Galvus® Vildagliptin

Nau'in 2 na ciwon sukari mellitus cuta ce ta rayuwa wanda ke haifar sakamakon cin zarafin insulin tare da sel.

Mutanen da ke da irin wannan malaise ba koyaushe suna iya ɗaukar matakan sukari daidai ta tsarin abinci da kuma matakai na musamman. Likitoci suna tsara Vildagliptin, wanda yake ragewa kuma yana riƙe glucose tsakanin iyakoki masu karɓa.

Bayani na gaba daya, abun da ya shafi da kuma sakin saki

Vildagliptin wakilin sabon aji ne na kwayoyi waɗanda ake amfani da su sosai wajen maganin cututtukan type 2. Yana tayar da tsibiran da ke motsa jiki kuma yana hana ayyukan dipeptidyl peptidase-4. Yana da tasirin hypoglycemic.

Ana iya tsara magungunan azaman azaman jiyya, kuma a hade tare da wasu magunguna. An haɗu da shi tare da ƙayyadaddun sulfonylurea, tare da thiazolidinedione, tare da metformin da insulin.

Vildagliptin sunan duniya ne don sashi mai aiki. A kasuwar magunguna akwai magunguna biyu tare da wannan kayan, sunayen kasuwancin su ne Vildagliptin da Galvus. Na farko ya ƙunshi kawai Vildagliptin, na biyu - haɗuwa da Vildagliptin da Metformin.

Siffar saki: Allunan tare da sashi na 50 MG, shiryawa - guda 28.

Magunguna da magunguna

Vildagliptin wani abu ne wanda ke hanzarta hana dipeptidyl peptidase tare da karuwa sosai a cikin GLP da HIP. Hormones an kebe shi cikin hanji cikin sa'o'i 24 kuma yana ƙaruwa saboda karɓar abinci. Abun yana haɓaka tsinkaye akan sel na betta don glucose. Wannan yana tabbatar da daidaituwa na aiki da sinadarin-insulin-insulin na insulin.

Tare da karuwa a cikin GLP, akwai karuwa a tsinkaye na sel alpha zuwa sukari, wanda ke tabbatar da daidaituwar tsarin glucose mai dogaro da insulin. Akwai raguwa a yawan yawan lemun tsami a cikin jini yayin aikin jiyya. Tare da raguwa a cikin glucagon, raguwa a cikin juriya na insulin yana faruwa.

Abubuwan da ke aiki suna ɗaukar hanzari, suna ƙara matakin kwayoyin a cikin jini bayan sa'o'i 2. An lura da ƙarancin furotin - ba fiye da 10%. An rarraba Vildagliptin daidai tsakanin sel jini da jini. Matsakaicin sakamako yana faruwa bayan 6 hours. Magungunan sun fi dacewa a kan komai a ciki, tare da abinci, ƙwayar sha yana ragewa zuwa kaɗan - by 19%.

Baiyi aiki ba kuma baya jinkirta kewa, ba gurbi bane. An samo shi a cikin jini na jini bayan sa'o'i 2. Rabin rayuwar daga jikin shine 3 hours, ba tare da la'akari da sashi ba. Biotransformation shine babbar hanyar wuce gona da iri. 15% na miyagun ƙwayoyi an keɓe su a cikin feces, 85% - daga kodan (ba a canzawa 22.9%). Mafi girman abin tunawa abu ya kasance ne bayan minti 120.

Manuniya da contraindications

Babban nuni ga alƙawarin shine ciwon sukari na 2. An tsara Vildagliptin a matsayin babban jiyya, maganin rikice-rikice na ɓangarori biyu (tare da halartar ƙarin magani), da kuma maganin ɓangarori uku (tare da halartar magunguna biyu).

A farkon lamari, ana gudanar da jiyya tare da motsa jiki da abinci da aka zaɓa musamman. Idan monotherapy ba shi da tasiri, ana amfani da hadadden tare da haɗuwa da magungunan masu zuwa: Kalamomin Sulfonylurea, Thiazolidinedione, Metformin, insulin.

Daga cikin abubuwan da ke faruwa sune:

  • maganin rashin jituwa,
  • mai aiki mai ɗaukar hoto,
  • ciki
  • karancin lactase
  • aikin hanta mai rauni,
  • Mutanen da ke ƙasa da shekara 18
  • bugun zuciya
  • lactation
  • rashin galactose.

Umarnin don amfani

Allunan ana daukar su a baki ba tare da an ambaci abinci ba. Dokar ta ƙaddara ta likita ne ya ƙaddara, la'akari da yanayin haƙuri da haƙuri ga magunguna.

Yawan shawarar da aka bada shawarar shine 50-100 mg. A cikin nau'in ciwon sukari mai tsanani 2, an sanya magani a 100 MG kowace rana. A haɗe tare da wasu magunguna (dangane da illolin motsa jiki), abincin yau da kullun shine 50 MG (kwamfutar hannu 1). Tare da rashin isasshen tasiri yayin magani mai wahala, kashi yana ƙaruwa zuwa 100 MG.

Babu cikakken bayani game da amfani da miyagun ƙwayoyi yayin daukar ciki da lactation. Sabili da haka, wannan rukuni ba a ke so shan magungunan da aka gabatar ba. Ya kamata a kula da kulawa ta musamman a cikin marasa lafiya da cutar hanta / koda.

Ba a ba da shawarar mutane underan shekaru 18 da yin amfani da miyagun ƙwayoyi ba. Ba bu mai kyau a tuƙa yayin shan magani.

Tare da yin amfani da vildagliptin, ana iya ƙaruwa a cikin ƙididdigar hanta. A yayin jiyya na dogon lokaci, ana bada shawara don yin nazarin ƙirar ƙwayar cuta don lura da yanayin da kuma yiwuwar daidaitawar magani.

Tare da karuwa a aminotransferases, ya zama dole a sake gwada jini. Idan alamun suka karu fiye da sau 3, an dakatar da maganin.

Side effects da yawan abin sama da ya kamata

Daga cikin yiwuwar abubuwan da suka faru masu lalacewa:

  • asthenia
  • rawar jiki, tsananin fushi, rauni, ciwon kai,
  • tashin zuciya, amai, bayyanuwar reflux esophagitis, rashin jin daɗi,
  • na gefe harshe,
  • maganin ciwon huhu
  • nauyi
  • hepatitis
  • fata, ƙaiƙayi, itticaria,
  • sauran halayen rashin lafiyan halayen.

Magungunan suna da haƙuri da kyau ta hanyar haƙuri, maganin da aka yarda da shi a kowace rana yana zuwa 200 MG kowace rana. Lokacin amfani da fiye da 400 ml, mai zuwa na iya faruwa: zazzabi, kumburi, ƙarancin ƙarshen, tashin zuciya, suma. Idan bayyanar cututtuka ta faru, ya zama dole a kurkura ciki kuma a nemi taimakon likita.

Hakanan yana yiwuwa a kara furotin C-mai amsawa, myoglobin, creatine phosphokinase. Sau da yawa ana lura da angioedema yayin haɗuwa da ACE inhibitors. Tare da janyewar miyagun ƙwayoyi, sakamako masu illa suna ɓacewa.

Hadin gwiwar Magunguna da Analogs

Yuwuwar ma'amala da vildagliptin tare da wasu kwayoyi ta ƙasa. Babu wani sakamako game da magunguna waɗanda ake amfani da su sau da yawa a cikin maganin cututtukan type 2 (Metformin, Pioglitazone da sauransu) da magungunan kunkuntar magunguna (Amlodipine, Simvastatin).

Magunguna na iya samun sunan kasuwanci ko suna iri ɗaya tare da kayan aiki. A cikin kantin magunguna zaka iya samun Vildagliptin, Galvus. Dangane da maganin contraindications, likitan ya tsara irin waɗannan magunguna waɗanda ke nuna tasirin warkewa iri ɗaya.

Magungunan kwayoyi sun hada da:

  • Onglisa (ingantaccen sinadari saxagliptin),
  • Januvia (abu - sitagliptin),
  • Trazenta (bangaren - linagliptin).

Kudin Vildagliptin daga 760 zuwa 880 rubles, ya danganta da gefen kantin magani.

Ya kamata miyagun ƙwayoyi su kasance a zazzabi na akalla digiri 25 a cikin wuri bushe.

Ra'ayoyin masana da marasa lafiya

Ra'ayoyin masana da ra'ayoyin masu haƙuri game da magunguna galibi tabbatacce ne.

Gabanin tushen shan magunguna a cikin marasa lafiya da ke dauke da ciwon sukari na 2, an lura da sakamako mai zuwa:

  • raguwa cikin saurin sukari,
  • gyara mai nuna yarda,
  • sauƙi na amfani
  • Tsarin jikin mutum yayin aikin monotherapy ya kasance iri ɗaya ne,
  • far yana haɗuwa da sakamako mai lalacewa,
  • sakamako masu illa suna faruwa a lokuta da dama,
  • rashin yanayin hypoglycemic yayin shan magani,
  • normalisation na lipid metabolism,
  • tsaro mai kyau
  • haɓaka metabolism,
  • ya dace da yawancin marasa lafiya da ke fama da ciwon sukari na 2.

Vildagliptin yayin gudanar da bincike ya tabbatar da inganci da kyakkyawan bayanin haƙuri. Dangane da hoton asibiti da alamu nazarce-nazarce, babu wasu maganganu na cututtukan cututtukan jini da aka lura yayin aikin magani.

Ana daukar Vildagliptin a matsayin magani mai narkewar ƙwayar cuta, wanda aka wajabta don masu ciwon sukari na 2. An sanya shi a cikin Rijistar Magunguna (RLS). An tsara shi azaman maganin hana ƙwaƙwalwar ƙwayar cuta kuma a haɗe tare da sauran jamiái. Ya danganta da yanayin cutar, tasirin magani, ƙila za a iya haɓaka miyagun ƙwayoyi tare da abubuwan da ake amfani da su na Metmorphine, abubuwan da ake amfani da su na sulfonylurea, insulin. Likitocin da ke halartar za su ba da umarnin daidai kuma za a kula da yanayin mai haƙuri. Sau da yawa, marasa lafiya da ke dauke da ciwon sukari na 2 suna da cututtukan da ke kama da juna. Wannan yana rikitar da zaɓi game da zaɓin mafi kyawun aikin glucose-low. A irin waɗannan halayen, insulin shine mafi kyawun hanyar don rage matakan sukari. Yawan cinsa mai yawa na iya haifar da hauhawar jini, hauhawar nauyi. Bayan binciken, an gano cewa amfani da Vildagliptin tare da insulin na iya samun kyakkyawan sakamako. Hadarin kamuwa da cututtukan zuciya, an rage kiba, an inganta kiba da narkewar ƙwayoyi ba tare da samun nauyi ba.

Frolova N. M., endocrinologist, likita na mafi girman rukuni

Na kasance ina shan Vildagliptin fiye da shekara guda, likita ya umurce ni da haɗin kai tare da Metformin. Na damu matuka cewa yayin dogon jiyya zan ƙara samun nauyi. Amma ta warke da nauyin kilogram 5 kacal daga cikin na 85. Daga cikin illolin sakamako, na lokaci-lokaci na samun maƙarƙashiya da tashin zuciya. Gabaɗaya, jiyya yana ba da sakamako da ake so kuma yana wucewa ba tare da wani tasiri mara amfani ba.

Olga, mai shekara 44, Saratov

Abubuwan bidiyo daga Dr. Malysheva game da samfuran da za a iya amfani dasu azaman ƙari ga kwayoyi don ciwon sukari:

Vildagliptin magani ne mai tasiri wanda ke rage matakan glucose kuma yana inganta aikin jijiyoyin jiki. Zai taimaka wa marasa lafiya waɗanda ba sa iya daidaita matakan sukari ta hanyar motsa jiki da abinci na musamman.

Form sashi

Tabletaya daga cikin kwamfutar hannu ya ƙunshi

abu mai aiki - vildagliptin 50 MG,

magabata: microcrystalline cellulose, lactose anhydrous, sitaci sittin glycolate nau'in A, magnesium stearate.

Allunan suna da fari zuwa haske launin shuɗi a launi, zagaye cikin sifa, tare da shimfiɗaɗɗen shimfiɗa kuma an sanya shi, aka zana shi da "NVR" a gefe ɗaya da "FB" a gefe guda.

Kayan magunguna

Pharmacokinetics

Bayan shigowa a kan komai a ciki, lokacin da zai isa Cmax na vildagliptin a cikin plasma jini shine sa'o'i 1.75. Lokacin da aka ɗauke shi da abinci, yawan shan magunguna yana raguwa kaɗan: akwai raguwa a Cmax da 19% kuma karuwa a Tmax zuwa awa 2.5. Duk da haka, cin abinci baya tasiri digiri na sha da kuma AUC.

Abin da ke ɗaure na vildagliptin ga ƙwayoyin plasma ƙasa kaɗan (9.3%). An rarraba magungunan daidai tsakanin plasma da ƙwayoyin jini. Rarraba na Vildagliptin yana faruwa mai yiwuwa ne mai wuce gona da iri, Vss a cikin daidaitawa bayan allurar iv shine lita 71.

Biotransformation shine hanya ta farko ta excretion na vildagliptin. A jikin mutum, kashi 69% na maganin yana canzawa. Babban metabolite - LAY151 (57% na kashi) ba shi da magunguna kuma yana samfuran hydrolysis na cyanocomponent. Kimanin 4% na kashi yana ɗaukar amly hydrolysis.

A cikin nazarin gwaji, an lura da kyakkyawan sakamako na DPP-4 akan hydrolysis na miyagun ƙwayoyi. Vildagliptin ba a metabolized tare da halayen cytochrome P450 isoenzymes. Nazarin cikin vitro ya nuna cewa vildagliptin baya hana ko sa cytochrome P450 isoenzymes.

Bayan fitowar vildagliptin mai alaƙa da 14C, kusan kashi 85% na kashi an fesa shi a cikin fitsari, 15% tare da feces. Kashi 23% na kashin da aka sha a baka yana toshe kodan ba canzawa. Lokacin da aka gudanar da su ga batutuwa masu ƙoshin lafiya, jimlar plasma da ƙarancin ɗaukar vildagliptin shine 41 l / h da 13 l / h, bi da bi. Matsakaicin rabin rayuwar miyagun ƙwayoyi bayan gudanarwar cikin jiyya shine kimanin awanni 2. Rabin rayuwar bayan maganin baka shine kimanin awanni 3 kuma baya dogara da kashi.

Vildagliptin yana kasancewa cikin hanzari kuma cikakkiyar bioavailability na bakinsa shine kashi 85%. A cikin kewayon kashi na warkewa, mafi girman fifiko na plasma na vildagliptin da kuma yankin da ke ƙarƙashin lokacin lokacin plasma maida hankali ne (AUC) kwatankwacin gwargwado daidai gwargwadon aikin da aka gudanar.

Groupsungiyoyin haƙuri na musamman

Babu bambance-bambance a cikin ma'aunin magunguna na Galvus® tsakanin maza da mata marasa lafiya na shekaru daban-daban kuma tare da samfuran jiki daban-daban (BMI). Ikon Galvus® don hana ayyukan dipeptidyl peptidase-4 (DPP-4) shima bai dogara da jinsi ba.

Ba a samo dogayen sigogin magunguna na miyagun ƙwayoyi Galvus® akan ƙirar taro ba. Thearfin magungunan Galvus® don hana ayyukan DPP-4 suma basu dogara da BMI na mai haƙuri ba.

Rashin aikin hanta

An yi nazarin tasirin cutar hanta a kan magunguna na Galvus® a cikin marasa lafiya da rauni mai rauni, matsakaici da matsanancin ƙarancin hanta a cewar Child-Pugh (daga maki 6 don laushi zuwa maki 12 don tsananin) idan aka kwatanta da marasa lafiya da ke kiyaye aikin hanta. Bayan kashi ɗaya na Galvus® (100 MG) a cikin marasa lafiya tare da rauni mai laushi zuwa matsakaici, an lura da raguwar bayyanar cutar a cikin ƙwayar cuta (da kashi 20% da 8%, bi da bi), yayin da a cikin marasa lafiya da raunin hepatic mai ƙarfi wannan wannan mai nuna ya ƙaru. da kashi 22 cikin dari. Tun da canji mafi girma (ƙaruwa ko raguwa) a cikin tsarin watsa shirye-shiryen Galvus® ya kusan 30%, wannan sakamakon ba a ɗauka da mahimmanci a asibiti. Babu wata alaka tsakanin tsananin tsananin cutar hanta da kuma girman canjin yanayin shigar Galvus®.

Ba'a ba da shawarar yin maganin Galvus® na miyagun ƙwayoyi ga marasa lafiya da ke fama da rauni na hanta, ciki har da halayen inda ƙimar ALT ko AST sun fi> sau 3 sama da iyakar babba na al'ada kafin a fara jiyya.

Paarancin aiki na haya

A cikin marasa lafiya da ke da rauni, matsakaici, da raunin ƙwaƙwalwar ƙwayar cuta, ƙimar AUC na vildagliptin ta ƙaru akan matsakaita 1.4, 1.7, da sau 2, bi da bi, idan aka kwatanta da marasa lafiya tare da aikin aikin kayyade. Darajar AUC na metabolite LAY151 ya karu da sau 1.6, 3.2 da 7.3, don metabolite BQS867 darajar ta karu a matsakaita kusan 1.5, 3 da 71.4, 2.7 da 7.3 a cikin marasa lafiya tare da m matsakaici da matsanancin aiki na haya, bi da bi, idan aka kwatanta da masu bada taimako na lafiya. A cikin marasa lafiya waɗanda ke da ƙarshen ƙarancin cutar koda, bayyanar cutar ta vildagliptin yana kama da fallasa a cikin marasa lafiya da gazawar ƙwayar cutar koda. A maida hankali ne LAY151 a cikin marasa lafiya da karshen-mataki cutar koda ya kusan 2-3 sau fi yadda a cikin marasa lafiya tare da mai girma na koda kasawa. A cikin marasa lafiya da ke fama da rauni na aikin ƙirar, ana iya buƙatar daidaita sashi (duba sashe "Sashi da Gudanarwa").

Fitowar vildagliptin ta hanyar hemodialysis yana da iyaka (3% a cikin awanni 3-4 na hemodialysis da aka yi 4 sa'o'i bayan an ɗauki kashi).

Pharmacokinetics a cikin Tsofaffi

A cikin tsofaffin batutuwa (≥70 shekara) waɗanda ba su da sauran cututtuka, akwai karuwa a cikin jimlar Galvus® (lokacin ɗaukar 100 MG sau ɗaya a rana) da 32% tare da haɓaka cikin ƙwayar plasma mafi girma da 18% idan aka kwatanta da lafiya batutuwa na ƙaramin. shekaru (18-40 years). Wadannan canje-canjen basu da mahimmancin asibiti. Arfin magungunan Galvus® don hana ayyukan DPP-4 bai dogara da shekarun mai haƙuri ba a cikin rukunin shekarun karatun.

Pharmacokinetics a cikin yara

Babu bayanai game da magungunan magungunan ƙwayoyi a cikin yara.

Babu wata shaida game da tasirin kabilanci akan magunguna na Galvus®.

Pharmacodynamics

Vildagliptin memba ne na ajin masu kara kuzari na kwayar insulin ta hanyar islet Kwayoyin na pancreas da kuma mai karfi mai inhibitor na dipeptidyl peptidase-4 (DPP-4), wanda aka tsara don inganta sarrafa glycemic.Sakamakon hanawa na DPP-4, matakan kwayoyin halittun ciki masu tasowa GLP-1 (glucagon-like peptide-1) da HIP (polypeptide-insulinotropic-insulinotropic polypeptide) suna ƙaruwa akan komai a ciki kuma bayan cin abinci.

Karɓar vildagliptin yana haifar da hanzarta cikakkiyar hana ayyukan DPP-4. A cikin marasa lafiya da ke dauke da ciwon sukari na 2, vildagliptin yana hana ayyukan enzyme DPP-4 na tsawon awanni 24.

Ta hanyar haɓaka matakan endogenous na waɗannan kwayoyin halittun da ke cikin jiki, vildagliptin yana ƙara haɓaka ƙwayoyin beta zuwa glucose, wanda ke haifar da karuwar glucose-dogara da insulin. Vildagliptin a cikin maganin yau da kullun na 50-100 MG yana inganta alamun alamun beta-cell a cikin marasa lafiya da ke fama da cutar sukari na 2. Matsakaicin haɓaka aikin ƙwayoyin beta ya dogara da matakin farko na rashin ƙarfi; a cikin mutane waɗanda ba sa fama da ciwon sukari mellitus (matakin glucose na al'ada), vildagliptin baya haɓakar insulin kuma ba ya rage matakin glucose.

Ta hanyar haɓaka matakin GLP na endogenous - 1, vildagliptin yana ƙara ƙwarewar ƙwayoyin alpha zuwa glucose, haɓaka glucose na glucose wanda ya wadatar. Bi da bi, hana isasshen ɓoyewar glucagon a cikin tasirin abinci yana taimakawa raguwar juriya insulin.

Improvedarin haɓakawa a cikin insulin / glucagon rabo saboda karuwar matakan hormones a lokacin hyperglycemia yana haifar da raguwar samar da glucose a cikin hanta akan komai a ciki kuma bayan cin abinci, don haka rage glycemia.

Ba a jinkirta ɓoye ƙwayar ƙwayar cuta, wanda shine ɗayan sanannun tasirin ƙarawar GLP-1, ba'a lura dashi ba yayin kulawa tare da vildagliptin. Bugu da ƙari, tare da yin amfani da vildagliptin, raguwa a cikin matakin lipemia bayan an lura da cin abinci, ba a haɗa shi da tasirin vildagliptin kan inganta aikin islet.

Alamu don amfani

Type 2 ciwon sukari mellitus:

kamar yadda monotherapy a hade tare da abinci da motsa jiki, da kuma a cikin marasa lafiya da contraindications zuwa far tare da metformin ko rashin haƙuri,

kamar yadda wani ɓangare na haɗakar haɗuwa biyu:

tare da metformin a cikin marasa lafiya da isasshen ikon sarrafa glycemic, duk da matsakaicin iyakar haƙuri tare da metformin monotherapy,

tare da sulfonylurea a cikin marasa lafiya da isasshen ikon sarrafa glycemic, duk da matsakaicin matsakaicin haƙuri da metformin monotherapy kuma a cikin marasa lafiya tare da contraindications zuwa metformin far ko rashin haƙuri,

tare da thiazolidinedione a cikin marasa lafiya da rashin isasshen iko na glycemic kuma a cikin marasa lafiya waɗanda suka dace da thiazolidinedione far,

kamar yadda wani bangare na maganin hadewar abubuwa uku tare da sulfonylurea da metformin, lokacin da abinci, motsa jiki, da kuma abubuwanda suka shafi jiki-biyu basa haifar da nasarar ingantaccen sarrafawar glycemic,

a hade tare da insulin (tare da ko ba tare da metformin ba), lokacin da abinci, motsa jiki, da tsayayyen kashi na insulin ba su haifar da isasshen sarrafawar glycemic.

Sashi da gudanarwa

Ana ɗaukar Galvus® a baki ba tare da la'akari da cin abinci ba.

Thewarin da aka ba da shawarar maganin a lokacin monotherapy ko kuma a matsayin ɓangare na maganin haɗin haɗakarwa guda biyu tare da metformin, thiazolidinedione ko kuma a matsayin ɓangare na maganin haɗin haɗuwa da abubuwa uku tare da sulfonylurea da metformin ko a hade tare da insulin, shine 100 MG a kowace rana, ana amfani da 50 MG da safe da 50 mg da yamma.

A matsayin ɓangare na maganin haɗakarwa biyu tare da sulfonylurea, maganin da aka ba da shawarar Galvus® shine 50 mg sau ɗaya a rana da safe. A cikin wannan rukuni na marasa lafiya, kashi 100 na MG kowace rana bai zama mafi tasiri ba fiye da kashi 50 na MG kowace rana.

Lokacin amfani dashi a hade tare da sulfonylurea, yi la'akari da rage yawan ƙwayar sulfonylurea don rage haɗarin cutar hypoglycemia.

Kada kuyi amfani da allurai fiye da 100 MG.

Idan mara lafiya bai dauki maganin a kan lokaci ba, ya kamata a dauki Galvus® da zaran mara lafiyar ya tuna wannan. Kada ku yi amfani da kashi biyu a ranar.

Aminci da tasiri na vildagliptin a matsayin ɓangare na maganin haɗin haɗakar abubuwa uku tare da metformin da thiazolidinedione ba a kafa su ba.

Informationarin bayani game da rukunin masu haƙuri na musamman

Tsofaffi marasa lafiya (≥ 65 shekara)

Lokacin da ake tsara magunguna ga marasa lafiya tsofaffi, ba a buƙatar daidaita sashi.

Marasa lafiya tare da nakasa aiki na renal

Ba a buƙatar daidaitawa ba lokacin da ake tsara magunguna ga marasa lafiya da matakin farko na gazawar renal (tare da sharewar in 50 ml / min). A cikin marasa lafiya da ke cikin matsakaiciyar rauni ko gazawar koda ko kuma tare da cutar koda, matakin da aka bada shawarar Galvus® shine 50 mg sau ɗaya a rana.

Marasa lafiya tare da nakasa aikin hanta

Galvus® bai kamata a wajabta shi ga marasa lafiya da ke fama da aikin hanta mai rauni ba, ciki har da marasa lafiya da aka fara jiyya, tare da karuwar ayyukan alanine aminotransferase (ALT) ko aspartate aminotransferase (AST)> sau 3 idan aka kwatanta da babba na al'ada (VGN).

Yara da matasa a cikin shekaru 18

Ba'a ba da shawarar sanya magunguna ga yara da matasa masu shekaru 18 da haihuwa ba. Ba a samun bayanai game da tasiri da amincin amfani da miyagun ƙwayoyi Galvus® a cikin yara da matasa a ƙarƙashin shekara 18 ba.

Side effects

Lokacin amfani da Galvus® azaman monotherapy ko a hade tare da wasu kwayoyi, yawancin raunin da aka samu sun kasance masu laushi, na ɗan lokaci, kuma baya buƙatar dakatar da ilimin. Ba a sami daidaituwa ba tsakanin yawan lokutan bala'i da shekaru, jinsi, ƙabila, tsawon lokacin amfani, ko tsarin allura.

Ana rarrabe halayen masu biyo baya ta hanyar yawan faruwa, tare da mafi yawan abin da aka nuna da farko.

Lokacin amfani da miyagun ƙwayoyiGalvus®kamar yadda monotherapy

Lokacin amfani da Galvus® a kashi 50 MG 1 lokaci / rana ko 2 sau / rana, yawan dakatarwar aikin jiyya saboda haɓakar halayen sakamako (0.2% ko 0.1%, bi da bi) bai kasance sama da wannan ba a cikin rukunin placebo (0.6%) ko magungunan kwatancen ( 0,5%).

A kan asalin maganin monotherapy tare da Galvus® a cikin kashi 50 na MG 1 lokaci / rana ko 2 sau / rana, abin da ya faru na hypoglycemia ba tare da ƙara yawan yanayin yanayin ya kasance 0.5% (2 mutane daga 409) ko 0.3% (4 cikin 1,082), wanda yake daidai da miyagun ƙwayoyi kwatancen da placebo (0.2%). Lokacin amfani da miyagun ƙwayoyi Galvus® a cikin hanyar monotherapy, babu karuwa a cikin nauyin jikin mai haƙuri.

Kulawar enzyme

Akwai rahotannin da ba a sani ba game da alamun cututtukan cututtukan hepatic (ciki har da hepatitis), wanda, a matsayin mai mulkin, asymptomatic kuma ba shi da sakamako na asibiti. Kamar yadda sakamakon binciken ya nuna, aikin hanta ya koma al'ada bayan dakatar da ilimin. Kafin fara jiyya tare da Galvus®, ya zama dole a duba aikin hanta don sanin ƙimar farko. Yayin kulawa tare da Galvus®, ya kamata a kula da aikin hanta a kowane watanni uku a cikin shekarar farko kuma a lokaci-lokaci ana dubawa daga baya. Idan mai haƙuri yana da ƙarin aiki na aminotransferases, wannan binciken yakamata a tabbatar da shi ta hanyar binciken na biyu, sannan kuma a kai a kai ƙayyade sigogin ƙirar ƙwayar ƙwayar halittar hanta har sai sun daidaita. Idan ayyukan AST ko ALT sun kasance sau 3 ko sama da iyakar babba na al'ada, ana bada shawara a soke maganin.

Tare da haɓaka jaundice ko wasu alamun aikin hanta mai rauni tare da yin amfani da Galvus®, ya kamata a dakatar da maganin ƙwayar cuta nan da nan. Bayan daidaita alamomin aikin hanta, ba za a iya dawo da magani ba.

Binciken asibiti game da vildagliptin a cikin marasa lafiya da ke da aji I-III na aiki bisa ga rarrabuwa da Associationungiyar Zuciya ta New York (NYHA) ta nuna cewa maganin vildagliptin baya tasiri a aikin hagu ko tashin hankali na rashin wadatar zuciya idan aka kwatanta da placebo. Kwarewar asibiti a NYHA aikin aji na marasa lafiya III masu shan vildagliptin suna da iyaka kuma babu sakamakon da aka kammala.

Babu wani gogewa game da amfani da vildagliptin a cikin gwaji na asibiti a cikin marasa lafiya tare da aji na aikin III bisa ga NYHA kuma, sabili da haka, ba a ba da shawarar amfani da waɗannan marasa lafiya ba.

A lokacin binciken da yakamata a jikin yatsun, an yi rikodin raunukan fata, gami da blister da ulcers. Kodayake ba a sami karuwa ba a raunukan fata yayin gwaji na asibiti, akwai iyakance kwarewa game da kula da marasa lafiya da cututtukan fata tare da ciwon sukari. Bugu da kari, rahotanni kan abin da ya faru na rauni na fata mai ban mamaki da fatawoyi sun sami karbuwa a lokacin tallan-bayan-tallace. Sabili da haka, lokacin rubuta magani, ana bada shawara ga marasa lafiya da masu ciwon sukari don saka idanu don cututtukan fata irin su blisters ko ulcers.

Amfani da vildagliptin yana da alaƙa da haɗarin haɓaka cutar hanji mai ƙwayar cuta.

Yakamata a sanar da marassa lafiya game da alamomin bayyanar cututtukan cututtukan cututtukan zuciya.

Idan akwai shakku na pancreatitis, ya kamata a dakatar da amfani da miyagun ƙwayoyi, idan an tabbatar da maganin pancreatitis, to bai kamata a sake farawa da maganin Galvus® ba. Dole ne a yi taka tsantsan lokacin amfani da miyagun ƙwayoyi a cikin marasa lafiya tare da tarihin mummunan ciwon ƙwayar cuta.

Kamar yadda kuka sani, sulfonylurea yana haifar da hypoglycemia. Marasa lafiya suna ɗaukar vildagliptin a hade tare da sulfonylurea suna haɗarin haɗarin haɓakar hypoglycemia. Ana iya buƙatar rage ƙwayar sulfonylurea don rage haɗarin cutar hypoglycemia.

Allunan suna dauke da lactose. Marasa lafiya tare da rashin haƙuri na fructose, ƙarancin Lappase, karancin ƙwayar glucose - galactose bai kamata yayi amfani da Galvus® ba.

Ciki da lokacin shayarwa

Babu cikakkun bayanai game da amfani da Galvus® a cikin mata masu juna biyu. Karatun dabbobi sun nuna ƙwayar haihuwa yayin amfani da ƙwayoyi masu ƙwayoyi. Ba a san yiwuwar haɗarin ga mutane ba. Saboda ƙarancin bayanai game da bayyanar ɗan adam, bai kamata a yi amfani da maganin ba lokacin daukar ciki.

Ba'a san ko an rage vildagliptin a cikin madara ba. Nazarin dabbobi sun nuna sakin vildagliptin cikin madara. Bai kamata a yi amfani da Galvus® ba yayin shayarwa.

Ba a gudanar da bincike kan tasirin Galvus® akan haihuwa ba.

Siffofin tasiri na miyagun ƙwayoyi akan karfin tuka motoci ko wasu hanyoyin haɗari

Ba a gudanar da nazari kan tasirin Galvus® akan iya tuki motocin ko wasu hanyoyin ba. Tare da ci gaba da wahala a lokacin jiyya tare da miyagun ƙwayoyi, marasa lafiya kada su fitar da motoci ko aiki tare da hanyoyin.

Yawan abin sama da ya kamata

Kwayar cutar lokacin amfani da miyagun ƙwayoyi a kashi na 400 MG / rana, ana iya lura da raunin ƙwayar tsoka, da wuya, huhu da tashin hankali, zazzabi, edema da haɓakawa na lokaci a cikin lipase maida hankali (2 sau mafi girma fiye da VGN). Tare da karuwa a cikin kashi na Galvus® zuwa 600 mg / rana, haɓakar edema na ƙarshen tare da paresthesias da haɓakar taro na CPK, ALT, furotin C-reactive da myoglobin mai yiwuwa ne. Duk alamun bayyanar cutar shaye-shaye da canje-canje a cikin ma'aunin dakin gwaje-gwaje sun ɓace bayan dakatar da miyagun ƙwayoyi.

Jiyya: cire miyagun ƙwayoyi daga jiki tare da cutar hemodialysis ba zai yiwu ba. Ko yaya, babban hydrolytic metabolite na vildagliptin (LAY151) za'a iya cire shi daga jiki ta hanyar hemodialysis.

Rijistar Rijistar Rijista

Novartis Pharma AG, Basel, Switzerland

Adireshin kungiyar da ke karbar bakuncin yankin Kazakhstan

da'awar daga mabukaci kan ingancin samfurin (samfurin)

Reshen of Novartis Pharma Services AG a Kazakhstan

050051 Almaty, st. Lugansk, 96

tel.: (727) 258-24-47

fax: (727) 244-26-51

2014-PSB / GLC-0683-s kwanan wata 07/30/2014 da EU SmPC

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