natgillin/translations-raw huggingface dataset:
In rats no treatment-related foetal abnormalities occurred following concomitant administration at exposure margins of approximately 28- to 29-fold for alogliptin and 2- to 2.5-fold for metformin at the maximum recommended human dose of 25 mg/day and 2,000 mg/day, respectively.
U štakora nisu viđene fetalne abnormalnosti nakon istodobne primjene u marginama izloženosti koje nadmašuju maksimalnu preporučenu dozu od 15 mg/dan i 2000 mg/dan za približno 28 do 29 puta za alogliptin i 2 do 2,5 puta za metformin.
Clinical studies conducted to support the efficacy and safety of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Klinička ispitivanja provedena za potvrdu djelotvornosti i sigurnosti Vipdometa uključivala su istodobnu primjenu alogliptina i metformina kao zasebnih tableta.
Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with metformin (n=203)
Ispitivanja dodatka kombiniranoj terapiji kontrolirana placebom Alogliptin 25 mg jedanput na dan s metforminom (n=203)
LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
FAS = analiza svih uključenih bolesnika (engl. full analysis set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) †Srednja vrijednost temeljena na metodi najmanjih kvadrata prilagođena prema prethodnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima * p<0,001 u usporedbi s placebom ili liječenjem placebom+kombinacijom
In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo.
Dodatno, 25 mg alogliptina, samog ili u kombinaciji s 30 mg pioglitazona, dovelo je u 16. tjednu u odnosu na placebo do statistički značajnih (p<0,001) sniženja ukupnih triglicerida izmjerenih kao postprandijalna inkrementalna promjena AUC(0-8) od početne vrijednosti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO OZNAČAVANJE (S PLAVIM OKVIROM) SAMO VIŠESTRUKA PAKIRANJA (2X98 TABLETA)
The safety and efficacy of Vipdomet in children and adolescents <18 years old have not been established.
Sigurnost i djelotvornost lijeka Vipdomet u djece i adolescenata
Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of whether patients were receiving concomitant metformin therapy.
Klinički značajna sniženja razina HbA1c u usporedbi s placebom su za 25 mg alogliptina opažena bez obzira na to jesu li bolesnici usporedno primali terapiju metforminom.
Alogliptin 25 mg once daily with a thiazolidinedione + metformin vs a titrating thiazolidinedione + metformin
Alogliptin 25 mg jedanput na dan s tiazolidindionom+metformin naspram titrirani tiazolidindion+metformin
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
Kako bi se održala sistemska izloženost alogliptinu slična onoj u bolesnika s normalnom funkcijom bubrega, u bolesnika s umjerenim i teškim oštećenjem bubrega, te sa završnim stadijem bolesti bubrega na dijalizi, potrebno je primijeniti nižu dozu alogliptina (vidjeti dio 4.2).
LOCF = last observation carried forward *Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
PPS = bolesnici koji su završili ispitivanje po protokolu (engl. per protocol set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) * Dokazana je statistička neinferiornost i superiornost † Srednja vrijednost metodom najmanjih kvadrata prilagođena prethodnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima
Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Nepoznate učestalosti: - Problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože ili bjeloočnica.
Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose.
Iako plodnost nije bila oštećena, u mužjaka je pri izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi opaženo je blago, statističko povećanje broja abnormalnih spermija.
- if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body) - if you recently had a heart attack or have severe circulatory problems including shock - if you have severe breathing difficulties - if you have liver disease - if you drink alcohol excessively (either every day or in large quantities only from time to time)
Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris. - ako imate tešku infekciju ili ste ozbiljno dehidrirani (izgubili ste mnogo vode iz tijela) - ako ste nedavno imali srčani udar ili teže probleme s cirkulacijom uključujući šok - ako imate izrazite teškoće pri disanju.
Alogliptin 25 mg once daily with a thiazolidinedione ± metformin or a sulphonylurea (n=195)
Alogliptin 25 mg jedanput na dan s tiazolidindionom±metformin ili sulfonilureja (n=195)
Therefore, haemodialysis is of little clinical benefit in removing alogliptin in overdose.
Stoga je hemodijaliza od male kliničke koristi.
The amount of Vipdomet will vary depending on your condition and the doses you currently take of metformin alone, metformin in combination with pioglitazone, insulin and/or individual tablets of alogliptin and metformin.
Količina Vipdometa će varirati ovisno o Vašem stanju, te lijekovima i dozama koje trenutačno uzimate, pojedinačno ili u kombinaciji
The results of bioequivalence studies in healthy subjects demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Rezultati ispitivanja bioekvivalencije u zdravih ispitanika pokazuju da su Vipdomet filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i metformina istodobno primijenjenih kao zasebne tablete.
Table 1: Adverse reactions System organ class Adverse reaction
Tablica 1: Nuspojave Organski sustav Nuspojava
Hepatic impairment Vipdomet should not be used in patients with hepatic impairment (see section 4.2).
Vipdomet se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dio 4.2).
Clinical studies conducted to support the efficacy of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Klinička ispitivanja provedena za potvrdu djelotvornosti Vipdometa uključivala su istodobnu primjenu alogliptina i metformina kao zasebnih tableta.
A lower dose of insulin may be considered to reduce the risk of hypoglycaemia.
Kako bi se smanjio rizik od hipoglikemije, potrebno je razmotriti sniženje doze inzulina.
Postmarketing reports of hepatic dysfunction including hepatic failure have been received.
Nakon stavljanja lijeka u promet primljene su prijave slučajeva disfunkcije jetre uključujući zatajenje jetre.
The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Značajna sniženja HbA1c opažena s 25 mg alogliptina s 30 mg pioglitazona i metforminom u usporedbi s 45 mg pioglitazona s metforminom bila su dosljedna tijekom čitavog 52-tjednog razdoblja liječenja (p<0,001 u svim vremenskim točkama).
For patients inadequately controlled on dual therapy with a maximal tolerated dose of metformin and pioglitazone, the dose of pioglitazone should be maintained, and Vipdomet administered concomitantly; alogliptin should be dosed at 12.5 mg twice daily (25 mg total daily dose) and metformin hydrochloride at a similar dose (either 850 mg or 1,000 mg twice daily) to that already being taken.
Za bolesnike u kojih adekvatna kontrola nije postignuta dvojnom terapijom maksimalnom podnošljivom dozom metformina i pioglitazona, dozu pioglitazona treba održavati, i Vipdomet primijeniti istodobno; alogliptin treba dozirati od 12,5 mg dvaput na dan (ukupna dnevna doza 25 mg), a metforminklorid u dozi sličnoj onoj koju bolesnik već uzima (850 mg ili 1000 mg dvaput na dan).
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin, the dose of Vipdomet should provide alogliptin dosed at 12.5 mg twice daily (25 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Za bolesnike u kojih adekvatna kontrola nije postignuta dvojnom terapijom inzulinom i maksimalnom podnošljivom dozom metformina, doza Vipdometa treba osigurati doziranje alogliptina od 12,5 mg dvaput na dan (ukupna dnevna doza 25 mg) i doza metformina slična onoj koju bolesnik već uzima.
INFORMATION IN BRAILLE Vipdomet 12.5 mg/850 mg
16. PODACI NA BRAILLEOVOM PISMU Vipdomet 12,5 mg/850 mg
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
U mladih štakora nakon primjene ponovljenih doza tijekom 4 i 8 tjedana nisu opaženi učinci povezani s alogliptinom.
However, the results of bioequivalence studies have demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Vipdomet filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i metformina istodobno primijenjenim kao zasebne tablete.
The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Dodavanje 25 mg alogliptina jedanput na dan terapiji s 30 mg pioglitazona u kombinaciji s metforminkloridom (srednja vrijednost doze = 1867,9 mg) dovelo je u 52. tjednu do poboljšanja HbA1c koje se pokazalo i neinferiornim i statistički superiornim onome postignutom terapijom s 45 mg pioglitazona s metforminom (srednja vrijednost doze = 1847,6 mg, tablica 3).
Alogliptin 25 mg once daily with insulin + metformin (n=126)
Alogliptin 25 mg jedanput na dan s inzulinom ± metformin (n=126)
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2 i 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi neposredno nakon primjene alogliptina.
Hypoglycaemia
Hipromeloza
For the different dose regimens Vipdomet is available in strengths of 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets.
Za različite režime doziranja Vipdomet je dostupan kao filmom obložene tablete u jačinama od 12,5 mg/850 mg i 12,5 mg/1000 mg.
Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
U 16. tjednu primjene 25 mg alogliptina, samog i u kombinaciji s 30 mg pioglitazona, postigla su se u odnosu na placebo, značajna smanjenja postprandijalne glukoze i postprandijalnog glukagona uz značajni porast postprandijalnih razina aktivnog GLP-1 (p<0,05).
INFORMATION IN BRAILLE Vipdomet 12.5 mg/1000 mg
16. PODACI NA BRAILLEOVOM PISMU Vipdomet 12,5 mg/1000 mg
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
Nakon stavljanja lijeka u promet bile su spontano prijavljene nuspojave akutnog pankreatitisa.
Hepatobiliary disorders hepatitis very rare
vrlo rijetko hipoglikemija često često
- Cold symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough - Rash - Itchy skin with or without hives - Headache - Indigestion, heartburn - Vomiting and/or diarrhoea - Metallic taste.
zimice, suhog kašlja - Osip - Svrbež kože s ili bez koprivnjače - Glavobolja - Probavne tegobe, žgaravica
Add-on combination therapy studies Alogliptin 25 mg once daily with metformin vs a sulphonylurea + metformin
Ispitivanja kao dodatka u kombiniranoj terapiji Alogliptin 25 mg jedanput na dan s metforminom naspram sulfonilureja+metformin
Significantly more patients receiving 12.5 mg alogliptin and 1.000 mg metformin hydrochloride twice daily (59.5%) achieved target HbA1c levels of < 7.0% compared to those receiving either 12.5 mg alogliptin twice daily alone (20.2%, p<0.001) or 1,000 mg metformin hydrochloride twice daily alone (34.3%, p<0.001) at Week 26.
U 26. tjednu je ciljne razine HbA1c od <7,0% postiglo značajno više bolesnika koji su primali 12,5 mg alogliptina i 1000 mg metforminklorida (59,5%) nego oni koji su primali ili samo alogliptin 12,5 mg dvaput na dan (20,2%, p<0,01) ili samo metforminklorid dvaput na dan (34,3%, p<0,001).
Obtain liver function tests promptly in patients with symptoms suggestive of liver injury.
U bolesnika sa simptomima koji ukazuju na oštećenje jetre treba odmah napraviti jetrene funkcijske testove.
Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
HbA1c od ≤ 7,0% postiglo značajno više bolesnika koji su primali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego onih koji su primali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation.
- smanjenjem stvaranja glukoze u jetri inhibicijom glukoneogeneze i glikogenolize - u mišićima, skromnim povećanjem osjetljivosti na inzulin, poboljšavajući perifernu pohranu i iskorištavanje glukoze - odgađanjem apsorpcije glukoze u crijevu.
Alogliptin as add-on therapy to metformin with a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kao dodatak terapiji metforminu s tiazolidindionom Dodavanje 25 mg alogliptina jedanput na dan terapiji pioglitazonom (srednja vrijednost doze = 35,0 mg, s ili bez metformina ili sulfonilureje) dovela je u usporedbi s dodatkom placeba do statistički značajnih poboljšanja HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
Following oral administration of an 850 mg metformin hydrochloride tablet, the peak plasma concentration was 40% lower, AUC was decreased by 25% and the time to peak plasma concentration (Tmax) was prolonged by 35 minutes.
AUC je bio smanjen za 25%, a vrijeme do postizanja vršne koncentracije u plazmi (Tmax) bilo je produženo za 35 minuta.
What Vipdomet looks like and contents of the pack - Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
Kako Vipdomet izgleda i sadržaj pakiranja - Vipdomet 12,5 mg/850 mg filmom obložene tablete (tablete) su svijetložute, ovalne (približno 21,0 mm duge i 10,1 mm široke), bikonveksne filmom obložene tablete s utisnutim oznakama „12.5/850“ na jednoj i „322M“ na drugoj strani.
The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Dodavanje 25 mg alogliptina jedanput na dan terapiji metforminkloridom (srednja vrijednost doze = 1847 mg) dovelo je u usporedbi s placebom do statistički značajnih poboljšanja HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
In addition, mean change from baseline in FPG at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća za 25 mg alogliptina s 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
Co-administration of 12.5 mg alogliptin and 1,000 mg metformin hydrochloride twice daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to either 12.5 mg alogliptin twice daily alone or 1,000 mg metformin hydrochloride twice daily alone.
Istodobna primjena 12,5 mg alogliptina i 1000 mg metforminklorida dvaput na dan dovela je u usporedbi sa samo 12,5 mg alogliptina dvaput na dan ili samo 1000 mg metforminklorida dvaput na dan do statistički značajnih poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost.
Vipdomet is used to lower blood sugar levels in adults with type 2 diabetes.
Vipdomet je koristi za snižavanje razina šećera u krvi u odraslih bolesnika sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 zove se i inzulin neovisni dijabetes melitus.
- if you have or have had a disease of the pancreas.
- ako imate bolest jetre.
Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Svaka filmom obložena tableta od 12,5 mg/850 mg sadrži 12,5 mg alogliptina u obliku alogliptinbenzoata i 850 mg metforminklorida.
More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Ciljne razine HbA1c od ≤7,0% postiglo je više bolesnika koji su primali 25 mg alogliptina s metforminom (48,5%) nego onih koji su primali glipizid s metforminom (42,8%) (p=0,004).
- in case of symptoms suggestive of liver injury during Vipdomet therapy.
Vipdomet - ako imate ili ste imali bolest gušterače - u slučaju simptoma koji ukazuju na ozljedu jetre tijekom liječenja lijekom Vipdomet.
Alogliptin as add-on therapy to metformin with insulin The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and FPG at Week 26 when compared to the addition of placebo (Table 2).
Alogliptin kao dodatna terapija metforminu i inzulinu Dodavanje 25 mg alogliptina jedanput na dan terapiji inzulinom (srednja vrijednost doze = 56,5 i.j., s ili bez metformina) dovelo je u usporedbi s placebom do statistički značajnih poboljšanja HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
Each 12.5 mg/1,000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1,000 mg metformin hydrochloride.
Svaka filmom obložena tableta od 12,5 mg/1000 mg sadrži 12,5 mg alogliptina u obliku alogliptinbenzoata i 1000 mg metforminklorida.
Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali 25 mg alogliptina (49,2%) nego oni koji su primali placebo (34,0%) (p=0,004).
Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs)) should be initiated with caution in metformin-treated patients.
U bolesnika liječenih metforminom potreban je oprez kad se započinje s primjenom lijekova koji mogu akutno oštetiti funkciju bubrega (kao što su antihipertenzivi, diuretici i nesteroidni protuupalni lijekovi (NSAIL-ovi)).
The pharmacokinetics of Vipdomet in children and adolescents <18 years old has not been established.
Farmakokinetika Vipdometa u djece i adolescenata
Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001).
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (44,4%) u usporedbi s onima koji su primali placebo (18,3%) (p<0,001).
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Metformin ima korisne učinke na metabolizam lipida u ljudi, neovisan o djelovanju na glikemiju.
- Vipdomet 12.5 mg/1,000 mg film-coated tablets (tablets) are pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side.
- Vipdomet 12,5 mg/1000 mg filmom obložene tablete (tablete) su blijedožute, ovalne (približno 22,3 mm duge i 10,7 mm široke), bikonveksne filmom obložene tablete s utisnutim oznakama „12.5/1000“ na jednoj i „322M“ na drugoj strani.
Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1000 mg film-coated tablets alogliptin/metformin hydrochloride
Vipdomet 12,5 mg/850 mg filmom obložene tablete Vipdomet 12,5 mg/1000 mg filmom obložene tablete alogliptin/metforminklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/026 196 (2x98) film-coated tablets (multipack)
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/843/026 196 (2x98) filmom obloženih tableta (višestruko pakiranje)
NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/1,000 mg tablets alogliptin/metformin hydrochloride
NAZIV LIJEKA Vipdomet 12,5 mg/1000 mg tablete alogliptin/metforminklorid
NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg tablets alogliptin/metformin hydrochloride
NAZIV LIJEKA Vipdomet 12,5 mg/850 mg tablete alogliptin/metforminklorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/025 196 (2x98) film-coated tablets (multipack)
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/843/025 196 (2x98) filmom obloženih tableta (višestruko pakiranje)
The pharmacokinetics of alogliptin in children and adolescents <18 years old has not been established.
Farmakokinetika alogliptina u djece i adolescenata
More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (0.8%) at Week 26.
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo više bolesnika koji su primali 25 mg alogliptina (7,8%) nego oni koji su primali placebo (0,8%) (p<0,001).
Vipdomet 12.5 mg/850 mg film-coated tablets
Vipdomet 12,5 mg/850 mg filmom obložene tablete alogliptin/metforminklorid
2630 Taastrup
4.8 Nuspojave
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 850 mg metformin hydrochloride.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 850 mg metforminklorida.
NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1,000 mg film-coated tablets
Vipdomet 12,5 mg/850 mg filmom obložene tablete Vipdomet 12,5 mg/1000 mg filmom obložene tablete