Metfogamm® 850 (Metfogamma® 850)

Piritsi limodzi lili:

Chithandizo chogwira ntchito: metformin hydrochloride - 850 mg.

Othandizira: hypromellose, povidone, stearate magnesium.

Mapangidwe a Shell: hypromellose, macrogol 6000, titanium dioxide (E 171).

Mapiritsi oyera a Oblong, ophatikizidwa ndi filimu, wokhala ndi cholakwika mbali zonse ziwiri, pafupifupi fungo.

Zotsatira za pharmacological

Metphogamma 850 ndi mankhwala amkamwa a hypoglycemic ochokera pagulu la Biguanide. Amalepheretsa gluconeogeneis m'chiwindi, amachepetsa mayamwidwe m'matumbo, imathandizira kugwiritsidwa ntchito kwa glucose, komanso imakulitsa chidwi cha minofu kuti insulini. Komabe, sizikhudza kubisika kwa insulini ndi ma cell a beta a kapamba. Amachepetsa mulingo wa triglycerides ndi lipoproteins wotsika m'magazi. Imakhazikika kapena kuchepetsa thupi. Ili ndi fibrinolytic mwina chifukwa chokakamira minofu ya plasminogen activator inhibitor.

Pharmacokinetics

Pambuyo pakamwa, mankhwalawa amadziwidwa kuchokera m'matumbo am'mimba. Bioavailability mutatenga muyezo Mlingo - 50-60%. Kuzindikira kwakukulu mu plasma ya magazi kumafika patatha maola awiri atatha kumwa. Sizikugwirizana ndi mapuloteni a plasma. Amadziunjikira mu ndulu zakumaso, chiwindi ndi impso. Imayatsidwa osasinthika ndi impso. Hafu ya moyo ndi 1.5-5,5 maola.

Ndi matenda aimpso, kuwonongeka kwa mankhwalawa ndikotheka.

Mlingo ndi makonzedwe

Mlingo wa Metfogamma 850 umakhazikitsidwa payekhapayekha, poganizira kuchuluka kwa shuga m'magazi. Mlingo woyambirira nthawi zambiri umakhala 850 mg (piritsi 1) patsiku, kuwonjezereka kwapang'onopang'ono kwa mlingo kumatheka kutengera mphamvu ya mankhwala. Mlingo wokonza mankhwalawa ndi 850-1700 mg (mapiritsi 1-2) patsiku. Mlingo wambiri watsiku ndi tsiku ndi 1700 mg (mapiritsi 2), kuikidwa kwa milingo yayikulu sikukula mphamvu ya mankhwalawa.

Mlingo wa tsiku ndi tsiku wopitilira 850 mg tikulimbikitsidwa mu Mlingo wachiwiri (m'mawa ndi madzulo). Odwala okalamba, tsiku lililonse mankhwala sayenera kupitirira 850 mg.

Mapiritsi a Metphogamm 850 ayenera kumwedwa ndi chakudya, chonse, osambitsidwa ndi madzi pang'ono (kapu yamadzi). Njira ya mankhwala ndi mankhwala ndi yayitali.

Zotsatira zoyipa

Kuchokera m'mimba: m'mimba, kusanza, kupweteka m'mimba, kutsegula m'mimba, kusowa kwa chakudya, "kukoma kwazitsulo" mkamwa. Muzochitika izi, kusiya kwa mankhwalawa nthawi zambiri sikufunikira, ndipo Zizindikiro zimatha pazokha osasintha mankhwalawa. Pafupipafupi komanso kuopsa kwa mavuto am'mimba kuchokera m'mimba thirakiti amatha kuchepa komanso kuwonjezeka pang'onopang'ono kwa mlingo wa metformin.

Thupi lawo siligwirizana: zotupa pakhungu.

Kuchokera ku endocrine system: hypoglycemia (makamaka ikagwiritsidwa ntchito mosakwanira).

Metabolism: nthawi zina, lactic acidosis (imafuna kusiya kwa mankhwala).

Kuchokera pa hemopoietic dongosolo: nthawi zina - megaloblastic anemia.

Bongo

Ndi bongo wa Metfogamma 850, lactic acidosis yokhala ndi zotsatira zakupha ndiyotheka. Zomwe zimayambitsa kukula kwa lactic acidosis amathanso kukhala cumulation wa mankhwalawa chifukwa cha kuwonongeka kwa impso. Zizindikiro zoyambirira za lactic acidosis ndi mseru, kusanza, kutsegula m'mimba, kutentha thupi, kupweteka kwam'mimba, kupweteka kwa minofu, ndiye kuti pali kuphatikizika kwamphamvu kupuma, chizungulire, chikumbumtima chodwala komanso kukula kwa chikomokere. gonekerani kuchipatala mwachangu ndipo mutatsimikiza kuchuluka kwa lactate, tsimikizirani kuti mwazindikira. Njira yothandiza kwambiri yochotsa lactate ndi Metphogamm 850 kuchokera m'thupi ndi hemodialysis. Chithandizo cha Zizindikiro zimachitidwanso. Ndi mankhwala ophatikizidwa a Metphogamm 850 okhala ndi kukonzekera kwa sulfonylurea, hypoglycemia imayamba.

Kuchita ndi mankhwala ena

Pogwiritsa ntchito munthawi yomweyo ndi zotumphukira za sulfonylurea, acarbose, insulin, mankhwala osokoneza bongo a anti-yotupa, mao inhibitors, oxytetracycline, zoletsa za ACE, clofibrate zotumphukira, cyclophosphamide, B-blockers, ndizotheka kuwonjezera zotsatira za hypoglycemic of metformin. Pogwiritsa ntchito munthawi yomweyo ndi glucocorticosteroids, kulera kwapakamwa, epinephrine, sympathomimetics, glucagon, mahomoni a chithokomiro, thiazide ndi "loop" diuretics, zotumphukira za phenothiazine, zotumphukira za nicotinic acid, ndizotheka kuchepetsa mphamvu ya hypoglycemic ya metformin.

Cimetidine amachepetsa kuchotsedwa kwa metformin, yomwe imawonjezera chiopsezo cha lactic acidosis.

Metformin itha kufooketsa mphamvu ya ma anticoagulants (zotumphukira za coumarin). Ndi kumwa nthawi yomweyo, lactic acidosis imayamba.

Zolemba zogwiritsira ntchito

Sikulimbikitsidwa kwa matenda owopsa, kuchulukitsa kwa matenda opatsirana ndi kutupa, kuvulala, matenda opweteka kwambiri, pamene insulin yasonyezedwa. Osagwiritsa ntchito musanachite opareshoni komanso patatha masiku awiri atachitidwa opereshoni.

Kugwiritsa ntchito Metfogamma 850 sikulimbikitsidwa osachepera masiku awiri asanafike komanso masiku awiri pambuyo pa x-ray kapena kufufuza kwa radiology pogwiritsa ntchito othandizira. Iwo ali osavomerezeka kugwiritsa ntchito mankhwala odwala pakudya ndi zoletsa caloric kudya (

Gulu la Nosological (ICD-10)

Mankhwala

Amalepheretsa gluconeogeneis m'chiwindi, amachepetsa mayamwidwe m'matumbo, imathandizira kugwiritsidwa ntchito kwa glucose, komanso imapangitsa chidwi cha minofu kulowa insulin. Amachepetsa mulingo wa triglycerides ndi lipoproteins wotsika m'magazi. Imakhala ndi fibrinolytic effect (imalepheretsa zochitika za minofu ya mtundu wa plasminogen activator inhibitor), imakhazikika kapena kuchepetsa thupi.

Contraindication

matenda ashuga ketoacidosis, matenda a shuga komanso chikomokere,

kwambiri aimpso ndi kwa chiwopsezo cha hepatic,

kulephera kwa mtima ndi kupuma,

pachimake gawo la infracenta,

pachimake ubongo

lactic acidosis ndikuwonetsa mu mbiri, mikhalidwe yomwe ingapangitse kukula kwa lactic acidosis, kuphatikizapo uchidakwa wambiri,

Zotsatira zoyipa

Kuchokera pamtima ndi magazi (hematopoiesis, hemostasis): nthawi zina megaloblastic anemia.

Kuchokera mmimba: mseru, kusanza, kupweteka m'mimba, kutsegula m'mimba, kusowa kwa chakudya, kulawa kwazitsulo mkamwa.

Kuchokera kumbali ya kagayidwe: hypoglycemia, nthawi zina, lactic acidosis (imafuna kusiya kwa mankhwala).

Zotsatira zoyipa: zotupa pakhungu.

Malangizo apadera

Sizikulimbikitsidwa pamatenda oyambitsidwa ndi matenda oyambitsidwa ndi matenda opatsirana komanso otupa, kuvulala, matenda opweteka kwambiri, musanachite opareshoni ndipo musanadutse masiku awiri atachitidwa, komanso mkati mwa masiku awiri isanachitike komanso mutatha kuyesa matenda (radiological and radiological) kugwiritsa ntchito mafayilo osiyanitsa). Sayenera kugwiritsidwa ntchito mwa odwala pazakudya zomwe zimachepetsa mphamvu ya caloric (zosakwana 1000 kcal / tsiku). Kugwiritsa ntchito mankhwalawa sikulimbikitsidwa mwa anthu opitilira zaka 60 omwe amagwira ntchito zolimbitsa thupi (chifukwa chowonjezera chiopsezo chokhala ndi lactic acidosis).

Kukopa pa kuyendetsa magalimoto ndi kugwira ntchito ndi njira. Palibe zotsatira (mukamagwiritsa ntchito ngati monotherapy). Kuphatikiza ndi ma hypoglycemic othandizira ena (sulfonylurea derivatives, insulin, etc.), chitukuko cha malo a hypoglycemic ndizotheka, momwe kuthekera kuyendetsa magalimoto ndi kuchita zina zomwe zingakhale zoopsa zomwe zimafunikira chidwi chochulukirapo komanso kuthamanga kwa zochitika zama psychomotor.

Wopanga

Werwag Pharma GmbH & Co KG, Kalverstrasse 7, 71034, Beblingen, Germany.

Wopanga: Artesan Pharma GmbH & Co KG, Wendlandstrasse, 1, 29439, Lyukhov, Germany.

Dragenopharm Apotheker Püschl GmbH & Co. KG, Gellstrasse, 1, 84529, Tittmoning, Germany.

CJSC ZiO-Zdorovye, Russia, 142103, Moscow Region, Podolsk, ul. Njanji, 2.

Ofesi yoyimira / bungwe lolandila zodandaula: ofesi yoyimira kampani ya Vervag Pharma GmbH & Co CG mu Russian Federation.

117587, Moscow, msewu waukulu wa Warsaw, 125 F, bldg. 6.

Tel. ((495) 382-85-56.

Mlingo

Mapiritsi okhala ndi mafilimu, 850 mg

Piritsi limodzi lili

yogwira mankhwala - metformin hydrochloride 850 mg

(ofanana ndi metformin 662.8 mg),

zotuluka: hypromellose (15000 mPas), Povidone K25, magnesium stearate,

kapangidwe ka sheath: hypromellose (5mPas), macrogol 6000, titanium dioxide (E171).

Mapiritsi okhala ndi mawonekedwe ndi biconvex pamwamba, wokutidwa ndi filimu yoyera, wokhala ndi chiopsezo mbali zonse ziwiri, 7.5 ± 0.5 x 21.5 ± 0.5) mm ndi kutalika (6.0 ± 6.8) mm.

Mankhwala

Pambuyo pakukonzekera pakamwa, metformin imatengedwa kuchokera m'mimba. Bioavailability mutatenga muyezo mlingo 50-60%. Casmx yayikulu kwambiri ya plasma ndende imafika patangotha ​​maola 2,5 pambuyo pakulowetsa. Sizikugwirizana ndi mapuloteni a plasma. Amadziunjikira tiziwalo tating'ono, minofu, chiwindi ndi impso. Metformin imatengedwa kupita ku maselo ofiira; Imayatsidwa osasinthika ndi impso. Hafu ya moyo ndi maola 6.5. Mu vuto laimpso, kuwonongeka kwa mankhwalawa ndikotheka. Amaganiziridwa kuti pharmacokinetics of metformin adsorption silinelinear.

Metfogamma® 850 imalepheretsa gluconeogenesis m'chiwindi, amachepetsa kuyamwa kwa m'matumbo, imathandizira kugwiritsidwa ntchito kwa glucose, komanso kumapangitsa chidwi cha minofu kulowa insulin. Metformin imathandizira kapangidwe ka glycogen mu intracellular pochita glycogen synthase, kumawonjezera kuthekera kwa mitundu yonse ya mapuloteni am'magazi a michere. Komabe, sizikhudza kubisika kwa insulini ndi ma cell a beta a kapamba. Ochepetsa kwathunthu cholesterol, triglycerides ndi otsika kachulukidwe lipoproteins m'mwazi. Imakhazikika kapena kuchepetsa thupi. Ili ndi fibrinolytic mwina chifukwa chokakamira minofu ya plasminogen activator inhibitor.

Kutulutsa mawonekedwe, ma CD ndi mawonekedwe a Metfogamm ® 850

Mapiritsi, okhala ndi zokutira kwamafuta oyera, amakhala osatha, ali ndi ngozi, osanunkhiza.

Othandizira: hypromellose (1500CPS), hypromellose (5CPS), povidone (K25), magnesium stearate, macrogol 6000, titanium dioxide.

Ma PC 10 - matuza (3) - mapaketi a makatoni.
Ma PC 10 - matuza (6) - mapaketi a makatoni.
Ma PC 10 - matuza (12) - mapaketi a makatoni.
20 ma PC. - matuza (6) - mapaketi a makatoni.

Mlingo

Khazikikani payekhapayekha, poganizira kuchuluka kwa shuga m'magazi.

Mlingo woyambirira nthawi zambiri umakhala 850 mg (1 tabu.) / Tsiku. Kuwonjezereka kwapang'onopang'ono kwa mlingo kumatheka kutengera mphamvu ya mankhwala. Mlingo wokonza ndi 850-1700 mg (mapiritsi 1-2) / tsiku. Mlingo wambiri watsiku ndi tsiku ndi 2550 mg (mapiritsi atatu).

Mlingo wa tsiku ndi tsiku wopitirira 850 mg tikulimbikitsidwa mu Mlingo 2 wogawanika (m'mawa ndi madzulo).

Odwala okalamba, mlingo woyenera sayenera kupitirira 850 mg / tsiku.

Mapiritsi ayenera kumwedwa ndi chakudya chonse, kutsukidwa ndi madzi pang'ono (kapu yamadzi).

Mankhwalawa adapangira kuti azigwiritsa ntchito kwa nthawi yayitali.

Chifukwa chowonjezera chiopsezo cha lactic acidosis, mu zovuta zazikulu za metabolic, mlingo uyenera kuchepetsedwa.

Kuyanjana kwa mankhwala osokoneza bongo

Pogwiritsa ntchito munthawi yomweyo ndi sulfonylurea zotumphukira, ma acarbose, insulin, NSAIDs, ma inhibitors a MAO, oxytetracycline, ma inhibitors a ACE, clofibrate zotumphukira, cyclophosphamide ndi beta-blockers, ndizotheka kuwonjezera mphamvu ya hypoglycemic ya metformin.

Pogwiritsa ntchito munthawi yomweyo ndi GCS, kulera kwapakamwa, epinephrine (adrenaline), sympathomimetics, glucagon, mahomoni a chithokomiro, thiazide ndi loopback diuretics, phenothiazine zotumphukira ndi nicotinic acid, kuchepa kwa mphamvu ya hypoglycemic ya metformin ndikotheka.

Cimetidine amachepetsa kuchotsedwa kwa metformin, chifukwa chomwe chiopsezo cha lactic acidosis chikuwonjezeka.

Metformin itha kufooketsa mphamvu ya ma anticoagulants (zotumphukira za coumarin).

Ndi munthawi yomweyo makonzedwe ndi Mowa, kukula kwa lactic acidosis ndikotheka.

Ndi munthawi yomweyo kugwiritsa ntchito nifedipine kumathandizira mayamwidwe a metformin, C max, amachepetsa kuchotsa.

Mankhwala a Cationic (amlodipine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, vancomycin) omwe amatulutsidwa m'mapikisano olimbana ndi machitidwe ogwiritsira ntchito ma tubular ndipo, ngati atachira, amatha kuonjezera C maxformform ndi 60%.

Zizindikiro zogwiritsidwa ntchito

- chithandizo cha matenda a shuga a mtundu wachiwiri kwa akuluakulu, makamaka odwala onenepa kwambiri, ngati kudya komanso kuchita masewera olimbitsa thupi sikungakuthandizeni

monga monotherapy kapena kuphatikiza ena antidiabetesic othandizira, kapena insulin

Zochita zamankhwala osokoneza bongo

Kuphatikiza komwe sikulimbikitsidwa.

Kuledzera kwa pachimake kumawonjezera chiopsezo cha lactic acidosis, makamaka pazochitika zotsatirazi:

- njala kapena kuperewera kwa chakudya,

M'pofunika kupewa kugwiritsa ntchito mankhwala osokoneza bongo omwe amamwa mowa pa mankhwalawa.

Muli mitundu yosiyanitsa ndi ayodini

Kugwiritsa ntchito kwa iodini mankhwala osokoneza bongo omwe amapezeka m'mitsempha kungayambitse kulephera kwa impso, zomwe zingayambitse kudziwitsidwa kwa metformin, komanso chiwopsezo cha lactic acidosis. Kugwiritsa ntchito metformin kuyenera kusiyidwa osagwiritsidwa ntchito ndi othandizira osiyanitsa awa, panthawi yophunzira ndi kugwiritsa ntchito kwawo komanso mkati mwa maola 48 atamaliza. Mankhwalawa amayenera kupitilizidwa patatha maola 48 kumapeto kwa kafukufukuyu ndikumaliza kuyesedwa kwachiwiri kwa matenda a impso ndipo zotsatira zoyenera zimapezeka.

Kuphatikiza komwe kumafunikira kusamala mwapadera mukamagwiritsa ntchito

Mankhwala omwe ali ndi chibadwa chawo cha hyperglycemic, mwachitsanzo, glucocorticoids (yogwiritsira ntchito mwazonse komanso zam'deralo), agonists a beta-2, sympathomimetics.

Odwala ayenera kudziwitsidwa za izi, ndikuwonetsetsa kuti amawunika kuchuluka kwa shuga m'magazi pafupipafupi, makamaka poyambira kulandira chithandizo. Ngati ndi kotheka, Mlingo wa metformin pa nthawi ya mankhwalawa uyenera kuchitika, makamaka mukagwiritsanso ntchito mankhwala ena mukasiya kugwiritsa ntchito.

Ma diuretics, makamaka odzola okodzetsa.

Popeza pali chiwopsezo cholepheretsa kugwira ntchito kwa aimpso, pamakhala chiopsezo chachikulu chotenga lactic acidosis.

ACE inhibitors angayambitse kuchepa kwa shuga m'magazi. Ngati ndi kotheka, Mlingo wa mankhwala a hypoglycemic uyenera kusinthidwa pochiza pogwiritsa ntchito ACE zoletsa ndipo mutatha kusiya mankhwalawa.