Litaelo tsa tšebeliso ea lithethefatsi Trazhenta

Letlapa le leng le le leng le koahetsoeng ka filimi le na le: ntho e sebetsang: linagliptin 5 mg,

li-excipients: mannitol, setene sa pregelatinized, Copovidone, magnesium stearate, Opadray pink (02F34337) (hypromellose 2910, titanium dioxide (E171), talc, macrogol 6000, oxide oxide e khubelu (E172).

Matlapa a biconvex a pota-potileng a nang le mekhabiso e manehiloeng, a koahetsoeng ka khetla ea filimi ea 'mala o bofubelu bo bobebe, ka mongolo oa letšoao la k'hamphani ka lehlakoreng le leng le ngotsoeng "D5" ka lehlakoreng le leng la letlapa.

Ketso ea pharmacological

Linagliptin ke inhibitor ea enzyme dipeptidyl peptidase-4 (morao-rao - DPP-4), e amehang ho inactivation ea li-impretins tsa li-hormone - glucagon-like peptide-1 (GLP-1) le glucose-insulinotropic polypeptide (GIP). Lihormone tsena li timetsoa ka potlako ke enzyme DPP-4. Lihorase tsena ka bobeli li kenella taolong ea 'mele ea glucose homeostasis. Sekhahla sa "secretin secretion" motšehare se tlase, se nyoloha ka potlako kamora ho ja. GLP-1 le GIP e ntlafatsa insulin biosynthesis le secretion ea eona ka pancreatic beta-ketki maemong a tloaelehileng le a phahameng a tsoekere ea mali. Ntle le moo, GLP-1 e fokotsa secretion ea glucagon ka lisele tsa pancreatic alpha, tse lebisang ho fokotseheng ha tlhahiso ea tsoekere maling. Linagliptin (TRAGENT) e sebetsa haholo ebile e amana hape le DPP-4, e bakang keketseho e tsitsitseng ea maemo a "incretin" le polokeho ea nako e telele mosebetsing oa bona. TRAGENTA e eketsa secretion e itšetlehileng ka glucose mme e fokotsa secretion ea glucagon, e hlahisang ntlafatso ea tsoekere ea glucose homeostasis. Linagliptin e tlama ho DPP-4 ka boikhethelo, ho eona vitro khethollo ea eona e feta seletho bakeng sa DPP-8 kapa ts'ebetso ea DPP-9 makhetlo a fetang 10,000.

Mofumahali

Ts'ebetso ea linagliptin ho plasma e fokotseha ka mekhahlelo e meraro. Bophelo ba halofo ea nako e telele bo telele, bo feta lihora tse 100, haholo-holo ka lebaka la tlamo e tsitsitseng ea linagliptin le enzyme ea DPP-4; Bophelo bo sebetsang ba halofo, kamora ho tsamaisoa khafetsa ea linagliptin ka tekanyetso ea 5 mg, ke lihora tse 12. Tabeng ea ho nka linagliptin ka tekanyetso ea 5 mg hang ka letsatsi, meeli e tsitsitseng ea plasma ea moriana e fihlelleha ka mor'a tekanyetso ea boraro. Nakong ea boemelong ba li-pharmacokinetics (kamora ho nka moriana ka tekanyetso ea 5 mg), AUC (sebaka se tlas'a nako ea nako ea mahloriso) ea plasma linagliptin e eketsehile ka hoo e ka bang 33% ha e bapisoa le tekanyetso ea pele.

Li-coefficients le li-coefficients tsa phapang lipakeng tsa bakuli ba fapaneng bakeng sa AUC ea linagliptin li ne li le nyane (12,6% le 28,5%, ka ho latellana). Litekanyetso tsa plasma AUC tsa linagliptin e nang le tekanyetso e ntseng e eketseha e ile ea eketseha hanyane ka hanyane. Pharmacokinetics ea linagliptin ho baithaopi ba phetseng hantle le ho bakuli ba nang le mofuta oa 2 lefu la tsoekere ka kakaretso e ne e tšoana.

Boaoavailability e felletseng ea linagliptin e batla e le 30%. Kamohelo ea linagliptin hammoho le lijo tse nang le mafura a mangata, nako e eketsehileng ea katleho le_tlhokomeliso Lihora tse 2 le ho fokotsa C_tlhokomeliso 15%, empa ha e na phello ho A11Co-72ch- Phello e matla ea liphetoho C_tlhokomeliso le T_tlhokomeliso ha e lebelloe. Ka hona, linagliptin e ka sebelisoa hammoho le lijo le ho sa tsotelloe lijo.

Ka lebaka la tlama ea lithethefatsi ho li-tishu, boholo bo hlahang ka bongata ba phepelo maemong a emeng a li-pharmacokinetics kamora ts'ebetso e le 'ngoe ea methapo ea linagliptin ka tekanyetso ea 5 mg ho isa lithutong tse phetseng hantle e ka bang lilithara tse 1110, e bonts'a phokotso e pharalletseng liseleng. Ho tlangoa ha lignagliptin ho liprotheine tsa plasma ho ipapisitse le khatello ea meriana mme e ka ba 99% ka tekanyo ea 1 nmol / L, 'me ka likhakanyo> 30 nmol / L e fokotseha ho 75-89%, e bonts'ang boemo ba tlamahano ea sehlahisoa le DPP-4 le likhakanyo tse ntseng li eketseha tsa lignagliptin . Likhatellong tse phahameng, ha ts'ebetso e felletseng ea DPP-4 e etsahala, 70-80% ea linagliptin e tlama liprotheine tse ling tsa plasma (ho fapana le DPP-4), 'me 30-20% ea lithethefatsi e ne e le plasma maemong a sa tsitsang.

Kamora taolo ea molomo e ngotsoeng 14C-linagliptin ka tekanyetso ea 10 mg ka moroto, hoo e ka bang 5% ea radioacaction e ile ea lokolloa. Karolo e nyane ea lithethefatsi tse amoheloang e sebelisoa. Ho fumanoe metabolite e le 'ngoe e kholo, ts'ebetso ea eona ke 13.3% ea litlamorao tsa linagliptin maemong a bophelo a pharmacokinetics, a se nang ts'ebetso ea meriana le a sa amang ts'ebetso ea inhibitory ea lignagliptin ho plasma khahlano le DPP-4.

Matsatsi a 4 kamora ho tsamaisoa ha linagliptin e ngotsoeng ka 14C kahare ho lithuto tse phetseng hantle, hoo e ka bang 85% ea lethal dose e ile ea hlakoloa (ka mongobo 80% le ka moroto 5%). Tlhotlhomiso ea reizinical ho pharmacokinetics e tsitsitseng ea mmuso e ne e ka ba 70 ml / min.

Ts'ebetso ea mokokotlo e sa sebetseng

Ho hlahloba li-pharmacokinetics tsa linagliptin (ka tekanyo ea 5 mg) ho bakuli ba nang le li-degrees tse fapaneng tsa ho hlaphoheloa ke renal ho sa feleng ha ho bapisoa le. lithuto tse phetseng hantle li ile tsa etsa thuto e bulehileng ka mofuta o mengata oa dosing. Phuputso eo e ne e kenyelletsa bakuli ba nang le bothata ba ho phekoloa ka methapo, bo neng bo arotsoe ho latela tumellano ea creatinine maling; 50 - 2.

Ho etsa dost liphetoho ho latela bong ba bakuli ha ho hlokehe. Thobalano e ne e se na phello e kholo litabeng tsa pharmacokinetics ea linagliptin (ho latela liphetho tsa tlhahlobo ea litlhare tsa litlatsetso tse entsoeng motheong oa data ho tsoa lithutong tsa karolo ea pele le ea II).

Phetoho ea tekanyetso ho latela lilemo tsa bakuli ha e hlokehe, hobane botsofali bo ne bo se na phello e matla kliniking ho pharmacokinetics ea linagliptin. Ho bakuli ba tsofetseng (lilemo tse 65-80, mokuli ea holileng ka ho fetisisa. O ne a le lilemo li 78) le ho bakuli ba banyenyane, maikutlo a plasma a linagliptin a ne a bapisoa.

Lithuto tsa pharmacokinetics tsa lignagliptin ho bana ha li e-so tšoaroe.

Matšoao a ho sebelisoa

TRAGENT e bontšoa ho bakuli ba baholo ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 ho ntlafatsa taolo ea glycemic: e le monotherapy

- bakeng sa bakuli ba nang le taolo e sa lekaneng ea glycemic feela ka ho ja kapa ka boikoetliso, hammoho le bakeng sa ba sa khoneng ho nka metformin ka lebaka la ho hloka mamello, kapa haeba metformin e loantsoe mabapi le ts'ebetso ea mokokotlo oa mokokotlo.

- metformin, haeba lijo le ho ikoetlisa hammoho le metformin li sa fane ka taolo e lekaneng ea glycemic,

- derivatives of sulfonylurea and metformin, haeba lijo le ho ikoetlisa hammoho le kalafo e kopaneng li sa fane ka taolo e lekaneng ea glycemic,

- insulin hammoho le metformin kapa ntle le eona, haeba lijo le ho ikoetlisa hammoho le kalafo e joalo li sa fane ka taolo e lekaneng ea glycemic.

Bokhachane le pelehi

Ts'ebeliso ea linagliptin ho basali baimana ha e so ithutoe.

Boithuto ba liphoofolo ha bo supe matšoao a ho beleha ho ba le bana. Joaloka mokhoa oa ho itšireletsa, TLHAKISO e lokela ho qojoa nakong ea kemolo.

Lintlha tse fumanoeng lithutong tsa pharmacodynamic ho liphoofolo li bontša ho kenella ha linagliptin kapa metabolites ea eona lebeseng la matsoele. Kotsi ea ho pepesetsoa masea kapa bana ha u ntse u anyesa ha e qheleloe ka thoko.

Qeto ea ho emisa ho anyesa kapa ho nka TRAG e lokela ho ipapisa le melemo ea ho anyesa lesea le kalafo ea 'm'ae.

Boithuto ba phello ea TRAGENT mabapi le thari ea motho ha e so etsoa. Boithuto ba liphoofolo bo bontšitse hore ha bo na phello e mpe ho tsoalo.

Tekanyetso le tsamaiso

Pilisi e khothalletsoang ke 5 mg mme e nkuoa nako e le 'ngoe ka letsatsi.

Ka tšebeliso e kopanetsoeng le metformin, tekanyo ea metformin e lokela ho lula e tšoana.

Ha u nka linagliptin hammoho le lintho tse tsoang ho sulfonylurea kapa insulin, litekanyetso tse tlase tsa sulfonylurea kapa tse tsoang ho insulin li lokela ho nkuoa ho fokotsa kotsi ea hypoglycemia.

Ts'ebetso ea mokokotlo e sa sebetseng

Bakuli ba nang le bothata ba ho etsa hore renal e sebetse hantle, ha boa hlokahala.

Ts'ebetso ea sebete e sa sebetseng

Boithuto ba Pharmacokinetic bo bontša hore phetoho ea lethal dose ha e hlokehe ho bakuli ba nang le ts'ebetso ea sebete e sa sebetseng, leha ho le joalo, ha ho na boiphihlelo ka ts'ebeliso ea bongaka ea meriana ho bakuli ba joalo.

Ho lokisoa ha dose ho latela lilemo ha ho hlokahale.

Leha ho le joalo, boiphihlelo ba kliniki le bakuli ba lilemo tse ka holimo ho 80 li lekane, sehlopha sena sa bakuli se lokela ho nkuoa ka hloko.

Bana le bacha

Tšireletseho le katleho ea linagliptin bakeng sa bana le bacha ha e so thehiloe.

Haeba tekanyetso ea moriana e lahlehile, e lokela ho nkuoa hang hoba mokuli a hopole sena. Se ke oa nka tekanyetso habeli ka letsatsi le le leng.

Litla-morao

Tšireletseho ea TRAGENT e ile ea hlahlojoa ka kakaretso ho bakuli ba 6602 ba nang le lefu la tsoekere la mofuta oa 2, ho kenyelletsa bakuli ba 5955 ba nkang lethal dose ea 5 mg.

Lithuto tse laoloang ke placebo li kenyelelitse lithuto moo linagliptin e sebelisitsoeng ka tsela e latelang:

ka mokhoa oa monotherapy (tšebeliso ea nakoana, e nkang libeke tse 4)

joalo ka monotherapy (nako> libeke tse 12) kenyelletsoa le metformin

ho kenyelletsa motsoako oa metformin le sulfonylureas

tlatsetso le insulin hammoho le metformin kapa ntle le eona.

Khafetsa ea litlamorao e bontšoa e le khafetsa (> 1/10), khafetsa (ho tloha 1/100 ho isa 1/1000 ho isa ho 1/10000 ho isa ho

Bongata

Nakong ea liteko tsa tliliniki tse laoloang lithutong tse phetseng hantle, tekanyetso e le 'ngoe ea linagliptin, e fihlang ho 600 mg (makhetlo a 120 ka tekanyo e khothalletsoang), e ne e mamelloa hantle. Motho ha a na boiphihlelo ka litekanyetso tse fetang 600 mg.

Haeba ho na le overdose, ho bohlokoa hore u sebelise mehato e tloaelehileng ea ts'ehetso, ka mohlala, ho tlosoa hoa moriana o sa tlotsoang ka har'a pampitšana ea ka mpeng, tlhahlobo ea kalafo le kalafo ho latela lipontšo tsa bongaka.

Ho sebelisana le lithethefatsi tse ling

Tlhahlobo ea tšebelisano ea lithethefatsi ea in vitro

Linagliptin ke inhibitor e fokolang ea tlhaselo ea CYP3A4 isoenzyme, le inhibitor e fokolang kapa e leka-lekaneng ea ts'ebetso ea ts'ebetso ea isoenzyme ena. Linagliptin ha e thibele tse ling tsa li-CYP isoenzymes ebile ha e ba khothalletse.

Linagliptin ke substrate bakeng sa P-glycoprotein (P-gp) le inhibits ho isa ho honyenyane P-glycoprotein-Mediated digoxin transport. Ha ho fanoa ka lintlha tsena le liphetho tsa litšebelisano tsa lithethefatsi tsa vivo, bokhoni ba linagliptin ba ho sebelisana le likarolo tse ling tsa P-gp bo nkuoa e le monyetla.

Thutong ea ho sebelisana le lithethefatsi tsa vivo

Matla a lithethefatsi tse ling ho linagliptin

Lintlha tse latelang tsa kliniki li bontša monyetla o fokolang oa ts'ebelisano e kholo ea ts'ebeliso ea lithethefatsi ka nako e tšoanang.

Metformin: tšebeliso e kopaneng ea metformin khafetsa ka tekanyetso ea 850 mg makhetlo a 3 ka letsatsi le linagliptin ka tekanyo ea 10 mg 1 nako ka letsatsi ha e ea ka ea tlisa liphetoho tse kholo kliniking ho pharmacokinetics ea linagliptin ho baithaopi ba phetseng hantle.

Litlamorao tsa Sulfonylurea: li-pharmacokinetics tse maemong a lekanang a 5 mg ea linagliptin ha lia ka tsa angoa ke tšebeliso e kopaneng ea tekanyetso e le 'ngoe ea 1,75 mg ea glibenclamide (glyburide).

Ritonavir: tšebeliso e kopaneng ea linagliptin (tekanyetso e le 'ngoe ea 5 mg ka molomo) le ritonavir (litekanyetso tse ngata tsa 200 mg ka molomo), inhibitor e sebetsang ea P-glycoprotein le isoenzyme CYP3A4, e matlafalitse boleng ba AUC le C_tah linagliptin ka makhetlo a 2 le makhetlo a 3, ka ho latellana. Ts'ebetso ea mahala ea khatello ea kelello, eo hangata e leng tlase ho 1% ea tekanyetso ea kalafo ea linagliptin, e eketsehile makhetlo a 4-5 ka mor'a ts'ebelisano-mmoho le ritonavir. Model ea likhathatso tsa plasma tsa linagliptin maemong a lekanang a li-pharmacokinetics ka ntle le ka ntle ho tsamaiso ea ritonavir e bonts'itse hore keketseho ea ho pepesoa ha ea lokela ho tsamaisana le keketseho ea ho bokellana ha lignagliptin. Liphetoho tsena ho pharmacokinetics ea lignagliptin ha li bohlokoa haholo tleliniking. Ka hona, litšebelisano tsa bohlokoa tsa kliniki le li-inhibitors tse ling tsa P-glycoprotein / SURZA4 ha lia lebelloa.

Rifampicin: ts'ebeliso e kopantsoeng ea 5 mg ea linagliptin le rifampicin, inducer e sebetsang ea P-gp le isoenzyme CYP3A4, e lebisitse ho fokotseheng hoa litekanyetso tsa AUC le C_tlhokomeliso lignagliptin, ka ho latellana, ka 39,6% le 43.8%, le ho fokotseha ha thibelo ea ts'ebetso ea basal ea dipeptidyl peptidase-4 ke 30%. Kahoo, ts'ebetso e sebetsang ea kliniki ea linagliptin, e sebelisoang hammoho le P-gp inducers e sebetsang, e kanna ea se ke ea atleha, haholoholo ka tšebeliso ea nako e telele ea motsoako ona. Ts'ebeliso e ts'oanang le li-inducers tse ling tse sebetsang tsa P-gp le CYP3A4, joalo ka carbamazepine, phenobarbital le phenytoin, ha e so ithutoe.

Matla a linagliptin ho lithethefatsi tse ling

Lithutong tsa bongaka, joalo ka ha ho bonts'itsoe ka tlase, ho ne ho se na phello e kholo litabeng tsa pharmacokinetics ea metformin, glyburide, simvastatin, warfarin, digoxin le lithibela-pelehi tsa molomo, tse netefalitsoeng ho vivo, 'me li thehiloe ho bokhoni bo tlase ba linagliptin ho kenella ts'ebelisanong ea lithethefatsi le substrates tsa CYP3A4 , CYP2C9, CYP2C8, P-dr le limolek'hule tsa "cation" tsa organic.

Metformin: tšebeliso e kopantsoeng ea linagliptin ka tekanyetso ea 10 mg hang ka letsatsi le 850 mg ea metformin, e leng subctate ea organic cations, ha e ea ka ea lebisa ho pharmacokinetics ea bohlokoa ea metformin ho baithaopi ba phetseng hantle. Kahoo, linagliptin ha se thibelo ea Uransportag.

Litlamorao tsa Sulfonylurea: tšebeliso e kopaneng ea 5 mg ea linagliptin le lethalinyana le le leng la 1.75 mg la glibenclamide (gliburide) le ile la lebisa ho fokotseha ho hoholo ho itekanetseng ho AUC le C_tlhokomeliso glibenclamide ka 14%. Kaha glibenclamide e thehiloe haholo ke CYP2C9, lintlha tsena li boetse li tiisa hore linagliptin hase inhibitor ea CYP2C9. Ha ho na litšebelisano tse bohlokoa tsa tliliniki li lebelletsoeng ka tse ling tse tsoang sulfonylurea derivatives (mohlala, glipizide, tolbutamide le glimepiride), eo, joalo ka glibenclamide, e thehiloe haholo ka CYP2C9.

Digoxin: Ts'ebeliso e kopantsoeng ea 5 mg ea linagliptin le 0,25 mg ea digoxin ha lia ka tsa ama li-pharmacokinetics tsa digoxin ho baithaopi ba phetseng hantle. Kahoo, ho vivo linagliptin ha se thibelo ea lipalangoang tse tsamaeang le P-glycoprotein.

Warfarin: linagliptin, e sebelisoang khafetsa ka tekanyetso ea 5 mg ka letsatsi, ha ea ka ea fetola pharmacokinetics ea S (-) kapa R (+) warfarin, e leng substrate ea CYP2C9 mme e tsamaisoa hang.

Simvastatin: linagliptin ha e nkuoa ke baithaopi ba phetseng hantle ka tekanyetso e mengata e bile le phello e fokolang ho pharmacokinetics ea simvastatin, substrate e ts'oarehang bakeng sa CYP3A4. Kamora ho nka linagliptin ka tekanyetso ea 10 mg (ka holimo ho lethal dose) hammoho le simvastatin ka tekanyetso ea 40 mg bakeng sa matsatsi a 6, AUC ea simvastatin ka plasma ea mali e eketsehile ka 34%, mme C_tlhokomeliso maling a plasma - ka 10%.

Mekhoa ea ho thibela pelehi ea molomo: tšebeliso e kopaneng ea linagliptin ka tekanyetso ea 5 mg ka levonorgestrel kapa ethinyl estradiol ha e fetole li-pharmacokinetics tsa lithethefatsi tsena.

Litlhokahalo tsa polokeho

TRAGENT ha ea lokela ho sebelisoa ho bakuli ba nang le lefu la tsoekere la mofuta oa 1 kapa bakeng sa kalafo ea lefu la tsoekere la ketoacidosis.

Ts'ebetso ea hypoglycemia maemong a ts'ebeliso ea linagliptin e le monotherapy e ne e tšoana le placebo.

Lithutong tsa kliniki, ho tlalehiloe hore liketsahalo tsa hypoglycemia maemong a ts'ebeliso ea linagliptin hammoho le lithethefatsi tseo ho lumeloang hore li baka hypoglycemia (metformin, thiazolidinedione derivatives) li ne li tšoana le phello e lumellanang ea placebo.

Ha u nka linagliptin ntle le litokollo tsa sulfonylurea (ka kalafo ea metformin ea mantlha), palo ea linyeoe tsa hypoglycemia e ile ea eketseha ha e bapisoa le sehlopha sa placebo.

Liphetho tsa sulfonylureas le insulin li ka baka hypoglycemia. Linagliptin ha e kopantsoe le lintho tse tsoang ho sulfonylurea le / kapa insulin e lokela ho nkuoa ka hloko. Haeba ho hlokahala, phokotso ea litekanyetso tsa sulfonylurea kapa insulin e ka etsahala.

Nakong ea ts'ebeliso ea morao-rao ea linagliptin, ho ile ha amoheloa litlaleho tsa boithatelo tsa nts'etsopele ea pancreatitis e mpe. Bakuli ba lokela ho tsebisoa ka letšoao le hlahelletseng la pancreatitis e matla: bohloko bo sa feleng ba mpeng. Pancreatitis regression e ile ea bonoa kamora ho khaotsa ho linagliptin. Haeba pancreatitis e belaelloa, TRAG e lokela ho khaotsa.

Sokolla foromo le sebopeho

Trazenta e fumaneha ka mokhoa oa matlapa a koahetsoeng ka filimi: biconvex, pota, e entsoe ka marako, e bofubelu bo bofubelu ka 'mala, e ngotsoe D5 ka lehlakoreng le leng le letšoao la k'hamphani ea tlhahiso ho tse ling (li-pcs tse 7. Metsoako e 4 kapa e 8, li-pcs tse 10. Litlatsetsong, likotong tse tharo tsa karete.

Sebopeho ka ho penta e le 'ngoe:

• ntho e sebetsang: linagliptin - 5 mg,
• likarolo tse thusang: setlolo sa pregelatinized, Copovidone, starch ea poone, magnesium stearate, mannitol,
• filimi sheath: Opadray pink 02F34337 (titanium dioxide, macrogol 6000, talc, hypromellose, dae oxideide red).

Tekanyetso le tsamaiso

Matlapa a trazent a nkuoa ka molomo. Ho nwa moriana ona ha ho a itshetleha ka nako ya ho ja mme ho ka etswa ka nako efe kapa efe ya letsatsi.

Motsoako o khothalelitsoeng ke Letlhare le le leng (5 mg) hang ka letsatsi.

Haeba tekanyo e latelang e hlotsoe, mokuli o lokela ho e sebelisa hang hang ha a hopola Letlapa le lahlehileng. Mena habeli tekanyetso ebe u nka matlapa a mabeli ka letsatsi le le leng.

Tabeng ea ho senyeha ha sebete le / kapa ts'ebetso ea liphio, le ho bakuli ba tsofetseng, tokiso ea lethal dose ha e hlokehe.

Litlamorao

Litlamorao tse ka bang teng tse tloaelehileng ho monotherapy le Trazent le kalafo e kopaneng le li-agents tse ling tsa hypoglycemic:

• tsamaiso ea tšilo ea lijo: pancreatitis,
• tsamaiso ea phefumoloho: khohlela,
• sesole sa mmele: hypersensitivity reaction,
• mafu a tšoaetsanoang: nasopharyngitis.

Lithethefatsi tse latelang e le karolo ea kalafo e rarahaneng li ka baka litlamorao tse ling tse latelang:

• pioglitazone, metformin le pioglitazone: hyperlipidemia le phaello ea boima,
• Sulfonylurea derivatives: hypertriglyceridemia,
• insulin: ho sokela,
• Tsohle tsa sulfonylurea le metformin: hypoglycemia.

Nakong ea tlhaiso ea morao-rao ea ho bapatsa, litlamorao tse tsoang litsamaisong le litho tse latelang li bonts'itsoe:

• tsamaiso ea tšilo ea lijo: ho ruruha ha mucous membrane ea mokokotlo oa molomo,
• sesole sa mmele: urticaria, edema ea Quincke,
• letlalo: lekhopho.

Litaelo tse khethehileng

Ha o sebelisa lithethefatsi Trazhenta ka nako e ts'oanang le tse tsoang ho sulfonylurea, ho lokela ho sebelisoe tlhokomeliso, hobane e ka baka hypoglycemia. Haeba ho hlokahala, ho ka khoneha ho fokotsa tekanyetso ea litokollo tsa sulfonylurea.

Trazhenta ha e eketse kotsi ea ho ba le mafu a tsamaiso ea methapo ea pelo.

Haeba pancreatitis e hlobaetsang e belaelloa, setlhare se lokela ho khaotsa.

Boithuto bo ikhethileng ba phello ea linagliptin mabapi le bokhoni ba ho khanna makoloi le ho sebetsa ka mekhoa e ka bang kotsi ha e so etsoa. Leha ho le joalo, ka lebaka la kotsi e eketsehang ea ho tsekela, nakong ea phekolo le moriana, tlhokomeliso e lokela ho sebelisoa ha ho etsoa lintho tse hlokang tlhokomelo e matla le lebelo la karabelo ea psychomotor.

Ho sebelisana le lithethefatsi

Ka tšebeliso e tšoanang ea lithethefatsi Trazhenta e nang le metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, rifampicin, ritonavir le lithibela-pelehi tsa molomo, li-pharmacokinetics tsa lignagliptin le litlhare tse thathamisitsoeng ha lia ka tsa fetoha kapa tsa fetoha haholo.

Mekhoa ea ts'ebeliso Trazenti le litekanyetso

Trazhenta e nooa ka molomo ka tekanyetso e khothalelitsoeng ea 5 mg (1 pilisi) hang ka letsatsi.

Sesebelisoa se nkuoa ka nako efe kapa efe ea letsatsi, ho sa tsotellehe lijo, ka ho khetheha letsatsi le leng le le leng ka nako e le 'ngoe. Haeba e 'ngoe ea matlapa e fosahetse, u ka e nka neng kapa neng hang ha mokuli a hopola sena, empa ha ho khothalletsoe ho nka tekanyetso e habeli ka letsatsi le le leng.

Tlhahisoleseling e eketsehileng

Lithethefatsi tse tsoang ho sulfonylureas, maemong a mangata, li kenya letsoho kholisong ea hypoglycemia. Ka hona, maemong a mang, ho ka khonahala ho fokotsa litekanyetso tsa bona ha u ntse u fana ka taelo le Trazhenta.

Bakeng sa bakuli ba nang le ho se sebetse hantle haholo ha renal, moriana ona o khothaletsoa ho nooa hammoho le litlhare tse ling tsa hypoglycemic.

Ho latela maikutlo, Trazhenta le li-analogue li fokotsa haholo khatello ea mali le glucose ea glycosylated ha o nka litafole tse potlakileng.

Ka lebaka la ho tsekela tse ka 'nang tsa etsahala, ho eletsoa haholo ha ho khannoa likoloi le mechini e meholo nakong ea kalafo ea lithethefatsi.

Litaelo tsa Trazent li bonts'a hore matlapa a lokela ho bolokoa lefifing, le omileng, le pholile 'me le sa fihlelehe ho bana.