa jakisoni wa mu mnofu kumakonzedwa pogwiritsa ntchito zosungunulira zomwe zimaperekedwa nthawi yomweyo isanachitike.

Mankhwalawa ayenera kukonzedwa ndikuthandizidwa ndi okhawo omwe amaphunzitsidwa bwino.

Asanalowe, jakisoni wokwanira ndi zosungunulira komanso botolo lomwe lili ndi mankhwalawa liyenera kuchotsedwa mufiriji ndikubwera ndi kutentha kwa firiji (mphindi 30-50 zimafunikira).

Sungani botolo ndi Octreotide Depot mosamalitsa. Kugunda vial mopepuka, onetsetsani kuti lyophilisate yonse ili m'munsi mwa vial.

Tsegulani ma phukusi ndi syringe, ikani singano ya 1.2 mm x 50 mm ku syringe kuti muthe kusungunulira.

Tsegulani zochulukirapo ndi zosungunulira ndikuyika mu syringe zonse zam'mapapo ndi zosungunulira, ikani gawo la nyere ya 3.5 ml.

Chotsani kapu ya pulasitiki mu vial yomwe ili ndi lyophilisate. Tetezani mankhwala opopera pa mphira ndi mowa.Ikani singano mu lyophilisate vial kudutsa pakati pa poyimitsira mphira ndikubowola mosamala zosungunulira pamodzi ndi khoma lamkati la vial osakhudza zomwe zili mu vial ndi singano. Chotsani syringe kuchokera pambale.

Valali imayenera kusuntha mpaka zosungunulira zimakhala zodzaza ndi ma lyophilisate komanso mawonekedwe a kuyimitsidwa (pafupifupi mphindi 3 mpaka 5). Kenako, osatembenuza botolo, muyenera kuyang'ana ngati pali bokosi louma kumakoma pansi pa botolo. Ngati ma lyophilisate owuma apezeka, siyani vial mpaka pakhuta bwino.

Mukamaliza kuwonetsetsa kuti palibe zotsalira zouma m'mimba, zomwe zili mkati mwa vial ziyenera kusakanizidwa mosamala mozungulira kwa masekondi 30-60 mpaka kuyimitsidwa kokhazikika. Osagwetsa kapena kugwedeza vial, chifukwa izi zitha kutha chifukwa cha kutayika komanso kuyimitsidwa koyenera.

Ikani mwachangu singano kudzera pa cholembera cha mphira mu vial. Kenako chepetsa gawo la singano pansi, ndikuyika botolo pamtunda wa madigiri 45, pang'onopang'ono kukoka kuyimitsidwa mu syringe kwathunthu. Osakujambulani botolo ndikulemba. Mankhwala ochepa amatha kukhalabe pamakoma komanso pansi pa vial. Zakumwa zomwe zatsalira pamakoma ndi pansi pa botolo zimaganiziridwa.

Mukangotola kuyimitsidwa, pindani ndi singano ndi piyano yapinki ndi singano yobiriwira (0.8 x 40 mm), ndikutembenuza mosamala syringe ndikuchotsa mpweya ku syringe.

Kuyimitsidwa kwa Octreotide Depot kuyenera kuperekedwa mofulumira mukakonzekera.

Kuyimitsidwa kwa Octreotide Depot sikuyenera kusakanikirana ndi mankhwala ena aliwonse mu syringe yomweyo.

Gwiritsani ntchito swab ya mowa kuti musambe jekeseni. Ikani singano mozama mu gluteus maximus, kenako ndikoka pang'ono syringe kuti mubwerere kuti muwonetsetse kuti chombocho sichingawonongeke. Fotokozerani kuyimitsidwa pang'onopang'ono ndi kupanikizika kosalekeza pa syringe plunger.

Ngati ilowa m'mtsempha wamagazi, tsamba la jakisoni ndi singano ziyenera kusinthidwa.

Mukatola singano, sinthani ndi singano ina yofanana.

Ndi jakisoni wobwereza, mbali zamanzere ndi zamanja ziyenera kusinthidwa.

Zotsatira zoyipa

Zotsatira zoyipa zimasonyezedwa malinga ndi kuchuluka kwa zomwe zimachitika mwatsatanetsatane: nthawi zambiri (≥1 / 10), nthawi zambiri (≥1 / 100,  1/10), nthawi zina (≥1 / 1000, 1 / 100), kawirikawiri (= ≥ 1/10000, 1 / 1000), kawirikawiri kwambiri (1 / 10000), kuphatikiza mauthenga amodzi.

- kupweteka kwam'mimba, kutulutsa, kudzimbidwa, kutsekula m'mimba

- zimachitika mdera mukamachita kupweteka kwamankhwala (kupweteka, kutupa, kufiyira, kuyamwa komanso kuwotcha)

-Hypothyroidism, kukanika kwa chithokomiro

- chizungulire, dyspnea, asthenia

- bradycardia, tachycardia, cholecystitis, kutaya tsitsi

- zotupa zoyipa, kuyabwa

nseru, kusanza, mapangidwe amiyala am'mimba chifukwa cha malabsorption (malabsorption)), zochitika zofanana ndi zotsekeka m'matumbo: kuphuka kwamkati, kupweteka kwambiri m'chigawo cha epigastric, kusokonezeka kwa khoma lam'mimba, minofu "chitetezo".

pachimake kapamba, anorexia, pafupipafupi mapapo, chiwindi hepatitis popanda cholestasis, hyperbilirubinemia, kuchuluka zamchere phosphatase, gamma glutamylase, transaminases, thrombocytopenia, hyperkalemia

matenda oopsa oopsa (pogwiritsa ntchito nthawi yayitali)

Kukula kwa mayendedwe akumaloko kumatha kuchepetsedwa ngati mugwiritsa ntchito yankho la kutentha kwa chipinda, kapena kuyika kachigawo kakang'ono ka njira yokhazikika.

Malipoti a malonda a zotsatira zoyipa

anaphylaxis, thupi lawo siligwirizana, urticaria zotupa

pachimake kapamba, pachimake chiwindi, cholestatic hepatitis, cholestasis, kutaya kwa bile, cholestatic jaundice

Zochita zamankhwala osokoneza bongo

Octreotide imachepetsa kuyamwa kwa cyclosporine, imachepetsa mayamwidwe a cimetidine. Kuwongolera mankhwalawa amomwe amathandizira pakukodzetsa, operekera mankhwala opatsirana, "pang'onopang'ono" calcium blockers, insulin, ndi mankhwala a hypoglycemic ofunikira ndikofunikira.

Ndi munthawi yomweyo kugwiritsa ntchito octreotide ndi bromocriptine, bioavailability wa yotsiriza ukuwonjezeka.

Mankhwala omwe amapangidwa ndi ma enzymes a cytochrome P450 dongosolo ndipo ali ndi yopyapyala njira zochizira ayenera kuikidwa mosamala.

Malangizo apadera

Ndi zotupa za pituitary zotulutsira GR, kuwunika mosamala odwala omwe amalandila Octreotide Depot ndikofunikira, chifukwa ndizotheka kuwonjezera kukula kwa zotupa ndikukula kwa zovuta zazikulu monga kufupikitsa kwa malo owonera. Muzochitika izi, kufunika kwa njira zina zochiritsira kuyenera kuganiziridwa.

Ntchito ya chithokomiro iyenera kuyang'aniridwa mwa odwala omwe akuchita chithandizo cha nthawi yayitali ndi Octreotide Depot.

Malipoti osowa a bradycardia adanenedwapo ndi octreotide. Pamenepa, zingakhale zofunikira kusintha mlingo wa mankhwalawa monga beta-blockers, calcium blockers blockers kapena mankhwala ogwiritsidwa ntchito kuwongolera malire a madzi-elekitirodi.

Mu 10-20% ya odwala omwe amalandila Octreotide Depot kwa nthawi yayitali, kuwoneka kwa miyala mu ndulu ndikutheka, chifukwa chake, zotsatirazi ziyenera kukumbukiridwa.

Malangizo pakuwongolera odwala panthawi ya chithandizo ndi Octreotide Depot ponena za mapangidwe a miyala ya ndulu.

Asanaikidwe ndi Octreotide Depot, odwala ayenera kupimidwa koyesa kwa ndulu,

Mankhwalawa ndi Octreotide-Depot, maulendo obwereza a ultrasound a ndulu amayenera kuchitidwa, makamaka pakadutsa miyezi 6-12,

ngati miyala ipezeka chithandizo chisanayambe, ndikofunikira kuyesa phindu la Octreotide-Depot mankhwala poyerekeza ndi chiopsezo chokhudzana ndi kukhalapo kwa ma gallstones. Palibe umboni uliwonse wa zoyipa za Octreotide Depot pa maphunzirowa kapena kudwala kwamatenda a gallstone.

Kuwongolera odwala omwe miyala ya gallbladder imapangidwa panthawi ya chithandizo cha Octreotide Depot.

a) Miyala ya asymptomatic gallbladder.

Kugwiritsa ntchito Octreotide Depot kutha kuyimitsidwa kapena kupitilizidwa - malinga ndi kuwunika kwa phindu / chiopsezo. Mulimonsemo, palibe chifukwa chochitira china chilichonse kupatula kupitiriza kuwonerera, kupangitsa pafupipafupi ngati kuli kofunikira.

b) Miyala ya Gallbladder yokhala ndi zizindikiro zamankhwala.

Kugwiritsa ntchito Octreotide Depot kutha kuyimitsidwa kapena kupitilizidwa - malinga ndi kuwunika kwa phindu / chiopsezo. Mulimonsemo, wodwalayo ayenera kuthandizidwa monga momwe zimakhalira ndi matenda ena a ndulu. Mankhwala amaphatikizapo kugwiritsa ntchito kuphatikiza kwa kukonzekera kwa bile acid (mwachitsanzo, chenodeoxycholic acid pa mlingo wa 7.5 mg / kg patsiku limodzi ndi ursodeoxycholic acid mu mgawo womwewo) motsogozedwa ndi ultrasound mpaka miyala itazimiririka.

Odwala omwe ali ndi insulinomas omwe amathandizidwa ndi Octreotide-Depot amatha kuwona kuwonjezereka ndi kutalika kwa hypoglycemia (izi zimachitika chifukwa cha kutanthauzira kwakukulu kwa chitetezo cha GH komanso glucagon kuposa chinsinsi cha insulin, komanso kufupikitsa kwa nthawi yoletsa kutulutsa insulin. Odwala otere ayenera kuyang'aniridwa koyambirira koyambirira kwa mankhwala ndi Octreotide-depot, komanso kusintha kulikonse kwa mankhwalawa. Kusinthasintha kwakukulu kwa kuchuluka kwa shuga m'magazi kungayesedwe kuti muchepetse mwakuwongolera pafupipafupi kwa Octreotide Depot.

Pakutuluka kwa magazi kuchokera kumitsempha ya varicose ya esophagus ndi m'mimba mwa odwala omwe ali ndi vuto la cirrhosis, chiwopsezo chokhala ndi matenda a shuga omwe amadalira odwala a shuga ndiwowonjezereka, komanso, kusintha kwa zofunika kwa insulin kwa odwala omwe ali ndi matenda osokoneza bongo ndikofunikira, chifukwa chake, muzochitika izi, kuwunika mwatsatanetsatane wamagazi a shuga ndikofunikira.

Odwala omwe ali ndi matenda a shuga a mtundu woyamba, Octreotide Depot akhoza kuchepetsa kufunika kwa insulin. Odwala opanda matenda a shuga komanso a 2 matenda a shuga omwe amakhala osungika pang'ono a insulin, makonzedwe a Octreotide Depot angapangitse kuchuluka kwa shuga m'magazi.

Odwala ena, octreotide amatha kusintha mayamwidwe m'matumbo, amachepetsa kuchuluka kwa vitamini B12 m'magazi ndikuyambitsa kupatuka kuzikhalidwe zamayeso a Schilling.

Mimba komanso kuyamwa

Palibe chokuchitikirani pakugwiritsidwa ntchito kwa mankhwalawa panthawi yapakati, mwanjira zotere mankhwalawa amadziwitsidwa malinga ndi momwe angadziwiritsire ntchito. Pa mankhwala ndi Octreotide Depot, kuyamwitsa kuyenera kusiyidwa.

Kugwiritsa ntchito kwa ana

Palibe chokuchitikira ndi Octreotide Depot mwa ana.

Zomwe zimachitika chifukwa cha mankhwalawa amatha kuyendetsa galimoto kapena njira zoopsa

Zotsatira zoyipa za Octreotide Depot zimatha kuwononga kwambiri kuyendetsa magalimoto ndi zinthu zina zomwe zimafuna kuti anthu azisamalira komanso azithamanga kwambiri.

Mankhwala Okhala Pamalo a Pharmacy

Dzinalo ndi dziko lakapangidwe

Deco Company LLC, Russian Federation

129344, Moscow, st. Yenisei, nyumba 3, nyumba 4

Dzinalo ndi dziko laomwe amalembetsa satifiketi

Farm Synthesis CJSC, Russian Federation

111024, Moscow, Kabelnaya 2-ya mseu, nyumba 2, p. 9

Adilesi ya bungweli yomwe imavomereza zodula kuchokera kwa ogula pamsika wazogulitsa (katundu) ku Republic of Kazakhstan

Raifarm LLP (Mfuti)

RepublicIC YA KAZAKHSTAN, Almaty, st. Timiryazev 42, bldg. 15/3 V.

Zithunzi za 3D

Lyophilisate pokonzekera kuyimitsidwa kwa mu mnofu makonzedwe a nthawi yayitali	1 fl.
ntchito:
octreotide	10 mg
20 mg
30 mg
zokopa: Copolymer wa DL-lactic ndi glycolic acid - 270/560 / 8 mg, D-mannitol - 85/85/85 mg, carboxymethyl cellulose sodium mchere - 30/30/30 mg, polysorbate 80 - 2/2 mg
Solvent mu ampoule (mannitol, jekeseni 0,8%)	1 amp
mannitol	0,016 g
madzi a jakisoni	mpaka 2 ml

Kufotokozera za mtundu wa kipimo

Lyophilized ufa kapena porous, wophatikizidwa ndi piritsi lambiri loyera kapena loyera ndi tint yoyera yachikasu.

Solvent: wopanda mandala wowonekera.

Kuyimitsidwanso: kuyimitsidwa koyera kwa zoyera kapena zoyera ndi tint yoyera yachikasu.

Zisonyezo Octreotide Depot

kasamalidwe koyenera ka mawonekedwe a matendawa kumachitika ndi sc octreotide,

Popeza palibe chithandizo chokwanira cha opaleshoni yamankhwala ndi ma radiation,

kukonzekera zochizira,

mankhwalawa pakati pa maphunziro a radiation mpaka pakukhalitsa

odwala osagwira ntchito.

Chithandizo cha endocrine chotupa cha m'mimba thirakiti ndi kapamba:

carcinoid zotupa zama phencenaid syndrome,

gastrinomas (Zollinger-Ellison syndrome),

glucagonomas (kuwongolera hypoglycemia munthawi ya ntchito, komanso kukonza mankhwalawa),

somatoliberinomas (zotupa zodziwika ndi kuchulukana kwa kukula kwa maselo a kukula kwa hormone).

Chithandizo cha khansa yotsekemera ya prostate ya mahomoni: monga gawo la kuphatikiza chithandizo pamaziko a opaleshoni kapena kuchitidwa kwachipatala.

Kupewa kwa chitukuko cha pancreatitis pachimake: ndi opaleshoni yayikulu pamimba yam'mimba komanso kulowetsedwa kwa thoracoabdominal (kuphatikizapoza khansa yam'mimba, kum'mero, colon, kapamba, chotupa cha chiwindi ndi chachiwiri.

Mimba komanso kuyamwa

Palibe chokuchitikira ndi Octreotide Depot pa nthawi yoyembekezera komanso nthawi yoyamwitsa. Chifukwa chake, pakakhala pakati, mankhwalawa amatchulidwa pokhapokha ngati phindu lomwe lingakhalepo kwa mayi limaposa chiwopsezo cha mwana wosabadwayo. Kuyamwitsa sikuvomerezedwa mukamagwiritsa ntchito mankhwalawa panthawi yoyamwa.

Wopanga

Kampaniyo ndiye mwini satifiketi yolembetsa: Farm-Sintez JSC.

Adilesi yazamalamulo: 111024, Russia, Moscow, ul. 2 Chingwe, 2, p. 46.

Adilesi: 121357, Russia, Moscow, ul. Vereyskaya, 29, p. 134, ofesi A403, A404.

Tele. ((495) 796-94-33, fakisi: (495) 796-94-34.

Bungwe likuvomera zonena: Farm-Synthesis JSC.

Zotsatira za pharmacological

Mankhwala Octreotide-Depot ndi njira yayitali yogwiritsira ntchito octreotide pamiyeso ya makonzedwe a intramuscular, kuonetsetsa kuti mankhwala othandizira octreotide ali m'magazi kwa milungu 4. Octreotide ndi njira yothandizira pathogenetic ya zotupa zomwe zimafotokozera momatostatin zolandilira. Octreotide ndi octapeptide yopanga yomwe imachokera ku chilengedwe cha mahomoni somatostatin komanso imabweretsa zotsatira zofananira zamankhwala, koma nthawi yayitali kwambiri. Mankhwalawa amapondera pang'onopang'ono kuchuluka kwa mphamvu ya kukula kwa mahomoni (GH), komanso ma peptides ndi serotonin opangidwa mu gastro - entero - pancreatic endocrine system.

Mwa anthu athanzi, octreotide, ngati somatostatin, imachepetsa kubisala kwa GR chifukwa cha arginine, zolimbitsa thupi ndi insulin hypoglycemia, kubisalira kwa insulin, glucagon, gastrin ndi zina zina zam'magazi a gastro-entero-pancreatic endocrine, chifukwa cha kudya, komanso kukondoweza kwa insulin arginine, chithokomiro cha thyrotropin choyambitsidwa ndi thyroliberin. Mphamvu yoletsa kuponderezedwa kwa GR mu octreotide, mosiyana ndi somatostatin, imafotokozedwa kwakukulu kwambiri kuposa kubisika kwa insulin. Makonzedwe a octreotide samatsatiridwa ndi chodabwitsa cha hypersecretion cha mahormone ndi makina oyipa amakono.

Odwala okhala ndi acomegaly, makonzedwe a octreotide depot form amapatsa ambiri ovomerezeka kuchepa kwa ndende ya GH komanso kukula kwa ndende ya insulin ngati kukula kwa chinthu 1 / somatomedin C (IGF-1).

Odwala ambiri okhala ndi acomegaly, mawonekedwe a deport octreotide amachepetsa kuopsa kwa zizindikiro monga kupweteka mutu, thukuta, paresthesia, kutopa, kupweteka m'mafupa ndi mafupa, zotumphukira neuropathy. Zinanenedwa kuti chithandizo chokhala ndi depot mawonekedwe a octreotide mwa odwala omwe ali ndi pituitary adenomas yobisala GH kunapangitsa kuchepa kwa kukula kwa chotupa.

Ndi chinsinsi cha zotupa za m'mimba za m'mimba (GIT) ndi kapamba, kugwiritsidwa ntchito kwa fomu ya octreotide kumapereka kuwunikira kosalekeza kwa zizindikiro zazikulu zamatendawa.

Fomu ya depositi ya octreotide pa mlingo wa 30 mg masabata 4 aliwonse imachepetsa kukula kwa chotupa kwa odwala omwe amatulutsa zobisalira komanso zotulutsira zotupa wamba (metastatic) neuroendocrine zotupa za khungu, iliac, akhungu,
kukwera kwa colon, transverse colon ndi vermiform zowonjezera, kapena metastase ya zotupa za neuroendocrine popanda cholinga chachikulu. Mankhwalawa anali othandiza pakuwonjezera nthawi yowonjezereka, onse pobisa komanso osabisala zotupa za neuroendocrine.

Mu zotupa zama carcinoid, kugwiritsidwa ntchito kwa octreotide kungayambitse kuchepa kwamphamvu kwa zizindikiro za matendawa, makamaka, monga kuyaka kwam'mimba komanso kutsekula m'mimba. Mwambiri, kusintha kwachipatala kumatsatiridwa ndi
kuchepa kwa plasma serotonin ndende ndi kupukusira kwa 5-hydroxyindoleacetic acid mkodzo.

Ndi glucagonomas, kugwiritsa ntchito octreotide nthawi zambiri kumabweretsa kuchepa kowoneka bwino kwa zotupa zosunthika, zomwe zimadziwika mwanjira imeneyi. Octreotide ilibe gawo lililonse pakukhudzika kwa matenda osokoneza bongo, omwe nthawi zambiri amawonetsedwa ndi glucagonomas, ndipo nthawi zambiri samakhala
Kuchepetsa kufunika kwa mankhwala a insulin kapena pakamwa a hypoglycemic. Odwala omwe ali ndi matenda am'mimba, octreotide amachititsa kuchepa kwake, komwe kumayendetsedwa ndi kuwonjezeka kwa thupi. Pogwiritsa ntchito octreotide, kuchepa msanga kwa glucagon m'madzi a m'magazi nthawi zambiri kumadziwika, komabe, ndi chithandizo chotere, izi sizipitilira. Nthawi yomweyo, kusintha kwa zindikiritso kumakhazikika nthawi yayitali.

Mu gastrinomas / Zollinger-Ellison syndrome, octreotide, wogwiritsidwa ntchito ngati monotherapy kapena kuphatikiza ndi Ng-histamine receptor blockers ndi proton pump inhibitors, itha kuchepetsa mapangidwe a hydrochloric acid m'mimba ndikuwongolera kusintha kwachipatala, kuphatikizapo komanso pokhudzana ndi kutsegula m'mimba. Ndikothekanso kuchepetsa kuuma ndi zizindikiro zina, zomwe mwina zimagwirizanitsidwa ndi kapangidwe ka peptides ndi chotupa, kuphatikiza mafunde. Mwa ena
Mu milandu, kuchepa kwa kuchuluka kwa gastrin mu plasma kumadziwika. Odwala omwe ali ndi insulinomas, octreotide amachepetsa kuchuluka kwa insulin ya magazi m'magazi. Odwala omwe ali ndi zotupa zogwiritsidwa ntchito, octreotide amatha kuonetsetsa kuti kubwezeretsanso ndi kukonzanso kwa syntoglycemia kumayang'anira ntchito. Odwala omwe ali ndi chotupa chosaoneka bwino komanso chotupa choopsa, kayendedwe ka glycemic kamatha kusintha popanda munthawi yomweyo
kuchepa kwanthawi yayitali mu ndende ya insulin m'magazi.

Odwala omwe ali ndi zotupa zosowa, hyperprodizing kukula kwa mahomoni akumasulidwa (somatoliberinomas), octreotide amachepetsa kuuma kwa zizindikiro za acromegaly. Izi, mwachiwonekere, zimagwirizanitsidwa ndi kuponderezedwa kwa kubisala kwa chinthu chotsitsa mahomoni amakulidwe komanso GH yokha. M'tsogolomu, ndizotheka kuchepetsa kukula kwa pituitary gland, yomwe idakulitsidwa musanalandire chithandizo.

Odwala omwe ali ndi khansa yokhala ndi khansa ya prostate (HGRP), dziwe la maselo a neuroendocrine omwe amafotokozera za kulandirana kwa somatostatin receptors kwa octreotide (mitundu ya SS2 ndi SS5) imawonjezeka, yomwe imapangitsa kudziwa kwa chotupa kuti octreotide. Kugwiritsa ntchito kwa mankhwala Octreotide-Depot osakanikirana ndi dexamethasone motsutsana ndi androgen blockade (mankhwala kapena operekera opaleshoni) mwa odwala omwe ali ndi HGRP kubwezeretsa chidwi cha mankhwala a mahomoni ndipo kumayambitsa kuchepa kwa prostate enieni antigen (PSA) muopitilira 50% ya odwala.

Odwala HGRG okhala ndi mafupa metastases, mankhwalawa amathandizana ndi kutchulidwa kwa nthawi yayitali. Kuphatikiza apo, mwa onse odwala omwe adagwirizana ndi mankhwala ophatikizika ndi Octreotide-depot, moyo ndi kupulumuka kwamtopola wopanda matenda zimayenda bwino.

Zowonetsa Octreotide-Depot

Mankhwalawa acromegaly:

kasamalidwe koyenera ka mawonekedwe a matendawa kumachitika ndi sc octreotide,
Popeza palibe chithandizo chokwanira cha opaleshoni yamankhwala ndi ma radiation,
kukonzekera zochizira,
mankhwalawa pakati pa maphunziro a radiation mpaka pakukhalitsa
odwala osagwira ntchito.

Mankhwalawa endocrine zotupa zam'mimba thirakiti ndi kapamba:

carcinoid zotupa zama phencenaid syndrome,
insulinomas
VIPoma
gastrinomas (Zollinger-Ellison syndrome),
glucagonomas (kuwongolera hypoglycemia munthawi ya ntchito, komanso kukonza mankhwalawa),
somatoliberinomas (zotupa zodziwika ndi kuchulukana kwa kukula kwa maselo a kukula kwa hormone),
Chithandizo cha odwala omwe amatulutsa chotupa komanso chosagwiritsa ntchito chotupa cha neuroendocrine cha khungu, ileamu, khungu, kukwera kwa colon, colon yophatikizika ndi zowonjezera, kapena metastases ya zotupa za neuroendocrine popanda kutsata kwenikweni.

Mankhwala a khansa yokhala ndi khansa ya prostate:

monga gawo la kuphatikiza chithandizo pamaziko a opaleshoni kapena kuchitidwa kwachipatala.

Poletsa pachimake postoperative pancreatitis:

opaleshoni yayikulu yam'mimba komanso kulowetsedwa kwa thoracoabdominal (kuphatikizapo khansa yam'mimba, esophagus, colon, kapamba, kuwonongeka kwa chotupa ndi chachiwiri kwa chiwindi).

Nambala za ICD-10

Khodi ya ICD-10	Chizindikiro
C17	Matenda oopsa a m'matumbo aang'ono
C18	Colorectal zilonda
C19	Roposigmoid zilonda zam'mimba
C25	Pancreatic zilonda
C61	Matenda oopsa a prostate
D13.6	Benign neoplasm wa kapamba
E16.1	Mitundu ina ya hypoglycemia (hyperinsulinism)
E16.3	Kuchuluka kwa secretion wa glucagon
E16.8	Matenda enanso otchulidwa mkati mwa kapamba
E22.0	Acromegaly ndi pituitary gigantism
E34.0	Carcinoid syndrome
K85	Pachimake kapamba

Mlingo

Mankhwalawa aceromegaly odwala amene s / c makonzedwe a octreotide amapereka okwanira kuwongolera mawonetseredwe a matendawa, analimbikitsa koyamba mlingo wa mankhwala Octreotide-Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. Mutha kuyamba kulandira chithandizo ndi Octreotide-Depot tsiku litapita s / c yoperekera octreotide. M'tsogolomu, mlingo umakonzedwa poganizira kuchuluka kwa ma seramu a GR ndi IGF-1, komanso zizindikiro zamatenda. Ngati pambuyo pa miyezi itatu ya chithandizo sikunatheke kukwaniritsa zokwanira zamankhwala komanso zamankhwala am'magazi (makamaka, ngati kuchuluka kwa GR kumakhalabe pamwamba pa 2,5 μg / L), mlingo umatha kupitilizidwa mpaka 30 mg kutumikiridwa pakatha milungu 4 iliyonse.

Odwala omwe amalandira mlingo wokhazikika wa Octreotide-depot amayenera kuyesedwa miyezi isanu ndi umodzi iliyonse kuti azikhala ndi GH ndi IGF-1.

Mankhwalawa endocrine zotupa zam'mimba ndipo kapamba mu odwala amene sc makonzedwe a octreotide amapereka okwanira kuwongolera mawonetseredwe a matenda, analimbikitsa koyamba mlingo wa Octreotide-Depot 20 mg uliwonse 4 milungu. The sc makonzedwe a octreotide ayenera kupitiliza kwa masabata awiri pambuyo koyamba mankhwala Octreotide-Depot.

Kubisa komanso kusabisala wamba (metastatic) neuroendocrine zotupa za khungu, ileamu, khungu, kukwera m'matumbo, kupatsirana kwamatumbo ndi zowonjezera, kapena metastasis ya zotupa za neuroendocrine popanda chotupa chachikulu: njira yolimbikitsidwa ya Octreotide Depot ndi 30 mg masabata 4 aliwonse. Octreotide-depot mankhwala ayenera kupitilizidwa mpaka zizindikiro za chotupa chikukula.

Pochiza khansa yokhala ndi khansa ya Prostate, mankhwala oyamba a Octreotide Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. Pambuyo pake, mlingo umakonzedwa poganizira mphamvu za seramu PSA ndende, komanso zizindikiro zamatenda. Ngati pambuyo pa miyezi 3 ya chithandizo sikunatheke
zokwanira matenda ndi zamankhwala amuzolengedwa (PSA kuchepetsa), mlingo akhoza kuchuluka kwa 30 mg kutumikiridwa aliyense 4 milungu.

Odwala omwe amalandila Octreotide Depot amayenera kuyesedwa mwezi uliwonse pozama za PSA.

Odwala omwe ali ndi vuto laimpso, chiwindi ndi okalamba odwala, palibe chifukwa chokonza dongosolo la mankhwala Octreotide-depot.

Pofuna kupewa pachimake postoperative pancreatitis, mankhwala Octreotide-Depot muyezo wa 10 kapena 20 mg kutumikiridwa kamodzi osadutsa masiku 5 ndipo pasanathe masiku 10 asanafike opaleshoni yomwe akufuna.

Malangizo pokonzekera kuyimitsidwa ndi kuperekedwa kwa mankhwalawo

Mukangotola kuyimitsidwa, pindani ndi singano ndi piyano yapinki ndi singano yobiriwira (0,8 x 40 mm), ndikutembenuza mosamala syringe ndikuchotsa mpweya ku syringe.

Gwiritsani ntchito swab ya mowa kuti musambe jekeseni. Ikani singano mozama mu gluteus maximus, kenako ndikoka pang'ono syringe kuti mubwerere kuti muwonetsetse kuti chombocho sichingawonongeke. Fotokozerani kuyimitsidwa pang'onopang'ono ndi kupanikizika kosalekeza pa syringe plunger.

Ngati ilowa m'mtsempha wamagazi, tsamba la jakisoni ndi singano ziyenera kusinthidwa. Mukatseka singano, sinthani ndi singano ina yofanana.

Ndi jakisoni wobwereza, mbali zamanzere ndi zamanja ziyenera kusinthidwa.

Zotsatira zoyipa

Zotsatira zamderalo: ndi i / m makonzedwe a Octreotide-depot, ululu ndiwotheka, samakonda kutupa ndi totupa pamalo a jekeseni (nthawi zambiri amakhala ofatsa, osakhalitsa).

Kuchokera mmimba thirakiti: anorexia, nseru, kusanza, kupweteka kwam'mimba, kutulutsa, kupangitsa kwa mpweya wambiri, mapando otayirira, kutsekula m'mimba, kuwotcha. Ngakhale kuchuluka kwa mafuta okhala ndi ndowe kumatha kuchuluka, pakadali pano palibe umboni kuti chithandizo cha nthawi yayitali ndi octreotide chingayambitse kuchepa kwa zinthu zina zomanga thupi chifukwa cha malabsorption (malabsorption).Nthawi zina, zochitika zofanana ndi zotumphukira m'matumbo zimatha kuchitika: kumatulutsa pang'onopang'ono, kupweteka kwambiri epigastric dera, kusokonezeka kwa khoma lam'mimba. Kugwiritsidwa ntchito kwa nthawi yayitali kwa Octreotide Depot kumatha kupangitsa kuti ma gallstones apangidwe.

Kuchokera pa kapamba: Nthawi zina pamakhala kupweteka kwa kapamba amene amapezeka m'maola kapena masiku ogwiritsa ntchito octreotide. Pogwiritsa ntchito nthawi yayitali, pakhala pali milandu yokhudza kapamba chifukwa cha cholelithiasis.

Kumbali ya chiwindi: pali malipoti osiyana a momwe chiwonetsero cha chiwindi chimagwirira ntchito (pachimake hepatitis popanda cholestasis yokhala ndi matenda a kuthana ndi octreotide), kukula kwapang'onopang'ono kwa hyperbilirubinemia, limodzi ndi kuwonjezeka kwa ALP, GGT komanso, mochepa, ma transaminase ena.

Kuchokera kumbali ya kagayidwe: popeza Octreotide Depot imapangitsa kwambiri mapangidwe a GR, glucagon ndi insulin, amatha kuthana ndi kagayidwe ka glucose. Kuchepetsa kwa kulolera kwa glucose mutatha kudya. Pogwiritsa ntchito nthawi yayitali ya Octreotide sc nthawi zina, hyperglycemia yosatha imatha. Hypoglycemia imawonedwanso.

Zina: kawirikawiri, kuchepa kwakanthawi kwa tsitsi kumanenedwa pambuyo pa kuperekedwa kwa octreotide, kupezeka kwa bradycardia, tachycardia, kupuma movutikira, zotupa pakhungu, anaphylaxis. Pali malipoti osiyana pa kakulidwe ka hypersensitivity reaction.

Octreotide depot, malangizo ogwiritsira ntchito: njira ndi mlingo

Octreotide Depot imapangidwira makonzedwe amkati.

Kuyimitsidwa kumakonzedwa ndi akatswiri odziwa ntchito zachipatala asanapange jekeseni kale. Ngati dilution wa lyophilisate ntchito zimaperekedwa zosungunulira.

Malangizo pokonzekera kuyimitsidwa ndi kuyang'anira Octreotide-depot:

Chotsani kukonzekera mufiriji ndikubweretsa kutentha kwa firiji (nthawi zambiri izi zimatenga mphindi 30 mpaka 50).
Kugwira botolo moongoka, ndikosavuta kugogoda kuti lyophilisate yonse igwere pansi.
Tsegulani ma phukusi ndi syringe ndikuyika singano ndi piyano yapinki 1.2x50 mm kukula kwake.
Tsegulani zochulukazo ndi zosungunulira, dzazani zonse zomwe zili mu syringe ndikuyika kwa 2 ml.
Chotsani thumba la pulasitiki ku vial ya lyophilized, mankhwalawa ng ombe ndi mowa wambiri.
Ikani singano ya syringe ndi zosungunulira mu vial kudzera pakatikati pa choyimira ndikutsanulira mosamala yankho mu khoma lamkati la vial osakhudza zomwe zili ndi singano.
Chotsani syringe ndikusiya vial osayenda mpaka lyophilisate itadzaza bwino ndi zosungunulira ndikupanga kuyimitsidwa (pafupifupi mphindi 3-5). Popanda kutembenuzira botolo, fufuzani ngati ma yofiyumu owuma pansi ndi makhoma. Ngati zitsalira zouma zouma zikapezeka, siyani valainiyo kwakanthawi kochepa kufikira utasungunuka kwathunthu.
Pambuyo poonetsetsa kuti palibe chosagwirizana ndi ma lyophilisate osakanikirana, sakanizani mosamala zomwe zili mu vial ija mozungulira kwa masekondi 30-60, kuti kuyimitsidwa kukhale kopanda tanthauzo. Musagwedezeke ndikuwatembenuza botolo, izi zitha kutha kutayika, zomwe zimapangitsa kuti mankhwalawa akhale osatheka.
Ikani mwachangu syringe ndi singano mu vial kudzera pakubisira. Tsitsani gawo la singano pansi ndikuyang'ana pa 45 ° vial, pang'onopang'ono sonkhanitsani kuyimitsidwa. Kuyimitsidwa kochepa kumatha kutsalira pansi ndi makhoma a vial. Zotsalira izi zimaperekedwa, chifukwa chake musayatsegule botolo mozungulira mukamamwa mankhwalawo.
Sinthanitsani singano yokhazikikayo ndi singano yobiriwira (0.8x40 mm), ndikutembenuza mosamala syringe ndikuchotsa mpweya.
Muthira mankhwala omwe ali ndi jakisoni ndi swab ya mowa.
Ikani singano mozama mu gluteus maximus ndikokera piston pang'ono kuti muwonetsetse kuti palibe chowonongeka m'matumba. Ngati ilowa m'mtsempha wamagazi, singano iyenera kusinthidwa kukhala mulifupi wina ndipo tsamba la jakisidwe liyenera kusinthidwa.
Fotokozerani kuyimitsidwa pakukanikiza mosalekeza gawo la syringe.

Kuyimitsidwa komwe kumapangidwa kuchokera ku lyophilisate ndi kopanda pake, koyera kapena kachikasu.

Ndi jakisoni wobwereza, minyewa yamanja ndi yamanzere ya gluteus iyenera kusinthidwa.

Octreotide Depot sayenera kusakanizidwa mu syringe yomweyo ndi mankhwala ena onse.

Mankhwala nthawi zonse amasungidwa mufiriji, koma patsiku la jakisoni, vial yokhala ndi lyophilisate ndi ampoule ndi zosungunulira amaloledwa kusungidwa kutentha.

Acromegaly mankhwala

Kwa odwala omwe kugwiritsa ntchito octreotide yocheperako (kwa jekeseni wa subcutaneous) amapereka chiwonetsero chokwanira cha matendawa, ndikotheka kuyambitsa makonzedwe a Octreotide-depot tsiku latha lomaliza la octreotide. Amayamba kulandira mankhwalawa 20 mg pakatha milungu 4 iliyonse, pamtengowu umagwiritsidwa ntchito kwa miyezi itatu. M'tsogolomu, adotolo amasintha mankhwalawa kutengera mawonekedwe ake a matendawa ndikuwonekera kwa GR ndi IGF-1 mu seramu yamagazi.

Ngati mkati mwa miyezi itatu sizotheka kukwaniritsa yankho lokwanira, zonse zamankhwala komanso zamankhwala am'magazi (makamaka, ngati kuchuluka kwa GR sikutsika 2,5 μg / l), mlingo umakulitsidwa mpaka 30 mg sabata iliyonse 4.

Ngati pambuyo pa miyezi itatu yogwiritsa ntchito mlingo wa Octreotide-depot 20 mg pali kuchepa kosalekeza kwa kuchuluka kwa GR mu seramu yamagazi pansipa 1 μg / l, kuphatikiza kwa IGF-1 kumakhala kosiyanitsa komanso kumatha kusintha kwa mawonekedwe a acromegaly, mlingo umodzi umatha kuchepetsedwa mpaka 10 mg. Chithandizo chikuyenera kupitilirabe moyang'aniridwa ndi zasayansi.

Odwala omwe amalandira khansa ya mankhwala amatha kudziwa kuchuluka kwa GR ndi IGF-1 kamodzi miyezi isanu ndi umodzi.

Ngati poika Octreotide-Depot akufunika ngati chithandizo chanthawi yochepa pakati pa maphunziro a radiation, komanso kwa odwala omwe opaleshoni ndi ma radiation akhala osagwira ntchito kapena osakwanira, ndikulimbikitsidwa kuti ayese mayeso a mankhwalawa mwachidule octreotide (wothandizira sc) kuti ayesere machitidwe ndi kulolerana kwaumwini, ndipo pokhapokha muzigwiritsa ntchito Octreotide Depot malinga ndi chiwembu chomwe tafotokozachi.

Kuyanjana kwa mankhwala osokoneza bongo

Octreotide imachepetsa mayamwidwe a cyclosporin m'matumbo ndikuchepetsa kuyamwa kwa cimetidine.

Ndi munthawi yomweyo kugwiritsa ntchito octreotide ndi bromocriptine, bioavailability wa yotsiriza ukuwonjezeka.

Chithandizo cha endocrine zotupa zam'mimba ndipo kapamba

Kwa odwala omwe kugwiritsa ntchito octreotide osakhalitsa amawongolera zisonyezo za matendawa, mlingo woyambirira wa mankhwalawa ndi 20 mg sabata iliyonse 4. Komanso, kuyambika kwa Octreotide-depot, kugwiritsa ntchito octreotide kumapitilizidwa kwa milungu ina iwiri.

Kwa odwala omwe sanalandirepo kale umuna wa octreotide, chithandizo chimalimbikitsidwa kuti ayambe ndi mlingo wa mankhwalawa s / c makonzedwe a 0 mg mg katatu pa tsiku kwa masabata awiri. Izi ndizofunikira kuti tiwone kuyenera ndi kulekerera kwake. Pokhapokha ndi pomwe Octreotide Depot angagwiritsidwe ntchito monga tafotokozera pamwambapa.

Ngati pambuyo pa miyezi itatu ya chithandizo pokhapokha pakakhala kusintha pang'ono, Octreotide Depot 30 mg pakatha masabata 4 aliwonse amadziwika. Mu milandu yomwe mkati mwa miyezi itatu yamankhwala mumatha kukwaniritsa kuwongolera kwakanema ndikuwonetsa zobereka, mankhwalawa amatha kuchepetsedwa mpaka 10 mg masabata 4 aliwonse.

Poyerekeza ndi kugwiritsa ntchito kwa Octreotide-depot masiku ena (makamaka m'miyezi iwiri yoyambirira ya chithandizo, mpaka mankhwala ogwidwa ndi plasma azigwira), mawonekedwe a matenda a endocrine zotupa za m'mimba ndi kapamba amatha kuzikitsidwa. Odwala oterewa amathandizidwanso kuphatikiza umuna wa octreotide mu mlingo womwe unakhazikitsidwa Octreotide Depot isanayambike.

Pankhani yobisa komanso yosabisala wamba chotupa cha neuroendocrine cha colon yopingasa, kukwera kwa colon, ileamu, khungu, jejunum ndi zowonjezera, komanso metastases ya zotupa za neuroendocrine popanda cholinga chachikulu, Octreotide-depot imayikidwa muyezo wa 30 mg sabata iliyonse 4. Mankhwalawa amapitilizidwa mpaka chotupa chitha kuwongoleredwa (mpaka zizindikire za kupita patsogolo kwake).

Chithandizo cha khansa ya Prostate yotsutsa ma cell

Mlingo woyamba wa Octreotide Depot ndi 20 mg milungu 4 iliyonse kwa miyezi itatu. M'tsogolomu, adokotala amasintha mankhwalawo kutengera matendawo mawonetseredwe ake am'magazi.

Ngati mkati mwa miyezi itatu ya chithandizo sichingatheke kukwaniritsa zowongolera zamatenda a matendawa ndi zolembera zam'magazi (kuchepa kwa PSA), mlingo umakulitsidwa mpaka 30 mg sabata iliyonse 4.

Octreotide-depot imagwiritsidwa ntchito kuphatikiza ndi dexamethasone omwe amagwiritsidwa ntchito mu fomu ya pakamwa malinga ndi chiwembu chotsatira: 4 mg / tsiku kwa mwezi umodzi, ndiye 2 mg / tsiku kwa masabata awiri, kenako 1 mg / tsiku.

Odwala omwe adalandirapo mankhwala a antiandrogen mankhwala, kuphatikiza kwa Octreotide-Depot + Dexamethasone kuphatikizidwa ndikugwiritsa ntchito analogi ya gonadotropin-kumasula mahomoni a fomu ya depot, yomwe imabayidwa kamodzi sabata iliyonse.

Mwezi uliwonse nthawi yamankhwala, ndikofunikira kudziwa kuchuluka kwa PSA.