Jardins - luna ʻōlelo kuhikuhi no ka hoʻohana ʻana

NA ININA
ma ka hoʻohana o ka lāʻau lapaʻau
JAHAIKA

E hoʻokuʻu i ke ʻano
pani ʻ -lelo ʻlelo

Hōʻike
Pākaukau 1 papa:
mea kūlohelohe: empagliflozin 10 a me 25 mg
nā mea waiwai: lactose monohydrate, microcrystalline cellulose, hyprolose (hydroxypropyl cellulose), sodium croscarmellose, colloidal silicon dioxide, magnesium stearate.
kiʻi mele: opadry melemele (02B38190) (hypromellose 2910, titanium dioxide (E171), talc, macrogol 400, kaila hao kaila puaʻokeʻo (E172).

ʻOhiʻohi
10 a me 30 papa.

Ka hana lāʻau lapaʻau
Jardins - Kauka 2 Sodium Glucose Transporter Inhibitor

Jardins, hōʻailona hōʻike no ka hoʻohana ʻana
Kauka 2 diabetes mellitus:
like monotherapy i loko o nā poʻe maʻi me ka loaʻa ʻole o ka ʻike glycemic hewa wale nō i ke ʻano o ke kī ʻana o ka meaʻai a me ka hoʻomaʻamaʻa, ʻo ke koho ʻana o ka metformin i manaʻo ʻia ʻaʻole kūpono no ka hemahema,
ma ke ʻano he lāʻau lapaʻau me nā mea haole hypoglycemic ʻē aʻe, e komo pū me ka insulin, i ka wā i noi ʻia ai ka hui me ka meaʻai a me ka hoʻomaʻamaʻa ʻole mai i ka pono o ka mana glycemic pono.

Nā Hoʻohui
hypersensitivity i kekahi o ka lāʻau,
maʻi diabetes type 1
maʻi maʻamau ketoacidosis,
nā maʻi hoʻoilina maʻamau (lactase deficiency, lactose intolerance, glucose-galactose malabsorption),
ʻO ka hana hoʻopili a me ka GFR ×

Nā palapala ʻano:

ʻO keʻano
Nā papa āpau 10 mg
ʻO nā papa pōpō biconvex me nā kihi beveled, i uhi ʻia me ka membrane kiʻi o ke kala melemele kukui me ke kahakaha ʻana o ka hōʻailona o ka hui ma kekahi ʻaoʻao o ka pā a me ka "S10" ma kēlā ʻaoʻao.
Nā 25 papa papa
ʻO nā papa bvalvex oval me nā kihi beveled, i kāwili ʻia me ka membrane kiʻi o ke kala melemele kukui, i kahakaha ʻia me ka hōʻailona o nā hui ma kahi ʻaoʻao o ka pā a me ka "S25" ma kēlā ʻaoʻao.

ʻO nā waiwai Pharmacological

Lapaʻau lāʻau
Ua hōʻike nui ʻia nā pharmacokinetics o empagliflozin i nā poʻe hana olakino olakino a me nā mea maʻi me nā maʻi maʻi type 2.
Kapehu
Ma hope o ka lawelawe waha, ua hoʻokomo koke ka empagliflozin i ka nui, ua loaʻa i ka nui o ka emepliflozin i loko o ke koko koko (Cmax) ma hope o 1.5 mau hola. A laila, ua hōʻemi ʻia ka ʻike o empagliflozin i ka plasma i ʻelua mau manawa.
Ma hope o ka loaʻa ʻana o ka empagliflozin, ka pae ākea ma lalo o ka pihi o ka manawa paʻa (AUC) i ka wā o ka hoʻokūkū ʻana i ka plasma he 4740 nmol x h / l, a me Cmax - 687 nmol / l.
ʻO nā pharmacokinetics o empagliflozin i nā mea hana olakino olakino a me nā mea maʻi me nā maʻi maʻi type 2 ua like like.
ʻAʻohe ʻai nui i ka hopena ma ka pharmacokinetics o empagliflozin.
Kahele
ʻO ka nui o ka hoʻolaha i ka wā o ka neʻe ʻana o ka plasma kaila e like me ka 73.8 lita. Ma hope o ka lawelawe waha ʻana e nā mea olakino olakino o ka inoa ʻo empagliflozin 14 C, nā pilina protein plasma he 86%.
Hāpai
ʻO ke ala nui o ka metabolism empagliflozin i loko o ke kanaka he glucuronidation me ka komo ʻana o ka uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 a me UGT1A9. ʻO nā metabolites ka mea i ʻike pinepine ʻia e ka emagliflozin ʻekolu mau mea huakaʻi glucuronic (2-0, 3-0 a me 6-0 glucuronides). ʻO ka hopena systemic o kēlā me kēia metabolite ka liʻiliʻi (ma lalo o 10% o ka hopena piha o ka empagliflozin).
Leʻaleʻa
ʻO ka hapa pio-hapalua kahi ma kahi o 12,4 hola. I ka hihia o ka hoʻohana ʻana i ka empagliflozin hoʻokahi manawa i ka lā, ua hōʻea kahi paʻa o ka plasma ma hope o ka helu ʻelima. Ma hope o ka lawelawe waha ʻana i ka inoa o ka inoa ʻo emagliflozin 14 C i nā mea hana olakino olakino, ma kahi o 96% o ka make i hoʻopiʻi ʻia (ma loko o nā ʻōpū o 41% a me nā kauā 54%). Ma loko o nā ʻōpū, ʻaʻole i hoʻololi ʻia ka hapa nui o ka lāʻau hōʻailona. Hoʻokahi wale nō hapa o ka lāʻau hōʻailona i hoʻopili ʻia ʻole e nā keiki.
ʻO ka pharmacokinetics i nā pōkole hanohano kūikawā
Hola paʻa kino hana
I nā maʻi me ka hōʻemi, hoʻohaʻahaʻa, a me ka maikaʻi ʻole (ren 2) a i nā mea maʻi a me ka hopena o ka hana hope ʻole, ʻoi aku ka nui o ka AUC o nā empagliflozin, ma kahi o 18%, 20%, 66%, a me 48% i hoʻohālikelike ʻia me nā mea maʻi me ka maʻamau hana hanu. I nā mea maʻi me ka hiki ʻole o ka maikaʻi ʻole a me nā poʻe maʻi me ka pau ʻole o ka hope o ka renal hope, ua like ka nui o ka plasma kiʻekiʻe o ka empagliflozin e like me nā waiwai kūpono i nā poʻe maʻi me ka hana maʻamau. I ka poʻe maʻi me ka hōʻemi a me ka hōʻeha ʻole o ka renal, ʻo ka nui o ka plasma kiʻekiʻe o ka empagliflozin ma kahi o 20% kiʻekiʻe ma mua o nā mea maʻi me ka hana maʻamau. Ua hōʻike nā hōʻike noiʻi pharmacokinetic i hōʻike i ke koena o ka hoʻomaʻemaʻe ʻana o nā empagliflozin i hoʻohaʻahaʻa me ka hoʻohaʻahaʻa i ka GFR, i alakaʻi ai i ka hopena o ka lāʻau lapaʻau.
Hōʻeha ka hana ʻoluʻolu
I nā mea maʻi me ka hana o ka puʻuwai maʻi iki o ke kaumaha, hōʻemi a me ka hōʻeha nui (e like me ka helu ʻana o nā keiki-Pugh), i hoʻonui ʻia nā waiwai o ka AUC o ka empagliflozin, ma kahi o 23%, 47% a me 75%, a me nā koʻikoʻi Stax, kēlā, e pili ana i ka 4%, 23 % a me 48% (hoʻohālikelike me nā mea maʻi me ka hana maʻamau puʻuwai).
Ke ʻano nui o ke kino kikoʻī, ke kino, ka lāhui a me nā makahiki ʻaʻole i hopena koʻikoʻi nā maʻi i ka pharmacokinetics o empagliflozin.
E na keiki
ʻAʻole i hana ʻia nā noi ʻana o nā pharmacokinetics o empagliflozin i loko o nā keiki.

Nā Hoʻohui

• Hypersensitivity i kekahi māhele o ka lāʻau,
• ʻAno maʻi type 1
• Maʻi molaʻi
• Hōʻemi i ka hoʻoilina hoʻoilina (lactase deficiency, lactose intolerance, glucose-galactose malabsorption),
• ʻO ka hoʻopiʻi ʻana o Renal ma ka GFR 2 (ma muli o ka hōʻoiaʻana).
• ʻLelo ʻia a me ka lactation,
• Ma kahi o 85 mau makahiki
• ʻO ka hoʻohana pū ʻana me nā analogues o ka peptide like-glucagon 1 (ma muli o ka nele o ka ʻikepili i ka pono a me ka palekana),
• ʻO nā keiki ma lalo o 18 mau makahiki (ma muli o ka lawa ʻole o ka ʻike i ka pono a me ka palekana).

Loaʻa ka hopena
ʻO ka nui o ka loaʻa ʻana o nā hanana pōʻino i ka poʻe maʻi e loaʻa ana i ka empagliflozin a i kahi placebo paha i loko o nā hoʻokolohua hopena. ʻO ka hopena maʻamau e hōʻike ai i ka hypoglycemia, i ʻike ʻia me ka hoʻohana ʻana i ka empagliflozin i hui pū ʻia me sulfonylurea a i ʻole derivatives i insulin (ʻike i ka wehewehe ʻana i nā kūmole pili kū hoʻokahi).
ʻO nā hōʻike ʻinoʻino i ʻike ʻia i nā mea maʻi e loaʻa ana i ka empagliflozin i nā haʻawina hoʻokele i ka pletebo i hōʻike ʻia ma ka Papa ma lalo (ua hoʻohālikelike ʻia nā hana ʻino e like me nā hui a me nā ʻōnaehana a like me nā huaʻōlelo i makemake ʻia e MedDRA) me kahi hōʻike o kā lākou mau kikoʻī. Ua wehewehe ʻia nā māhele maʻamau ʻoi loa: pinepine pinepine (> 1/10), pinepine pinepine (mai>>, 1/100 a> 1/1000 a> 1/10000 i ka wehewehe ʻana i nā hewa hōʻino o kēlā kanaka.
Hypoglycemia
ʻO ka ulu ʻana o ka hypoglycemia i hilinaʻi ʻia ma ka concomitant hypoglycemic therapy i hoʻohana ʻia.
ʻO ka ʻeha o ka hypoglycemia (ka glucose o ke koko 3.0 - 3.8 mmol / L (54-70 mg / dl)) i ka hanana ʻana o ka hypoglycemia palupalu i ka poʻe maʻi e lawe ana i ka empagliflozin a i kahi plebo paha he monotherapy, a ma ka hihia e hoʻohui ai i ka empagliflozin e ka metformin a i ka hihia o ka hoʻohui o empagliflozin i pioglitazone (± metformin). Ma ka hihia o ka hoʻokele empagliflozin i hui pū me nā derivatives metformin a me derivl o sulfonylurea, ʻoi ka nui o ke kumu o ka hypoglycemia (10 mg: 10.3%, 25 mg: 7.4%) i ʻole me ka placebo i loko o kahi hui like (5.3%).
ʻO ka hypoglycemia koʻikoʻi (kahe koko koko ma lalo o 3 mmol / L (54 mg / dL))
ʻO ka ulu ʻana o ka hypoglycemia koʻikoʻi i like like me nā mea maʻi e lawe ana i ka empagliflozin a me ka placebo e like me ka monotherapy. Ma ka hihia o ka hoʻokele empagliflozin i hui pū me nā derivatives metformin a me derivl o sulfonylurea, ʻoi ka nui o ke kumu o ka hypoglycemia (10 mg: 5.8%, 25 mg: 4.1%) i ʻole me ka pletebo i ka hui pū like (3.1%).
Pāʻai wikiwiki
ʻO ka nui o ka hoʻonui ʻana i ka urination (mau hōʻailona e like me pollakiuria, polyuria, nocturia i loiloi ʻia) ʻoi aku ka kiʻekiʻe me ka empagliflozin (ma kahi kiko o 10 mg: 3.4%, ma ke ʻano o 25 mg: 3.2%) ma mua o ka placebo (1 %). Ua hoʻohālikelike ʻia ka ulu ʻana o nocturia i ka hui o nā mea maʻi e lawe ana i ka empagliflozin a i ka hui o nā mea maʻi e lawe ana i ka placebo (ma mua o 1%). ʻO ka ikaika o kēia mau hopena heleʻoluʻolu a maʻalahi paha.
ʻAʻohe maʻi ʻeha
ʻO ka ulu ʻana o nā maʻi o ka urinary like a like me ka empagliflozin 25 mg a me ka placebo (7.6%), akā ke kiʻekiʻe aʻe me ka empagliflozin 10 mg (9.3%). E like me ka pletebo, nā maʻi urinary tract me ka empagliflozin i ʻike pinepine i nā mea maʻi me ka mōʻaukala o nā maʻi a me ka hopena o ka urinary. ʻO ka mea i loaʻa i nā maʻi o ka urinary like like me nā mea maʻi e lawe ana i ka empagliflozin a me ka placebo. ʻOi aku ka maʻamau o nā maʻi ʻeha i loko o nā wāhine.
Nā maʻi maʻi genital
ʻO ka ulu ʻana o nā hanana pōʻino e like me ka candidiasis vaginal, vulvovaginitis, balanitis a me nā maʻi ʻeha ʻē aʻe ʻoi aku ka kiʻekiʻe me ka empagliflozin (ma ke ʻano o 10 mg: 4.1%, ma ke ʻano o 25 mg: 3.7%) ma mua o ka pletebo (0 , 9%). ʻOi aku ka maʻi o nā maʻi ma ka wahine. ʻO ke ʻano o ka maʻi ʻōpū o ke ʻano hele a maʻalahi hoʻi.
ʻO ka hypovolemia
ʻO ka mea i loaʻa i ka hypovolemia (i hōʻike ʻia e ka hoʻohaʻahaʻa i ke koko, a me ka hypotension orthostatic arterial, dehydration, ʻeha) ua like like me ka lā empagliflozin (ma kahi o ka pā o 10 mg: 0.5%. I kahi dosis o 25 mg: 0.3%) a me ka placebo (0, 3%). I ka poʻe maʻi i ʻoi aku ma mua o 75 mau makahiki, ua hoʻohālikelike ka pilikia o hypovolemia i nā poʻe maʻi e lawe ana i ka empagliflozin ma ke ʻano o 10 mg (2.3%) a me ka placebo (2.1%), akā ke kiʻekiʻe aʻe i nā mea maʻi e lawe ana i ka empagliflozin ma kahi o 25 mg (4.4%) )

Ke keu

Hoʻopili pū me nā lāʻau ʻē aʻe
I ka hōʻike vitro hoʻonaninau lāʻau
ʻAʻole i hoʻopaʻa ai ʻo Empagliflozin i ka hana, ʻaʻole hoʻohālikelike, a i ʻole hoʻohiolo iā CYP450 isoenzymes. ʻO ke ala nui o ka metabolism human empagliflozin ka glucuronidation me ka komo ʻana o ka uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 a me UGT1A9. ʻAʻole ʻo Empagliflozin e kāohi iā UGT1A1. ʻO nā hōʻiliʻili o ka lālani o ka empagliflozin a me nā lālani i hoʻohālikelike i ka CYP450 a me UGT1A1 isoenzymes i manaʻo ʻia i like ʻole.
ʻO Empagliflozin kahi papa hana no ka glycoprotein P (P-gp) a me nā ʻōnaehana pale o ka pale umauma (BCRP). akā, ʻaʻole i pale ʻia nā dosis therapeutic i kēia mau protein. Ma muli o ka ʻikepili mai nā haʻawina vitro, ʻike ʻia ka hiki ʻole o ka empagliflozin ke hoʻopili me ka lāʻau lapaʻau e substrate no ka glycoprotein P (P-gp) i ka hiki ʻole. ʻO Empagliflozin kahi papa lepo no nā mea lawe anionic organik: OATZ, OATP1B1 a me OATP1VZ, akā ʻaʻole ia kahi papa kuhikuhi no ka mea lawe anionic meaola 1 (OAT1) a me nā mea lawe cationic carriers 2 (OST2). Eia naʻe, ʻo ka hoʻopili ʻana i nā lāʻau lapaʻau ka empagliflozin me nā lāʻau lapaʻau nā substrate no nā mea lawe palaka e pili ana i luna e manaʻo ʻia he hana ʻole ʻole.
Ma ka vivo lāʻau e hoʻoponopono nei i ka loiloi
ʻAʻole loli i ka pharmacokinetics o empagliflozin i nā mea hana olakino maikaʻi i ka wā i hoʻohana pū ʻia me metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide a me hydrochlorothiazide. ʻO ka hui pū ʻana o ka empagliflozin me gemfibrozil, rifampicin a me ka probenecid i hōʻike i ka hoʻonui ʻia ʻana o ka AUC o empagliflozin e 59%, 35% a me 53%, akā, ʻaʻole i manaʻo ʻia kēia mau loli.
ʻAʻohe o ka maʻi nui o Empagliflozin e pili i ka pharmacokinetics o ka metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin. digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide a me nā mea hoʻohālikelike waha.
Diuretics
Hiki i ka Empagliflozin hiki ke hoʻonui i ka hopena diuretic o thiazide a me ka "loop" diuretics, a ma ia manawa e hoʻonui ai i nā kīʻaha o ka dehydration a me ka hypotension arterial.
ʻO ka insulin a me nā lāʻau lapaʻau e hoʻoikaika i kāna hūnā
ʻO ka insulin a me nā lāʻau lapaʻau e hoʻoikaika i kāna mea huna, e like me ka sulfonylureas, e hoʻonui i ka ʻeha o ka hypoglycemia. No laila, me ka hoʻohana pū ʻana o empagliflozin me ka insulin a me nā lāʻau lapaʻau e hoʻoikaika ai i kona ʻimi, pono paha e hōʻemi i kā lākou dosis, i mea e pale ai i ka maʻi o ka hypoglycemia.

Nā ʻōlelo kikoʻī

Hoʻopilikia i ka hiki ke hoʻokau i nā kaʻa a me nā māka
Ua mālama ʻia nā haʻawina hauoli e pili ana i ka hopena o ka empagliflozin e hiki ai ke hoʻokele i nā kaʻa a ʻaʻole i lawe ʻia nā hana. E mālama pono i ka poʻe maʻi i ka wā e kaʻi aku ana i nā kaʻa a me nā hana, ʻoiai ke hoʻohana ʻana i ka lāʻau JARDINS (ʻoi aku ka hoʻohui me ka sulfonylurea derivatives a / a i ʻole insulin), ulu ka hypoglycemia.

Mea hana

ʻAoa a me ka helu o ka wahi o ka hana o ka huahana lapaʻau
Beringer Ingelheim Pharma GmbH & Co.KG
Binger Strasse 173, 55216 Ingelheim am Rhein, Kelemānia

Hiki iā ʻoe ke loaʻa hou nā ʻike e pili ana i ka lāʻau lapaʻau, e hoʻouna pū ana i kāu hoʻopiʻi a me ka ʻike e pili ana i nā hanana ʻino i ka ʻōlelo ma hope nei ma Russia
ʻOihana ʻo Beringer Ingelheim
125171. Pokukala, Leningradskoye Shosse, 16A p. 3

ʻO nā pani Jardins

ʻO kēia nā papa pili i kala ʻia. Hōʻike: kukui ʻōmaʻomaʻo, oval a i ʻona paha (ma muli o ke ʻano), hoʻolālā - nā papa biconvex me nā kihi beveled a me nā hōʻailona a me nā mea i kahakaha ʻia o ka mea hana ma kahi ʻaoʻao. Hoʻokomo ʻia kahi lāʻau lapaʻau ma Kelemānia e hoʻohaʻahaʻa i ke koko glucose i loko o ka maʻi diabetes type 2.

ʻO ka lāʻau lapaʻau hypoglycemic oral, me ka mea ikaika - empagliflozin. Hōʻike ʻia ka ʻike kikoʻī a me nā hewa ma ka papa ʻaina:

Paʻi ʻia 1 papa (mg)

opadray melemole (hypromellose, titanium dioxide, talc, macrogol, hao ʻelehe hoʻoneʻe melemele)

Ka hana lāʻau lapaʻau

He hoʻohuli ʻo Empagliflozin i kahi mea hoʻoneʻe hou a paʻa i ka ʻano o ka sodium e hilinaʻi ʻia o ka sodium. Ua hōʻoia ʻia ʻepekema a ua koho maikaʻi loa ka empagliflozin no nā alakaʻi ʻē aʻe i kuleana no ka home home home glucose i loko o nā ʻili kino. Loaʻa i ka waiwai i ka hopena glycemic i loko o nā mea maʻi me ka maʻi diabetes type 2 ma ke hoʻemi ʻana i ke kao o ke kō i loko o nā keiki. ʻO ka nui o ka glucose i hoʻopuka ʻia e kēia hana e kū pololei ana i ka helu o ka kānana o ka glomeruli o nā keiki.

Ua hōʻike ʻia nā noiʻi i nā mea maʻi me ka diabetes type 2, ʻoi ka nui o ka glucose i hoʻopiʻi ʻia ma hope o ka loaʻa mua ʻana i ka pupu a mua ka hopena i hoʻokahi lā. Ke noho nei kēia mau ʻōuli i ka wā e lawe ai i 25 mg o ka empagliflozin no hoʻokahi mahina. ʻO ka hoʻonuiʻana o ka kōpī o ka kōpī i nā keiki i alakaʻi i kahi emi o kona kaohi i ke koko o ka mea maʻi. ʻO ka lāʻau lapaʻau e hōʻemi i ka hoʻouluʻana o ka glucose i ke koko, me ka mālama ʻole o ka meaʻai.

ʻO kahi māhele kūʻokoʻa o ka insulin e hōʻemi i ka hopena o ka hypoglycemia.ʻO ka mea o ka hana o ka hana ikaika ka mea i hilinaʻi ma ka hana o nā mokupuni o Langerhans a me ka metabolism insulin. Ua ʻike nā ʻepekema ʻepekema i nā hopena maikaʻi o ka empagliflozin ma ka hoʻohālikelike i nā peptides hana o ka hana maʻamau o kēia mau puna. Hoʻonui ka hoʻonui ʻana i ka glucose i mea e nalowale ai i nā calorie, e hoʻemi ana i ke kaumaha o ke kino. I ka wā o ka hoʻohana ʻana o ka empagliflozin, ua ʻike ʻia ka glucosuria.

Nā hōʻailona no ka hoʻohana ʻana

Hōʻike ʻia no nā mea maʻi me ka diabetes mellitus type 2 ma kahi papaʻai ma ke ʻano pāʻani, ʻaʻole hiki ke ʻohi pono i nā hōʻailona glycemic. Me ka hoʻomau ʻana o Metformin, hiki i ka monotherapy me Jardins. Inā loaʻa kahi hopena kūpono i ka hopena kūpono, hoʻohui ʻia ka hoʻohana ʻana me nā lāʻau lapaʻau hypoglycemic ʻē aʻe, me ke ʻano o ka insulin.

Nā Kauka Jardins

Lawe ʻia nā papa papaʻaila, me ka manaʻo ʻole o ka lā o ka lā a me ka meaʻai. Hoʻomaopopo ʻia e hoʻomaka i ka lawe ʻana me 10 mg i kēlā me kēia lā, inā ʻaʻole i hiki ka hopena kūpono, a laila piʻi i ka 25 mg. Inā no kekahi kumu ʻaʻole lākou i lawe i ka lāʻau lapaʻau, a laila e inu koke ʻoe, e like me kā lākou hoʻomanaʻo. ʻAʻole hiki ke hoʻopau ʻia ka nui ʻelua. I kahi hihia o nā hana hōʻemi lēwa, ʻaʻole i ʻae ʻia ka hoʻoponopono ʻana, a ʻaʻole ʻae ʻia nā mea maʻi me nā maʻi o ka pūpū.

I ka wā hāpai

Hoʻohana ʻia ka hoʻohana ʻana i nā papa i ka wā hapai ma muli o ka loaʻa ʻole o ka ʻike mai ka hoʻopaʻa ʻana i ka pono a me ka palekana. Ua hōʻike ʻia nā haʻawina holoholona preclinical i ka liʻiliʻi o ka neʻe empagliflozin i ke kahe koko. ʻAʻole i pale ʻia ka hopena o ka hoʻolaha i ka pūpū a me ka pēpē. Inā pono, pono ʻoe e hoʻōki i ka lawe ʻana i ka lāʻau i ka wā hāpai.

I ke wā kamaliʻi

ʻO ka mālama ʻia me ka lāʻau lapaʻau i nā keiki a me nā ʻōpio ma lalo o 18 mau mea e contraindicated loa. Hoʻohui ʻia me ka ʻike noiʻi ʻike ʻole. ʻAʻole maikaʻi ʻia ka hopena a me ka palekana o ka waiwai emakela empagliflozin no nā keiki. No ka hoʻopau ʻana i nā pilikia o ka hōʻeha i ka olakino ʻōpiopio, ua pāpā ʻia ʻo Jardins. ʻOi aku ka maikaʻi e koho i kekahi lāʻau lapaʻau i hōʻoia ʻia.

Nā kiʻi 3D

ʻO ka wehewehe ʻana i ke ʻano dosis

Nā papa ʻaina 10 mg: ua hoʻopuni nā bildvex me nā kihi beveled, i uhi ʻia me ka membrane o ke kiʻi ʻoniʻoni ʻoni kukui, me ke kahakaha ʻana o ka hōʻailona o ka hui ma kekahi ʻaoʻao a me "S10" ma kēlā ʻaoʻao.

25 papa papa: oval biconvex me nā kihi beveled, i uhi ʻia me ka membrane kiʻi o ke kala melemele kala, me ke kahakaha ʻana o ka hōʻailona o ka hui ma kekahi ʻaoʻao a me "S25" ma kēlā ʻaoʻao.

Lapaʻau lāʻau

ʻO Empagliflozin kahi mea hoʻihoʻi ikaika a me ka pale o ke kaohi ʻana o ka sodium sodium-dependant type 2 me ke kaila e koi ai i ka 50% o ka hana hoʻoulu (IC)₅₀), e like me 1,3 nmol. ʻO ka koho ʻana o ka empagliflozin he 5,000 mau manawa iʻoi aʻe ma mua o ka wae ʻana o ka paʻakai meli hoʻonaʻauao sodium, nona ke kuleana o ke kao o ka glucose i loko o ka ʻawaʻawa. Eia kekahi, ua loaʻa ka empagliflozin i kahi koho kiʻekiʻe no nā transporters glucose hou ke kuleana no ka home home home glucose.

ʻO ka sodium-hilinaʻi glucose transporter type 2 ke kumu nui o ka hānai lawe nui i kuleana no ka reabsorption o ka glucose mai ka renom glomeruli hou i loko o ke kahe wai. Hoʻonui ka Empagliflozin i ka mālama glycemic i nā mea maʻi me ka diabetes mellitus type 2 (T2DM) ma ka hoʻemi ʻana i ka glucose reabsorption. ʻO ka nui o ka glucose i hilo ʻia e nā keiki e hoʻohana i kēia hana hiki ke pili i ke kūpaʻa o ka glucose i ke koko a me GFR. Hōʻike i ka sodium-dependence glucose transporter type 2 i nā mea maʻi me ka diabetes type 2 a me ka hyperglycemia alakaʻi i ka hoʻohemo ʻana o ka nui o ka glucose e nā pōʻai.

Ma kahi noiʻi haukaʻi he 4 mau hebedoma i loaʻa i loko o nā mea maʻi me ka maʻi diabetes type 2, hoʻonui nui ʻia ka glucose glucose ma hope o ka manawa mua o ka empagliflozin i hoʻohana ʻia, ua hoʻomau ʻia kēia hopena no nā hola 24. Ua hoʻomau ka hoʻonui ʻana o ka hoʻonui ʻana i ka glucose ka lolo a hiki i ka hopena o ka hoʻōla, ka nui. kahi dosis no 25 mg 1 mau manawa i kēlā me kēia lā, ma kahi o 78 g / lā. I ka poʻe maʻi me ka maʻi type 2, he piʻi nui aʻe o ka glucose o ka glucose e nā huaʻai i alakaʻi i kahi emi koke o ke kao o ka glucose i ka plasma koko.

ʻO Empagliflozin (ma kahi o ka 10 a me 25 mg) ka hoʻokaʻawale ʻana i ke kaila o ka glucose i loko o ke koko koko a i ke ʻano hoʻi o ka wikiwiki a ma hope o ka ʻai.

ʻO ka hana o ka hana o ka empagliflozin ʻaʻole i hilinaʻi i ka kūlana hana o nā peka beta pancreatic a me ka metabolism insulin, ka mea e hāʻawi aku i kahi haʻahaʻa haʻahaʻa o ka hiki ke hoʻomau i ka hypoglycemia. Ua hōʻike ʻia nā hopena maikaʻi o ka empagliflozin i ka poʻe hoʻohālikelike i ka hana o ka beta cell, me ka huaʻōlelo HOMA-β (ka loiloi no ka loiloi i ka homeostasis-B) a me ka hoʻohālikelike o ka proinsulin i ka insulin. Hoʻopili ia, ʻo ke kāpae ʻana o ka glucose i nā huaʻai e hōʻeha i ka hina o ke kaloli, e hoʻopili ʻia me ka hoʻemi ʻana o ka nui o ke kiko adipose a me ka hoʻolilo ʻana i ke kaupaona kino.

Loaʻa ka Glucosuria i ka wā o ka hoʻohana ʻana i ka empagliflozin i hoʻopili ʻia me ka piʻi iki o ka diuresis, hiki iā ia ke hāʻawi i kahi emi o ke kahe o ke koko.

I nā haʻawina maʻi ma kahi i hoʻohana ai ka empagliflozin i ke ʻano o ka monotherapy, hui pū me ka metformin, hui hui pū me ka metformin i nā mea maʻi me ke maʻi maʻi maʻi ʻoʻi hou, 2 ka hoʻohui hui me nā metformin a me nā konopulepo sulfonylurea, hui hui pū me ka pioglitazone +/− metformin, hui pū me ka linagliptin i nā mea maʻi me ka maʻi maʻi diabetes mellitus 2, hui pū me ka linagliptin, hoʻohui i ka metformin therapy, hui pū me ka linagliptin i hoʻohālikelike ʻia me ka paracetam. o i nā mea maʻi me ka kontrol glycemic kulang i ka wā e lawe ai i ka linagliptin a me ka metformin, hui pū me ka metformin versus glimepiride (nā hōʻike mai ka noiʻi 2 mau makahiki), hui pū me ka insulin (nui o ka inikua hana hoʻonāina pūlima) +/− metformin, hui pū me ka insulin basal. , hui hui pū me ka DPP-4 inhibitor, metformin +/− i ka lāʻau lapaʻau hypoglycemic oral, ua hōʻike ʻia ka nui o ka helu ma HbA1_{c hoowela}, he hoʻohaʻahaʻa i ka hoʻoliʻiliʻi ʻana o ka glucose plasma, a me ka hoʻohaʻahaʻa ʻana i ke koko a me ke kaumaha o ke kino.

Ua hōʻike ʻia kahi haʻawina haumania i ka hopena o ka lāʻau Jardins ® i ka pinepine o nā hanana cardiovascular ma nā maʻi me ka maʻi diabetes type 2 a me ke kiʻekiʻe cardiovascular kiʻekiʻe (i wehewehe ʻia ʻo ka loaʻa ʻana o kekahi o kēia mau maʻi a me: a me nā kūlana: ka maʻi ʻalani coronary (he mōʻaukala o ka myocardial infarction, coronary artery bypass grafting) , IHD me ka pōʻino o kekahi moku coronary, ʻo IHD me ka pōʻino i kekahi mau moku coronary), ka mōʻaukala o ischemic a hemorrhagic stroke, maʻi maʻi pā peripheral me a ʻole ʻole mau hōʻailona) e loaʻa ana i ka maʻamau hydrochloric Inc, a komo pū hypoglycemic Luna a me ka Luna no ka iapaau ana o ka mea'ōnaehana mānowai koko ka maʻi. ʻO nā hihia o ka make cardiovascular, non-fatal myocardial infarction a me nā mea hōʻeha non-fatal i loiloi ʻia ʻo ia kahi hopena kumu mua. ʻO ka make Cardiovascular, ka make maʻamau, ka hoʻomohala ʻana o nā nephropathy a i ʻole ka piʻi nui ʻana o ka nephropathy, a me ka hoʻokipa ʻana no ka hōʻeha ʻana o ka puʻuwai i koho ʻia e like me nā mea i hoʻomaka mua ʻia.

Ua hoʻonui ʻo Empagliflozin i ke ola holoʻokoʻa ma o ka hōʻemi ʻana i nā hihia o ka make cardiovascular. Ua hōʻemi ʻo Empagliflozin i ka hopena o ka hoʻokipa ʻana no ka hōkole o ka naʻau. Eia nō hoʻi, ma kahi noiʻi haumania, ua hōʻike ʻia i hōʻemi ʻia ʻo ka lāʻau Jardins ® i ka hōʻemi o ka nephropathy a i ʻole ka ulu kino ʻana o ka nephropathy.

I ka poʻe maʻi me ka macroalbuminuria mua, ua ʻike ʻia ka nui o ka lāʻau Jardins ® e hoʻohālikelike pinepine ʻia i ka placebo i alakaʻi i ka norm-or microalbuminuria (pākēnē ʻo 1.82, 95% CI: 1.4–2.37).

Lapaʻau lāʻau

Ua hōʻike piha ʻia kahi lāʻau lapaʻau o ka empagliflozin i nā poʻe hana olakino olakino a me nā mea maʻi me ka maʻi maʻi 2.

Kapehu. Empagliflozin ma hope o ka lawe waha ʻana, ua wikiwiki koke ʻo C, C_max ua loaʻa i ka empagliflozin i ka plasma ma hope o nā hola 1.5. A laila, hoʻemi ka manaʻo o empagliflozin i ka plasma i ʻelua mau manawa. Ma hope o ka lawe ʻana i ka empagliflozin ma kahi o 25 mg o hoʻokahi i hoʻokahi lā, ʻo ka awelika ʻo AUC i ka manawa C_{ai ʻo ss} i loko o plasma he 4740 nmol · h / l, a me ke kumukūʻai o C_max - 687 nmol / L.

ʻO nā pharmacokinetics o empagliflozin i nā mea hana olakino olakino a me nā mea maʻi me nā maʻi maʻi type 2 ua like like.

ʻAʻohe ʻai nui i ka hopena ma ka pharmacokinetics o empagliflozin.

Kahele. V_{e d} i ka wā o ka plasma C_{ai ʻo ss} ma kahi o 73.8 lita. Ma hope o ka lawelawe waha ʻana e nā mea holomua olakino maikaʻi o ka inoa ʻo ka inoa ʻo emagliflozin 14 C, nā pilina o ka protein protein he 86.2%.

Hāpai. ʻO ke ala nui o ka metabolism empagliflozin i loko o ke kanaka he glucuronidation me ke komo ʻana o UDP-GT (UGT2B7, UGT1A3, UGT1A8 a me UGT1A9). ʻO nā metabolites ka mea i ʻike nui ʻia e ka empagliflozin he 3 mau conjurates glucuronic (2-O, 3-O a me 6-O glucuronide). ʻO ka hopena systemic o kēlā me kēia metabolite ka liʻiliʻi (ma lalo o 10% o ka hopena piha o ka empagliflozin).

Leʻaleʻa. T_1/2 aia ma kahi o 12.4 mau hola.ʻI ka hihia o ka hoʻohana ʻana i nā empagliflozin 1 manawa i kēlā me kēia lā C_{ai ʻo ss} i ka plasma ua loaʻa ma hope o ka helu ʻelima. Ma hope o ka lawelawe waha ʻana i ka inoa o ka inoa ʻo emagliflozin 14 C i nā mea hana olakino olakino, ma kahi o 96% o ka make i hoʻopiʻi ʻia (ma loko o nā ʻōpū o 41% a me nā kauā 54%).

Ma loko o nā ʻōpū, ʻaʻole i hoʻololi ʻia ka hapa nui o ka lāʻau hōʻailona. Hoʻokahi wale nō hapa o ka lāʻau hōʻailona i hoʻopili ʻia ʻole e nā keiki.

ʻO ka pharmacokinetics i nā pōkole hanohano kūikawā

Hola paʻa kino hana. I nā maʻi me ka maʻi (60 2), i hōʻeha (30 2), hōʻeha loa (GFR 2) pilikia ʻole, a me nā mea maʻi me ka hopena o ka hope lōkihi, ʻoi aku ka nui o ka AUC o ka ʻai e hoʻonui ʻia ai he 18, 20, 66, a me 48%. hana maoli maʻi. I nā mea maʻi me ka hiki ke hoʻololi ʻana i ka pilikia o ka renal a me nā mea maʻi me ka hopena o ka hana hope ʻole C_max ʻo ka empagliflozin i ka plasma ua like like me nā waiwai kūpono i nā mea maʻi me ka hana maʻamau. I ka poʻe maʻi me ka hōʻeha a me ka maikaʻi ʻole o ka pale_max empagliflozin i loko o plasma i kahi 20% kiʻekiʻe ma mua o nā mea maʻi me ka hana maʻamau maʻamau. Ua hōʻike nā hōʻike noiʻi pharmacokinetic i hōʻike i ke koena o ka hoʻomaʻemaʻe ʻana o nā empagliflozin i hoʻohaʻahaʻa me ka hoʻohaʻahaʻa i ka GFR, i alakaʻi ai i ka hopena o ka lāʻau lapaʻau.

Hōʻeha ka hana ʻoluʻolu. I nā mea maʻi me ka hana aho o ka palaualelo o ke ʻano palupalu, hōʻeha a me ke koʻikoʻi (e like me ka helu ʻana o nā keiki-Pugh), ua hoʻonui ʻia nā waiwai o ka AUC o ka empagliflozin ma aneane 23, 47 a me 75%, ia manawa, a me C_max ma kahi o 4, 23 a me 48%, kēlā me kēia (hoʻohālikelike ʻia me nā mea maʻi me ka hana maʻamau puʻuwai).

ʻAʻole i loaʻa kahi hopena koʻikoʻi o ka BMI, ka wahine, ka lāhui, a me ka makahiki i nā pharmacokinetics o empagliflozin.

E na keiki. ʻAʻole i hana ʻia nā noi ʻana o nā pharmacokinetics o empagliflozin i loko o nā keiki.

Nā hōʻikeʻike o ka lāʻau Jardins ®

ʻAno 2 mellitus mole:

- e like me ka monotherapy i ka poʻe maʻi me ka hiki ʻole o ka mālama glycemic control wale nō e kūʻē ana i ke kūlana o ka meaʻai a me ka hoʻōla, ʻo ka koho ʻana o ka metformin ka mea hiki ʻole ke kīlei ʻana,

- me he mea hoʻohui lāʻau me nā mea haole hypoglycemic ʻē aʻe, e komo pū me ka insulin, i ka wā i noi ʻia ai ka terapi me ka meaʻai me ka hoʻomaʻamaʻa ʻana ʻaʻole i hāʻawi i ka mana glycemic pono.

Hōʻike ia no nā poʻe maʻi me ka maʻi diabetes mellitus type 2 a me ke kaona cardiovascular kiʻekiʻe * i hui pū ʻia me ka lāʻau maʻamau no nā maʻi cardiovascular ma kahi e hōʻemi ai:

- kaukaʻi kino ma ka hoʻemi ʻana i ka maʻi kuhi cardiovascular,

- ka maʻi cardiovascular a i ʻole ka hoʻomaha ʻo ia ma kahi pilikia o ka naʻau.

* ʻO ka hopena cardiovascular kiʻekiʻe ka mea i hōʻike ʻia ma ka liʻiliʻi loa o kekahi o nā maʻi a me / a me nā kūlana paha: coronary heart heart (history of myocardial infarction, coronary artery bypass, coronary artery disease me ka hōʻino i hoʻokahi pahu coronary, maʻi ʻeha coronary me ka hōʻino i kekahi mau moku coronary), ischemic a hemorrhagic stroke ka mōʻaukala o kēlā me kēia maʻi ʻōiwi.

ʻŌpū a me ka lactation

Hoʻohana ʻia ka hoʻohana ʻana o ka empagliflozin i ka wā hapai ma muli o ka lawa ʻole o ka ʻikepili i ka pono a me ka palekana.

ʻO nā ʻikepili i loaʻa i nā noi preclinical i nā holoholona e hōʻike i ka komo ʻana o ka empagliflozin i loko o ka waiū umauma. Hōʻalo ʻia ka nui o ka hoʻolaha ʻana i nā pēpē a me nā keiki i ka wā o ka hoʻoulu ʻana. Hoʻohana ʻia ka hoʻohana ʻana o ka empagliflozin i ka wā o ka hoʻoulu ʻana. Inā pono, e hoʻohana ʻia ka hoʻohana ʻana o empagliflozin i ka wā o ka hoʻoulu ʻana.

Nā hopena hopena

ʻO ka nui o ka loaʻa ʻana o nā hanana pōʻino i ka poʻe maʻi e loaʻa ana i ka empagliflozin a i kahi placebo paha i loko o nā hoʻokolohua ʻoihana like ʻole. ʻO ka hopena maʻamau loa e hōʻike ʻia ana i ka hypoglycemia, i nānā ʻia me ka hoʻohana ʻana i ka empagliflozin i hui pū ʻia me nā dermoni sulfonylurea a i ʻole insulin (e nānā ʻO ka wehewehe ʻana i nā hopena kūlike maikaʻi).

ʻO nā hōʻike ʻinoʻino i ʻike ʻia i nā mea maʻi e loaʻa ana i ka empagliflozin i loko o nā papa hoʻokele i ka pletebo i hōʻike ʻia ma lalo iho nei (ua hoʻohālikelike ʻia nā pōʻino e like me nā kino a me nā ʻōnaehana a like i makemake ʻia MedDRA huaʻōlelo) e hōʻike ana i ko lākou alapine kūʻokoʻa. Ka wehewehe pinepine ʻia nā ʻāpana pinepine: ʻo ka pinepine (≥1 / 10), pinepine (mai ka ≥1 / 100 i ke kahe koko, a me ka hypotension orthostatic, ʻōpū, nāwaliwali) ka like ma ka hihia o ka empagliflozin (ma kahiʻu o 10 mg - 0.6%. i ka pā o 25 mg - 0.4%) a me placebo (0.3%). I ka poʻe maʻi i ʻoi aku ma mua o 75 mau makahiki, ua hoʻohālikelike ka pilikia o hypovolemia i nā poʻe maʻi e lawe ana i ka empagliflozin ma ke ʻano o 10 mg (2.3%) a me ka placebo (2.1%), akā ke kiʻekiʻe aʻe i nā mea maʻi e lawe ana i ka empagliflozin ma kahi o 25 mg (4.3%) )

Hoʻohui

Diuretics. Hiki i ka Empagliflozin ke hoʻonui i ka hopena diuretic o thiazide a me ka diuretics loop, ʻo ia hoʻi, e hoʻonui ai i ka hōʻeha o ka dehydration a me hypotension arterial.

ʻO ka insulin a me nā lāʻau lapaʻau e hoʻoikaika i kāna hūnā. ʻO ka insulin a me nā lāʻau lapaʻau e hoʻoikaika i kāna mea huna, e like me ka sulfonylureas, e hoʻonui i ka ʻeha o ka hypoglycemia. No laila, me ka hoʻohana pū ʻana o empagliflozin me ka insulin a me nā lāʻau lapaʻau e hoʻoikaika ai i kona ʻimi, pono paha e hōʻemi i kā lākou dosis, i mea e pale ai i ka maʻi o ka hypoglycemia.

ʻO ka loiloi o ka hana ʻikepili i ka vitro. ʻAʻole i hoʻopaʻa ai ʻo Empagliflozin i ka hana, ʻaʻole hoʻohālikelike, a i ʻole hoʻohiolo iā CYP450 isoenzymes. ʻO ke ala nui o ka metabolism human empagliflozin ka glucuronidation me ke komo ʻana o UDP-GT (UGT2B7, UGT1A3, UGT1A8 a me UGT1A9). ʻAʻole ʻo Empagliflozin i kālai i ʻo UGT1A1, UGT1A3, UGT1A8, UGT1A9 a i UGT2B7. ʻO nā hōʻiliʻili o ka lālani o ka empagliflozin a me nā lāʻau lapaʻau i hoʻohālikelike i ka CYP450 a me UGT isoenzymes i manaʻo ʻia i like ole. ʻO Empagliflozin kahi papa hana no ka P-gp a me kahi protein e hoʻoholo ai i ka BCRP, akā ma nā lāʻau therapeutic ʻaʻole i pale i kēia mau protein. Kuhi ʻia nā ʻikepili mai nā noi i loko o vitro , ke manaʻoʻiʻo nei ka hiki o ka empagliflozin i ke kamaʻilio ʻana me ka lāʻau lapaʻau e no nā P-gphiki ole. ʻO Empagliflozin kahi papa lepo no nā mea lawe anionic organik: OAT3, OATP1B1 a me OATP1B3, akā ʻaʻole ia kahi papa kuhikuhi no ka mea lawe anionic organik 1 (OAT1) a me nā mea lawe cationic carriers 2 (OCT2). Eia naʻe, ʻo ka hoʻopili ʻana i nā lāʻau lapaʻau ka empagliflozin me nā lāʻau lapaʻau nā substrate no nā mea lawe palaka e pili ana i luna e manaʻo ʻia he hana ʻole ʻole.

ʻO ka loiloi o nā pilina pili i ka vivo. Me ka hoʻohana pū ʻana o ka empagliflozin me nā lāʻau lapaʻau maʻamau, ʻaʻole i ʻike ʻia nā pilina lapaʻau koʻikoʻi. Hōʻike nā hopena o nā noiʻi pharmacokinetic ʻaʻole pono e hoʻololi i kēiaʻano o ka lāʻau lapaʻau Jardins ® aʻo ia ka mea me nā lāʻau lapaʻau maʻamau.

ʻAʻole loli i ka pharmacokinetics o empagliflozin i nā mea hana olakino maikaʻi i ka wā i hoʻohana pū ʻia me metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, a ma ka poʻe maʻi me ka diabetes type 2 inā hoʻohana pū ʻia me ka torasemoridide a me ka hydrochloride hydro.

Me ka hui pū ʻana o ka empagliflozin me gemfibrozil, rifampicin a me probenecid, he hoʻonui i ka AUC o nā empagliflozin e 59, 35 a me 53%, i kēlā me kēia helu, akā, ʻaʻole i manaʻo ʻia kēia mau loli.

ʻAʻole ka hopena o Empagliflozin i ka hopena nui ma ka pharmacokinetics o ka metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide a me nā mea hoʻohiwahiwa i loko o nā limahana olakino.

Hoʻohui nūhou

Hoʻonui ʻo ia i ka hopena diuretic o nā diuretics ʻano like ʻole, e hoʻonui ana i ka hōʻemi o ka dehydration a me hypotension arterial. Hiki i nā deriv mai i loko o ka insulin a me ka sulfonylurea. Me ka hoʻohana pū ʻana o ka lāʻau lapaʻau me ka insulin, pono kahi hōʻemi i ka hoʻokaʻawale ʻana e pale aku i kahi kūlana hypoglycemic.ʻO ka pilina o ka lāʻau e pili ana i ka empagliflozin a me nā lāʻau lapaʻau e pili ana i ka hoʻohuihui o nā isoenzymes i manaʻo ʻia he palekana.

Empagliflozin - ka mea hana hoʻomehana i nā papa, ʻaʻole i pili i ka waiwai ʻo ka lāʻau lapaʻau e pili ana i nā lāʻau i lalo nei: Metformin, Glimepiride, Pioglitazone, Warfarin, Digoxin, Ramipril, Simvastatin, Hydrochlorothiazide, Torasemide a me nā mea hoʻohālikelike waha. Me ka hoʻohana like ʻana me kēia mau lāʻau lapaʻau maʻamau, ʻaʻole pono kahi loli ʻana.

ʻO Jardins Analogs

Ma ka mākeke lāʻau o ka Russian Federation, hoʻokahi wale nō lāʻau i hoʻokumu ʻia ma ke kumu o kahi waiwai - empagliflovin. ʻAʻole loaʻa iā Jardins ka hōʻoia i hōʻoia. ʻO nā papa hypoglycemic ʻē aʻe kekahi i nā mea ikaika i ka hoʻolālā ʻana a hana like ʻole ma ke kino o ke kanaka. E pili ana kēia:

Jardins - nā ʻōlelo aʻoaʻo no ka hoʻohana, nā kumu kūʻai, nā loiloi a me nā analog

Ua manaʻo ʻia ʻo Diabetes mellitus kekahi o nā maʻi maʻamau loa ma ka lewa. I ka Lūkini Russian, kahi o 10 miliona mau kānaka i hōʻeha ʻia mai kēia maʻi. ʻOi aku ka nui o lākou e hoʻohana i ka lāʻau lapaʻau Jardins ma muli o kona kūpono.

ʻO Jardiance ka inoa Latin. INN lāʻau: Empagliflozin (Empagliflozin).

ʻO Jardins kahi hopena antidiabetic.

Hoʻolaha ATX: A10BK03.

Loaʻa ka lāʻau lapaʻau i ke ʻano o nā lāʻau hoʻomohala a-paʻilima. 1 papa pili i 25 a 10 mg o ka empagliflozin (ka mea hana hoʻomohala). Mea ʻē aʻe:

• ka leʻaleʻa talcum
• titanium hone
• hoʻohi ka wai ʻona kala (dye),
• laktosa lactose,
• Hoʻopiʻi
• cellulose microcrystals.

Loaʻa ka lāʻau lapaʻau i ke ʻano o nā lāʻau hoʻomohala a-paʻilima.

Hoʻopili ʻia nā papa i nā palaka o 10 mau pcs. Ka pahu 1 i kahi 1 a i 3 mau palaka.

Me ka mālama pono

Hoʻomaʻamaʻa ʻia ka lāʻau lapaʻau inā:

• hana huna haʻahaʻa haʻahaʻa o nā cell i loaʻa i ka pancreas,
• hui me sulfonylurea a me insulin derivatives,
• nā maʻi ʻeha e pili ai i ka pohō nui loa,
• elemakule.

ʻLoe a me ke kākele

Lawe ʻia nā peni. ʻO ka maʻa mua he 10 mg hoʻokahi i ka lā. Inā hiki ʻole kēia nui o ka lāʻau lapaʻau i hiki ke hāʻawi i ka mālama glycemic, a laila piʻi ka hopena i 25 mg. ʻO ka dosage nui loa he 25 mg / lā.

Lawe ʻia nā peni.

ʻAʻole pili ʻia ka hoʻohana ʻana i nā papa i ka manawa o ke ao a i ʻole ka ʻai ʻana o ka meaʻai. ʻAʻole pono i 1 lā ke noi i kahi pālua i pālua.

Hoʻopilikiaʻia nā maʻi maʻi e Jardins

Ua hōʻike ʻia nā hoʻokolohua haukapila i ka lāʻau lapaʻau e nīnau nei ka lāʻau wale nō no ka mālama ʻana i ka maʻi mellitus (type II), ma nā hopena i hōʻeha ʻia o nā maʻi CVD a me ka make o ka make mai nā mea āpau e hōʻemi ʻia. Lā ʻia ka hoʻohana ʻana i ka lāʻau lapaʻau no nā poʻe maʻi me nā maʻi maʻi type 1.

Nā hōʻike hōʻike a nā kauka a me nā mea maʻi e pili ana iā Jardins

ʻO Galina Aleksanina (ʻoihana), 45 mau makahiki, ʻo St. Petersburg.

ʻO kahi palekana palekana e hōʻeha i nā hopena ʻaoʻao (i kaʻu hoʻomaʻamaʻa). Kūpono nui ke kumukūʻai kiʻekiʻe e ka hana lāʻau lapaʻau i ka lāʻau. Hoʻoholo ʻia ka hopena placebo. Eia kekahi, ʻaʻohe ona analog i Rusia, a hana like nā ʻano like me nā ʻano like ʻole.

Anton Kalinkin, 43 makahiki, Voronezh.

He maikaʻi ka hāmeʻa. ʻO wau, ma ke maʻi maʻi maʻi me ka ʻike, ua piha loa wau i kāna hana. ʻO ka mea nui, ʻo ka mālama pono ʻana i nā ʻōkuhi no ka hoʻohana. ʻO ka hihia wale nō kēia e hiki ke pale i nā hopena ʻona, i hōʻoia ʻia ma ka hoʻomaʻamaʻa. I waena o nā hemahema, hiki i ka mea ke wehewehe wale i ke kumukūʻai kiʻekiʻe a me ke kīpē ʻole i kūʻai ʻia ka lāʻau lapaʻau ma nā lāʻau āpau a pau.

Jardins: ʻōlelo kuhikuhi no ka hoʻohana ʻana

Lapaʻau lāʻau

ʻO Empagliflozin kahi reversible, ikaika hana, selective a me ka pale pale o ka type 2 sodium-depend glucose transporter me ka neʻe ʻana e koi ai i ka 50% o ka hana hoʻoulu (IC50) o 1,3 nmol.

ʻO ka koho ʻana o ka empagliflozin he 5,000 mau manawa i ʻoi aku ma mua o ka hoʻohana ʻana o ka mea hoʻonaninani glucose mālaʻa o ka sodium e kuleana no ka hoʻopio ʻana o ka glucose i loko o ka ʻawaʻawa. Eia kekahi, ua loaʻa ka empagliflozin i kahi koho kiʻekiʻe no nā transporters glucose hou ke kuleana no ka home home home glucose.

ʻO ka sodium-hilinaʻi type 2 glucose transporter ka mea nui e lawe ai i ka protein lawe nui e pili ana i ka reabsorption o ka glucose mai ka glomeruli renal i loko o ke kahe wai. Hoʻonui ka Empagliflozin i ka mālama glycemic i nā mea maʻi me ka diabetes mellitus type 2 (T2DM) ma ka hoʻemi ʻana i ka glucose reabsorption.

ʻO ka nui o ka glucose i hilo ʻia e nā keiki e hoʻohana i kēia hana hiki ke pili i ke kūpaʻa o ka glucose i ke koko a me ka huina filtration glomerular (GFR). ʻO ka wehe ʻana o ka mea lawe sodium e hilinaʻi nei i ka hoʻohālikelike type 2 i nā mea maʻi me ka diabetes type 2 a me ka hyperglycemia alakaʻi i ka hoʻohemo ʻana o ka nui o ka glucose e nā pōʻai.

I nā haʻawina haumania, ua loaʻa i nā mea maʻi me ka maʻi type 2, ua hoʻonui ʻia ka hoʻōla o ka glucose ma nā huaʻai ma hope o ka hoʻohana mua ʻana o ka empagliflozin, ua hoʻomau ʻia kēia hopena no 24 mau hola.

Hoʻonui ka hoʻonui ʻana o ka glucose i ka glucose e nā keiki a hiki i ka hopena o ka mālama manawa 4-pule, me ka empagliflozin ma kahi maʻa o 25 mg hoʻokahi i ka lā, ma ka awelika, ma kahi o 78 g / lā. I ka poʻe maʻi me ka maʻi type 2, he piʻi nui aʻe o ka glucose o ka glucose e nā huaʻai i alakaʻi i kahi emi koke o ke kao o ka glucose i ka plasma koko.

Hoʻopau i ka Empagliflozin i ke kukuna o ka glucose i ka pulu koko a i ke ʻano no ka wikiwiki a ma hope o ka ʻai ʻana. ʻO ka hana ole-insulin-hilinaʻi i ka hana o ka empagliflozin e hāʻawi i kahi haʻahaʻa haʻahaʻa o ka hiki ke hoʻomohala ʻia ka hypoglycemia. ʻAʻole i hilinaʻi ʻia ka hopena o ka empagliflozin i ka hana o ka hana o nā pupu beta pancreatic a me nā metabolism insulin.

Ua hōʻike ʻia ka hopena maikaʻi o ka empagliflozin i ka poʻe hoʻohālikelike i ka hana o ka beta cell, me ka HOMA-? Index (ka loiloi no ka loiloi i ka homeostasis-B) a me ka ratio o ka proinsulin i ka insulin. Hoʻopili ia, ʻo ke kāpae ʻana o ka glucose i nā huaʻai e hōʻeha i ka hina o ke kaloli, e hoʻopili ʻia me ka hoʻemi ʻana o ka nui o ke kiko adipose a me ka hoʻolilo ʻana i ke kaupaona kino. Loaʻa ka Glucosuria i ka wā o ka hoʻohana ʻana i ka empagliflozin i hoʻopili ʻia me ka piʻi iki o ka diuresis, hiki iā ia ke hāʻawi i kahi emi o ke kahe o ke koko.

I nā hoʻokolohua olakino kahi i hoʻohana ai ʻo empagliflozin i mea monotherapy, hui pū me ka metformin, hui hui pū me ka metformin a me ka hopena ole o ka sulfonylurea, hui hui pū me ka metformin hoʻohālikelike i ka glimepiride, hui hoʻohui me ka pioglitazone +/- metformin, i hui pū me ka dipeptidyl peptide inhibitor 4 (DPP-4), metformin +/- i kekahi lāʻau lapaʻau hypoglycemic waha, ma ke ʻano o ka hui pū ʻana me ka insulin, he waiwai nui ia ʻO kaʻu hōʻemi i ka glycosylated HbAlc hemoglobin a me ka hoʻohaʻahaʻa ʻana i ka kaila glucose glucose wikiwiki.

Ua hōʻike nui ʻia nā pharmacokinetics o empagliflozin i nā poʻe hana olakino olakino a me nā mea maʻi me nā maʻi maʻi type 2.

Ma hope o ka lawelawe waha, ua hoʻokomo koke ka empagliflozin i ka nui, ua loaʻa i ka nui o ka emepliflozin i loko o ke koko koko (Cmax) ma hope o 1.5 mau hola. A laila, ua hōʻemi ʻia ka ʻike o empagliflozin i ka plasma i ʻelua mau manawa.

Ma hope o ka lawe ʻana i ka empagliflozin, ʻo ka ʻāina maʻamau ma lalo o ka pihi paʻa ʻana i ka manawa (AUC) i ka wā o ka hoʻokele ʻana i ka plasma mālaʻi, 4740 nmol x hola / L, a me ka waiwai Cmax he 687 nmol / L. ʻO nā pharmacokinetics o empagliflozin i nā mea hana olakino olakino a me nā mea maʻi me nā maʻi maʻi type 2 ua like like.

ʻAʻohe ʻai nui i ka hopena ma ka pharmacokinetics o empagliflozin.

ʻO ka nui o ka hoʻolaha i ka wā o ka neʻe ʻana o ka plasma kaila e like me ka 73.8 lita. Ma hope o ka lawelawe waha ʻana e nā mea olakino olakino o ka inoa ʻo empagliflozin 14C, ʻo ka protein ʻana o ka plasma he 86%.

ʻO ke ala nui o ka metabolism empagliflozin i loko o ke kanaka he glucuronidation me ka komo ʻana o ka uridine-5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 a me UGT1A9. ʻO nā metabolites ka mea i ʻike pinepine ʻia e ka emagliflozin ʻekolu mau mea huakaʻi glucuronic (2-0, 3-0 a me 6-0 glucuronides). ʻO ka hopena systemic o kēlā me kēia metabolite ka liʻiliʻi (ma lalo o 10% o ka hopena piha o ka empagliflozin).

ʻO ka hapa pio-hapalua kahi ma kahi o 12,4 hola. I ka hihia o ka hoʻohana ʻana i ka empagliflozin hoʻokahi manawa i ka lā, ua hōʻea kahi paʻa o ka plasma ma hope o ka helu ʻelima.

Ma hope o ka lawelawe waha ʻana i ka inoa o ka inoa ʻo emagliflozin 14C i nā mea hana olakino olakino, ma kahi o 96% o ka make i hoʻopio ʻia (ma loko o nā ʻōpū o 41% a me nā kauā 54%) Ma loko o nā ʻōpū, ʻaʻole i hoʻololi ʻia ka hapa nui o ka lāʻau hōʻailona.

Hoʻokahi wale nō hapa o ka lāʻau hōʻailona i hoʻopili ʻia ʻole e nā keiki. ʻO ka pharmacokinetics i nā pōkole hanohano kūikawā

Hola paʻa kino hana

I nā maʻi me ka maʻi palupalu māmā, maʻalahi a me ka pilikia (30 https: //apteka.103.xn--p1ai/jardins-13921690-instruktsiya/

Nā Jardins ™ papa he 10 mg 30 pcs

ʻAʻole i ʻōlelo ʻia ʻo Jardins® no nā maʻi me nā maʻi maʻi type 1 a no ka mālama ʻana i ka ketoacidosis maʻi maʻi.

Me ka hoʻohana ʻana o nā mea hoʻohālike transporter glucose 2 mau, e komo pū me ka empagliflozin, nā hanana loaʻa ʻole o ka ketoacidosis maʻi. I kekahi o kēia mau hihia, ua kuhi ʻia nā hōʻike a like me ka nui o ka piʻi ʻana o ka nui o ka glucose o ke koko (ʻaʻole iʻoi aku ma mua o 14 mmol / L (250 mg / dl)).

ʻO ka pilikia o ka hoʻomohala ʻana i ka ketoacidosis maʻi maʻi e noʻonoʻo inā he mau nonspecific hōʻailona e like me ka nausea, ka luaʻi, ka nele o kaʻai ʻana, ka ʻōpū o ka ʻōpū, ka makewai nui, ka waʻa ʻana o ka hanu, ka puʻuwai, ka lohi a me ka lohi o ka hiamoe. Inā loaʻa kēlā mau ʻano, e ʻike koke ʻia nā mea maʻi no ka ketoacidosis, ʻaʻohe o ke kaila o ke kaila o ke koko. ʻO ka hoʻohana ʻana i ka lāʻau Jardins® e pono e hoʻokuʻu a hoʻokū ʻole a hiki i ke kūkulu ʻana i ka maʻi.

Hiki i ka nui o ka ulu ʻana i ka ketoacidosis maʻi maʻi i nā mea maʻi ma ka ʻai haʻahaʻa haʻahaʻa haʻahaʻa, nā mea maʻi me ka maʻi kaumaha, nā mea maʻi me ka mōʻauī o ka ketoacidosis, a i nā mea maʻi me ka hana huna haʻahaʻa o ka pancreatic β-cells. I kēlā mau maʻi maʻi, e hoʻohana pono ʻo Jardins® me ka akahele. Pono ke nānā ʻana ma ka wā e hoʻemi ana i ka nui o ka insulin.

ʻO ka hoʻomākaukau ʻana o Jardins® ma loko o kahi papa 10 mg e loaʻa ka 162.5 mg o ka lactose, me kahi kaena o 25 mg e loaʻa ana ka 113 mg o ka lactose, no laila, ʻaʻole pono ka lāʻau lapaʻau i nā mea maʻi me nā maʻi maʻamau o ka maʻi e like me ka hemahema lactase, intolerance lactose, malabsorption glucose-galactose.

Ua hōʻike ʻia nā haʻawina haukaʻa ʻo ka mālama ʻana me ka empagliflozin ʻaʻole i alakaʻi i kahi hoʻonui o ka puʻuwai cardiovascular. ʻO ka hoʻohana ʻana o ka empagliflozin i kahi lāʻau o 25 mg ʻaʻole i alakaʻi i ka lōʻihi o ka manawa QT.

Me ka hoʻohui pū ʻana o ka lāʻau Jardins® me nā derivatives sulfonylurea a i ʻole me ka insulin, he ʻaina e hoʻemi ʻia ana i ka derebatives sulfonylurea / insulin e koi ʻia ma muli o ka loaʻa mai o ka hypoglycemia.

ʻAʻole i aʻo ʻia ʻo Empagliflozin i hoʻohui ʻia me nā ponaide like-pona (1 pPide-1).

ʻO ka maikaʻi o ka lāʻau Jardins® e pili ana i ka hana o nā keiki, no laila e kuhikuhi ʻia e nānā i ka hana o nā palupalu ma mua o kona koho ʻana a me ka manawa maʻamau i ka wā o ka mālama ʻana (ma kahi o 1 manawa i kēlā me kēia makahiki), a ma mua hoʻi o ke kau ʻana i ka therapy concomitant, ka mea hiki ke hoʻopilikia i ka hana o ka keiki. ʻO ka hoʻohana ʻana o ka lāʻau lapaʻau i nā mea maʻi me ka hana ʻole o ka renal (ʻaʻole i aʻo ʻia ʻo GFR