Jardins - umarnin * amfani don amfani

INGANTA
a kan amfani da miyagun ƙwayoyi
JARDINS

Fom ɗin saki
Allunan mai rufe fim

Abun ciki
Kwamfutar hannu 1 ya ƙunshi:
abu mai aiki: empagliflozin 10 da 25 MG
tsofaffi: lactose monohydrate, microcrystalline cellulose, hyprolose (hydroxypropyl cellulose), sirinum croscarmellose, silloon silicon dioxide, magnesium stearate.
Abun fim: opadry rawaya (02B38190) (hypromellose 2910, titanium dioxide (E171), talc, macrogol 400, daskararren baƙin ƙarfe baƙin ƙarfe oxide (E172).

Kamawa
Allunan 10 da 30.

Aikin magunguna
Jardins - Mai hana Jirgin ruwan Siriz na Sigin guda 2 na Inhibitor

Jardins, alamu don amfani
Type 2 ciwon sukari mellitus:
kamar yadda monotherapy a cikin marasa lafiya da rashin isasshen iko glycemic kawai a kan tushen abinci da motsa jiki, alƙawarin metformin wanda ake ganin bai dace ba saboda rashin haƙuri,
azaman hanyar haɗin gwiwa tare da sauran jamiái na hypoglycemic, ciki har da insulin, lokacin da maganin da aka yi amfani da shi tare da abinci da motsa jiki ba ya ba da ikon sarrafa glycemic da ake bukata.

Contraindications
hypersensitivity ga kowane bangaren na miyagun ƙwayoyi,
nau'in ciwon sukari guda 1
mai ciwon sukari ketoacidosis,
rikicewar cututtukan hereditary (rashi lactase, rashin haƙuri a cikin lactose, glucose-galactose malabsorption),
gazawar koda tare da GFR ×

Tsari sashi:

Bayanin
Allunan kwayoyi 10
Zoben biconvex mai zagaye tare da yanke gefuna, an rufe shi da murfin fim na launin rawaya mai haske tare da zanen alamar kamfanin a gefe ɗaya na kwamfutar hannu da kuma "S10" a gefe guda.
Allunan 25 MG
Allunan biconvex mai kyau tare da gefuna da aka yanke, an rufe shi da membrane fim na launin rawaya mai haske, aka zana shi tare da alamar kamfanin a gefe ɗaya na kwamfutar hannu da kuma "S25" a gefe guda.

Kayan magunguna

Pharmacokinetics
An yi nazarin magungunan likitanci na empagliflozin a cikin masu ba da agaji na lafiya da kuma a cikin marasa lafiya da ke fama da ciwon sukari na 2.
Damuwa
Bayan gudanar da maganin baka, an kwantar da empagliflozin cikin sauri, mafi girman maida hankali na empagliflozin a cikin jini (Cmax) ya kai bayan sa'o'i 1.5. Sannan, maida hankali na empagliflozin a cikin plasma ya ragu a matakai biyu.
Bayan karɓar empagliflozin, matsakaicin yanki a ƙarƙashin tsarin lokacin-lokaci (AUC) yayin ɗaukar matakan-ƙasa na plasma shine 4740 nmol x h / l, da Cmax - 687 nmol / l.
Kasuwancin magunguna na empagliflozin a cikin masu sa kai masu lafiya kuma a cikin marasa lafiya da ke da nau'in ciwon sukari na 2 sun kasance iri ɗaya ne.
Cin abinci ba shi da tasiri mai mahimmanci a asibiti kan magunguna na empagliflozin.
Rarraba
Ofarancin rarrabuwa yayin aiwatar da yanayin-daidaitaccen ƙwaƙwalwar ƙwaƙwalwar ƙasa ya kai kimanin lita 73.8. Bayan sarrafawar baka ta hanyar kwararrun masu ba da agaji na masu alama mai taken 14 C, nauyin plasma yana da kashi 86%.
Tsarin rayuwa
Babban hanyar metabolism na empagliflozin a cikin mutum shine glucuronidation tare da halartar uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 da UGT1A9. Mafi yawan abubuwan da aka gano ana amfani dasu na empagliflozin sune conjugates glucuronic guda uku (2-0, 3-0 da 6-0 glucuronides). Sakamakon tsarin tsari na kowane metabolite karami ne (kasa da 10% na yawan tasirin empagliflozin).
Kiwo
Bayanin rabin rayuwa sunkai kimanin awa 12.4. Game da amfani da empagliflozin sau daya a rana, an sami daidaituwa ta plasma bayan anci kashi na biyar. Bayan aiwatar da maganin baka na alama mai taken 14 C a cikin masu sa kai masu lafiya, kusan kashi 96% na kashi an cire shi (ta hanjinsu kashi 41% da kodan 54%). Ta hanyar hanji, yawancin magungunan da aka yiwa lakabi an cire su. Kashi rabi na magungunan da aka yi wa lakabi da kodan ba su sake su ba.
Pharmacokinetics a cikin yawan haƙuri na musamman
Paarancin aiki na haya
A cikin marasa lafiya da ke da sassauci, matsakaici, da gazawar haɓaka na yara (30 2) kuma a cikin marasa lafiya da gazawar ƙarancin ƙaddamarwar ƙaddamarwa, ƙungiyar ta AUC na empagliflozin ya karu, bi da bi, game da 18%, 20%, 66%, da 48% idan aka kwatanta da marasa lafiya da al'ada aikin koda. A cikin marasa lafiya da gazawar matsakaiciyar matsakaici kuma cikin marasa lafiya da gazawar ƙarshen matakin ƙaddamarwa, matsakaicin mafi girman plasma na empagliflozin ya yi daidai da ƙimar da aka daidaita a cikin marasa lafiya tare da aikin na koda. A cikin marasa lafiya da rauni mai rauni da gazawa mai rauni, matsakaicin yawan plasma na empagliflozin ya kusan 20% mafi girma fiye da marasa lafiya tare da aikin na al'ada. Bayanan bincike na ƙididdigar yawan jama'a ya nuna cewa ƙarshen sharewar empagliflozin ya ragu tare da rage GFR, wanda ya haifar da karuwa a sakamakon ƙwayar.
Rashin aikin hanta
A cikin marasa lafiya waɗanda ke fama da rauni na hanta na matsakaici, matsakaici da matsanancin ƙarfi (bisa ga ƙididdigar Yara-Pugh), ƙimar AUC na empagliflozin ya karu, bi da bi, kusan kashi 23%, 47% da 75%, da dabi'un Stax, bi da bi, kimanin 4%, 23 % da 48% (idan aka kwatanta da marasa lafiya tare da aikin hanta na al'ada).
Tashin jikin mutum, jinsi, tsere da shekaru ba shi da tasiri mai tasiri a asibiti kan magunguna na empagliflozin.
Yara
Ba a gudanar da karatun likitancin magungunan empagliflozin a cikin yara ba.

Contraindications

• Rashin hankali ga kowane bangare na miyagun ƙwayoyi,
• Type 1 ciwon sukari
• Ketoacidosis mai ciwon sukari
• Rashin raunin gado (rashin lactase, rashin haƙuri a cikin lactose, glucose-galactose malabsorption),
• Rashin nasara a cikin GFR 2 (saboda rashin aiki),
• Ciki da lactation,
• Sama da shekara 85
• Amfani a hade tare da analogues na glucagon-kamar peptide 1 (saboda rashin bayanai akan inganci da aminci),
• Yara underan shekaru 18 (saboda karancin bayanai akan inganci da aminci).

Side sakamako
Gaba ɗaya abubuwan haɗari a cikin marasa lafiya da ke karɓar empagliflozin ko placebo a cikin gwaji na asibiti sun yi kama. Abubuwan da suka fi dacewa da mummunan tasirin shine hypoglycemia, wanda aka lura tare da yin amfani da empagliflozin a hade tare da maganin sulfonylurea ko abubuwan insulin (duba bayanin yanayin halayen mutum).
An gabatar da halayen mara kyau a cikin marasa lafiya da ke karɓar empagliflozin a cikin nazarin sarrafa-inbos a cikin Tebur da ke ƙasa (an daidaita halayen da suka dace da gabobin da tsarin kuma daidai da sharuɗɗan da MedDRA suka zaɓa) tare da nuni da cikakken adadin su. An bayyana nau'ikan nau'in rarrabuwa kamar haka: sosai akai (> 1/10), akai-akai (daga>, 1/100 zuwa> 1/1000 zuwa> 1/10000 zuwa Bayanin halayen mutum masu illa
Hypoglycemia
Abinda ya faru na hypoglycemia ya dogara ne akan maganin kwantar da hankali wanda aka yi amfani dashi.
Matsakaicin hypoglycemia (glucose jini 3.0 - 3.8 mmol / L (54-70 mg / dl)) Halin da aka samu mai laushi ya kasance daidai a cikin marasa lafiya suna ɗaukar empagliflozin ko placebo a matsayin monotherapy, kamar yadda kuma a cikin batun ƙara empagliflozin zuwa metformin da a cikin batun ƙari na empagliflozin zuwa pioglitazone (± metformin). Lokacin da aka ba da empagliflozin a hade tare da kayan aikin metformin da sulfonylurea, abin da ya faru na hypoglycemia ya kasance mafi girma (10 mg: 10.3%, 25 mg: 7.4%) fiye da tare da placebo a cikin haɗin guda (5.3%).
Mai tsananin rashin ƙarfi a cikin jini (glucose jini a ƙasa da 3 mmol / L (54 mg / dL)
Abinda ya faru na rashin ƙarfi na jini ya kasance iri ɗaya a cikin marasa lafiya suna ɗaukar empagliflozin da placebo azaman monotherapy. Lokacin da aka ba da empagliflozin a hade tare da abubuwan da suka faru na metformin da sulfonylurea, abin da ya faru na hypoglycemia ya kasance mafi girma (10 mg: 5.8%, 25 mg: 4.1%) fiye da tare da placebo a cikin haɗin guda (3.1%).
Urin saurin hanzari
Mitar karuwar urination (alamu kamar su pollakiuria, polyuria, nocturia an kimanta su) sun kasance tare da empagliflozin (a kashi 10 mg: 3.4%, a kashi na 25 MG: 3.2%) fiye da na placebo (1 %). Abinda ya faru da nocturia ya kasance daidai a cikin rukuni na marasa lafiya suna shan empagliflozin kuma a cikin rukuni na marasa lafiya suna shan placebo (ƙasa da 1%). Intensarfafa waɗannan tasirin sakamako masu laushi ne ko matsakaici.
Kwayar cututtukan hanji
Hatsarin cututtukan urinary fili ya kasance daidai da empagliflozin 25 MG da placebo (7.6%), amma mafi girma tare da empagliflozin 10 MG (9.3%). Kamar yadda yake da placebo, cututtukan urinary fili tare da empagliflozin sun kasance mafi yawan jama'a a cikin marasa lafiya da tarihin cututtukan cututtukan hanji da na hanji da ke komawa baya. Abinda ya faru da cututtukan urinary fili sun kasance iri ɗaya a cikin marasa lafiya suna shan empagliflozin da placebo. Cutar cututtukan hanji ta fi yawa a cikin mata.
Cutar cututtukan ciki
Halin da ke faruwa na haɗari kamar su candidiasis na farji, vulvovaginitis, balanitis da sauran cututtukan ƙwayar cuta sun kasance mafi girma tare da empagliflozin (a kashi 10 mg: 4.1%, a kashi na 25 MG: 3.7%) fiye da na placebo (0 , 9%). Yawancin cututtukan maza sun fi yawa a cikin mata. Intensarfin cututtukan ƙwayar cuta ya kasance mai sauƙi ko matsakaici.
Hypovolemia
Halin da ke faruwa na hypovolemia (wanda aka nuna da raguwa a cikin karfin jini, orthostatic artpot hypotension, dehydration, fainting) ya kasance iri ɗaya a cikin yanayin empagliflozin (a kashi 10 mg: 0.5%. A kashi na 25 MG: 0.3%) da placebo (0, 3%). A cikin marasa lafiya waɗanda suka girmi shekaru 75, abin da ya faru na hypovolemia ya kasance daidai a cikin marasa lafiya suna shan empagliflozin a kashi 10 mg (2.3%) da placebo (2.1%), amma mafi girma a cikin marasa lafiya suna shan empagliflozin a kashi na 25 MG (4.4%) )

Yawan abin sama da ya kamata

Yin hulɗa tare da wasu kwayoyi
A cikin kimantawar hulɗa da magunguna na vitro
Empagliflozin baya hana, hana aiki, ko sa CYP450 isoenzymes. Babban hanyar metabolism na mutum shine glucuronidation tare da halartar uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 da UGT1A9. Empagliflozin baya hana UGT1A1. Abun hulɗa na miyagun ƙwayoyi na empagliflozin da kwayoyi waɗanda suke musanyawa da CYP450 da UGT1A1 isoenzymes ana ɗaukarsu ba zato bane.
Empagliflozin shine madadin sinadarai na glycoprotein P (P-gp) da furotin na maganin nono (BCRP). amma a allurai warkewa baya hana wadannan kariyar. Dangane da bayanai daga binciken in vitro, an yi imanin cewa ikon empagliflozin don yin hulɗa tare da kwayoyi waɗanda ke canza abubuwa don glycoprotein P (P-gp) ba zato ba tsammani. Empagliflozin shine maɓallin jirgi mai ɗaukar kwayoyin: OATZ, OATP1B1 da OATP1VZ, amma ba gurbi bane ga masu ɗaukar jigilar kwayoyin 1 (OAT1) da masu ɗaukar kwayoyin cationic 2 (OST2). Koyaya, hulɗa da miyagun ƙwayoyi na empagliflozin tare da kwayoyi waɗanda ke canza magungunan kariyar da aka bayyana a sama ana ɗaukarsu ba zato bane.
A cikin tantancewar magungunan vivo
Magungunan magunguna na empagliflozin ba su canzawa a cikin masu sa kai na lafiya lokacin da aka yi amfani dasu tare da metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide da hydrochlorothiazide. Haɗewar amfani da empagliflozin tare da gemfibrozil, rifampicin da probenecid sun nuna karuwa a cikin AUC na empagliflozin da kashi 59%, 35% da 53%, bi da bi, amma ba a la'akari da waɗannan canje-canjen a matsayin mai mahimmanci.
Empagliflozin bashi da tasiri mai tasiri a asibiti akan magunguna na metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin. digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide da rigakafi na baka.
Diuretics
Empagliflozin na iya inganta tasirin cutar ta thiazide da “madauki”, wanda a biyun na iya kara hadarin rashin ruwa da jijiyoyin jini.
Insulin da kwayoyi wadanda ke inganta sirrinta
Insulin da kwayoyi waɗanda ke inganta sirrinsa, irin su sulfonylureas, na iya ƙaruwa da haɗarin cututtukan jini. Sabili da haka, tare da amfani da empagliflozin na lokaci guda tare da insulin da kwayoyi waɗanda ke haɓaka ƙwarewar ta, yana iya zama dole don rage adadin su, don guje wa haɗarin cutar hypoglycemia.

Umarni na musamman

Tasiri kan iya tuka motoci da injinan
Karatuttukan asibiti akan tasirin empagliflozin akan ikon tuka motoci da abubuwan da ba'a gudanar dasu ba. Marasa lafiya suyi hankali lokacin tuki motoci da abubuwan sarrafawa, tunda lokacin amfani da JARDINS miyagun ƙwayoyi (musamman a hade tare da abubuwan da ake amfani da su na sulfonylurea da / ko insulin), ƙwanƙwasa jini na iya haɓaka.

Mai masana'anta

Suna da adireshin wurin kera kayayyakin magani
Beringer Ingelheim Pharma GmbH & Co.KG
Binger Strasse 173, 55216 Ingelheim am Rhein, Jamus

Kuna iya samun ƙarin bayani game da miyagun ƙwayoyi, kamar yadda ku aika kukanku da bayani game da mummunan lamari ga adireshin da ke gaba a Rasha
LLC Beringer Ingelheim
125171. Moscow, Leningradskoye Shosse, 16A shafi 3

Jardins kwayoyin hana daukar ciki

Waɗannan allunan da aka sanya a fim. Bayyanar yanayin: haske rawaya, m ko zagaye (dangane da sashi), ƙira - allunan biconvex tare da yanke gefuna da alamomin kamfanin masana'antun a gefe ɗaya. An samar da magani a Jamus don rage glucose jini a cikin nau'in ciwon sukari na 2.

Magungunan hypoglycemic na baka, tare da abu mai aiki - empagliflosin. Cikakken abun da ke ciki da kuma sigogi yana nunawa a cikin tebur:

Sashi 1 kwamfutar hannu (MG)

launin rawaya opadray (hypromellose, titanium dioxide, talc, macrogol, iron dye oxide yellow)

Aikin magunguna

Empagliflozin mai iya canzawa ne, yana aiki sosai, mai hanawa mai ɗaukar jigilar glucose mai lamba 2 wanda ke ɗaukar mai. An tabbatar da shi a kimiyance cewa empagliflozin yana da zaɓi sosai don sauran masu jagoranci waɗanda ke da alhakin glucose homeostasis a cikin kyallen kayan jiki. Abun yana da tasirin glycemic a cikin marasa lafiya da ke dauke da ciwon sukari na 2 ta hanyar rage yawan sukari a cikin kodan. Yawan glucose din da wannan injin din ya fito kai tsaye ya dogara da yawan rubin kayan halittar kananan yara na kodan.

Nazarin ya nuna cewa a cikin marasa lafiya da ke dauke da ciwon sukari na 2, yawan glucose ya keɓance bayan kwayar ta farko da aka ɗauka kuma tasirin ya ci kwana ɗaya. Wadannan alamun suna wanzuwa yayin shan 25 MG na empagliflozin na tsawon wata daya. Asedara yawan fitar da sukari da ƙodan ya haifar da rage yawan haɗuwarsa cikin jinin mai haƙuri. Magungunan yana rage taro glucose a cikin jini, ba tare da la'akari da yawan abinci ba.

Abun da ke cikin insulin-mai zaman kansa yana rage hadarin cututtukan hypoglycemia.Hanyar aiwatar da aiki mai aiki baya dogara da aikin tsibirin Langerhans da metabolism metabolism. Masana kimiyya sun lura da tasirin sakamako na empagliflozin akan ƙananan peptides na ayyukan aikin waɗannan sel. Asedara yawan motsawar glucose yana haifar da asarar adadin kuzari, wanda ke rage nauyin jiki. Yayin amfani da empagliflozin, ana lura da glucosuria.

Alamu don amfani

An nuna shi ga marasa lafiya da nau'in ciwon sukari na 2 a kan tsayayyen abinci da wasa wasanni, wanda ba shi yiwuwa a sarrafa alamu daidai. Tare da rashin haƙuri na Metformin, monotherapy tare da Jardins mai yiwuwa ne. Idan ilimin ba shi da wani tasiri da ya dace, yin amfani da haɗin gwiwa tare da sauran magunguna na hypoglycemic, gami da insulin, mai yiwuwa ne.

Jardins

Allunan ana ɗaukarsu a baki, ko da kuwa lokacin rana ko abinci. An bada shawarar fara shan tare da 10 MG kowace rana, idan ingantaccen sakamako bai faru ba, to sai ku ƙara zuwa 25 MG. Idan saboda wasu dalilai basu dauki maganin ba, to ya kamata ku sha shi nan da nan, kamar yadda suka tuna. Ba za a iya cinye biyu ba. Game da aikin hanta mai rauni, ba a buƙatar gyara, kuma ba a yarda wa masu haƙuri da cututtukan koda.

A lokacin daukar ciki

Yin amfani da Allunan yayin daukar ciki yana tazara ne sakamakon karancin bayanai daga binciken inganci da aminci. Nazarin dabbobi na preclinical sun nuna alama ta yiwuwar ɓoyewar empagliflozin a cikin jinin uteroplacental. Hadarin kamuwa da tayin da mahaifa baya cikin su. Idan ya cancanta, kuna buƙatar dakatar da shan maganin yayin daukar ciki.

A lokacin ƙuruciya

Jiyya tare da miyagun ƙwayoyi a cikin yara da matasa a karkashin 18 an ƙaura sosai. Haɗin kai tare da isasshen bayanan bincike. Ba a tabbatar da ingancin da amincin abu mai ƙarfi ba. Don cire haɗarin cutar da lafiyar yara, an haramta Jardins. Gara a zabi wani magani wanda aka yarda dashi.

Hotunan 3D

Bayanin sigar sashi

Allunan 10 MG: zagaye biconvex tare da yanke gefuna, an rufe shi da membrane fim na launi mai launin rawaya, tare da zanen alamar kamfanin a gefe guda kuma “S10” a gefe guda.

Allunan 25m: m biconvex tare da yanke gefuna, an rufe shi da membrane fim na launin rawaya mai haske, aka zana shi tare da alamar kamfanin a gefe guda kuma “S25” a gefe guda.

Pharmacodynamics

Empagliflozin mai iya canzawa ne mai aiki mai mahimmanci wanda zai iya yin gwagwarmaya mai hana nau'in mai 2 sodium-dogara mai jigilar glucose tare da maida hankali da ake buƙata don hana 50% na aikin enzyme (IC₅₀), daidai yake da nmol 1.3. Zaɓin empagliflozin sau 5,000 sau mafi girma daga zaɓi na nau'in 1 sodium-dogara mai ɗaukar glucose, wanda ke da alhakin ɗaukar glucose a cikin hanji. Bugu da kari, an gano cewa empagliflozin yana da babban zaɓi don sauran masu jigilar glucose masu alhakin glucose homeostasis a cikin kyallen iri daban-daban.

Sodium-dogara mai jigilar glucose nau'in 2 shine babban furotin mai ɗaukar nauyi wanda ke da alhakin sake sarrafa glucose daga koda na glomeruli a cikin jini. Empagliflozin yana inganta kulawar glycemic a cikin marasa lafiya da ke dauke da nau'in ciwon sukari guda 2 (T2DM) ta rage rage ƙwayar abinci na koda. Yawan glucose din da kodan ke amfani da wannan kayan ya dogara da tattarawar glucose a cikin jini da GFR. Haramcin jigilar mai dauke da nauyin ƙwayar sodium mai nau'in 2 a cikin marasa lafiya da ke ɗauke da ciwon sukari na 2 da hauhawar jini ke haifar da kawar da yawan ƙwayar glucose da kodan.

A cikin binciken asibiti na mako-mako 4, an gano cewa a cikin marasa lafiya da ke da nau'in ciwon sukari na 2, haɓakar glucose na koda ya tashi nan da nan bayan an yi amfani da kashi na farko na empagliflozin, wannan sakamako ya ci gaba na sa'o'i 24. Ci gaba da haɓakar ƙoshin koda ya ci gaba har zuwa ƙarshen jiyya, adadin kashi 25 na MG sau 1 a rana, akan matsakaita kimanin 78 g / day. A cikin marasa lafiya da ke dauke da ciwon sukari na 2, haɓakar haɓakar glucose ta hanta ya haifar da raguwar hanzarin ƙwayar glucose a cikin jini.

Empagliflozin (a kaso na 10 da 25 MG) yana rage yawan haɗuwar glucose a cikin jini na jini a batun yin azumi da bayan cin abinci.

Hanyar aikin empagliflozin baya dogara da yanayin aikin ƙwayoyin beta na pancreatic da metabolism metabolism, wanda ke ba da gudummawa ga ƙananan haɗarin yiwuwar haɓakar haɓakar jini. Abubuwan sakamako masu kyau na empagliflozin akan alamun alamu na aikin kwayar beta, gami da tsarin HOMA-β (samfurin don kimanta homeostasis-B) da kuma rabo na proinsulin zuwa insulin, an lura. Bugu da ƙari, ƙarin kawarda glucose ta hanta yana haifar da asarar adadin kuzari, wanda ya biyo tare da rage yawan ƙwayar adipose da raguwar nauyin jiki.

Glucosuria ya lura yayin amfani da empagliflozin yana haɗuwa tare da ɗan ƙara ƙarancin diureis, wanda zai iya ba da gudummawa ga raguwar matsakaici a cikin jini.

A cikin nazarin asibiti inda aka yi amfani da empagliflozin a cikin hanyar monotherapy, maganin haɗi tare da metformin, maganin haɗin gwiwa tare da metformin a cikin marasa lafiya da sabon ciwon sukari na 2, haɗuwa tare da maganin metformin da magungunan sulfonylurea, haɗuwa tare da pioglitazone +/− metformin, haɗuwa tare da linagliptin a marasa lafiya da sabon cutar sukari mellitus 2, hadewar magani tare da linagliptin, an kara zuwa maganin metformin, maganin hade tare da linagliptin idan aka kwatanta da paracet o a cikin marasa lafiya da rashin isasshen kulawar glycemic yayin shan linagliptin da metformin, haɗin haɗi tare da metformin a kan glimepiride (bayanai daga binciken shekaru 2), haɗuwa tare da insulin (yawancin insulin allurar allura) +/− metformin, haɗuwa tare da maganin insalin , haɗin haɗi tare da mai hana DPP-4 inhibitor, metformin +/− wani maganin ƙwaƙwalwar ƙwayar cuta na hypoglycemic, an tabbatar da raguwar ƙididdiga a HbA1_c, raguwa a cikin kwantar da hankalin glucose na jini, da kuma raguwa a hawan jini da nauyin jikin mutum.

Nazarin asibiti ya bincika tasirin magungunan Jardins ® kan yawan abubuwan da suka faru na jijiyoyin jini a cikin marasa lafiya da ke da nau'in ciwon sukari na 2 da babban haɗarin zuciya (wanda aka ayyana a matsayin kasancewar aƙalla ɗaya daga cikin cututtukan da / ko yanayi: cututtukan hanta na jijiyoyin jini (tarihin cutar sankara, sanadin bugun zuciya da jijiyoyin zuciya). , IHD tare da lalacewar jirgin ruwa na gudawa, IHD tare da lalacewar tasoshin jijiyoyin jini da yawa), tarihin ischemic ko bugun jini, cututtukan jijiyoyi tare da ko ba tare da alamu ba) suna karbar daidaitattun hydrochloric far, wanda ya hada hypoglycemic jamiái da kuma jamiái domin lura da cututtuka na zuciya cututtuka. An tantance cututtukan cututtukan zuciya, rashin rauni mai rauni na rauni da rashin bugun jini a matsayin matakin farko. Mutuwar zuciya, mutuwar gabaɗaya, haɓakar nephropathy ko haɓaka ci gaba da ƙwaƙwalwar ƙwayar cuta, da kuma asibiti don gazawar zuciya kamar yadda aka zaɓi ƙarin ƙarshen tsinkaye.

Empagliflozin ya inganta rayuwar gabaɗaya ta hanyar rage yawan cututtukan zuciya. Empagliflozin ya rage hadarin asibiti don rashin zuciya. Hakanan, a cikin binciken asibiti, an nuna cewa miyagun ƙwayoyi Jardins the sun iya rage haɗarin cutar nephropathy ko ci gaba da haɓaka na nephropathy.

A cikin marasa lafiya tare da macroalbuminuria na farko, an gano cewa maganin Jardins ® yana da muhimmanci sosai sau da yawa idan aka kwatanta da placebo wanda ya haifar da tsayayyen Normo- ko microalbuminuria (rabo hadarin 1.82, 95% CI: 1.4-2.37).

Pharmacokinetics

An yi nazarin magungunan likitanci na empagliflozin a cikin masu ba da agaji na lafiya da marasa lafiya da ke fama da ciwon sukari na 2.

Damuwa. Empagliflozin bayan maganin baka yana da sauri a hankali, C_max Ya isa cikin plasma bayan awa 1.5. Sa’annan, yawan faduwar empagliflozin a cikin plasma ya ragu a matakai biyu. Bayan shan empagliflozin a kashi na 25 na MG sau ɗaya a rana, matsakaicin AUC a lokacin C_ss a cikin jini shine 4740 nmol · h / l, kuma darajar C_max - 687 nmol / L.

Kasuwancin magunguna na empagliflozin a cikin masu sa kai masu lafiya da marasa lafiya da ke da nau'in ciwon sukari na 2 sun kasance iri ɗaya ne.

Cin abinci ba shi da tasiri mai mahimmanci a asibiti kan magunguna na empagliflozin.

Rarraba. V_d yayin plasma C_ss ya kusan lita 73.8. Bayan sarrafawar baka ta hanyar kwararrun masu ba da agaji na masu alama mai suna 14 empagliflozin 14, ɗaukar ƙwayar plasma yana da kashi 86.2%.

Tsarin rayuwa. Babban hanyar metabolism na empagliflozin a cikin mutum shine glucuronidation tare da halartar UDP-GT (UGT2B7, UGT1A3, UGT1A8 da UGT1A9). Abubuwan da aka fi sani da metabolites na empagliflozin sune 3 glucuronic conjugates (2-O, 3-O da 6-O glucuronide). Sakamakon tsarin tsari na kowane metabolite karami ne (kasa da 10% na yawan tasirin empagliflozin).

Kiwo. T_1/2 ya kasance kusan sa'o'i 12.4. Game da amfani da empagliflozin 1 lokaci ɗaya kowace rana C_ss a cikin plasma an cimma shi bayan kashi na biyar. Bayan aiwatar da maganin baka na alama mai taken 14 C a cikin masu sa kai masu lafiya, kusan kashi 96% na kashi an cire shi (ta hanjinsu kashi 41% da kodan 54%).

Ta hanyar hanji, yawancin magungunan da aka yiwa lakabi an cire su. Kashi rabi na magungunan da aka yi wa lakabi da kodan ba su sake su ba.

Pharmacokinetics a cikin yawan haƙuri na musamman

Paarancin aiki na haya. A cikin marasa lafiya masu laushi (60 2), matsakaici (30 2), mai tsanani (GFR 2) gazawar renal, da kuma marasa lafiya da gazawar ƙarancin ƙarancin ƙaddamarwa, ƙungiyar AUC na empagliflozin ta ƙaru da kusan 18, 20, 66, da 48%, bi da bi, idan aka kwatanta da marasa lafiya tare da aikin koda na al'ada. A cikin marasa lafiya da matsakaiciyar renal kasawa da kuma marasa lafiya da karshen-mataki na koda kasawa C_max empagliflozin a cikin plasma ya kasance daidai da dabi'u masu dacewa a cikin marasa lafiya da keɓaɓɓen aikin renal. A cikin marasa lafiya tare da m zuwa ga mai rauni renal mai rauni_max empagliflozin a cikin plasma ya kusan 20% mafi girma fiye da marasa lafiya da keɓaɓɓen aikin koda. Bayanan bincike na ƙididdigar yawan jama'a ya nuna cewa ƙarshen sharewar empagliflozin ya ragu tare da rage GFR, wanda ya haifar da karuwa a sakamakon ƙwayar.

Rashin aikin hanta. A cikin marasa lafiya waɗanda ke fama da aikin hanta mai rauni, matsakaici da matsanancin digiri (bisa ga ƙididdigar Childaukar Yara), ƙimar AUC ta empagliflozin ta ƙaru da kusan 23, 47 da 75%, bi da bi, da C_max kusa da 4, 23 da 48%, bi da bi (idan aka kwatanta da marasa lafiya da aikin hanta na al'ada).

BMI, jinsi, jinsi, da shekaru ba su da tasiri mai mahimmanci a asibiti kan magunguna na empagliflozin.

Yara. Ba a gudanar da karatun likitancin magungunan empagliflozin a cikin yara ba.

Alamun magungunan Jardins ®

Type 2 ciwon sukari mellitus:

- kamar yadda monotherapy a cikin marasa lafiya da rashin isasshen iko glycemic kawai a kan tushen abinci da motsa jiki, alƙawarin metformin wanda ba shi yiwuwa saboda rashin haƙuri,

- azaman maganin haɗin gwiwa tare da sauran wakilai na hypoglycemic, ciki har da insulin, lokacin da maganin da aka yi amfani da shi tare da abinci da motsa jiki ba ya ba da ikon sarrafa glycemic.

An ba da alama ga marasa lafiya da ke fama da ciwon sukari na 2 na ciwon suga da kuma haɗarin zuciya da yawa * a hade tare da daidaitaccen jiyya na cututtukan zuciya don ragewa:

- yawan mace-mace ta hanyar rage yawan mutuwar zuciya,

- mutuwar zuciya ko asibiti saboda rauniwar zuciya.

* Babban hatsarin zuciya yana bayyana shine kasancewar aƙalla ɗaya daga cikin cututtukan da ke gaba da / ko yanayi: cututtukan zuciya da na jijiyoyin jini (tarihin cutar sankara, bugun zuciya da jijiyoyin jini, cutar jijiya tare da lalacewar jirgin ruwa na jijiyoyin zuciya, cututtukan jijiyoyin zuciya tare da lalacewar tasoshin jijiyoyin jini da yawa), bugun zuciya ko bugun jini. tarihin cututtukan mahaifa (tare da ko ba tare da alamu ba).

Haihuwa da lactation

Yin amfani da empagliflozin yayin daukar ciki an hana shi saboda isasshen bayanai akan inganci da aminci.

Bayanan da aka samu a cikin binciken kwaskwarima a cikin dabbobi suna nuna shigarwar empagliflozin cikin madara. Ba a cire haɗarin haɗuwa da jarirai da yara yayin shayarwa ba. Yin amfani da empagliflozin lokacin shayarwa yana da hani. Idan ya cancanta, yakamata a daina amfani da empagliflozin yayin shayarwa.

Side effects

Gaba ɗaya abubuwan haɗari a cikin marasa lafiya da ke karɓar empagliflozin ko placebo a cikin gwaji na asibiti sun yi kama. Halin da ya fi dacewa da rikice-rikice ya kasance hypoglycemia, an lura da shi ta hanyar amfani da empagliflozin a hade tare da abubuwan da suka samo asali na sulfonylurea ko insulin (duba) Bayanin mummunan halayen da aka zaɓa).

An gabatar da halayen mara kyau a cikin marasa lafiya da ke karɓar empagliflozin a cikin karatun da aka sarrafa-placebo ana gabatar da su a ƙasa (halayen muni an rarrabe su da gabobin da tsarin kuma bisa ga fifita MedDRA sharuddan) yana nuna cikakken mitar su. An bayyana nau'ikan rarrabewa kamar haka: sau da yawa (≥1 / 10), sau da yawa (daga ≥1 / 100 zuwa hauhawar jini, orthostatic artpot hypotension, fitsari, fainting) ya kasance daidai a cikin yanayin empagliflozin (a kashi na 10 mg - 0.6%, a kashi 25 na 25 - 0.4%) da placebo (0.3%). A cikin marasa lafiya waɗanda suka girmi shekaru 75, haɗarin hypovolemia ya yi daidai a cikin marasa lafiya suna shan empagliflozin a kashi 10 mg (2.3%) da placebo (2.1%), amma mafi girma a cikin marasa lafiya suna ɗaukar empagliflozin a kashi na 25 MG (4.3%) )

Haɗa kai

Diuretics. Empagliflozin na iya haɓaka tasirin cutar thiazide da dip, wanda, bi da bi, na iya haɓaka haɗarin rashin ruwa da jijiyoyin jini.

Insulin da kwayoyi wadanda ke inganta sirrinta. Insulin da kwayoyi waɗanda ke inganta sirrinsa, irin su sulfonylureas, na iya ƙaruwa da haɗarin cututtukan jini. Sabili da haka, tare da amfani da empagliflozin na lokaci guda tare da insulin da kwayoyi waɗanda ke haɓaka ƙwarewar ta, yana iya zama dole don rage adadin su, don guje wa haɗarin cutar hypoglycemia.

Nazarin hulɗa da magunguna a cikin vitro. Empagliflozin baya hana, hana aiki, ko sa CYP450 isoenzymes. Babban hanyar metabolism na mutum shine glucuronidation tare da halartar UDP-GT (UGT2B7, UGT1A3, UGT1A8 da UGT1A9). Empagliflozin baya hana UGT1A1, UGT1A3, UGT1A8, UGT1A9 ko UGT2B7. Abun hulɗa na miyagun ƙwayoyi na empagliflozin da kwayoyi waɗanda suke canzawa na CYP450 da UGT isoenzymes ana ɗaukarsu ba zato bane. Empagliflozin shine madadin P-gp da furotin wanda ke yanke shawarar BCRP, amma a cikin magungunan warkewa baya hana wadannan kariyar. An samo asali ne daga bayanai daga karatu a cikin vitro , an yi imanin cewa ikon empagliflozin yin hulɗa tare da kwayoyi waɗanda ke canzawa P-gpne wanda ake iya shakkar aukuwarsa. Empagliflozin shine mai yankan jigilar kwayoyin halitta na Oion: OAT3, OATP1B1 da OATP1B3, amma ba musanyawa bane ga masu ɗaukar kwayoyin 1 (OAT1) da masu ɗaukar kwayoyin cationic 2 (OCT2). Koyaya, hulɗa da miyagun ƙwayoyi na empagliflozin tare da kwayoyi waɗanda ke canza magungunan kariyar da aka bayyana a sama ana ɗaukarsu ba zato bane.

Nazarin hulɗa da magunguna a vivo. Tare da yin amfani da haɗin gwiwar empagliflozin tare da sauran kwayoyi da aka saba amfani dasu, ba a lura da mahimmancin hulɗa da magunguna ba. Sakamakon bincike na kantin magani ya nuna cewa babu buƙatar canza kashi na maganin Jardins ® yayin amfani da shi tare da magungunan yau da kullun.

Magunguna na empagliflozin ba ya canzawa a cikin masu sa kai na lafiya lokacin da aka yi amfani da su tare da metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, kuma a cikin marasa lafiya da nau'in ciwon sukari na 2 idan ana amfani dasu tare da torasemoridide da hydrochloride hydrochlor.

Tare da yin amfani da haɗin gwiwar empagliflozin tare da gemfibrozil, rifampicin da probenecid, karuwa a cikin AUC na empagliflozin da 59, 35 da 53%, bi da bi, duk da haka, ba a la'akari da waɗannan canje-canje ba a asibiti.

Empagliflozin bashi da tasiri mai mahimmanci a kan magunguna na metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide da maganin hana haihuwa a cikin masu sa kai masu lafiya.

Hulɗa da ƙwayoyi

Yana haɓaka tasirin diuretic na diuretics daban-daban, wanda ke haɓaka haɗarin rashin ruwa da jijiyoyin jini. Abubuwan insulin da na abubuwan sulfonylurea na iya haifar da cutar hypoglycemia. Tare da yin amfani da miyagun ƙwayoyi tare da insulin, ragewa sashi yana da mahimmanci don guje wa yanayin hypoglycemic .. hulɗa da miyagun ƙwayoyi na empagliflozin da kwayoyi waɗanda suke canzawa na isoenzymes an dauki lafiya.

Empagliflozin - kayan aiki mai aiki a cikin allunan, ba ya shafar kayan kayyakin magunguna na ƙwayoyi masu zuwa: Metformin, Glimepiride, Pioglitazone, Warfarin, Digoxin, Ramipril, Simvastatin, Hydrochlorothiazide, Torasemide da maganin hana haihuwa. Tare da yin amfani da wannan lokaci tare da waɗannan magungunan da aka saba amfani dasu, canjin sashi ba a buƙata.

Jardins Analogs

A kasuwar miyagun ƙwayoyi na Tarayyar Rasha, akwai magunguna guda ɗaya kawai da aka kirkira bisa tushen abu - empagliflovin. Jardins ba shi da takaddun shaida. Sauran allunan rigakafin jini suna da wasu abubuwa masu aiki a cikin abun da ke ciki kuma suna aiki daban-daban akan jikin mutum. Wadannan sun hada da:

Jardins - umarnin don amfani, farashi, sake dubawa da kuma alamun analogues

Ana daukar cutar sukari mellitus daya daga cikin cututtukan da suka zama ruwan dare a duniya. A cikin Tarayyar Rasha, 'yan ƙasa miliyan 10 suna fama da wannan cuta. Yawancinsu sun fi son amfani da magani Jardins saboda ingancinsa.

Sunan Latin shine Jardiance. INN miyagun ƙwayoyi: Empagliflozin (Empagliflozin).

Jardins yana da tasirin maganin ƙwayar cuta.

Tsarin ATX: A10BK03.

Ana samun maganin ta hanyar kwaya mai narkewa. 1 kwamfutar hannu 1 ya ƙunshi 25 ko 10 MG na empagliflozin (sashi mai aiki). Sauran abubuwa:

• foda talcum
• titanium dioxide
• baƙin ƙarfe baƙin ƙarfe oxide (fenti),
• lactose monohydrate,
• Hyprolose
• microcrystals cellulose.

Ana samun maganin ta hanyar kwaya mai narkewa.

Allunan an cika su a blisters na 10 inji mai kwakwalwa. Akwatin 1 yana dauke da blister 1 ko 3.

Tare da kulawa

An wajabta maganin a hankali lokacin da:

• secretarancin ayyukan sirrin sel sel da ke cikin kashin kansa,
• hade tare da abubuwan kwalliya na insulinlirea da insulin,
• cututtukan gastrointestinal wanda ya shafi asarar ruwa mai yawa,
• tsufa.

Sashi da gudanarwa

Ana shan kwayoyin cikin baka. Sigar farko shine 10 MG 1 sau ɗaya kowace rana. Idan wannan adadin maganin ba zai iya ba da ikon sarrafa glycemic ba, to kashi ya hau zuwa 25 MG. Matsakaicin sashi shine 25 MG / rana.

Ana shan kwayoyin cikin baka.

Amfani da allunan bai dace da lokacin rana ba ko kuma cin abinci. Ba a so 1 rana don amfani da kashi biyu.

Jardins

Gwaje-gwaje na asibiti sun tabbatar da cewa maganin da ake tambaya shine kawai magani don lura da ciwon sukari mellitus (nau'in II), wanda a cikin hadarin abubuwan da suka faru na cututtukan CVD da ƙarancin mace-mace daga irin waɗannan cututtukan ke raguwa. Haramun ne a yi amfani da maganin ga masu fama da ciwon sukari na 1.

Shaidun likitoci da marasa lafiya game da Jardins

Galina Aleksanina (therapist), 45 years old, St. Petersburg.

Amintaccen magani wanda baya haifar da sakamako masu illa (a aikace na). Babban farashin yana da cikakkiyar lada ta aikin magunguna na miyagun ƙwayoyi. Rashin lafiyar placebo an yanke hukunci gaba daya. Bugu da ƙari, ba shi da alamun analogues a Rasha, kuma magunguna masu kama da haka suna yin daban.

Anton Kalink, dan shekara 43, Voronezh.

Kayan aiki yana da kyau. Ni, a matsayin mai ciwon sukari tare da gwaninta, na gamsu da aikin sa. Abu mafi mahimmanci shine a hankali bincika umarnin don amfani. A wannan yanayin ne kawai za'a iya magance cutarwa, wanda aka tabbatar da kansa a aikace. Daga cikin gazawar, mutum na iya bambanta kawai babban farashin da gaskiyar cewa ba a sayar da maganin a cikin dukkanin kantin magunguna.

Jardins: umarnin don amfani

Pharmacodynamics

Empagliflozin mai iya canzawa ne, yana aiki sosai, mai zaɓe kuma mai hana mai hawa suttura mai motsa jini na nau'in 2 mai dauke da sinadarin sodium tare da maida hankali da ake buƙata don hana 50% na aikin enzyme (IC50) na 1.3 nmol.

Zaɓin na empagliflozin sau 5,000 sau mafi girma daga zaɓi na nau'in 1 sodium-dogara mai ɗaukar glucose wanda ke da alhakin ɗaukar glucose a cikin hanji. Bugu da kari, an gano cewa empagliflozin yana da babban zaɓi don sauran masu jigilar glucose masu alhakin glucose homeostasis a cikin kyallen iri daban-daban.

Mai jigilar sodium-mai ɗaukar nauyin glucose 2 shine babban furotin mai ɗaukar nauyi wanda ke da alhakin sake sarrafa glucose daga renal glomeruli a cikin jini. Empagliflozin yana inganta kulawar glycemic a cikin marasa lafiya da ke dauke da nau'in ciwon sukari guda 2 (T2DM) ta rage rage ƙwayar abinci na koda.

Yawan glucose din da kodan ke amfani da shi ta hanyar amfani da wannan kayan ya dogara da tattarawar glucose a cikin jini da kuma yawan narkewar duniya (GFR). Hibarfin mai ɗaukar nauyin sodium wanda ke da nau'in glucose na 2 a cikin marasa lafiya da ke ɗauke da ciwon sukari na 2 da hauhawar jini ke haifar da kawar da yawan ƙwayar glucose da kodan.

A cikin binciken asibiti, an gano cewa a cikin marasa lafiya da ke dauke da ciwon sukari na 2, yawan ƙwayar glucose ta hanta ya karu nan da nan bayan an yi amfani da kashi na farko na empagliflozin, wannan sakamakon ya ci gaba na tsawon awanni 24.

Haɓakar haɓakar glucose ta ƙodan ya ci gaba har zuwa ƙarshen lokacin makonni 4, tare da empagliflozin a cikin kashi 25 na MG sau ɗaya a rana, a matsakaici, kimanin 78 g / day. A cikin marasa lafiya da ke dauke da ciwon sukari na 2, haɓakar haɓakar glucose ta hanta ya haifar da raguwar hanzarin ƙwayar glucose a cikin jini.

Empagliflozin yana rage yawan glucose a cikin jini na jini a batun yin azumi da bayan cin abinci. Hanyar da ba ta insulin-dogara da aikin na empagliflozin yana ba da gudummawa ga ƙananan haɗarin yiwuwar haɓakar haɓakar jini ba. Tasirin empagliflozin baya dogara da yanayin aikin ƙwayoyin beta na ciki da kuma metabolism metabolism.

An lura da tasirin tasirin empagliflozin akan alamun alamu na aikin kwayar beta, gami da HOMA-? Index, an lura. (samfurin don kimantawa homeostasis-B) da kuma rabo daga proinsulin zuwa insulin. Bugu da ƙari, ƙarin kawarda glucose ta hanta yana haifar da asarar adadin kuzari, wanda ya biyo tare da rage yawan ƙwayar adipose da raguwar nauyin jiki. Glucosuria ya lura yayin amfani da empagliflozin yana haɗuwa tare da ɗan ƙara ƙarancin diureis, wanda zai iya ba da gudummawa ga raguwar matsakaici a cikin jini.

A cikin gwaji na asibiti inda aka yi amfani da empagliflozin azaman monotherapy, maganin haɗin gwiwa tare da metformin, maganin haɗuwa tare da metformin da abubuwan da suka dace na sulfonylurea, maganin haɗi tare da metformin idan aka kwatanta da glimepiride, maganin haɗin gwiwa tare da pioglitazone +/- metformin, azaman haɗin haɗi tare da dipeptidyl peptide inhibitor 4 (DPP-4), metformin +/- wani nau'in maganin baka na jini, a cikin hanyar haɗin kai tare da insulin, ya kasance ƙididdigar ƙididdiga raguwa na a cikin glycosylated HbAlc haemoglobin da kuma ragewa a cikin azumi plasma taro taro.

An yi nazarin magungunan likitanci na empagliflozin a cikin masu ba da agaji na lafiya da kuma a cikin marasa lafiya da ke fama da ciwon sukari na 2.

Bayan gudanar da maganin baka, an kwantar da empagliflozin cikin sauri, mafi girman maida hankali na empagliflozin a cikin jini (Cmax) ya kai bayan sa'o'i 1.5. Sannan, maida hankali na empagliflozin a cikin plasma ya ragu a matakai biyu.

Bayan ɗaukar empagliflozin, matsakaicin yanki a ƙarƙashin ɓoye-lokaci na lokaci (AUC) yayin ɗaukar matakin-plasma mai daidaituwa shine 4740 nmol x awa / L, kuma darajar Cmax shine 687 nmol / L. Kasuwancin magunguna na empagliflozin a cikin masu sa kai masu lafiya kuma a cikin marasa lafiya da ke da nau'in ciwon sukari na 2 sun kasance iri ɗaya ne.

Cin abinci ba shi da tasiri mai mahimmanci a asibiti kan magunguna na empagliflozin.

Ofarancin rarrabuwa yayin aiwatar da yanayin-daidaitaccen ƙwaƙwalwar ƙwaƙwalwar ƙasa ya kai kimanin lita 73.8. Bayan sarrafawar baka ta hanyar kwararrun masu ba da agaji na masu alama mai taken 14ag, na ɗaukar ƙwayar plasma yana da kashi 86%.

Babban hanyar metabolism na empagliflozin a cikin mutum shine glucuronidation tare da halartar uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 da UGT1A9. Mafi yawan abubuwan da aka gano ana amfani dasu na empagliflozin sune conjugates glucuronic guda uku (2-0, 3-0 da 6-0 glucuronides). Sakamakon tsarin tsari na kowane metabolite karami ne (kasa da 10% na yawan tasirin empagliflozin).

Bayanin rabin rayuwa sunkai kimanin awa 12.4. Game da amfani da empagliflozin sau daya a rana, an sami daidaituwa ta plasma bayan anci kashi na biyar.

Bayan gudanar da maganin baka na alama mai alama na 14C a cikin masu sa kai masu lafiya, kusan kashi 96% na kashi an cire shi (ta hanjinsu kashi 41% da kodan 54%). Ta hanyar hanji, yawancin magungunan da aka yiwa lakabi an cire su.

Kashi rabi na magungunan da aka yi wa lakabi da kodan ba su sake su ba. Pharmacokinetics a cikin yawan haƙuri na musamman

Paarancin aiki na haya

A cikin marasa lafiya masu rauni, matsakaici, da gazawar haɓaka koda (30 https: //apteka.103.xn--p1ai/jardins-13921690-instruktsiya/

Jardins ™ Allunan 10 MG 30 inji mai kwakwalwa

Ba'a bada shawarar Jardins® ga marasa lafiya masu fama da ciwon sukari na 1 da kuma maganin ketoacidosis masu ciwon sukari ba.

Ta yin amfani da inhibitors na jigilar glucose mai nau'in nau'in 2, gami da empagliflozin, ba a sami rahoton yawancin cutar ketoacidosis masu ciwon sukari ba. A wasu daga cikin waɗannan maganganun, alamu sun kasance marasa daidaituwa kuma an bayyana su a matsayin karuwa na matsakaici a cikin haɗuwa da glucose na jini (ba fiye da 14 mmol / L (250 mg / dl) ba.

Hadarin da ke tattare da cutar ketoacidosis mai ciwon sukari yakamata yayi la'akari idan ba bayyanar cututtuka ba kamar tashin zuciya, amai, rashin ci, ciwon ciki, tsananin kishirwa, karancin numfashi, rashin kwanciyar hankali, gajiya mara nauyi ko rashin nutsuwa. Idan irin waɗannan bayyanar cututtuka suka haɓaka, ya kamata a bincika marasa lafiya nan da nan don ketoacidosis, ba tare da la'akari da yawan glucose na jini ba. Yin amfani da miyagun ƙwayoyi Jardins J ya kamata a dakatar ko dakatar da shi har sai an tabbatar da cutar.

Babban haɗarin haɓakar cutar ketoacidosis mai ciwon sukari yana yiwuwa a cikin marasa lafiya akan abinci mai narkewa mai ƙima sosai, marasa lafiya masu fama da rashin ruwa mai ƙoshin lafiya, marasa lafiya waɗanda ke da tarihin ketoacidosis, ko marasa lafiya da ƙarancin ayyukan sirrin cells-sel. A cikin irin waɗannan marasa lafiya, ya kamata a yi amfani da Jardins® tare da taka tsantsan. Ana buƙatar taka tsantsan yayin rage yawan insulin.

Shirye-shiryen Jardins® a cikin kwamfutar hannu na 10 mg yana dauke da 162.5 mg na lactose, tare da sashi na 25 MG ya ƙunshi 113 mg na lactose, sabili da haka, bai kamata a yi amfani da miyagun ƙwayoyi a cikin marasa lafiya da keɓaɓɓiyar cuta ta gado kamar ƙarancin lactase, rashin lactose, rashin haƙuri a cikin glucu-galactose malabsorption.

Nazarin asibiti ya nuna cewa magani tare da empagliflozin baya haifar da karuwa a cikin hadarin zuciya. Yin amfani da empagliflozin a kashi na 25 MG ba ya haifar da tsawaita tazara QT.

Tare da haɗakar amfani da miyagun ƙwayoyi Jardins® tare da abubuwan da aka samo na sulfonylurea ko tare da insulin, ana iya buƙatar rage ƙwayar kashi na sulfonylurea / insulin saboda haɗarin haɗarin hypoglycemia.

Ba a yi nazarin Empagliflozin ba a hade tare da glucagon-like peptide-1 analogues (GLP-1).

Ingancin ƙwayar Jardins® yana dogara da aikin kodan, saboda haka ana ba da shawarar saka idanu akan aikin kodan kafin alƙawarinta da lokaci-lokaci yayin jiyya (aƙalla lokaci 1 a kowace shekara), da kuma kafin lokacin da aka ba da izini don maganin ƙoshin lafiya, wanda zai iya cutar da aikin koda. Yin amfani da miyagun ƙwayoyi a cikin marasa lafiya da gazawar renal (GFR ba da shawarar ba