natgillin/translations-raw huggingface dataset:
104 25 Stockholm Sweden
104 25 Stockholm Sweden valproatna kiselina natrijev valproat
Valproát chrono Sandoz 300 mg tablety s predľženým uvoľňovaním
Valproát chrono Sandoz 300 mg tablety s predľženým uvoľňovaním tableta s prilagođenim oslobađanjem
Depakine Enteric 500 mg 500 mg
Depakine Enteric 500 mg 500 mg tablet
Epilim Syrup 200mg/5ml
Epilim Syrup 200mg/5ml oralna otopina
Depakine Chronosphere 1000 mg, granulaat met gereguleerde afgifte
Depakine Chronosphere 1000 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Valproid acid, Sodium valproate
valproatna kiselina, natrijev valproat
Depakine Chronosphere 750 mg, granulaat met gereguleerde afgifte
Depakine Chronosphere 750 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Solution for injection
otopina za injekciju u venu
Convulex 300 mg/ml kvapky 300mg/ml
CONVULEX 300 mg/ML
Valproic acid Convulex 150 mg kapsuly
Convulex 150 mg kapsuly kapsula
Ergenyl Chronosphere 1000 mg Retardgranulat
Ergenyl Chronosphere 1000 mg Retardgranulat granule s produljenim oslobađanjem
Epilim Chronosphere 1000mg prolonged-release granules
Epilim Chronosphere 1000mg prolonged-release granules granule s produljenim oslobađanjem
Epilim Liquid 200mg/5ml
Epilim Liquid 200mg/5ml oralna otopina
Depakine Chronosphere 100 mg, granulaat met gereguleerde afgifte
Depakine Chronosphere 100 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Valproic acid Convulex 300 mg gastroresistant capsules, soft
Convulex 300 mg gastroresistant capsules, soft želučanootporna kapsula, meka
Ergenyl Chronosphere 750 mg Retardgranulat
Ergenyl Chronosphere 750 mg Retardgranulat granule s produljenim oslobađanjem
Ergenyl Chronosphere 250 mg Retardgranulat
Ergenyl Chronosphere 250 mg Retardgranulat granule s produljenim oslobađanjem
400, poeder voor injectievloeistof 400 mg
Depakine i.v. 400, poeder voor injectievloeistof 400 mg prašak i otapalo za otopinu za injekciju u venu
Valproic acid Convulex Capsules 150mg 150 mg
Convulex Capsules 150mg 150 mg želučanootporna kapsula
103, Alexander Stamboliiski Blvd 1303 Sofia
1303 Sofia
Depakine Chronosphere 250 mg, granulaat met gereguleerde afgifte
Depakine Chronosphere 250 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Epilim Chronosphere MR 1000mg Modified Release Granules
Epilim Chronosphere MR 1000mg Modified Release Granules granule s prilagođenim oslobađanjem
Valproic acid Convulex 150 mg gastroresistant capsules, soft
Convulex 150 mg gastroresistant capsules, soft želučanootporna kapsula, meka
Ergenyl intravenös
Ergenyl oralna otopina
Valproic acid Convulex 300 mg kapsuly
Convulex 300 mg kapsuly kapsula
Depakine Chronosphere 500 mg, granulaat met gereguleerde afgifte
Depakine Chronosphere 500 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Propymal Enteric 450 mg, maagsapresistente capsules želučanootporna kapsula
Epilim Chrono 500mg Controlled Release Tablets
Epilim Chrono 500mg Controlled Release Tablets tableta s prilagođenim oslobađanjem
Ergenyl Chronosphere 100 mg Retardgranulat
Ergenyl Chronosphere 100 mg Retardgranulat granule s produljenim oslobađanjem
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln
Depakine Chronosphere 1000 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula želučanootporna kapsula, meka
Coated tablet
Delepsine tablet
Epilim Chronosphere 750mg prolonged-release granules
Epilim Chronosphere 750mg prolonged-release granules granule s produljenim oslobađanjem
Valproic acid Convulex 500 mg kapsuly
Convulex 500 mg kapsuly kapsula
Valproic acid Convulex 500 mg gastroresistant capsules, soft
Convulex 500 mg gastroresistant capsules, soft želučanootporna kapsula, meka
Episenta 1000mg Prolongedrelease Granules
Episenta 1000mg Prolongedrelease Granules granule s produljenim oslobađanjem
Natriumvalproaat chrono 300 mg Teva, tabletten met gereguleerde afgifte
Natriumvalproaat chrono 300 mg Teva, tabletten met gereguleerde afgifte tableta s prilagođenim oslobađanjem
Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Propymal Enteric 600 mg, maagsapresistente capsules želučanootporna kapsula
Valproic acid CONVULEX 500 mg retard filmtabletta prolonged release film-coated tablet
CONVULEX 500 mg retard filmtabletta filmom obložena tableta s produljenim oslobađanjem
Valproic acid CONVULEX 300 mg retard filmtabletta prolonged release film-coated tablet
CONVULEX 300 mg retard filmtabletta filmom obložena tableta s produljenim oslobađanjem
Valproate Mylan
seminatrijev valproat
Valproic acid Delepsine
Delepsine oralna otopina
Gastro-resistant film-coated tablet
Diplexil filmom obložena tableta
Epilim Chronosphere MR 750mg Modified Release Granules
Epilim Chronosphere MR 750mg Modified Release Granules granule s prilagođenim oslobađanjem
Epilim Chrono 200mg Controlled Release Tablets
Epilim Chrono 200mg Controlled Release Tablets tableta s prilagođenim oslobađanjem
Epilim 500 Gastro resistant tablets
Epilim 500 Gastro resistant tablets želučanootporne tablete
Epilim Chronosphere 250mg prolonged-release granules
Epilim Chronosphere 250mg prolonged-release granules granule s produljenim oslobađanjem
Epilim Chronosphere 500mg prolonged-release granules
Epilim Chronosphere 500mg prolonged-release granules granule s produljenim oslobađanjem
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose
MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln
Depakine Chronosphere 750 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Powder and solvent for solution for injection/infusion
prašak i otapalo za otopinu za injekciju/infuziju u venu
Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Propymal Enteric 150 mg, maagsapresistente capsules želučanootporna kapsula
Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula želučanootporna kapsula, meka
Epilim Chronosphere MR 250mg Modified Release Granules
Epilim Chronosphere MR 250mg Modified Release Granules granule s prilagođenim oslobađanjem
Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Propymal Enteric 300 mg, maagsapresistente capsules želučanootporna kapsula
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln
Depakine Chronosphere 100 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
Ergenyl Chronosphere 500 mg Retardgranulat
Ergenyl Chronosphere 500 mg Retardgranulat granule s produljenim oslobađanjem
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 1000 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Natriumvalproaat chrono 500 mg Teva, tabletten met gereguleerde afgifte
Natriumvalproaat chrono 500 mg Teva, tabletten met gereguleerde afgifte tableta s prilagođenim oslobađanjem
Calcium divalproate
Germany kalcijev divalproat
Epilim 200 Gastro Resistant Tablets
Epilim 200 Gastro Resistant Tablets želučanootporne tablete
Valproic acid Convulex Capsules 500mg 300 mg
Convulex Capsules 500mg 300 mg želučanootporna kapsula
Epilim Chronosphere MR 100mg Modified Release Granules
Epilim Chronosphere MR 100mg Modified Release Granules granule s prilagođenim oslobađanjem
Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula želučanootporna kapsula, meka
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
Epilim Chrono 300mg Controlled Release Tablets
Epilim Chrono 300mg Controlled Release Tablets tableta s prilagođenim oslobađanjem
Lyophilisate and solvent for suspension for injection
Ergenyl prašak i otapalo za otopinu za injekciju u venu
Epilim Chronosphere 100mg prolonged-release granules
Epilim Chronosphere 100mg prolonged-release granules granule s produljenim oslobađanjem
Powder and solvent for solution for injection
prašak i otapalo za otopinu za injekciju u venu
Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz prašak i otapalo za otopinu za injekciju u venu
Valproic acid Convulex Capsules 300mg 500 mg
Convulex Capsules 300mg 500 mg želučanootporna kapsula
Valproic acid Convulex 300 mg - Kapseln 300 mg
Convulex 300 mg - Kapseln 300 mg želučanootporna kapsula, meka
Episenta 500mg Prolongedrelease Granules
Episenta 500mg Prolongedrelease Granules granule s produljenim oslobađanjem
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 750 mg, granulés à libération prolongée en sachet-dose
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 750 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose
MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Epilim Chronosphere MR 50mg Modified Release Granules
Epilim Chronosphere MR 50mg Modified Release Granules granule s prilagođenim oslobađanjem
Epilim Chronosphere MR 500mg Modified Release Granules
Epilim Chronosphere MR 500mg Modified Release Granules granule s prilagođenim oslobađanjem
Valproic acid Convulex 150 mg - Kapseln 150 mg
Convulex 150 mg - Kapseln 150 mg želučanootporna kapsula, meka
Powder for injection Intravenous use
Ergenyl intravenös otopina za injekciju u venu
MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose
MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Prolonged-release granules in sachet
Ergenyl Retard granule s produljenim oslobađanjem in a sachet
Valproic acid Orfiril
Orfiril oralna otopina
MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose
MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln granule s produljenim oslobađanjem
Valproic acid ORFIRIL
Epilim Liquid oralna otopina
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 100 mg, granulés à libération prolongée en sachet-dose
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 100 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Generica KG Südwestpark 50
DEPAKINE CHRONO (SPHERE) 250 mg/sachet
DEPAKINE CHRONO (SPHERE) 250 mg/vrećica obložene granule u vrećici
Valproic acid Convulex 500 mg - Kapseln 500 mg
Convulex 500 mg - Kapseln 500 mg želučanootporna kapsula, meka
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 500 mg, granulés à libération prolongée en sachet-dose
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 500 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 50 mg, granulés à libération prolongée en sachet-dose
VALPROATE DE SODIUMACIDE VALPROIQUE DELALANDE L.P. 50 mg, granulés à libération prolongée en sachet-dose granule s produljenim oslobađanjem
Valproic acid CONVULEX 100 mg/ml oldatos injekció
CONVULEX 100 mg/ml oldatos injekció otopina za injekciju u venu
Modified-release granules
Depakin granule s prilagođenim oslobađanjem
DEPAKINE CHRONO (SPHERE) 750 mg/sachet
DEPAKINE CHRONO (SPHERE) 750 mg/vrećica obložene granule u vrećici
Valproic acid Convulex
Convulex oralna otopina
Sodium Valproate Tablets 200mg
Sodium Valproate Tablets 200mg obložena tableta kroz usta
Film-coated tablet Oral Use
Dipromal filmom obložena tableta
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation
Dodatak II Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Odobrenja za stavljanje u lijeka promet za kombinirane hormonalne kontraceptive koji sadrže klormadinon predmetom su uvjeta navedenih u Dodatku IV.
The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied.
Nakon razmatranja preporuke PRAC-a od dana 10. listopada 2013. godine u skladu sa člankom 107k(3) Direktive 2001/83/EZ, CHMP je mišljenja da odobrenja za stavljanje u promet kombiniranih hormonalnih kontraceptiva koji sadrže klormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norgestimat trebaju biti izmijenjena.
The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Dopune relevantnih dijelova Sažetak opisa svojstava lijeka i Uputa o lijeku navedeni su u Dodatku III.
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
I u indikaciji kontracepcije ostaje povoljan, što je predmetom usuglašenih uvjeta, ograničenja, upozorenja, drugih izmjena u informacijama o lijeku i dodatnih mjera minimiziranja rizika.
Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
I u indikaciji kontracepcije ostaje povoljan, no predmetom je uključivanja usuglašenih ograničenja, upozorenja i drugih izmjena u informacijama o proizvodu.
Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/10/654/001 Leflunomide ratiopharm 10 mg Film-coated tablet
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/10/654/001 Leflunomid ratiopharm 10 mg Filmom obložena tableta Kroz usta
Other medicines and Januvia
Drugi lijekovi i Januvia
What Januvia is and what it is used for
Što je Januvia i za što se koristi
STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
PRESTANITE uzimati lijek Januvia i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
What Januvia contains
Što Januvia sadrži
What Januvia looks like and contents of the pack
Kako Januvia izgleda i sadržaj pakiranja
Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Datum posljednje obnove odobrenja: 23. veljače 2012.
Do not take Januvia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati lijek Januvia - ako ste alergični na sitagliptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Your doctor may ask you to stop Januvia.
Vaš liječnik može zatražiti da prestanete s uzimanjem lijeka Januvia.
Due to lack of human data, Januvia should not be used during pregnancy.
Zbog nedostatka podataka o primjeni u ljudi, Januvia se ne smije uzimati tijekom trudnoće.
If you have kidney problems, your doctor may prescribe lower doses(such as 25mg or 50mg).
Ako imate tegobe s bubrezima, liječnik Vam može propisati niže doze (kao što su 25 mg ili 50 mg).
If you take more Januvia than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Ako uzmete više lijeka Januvia nego što ste trebali Uzmete li veću dozu ovog lijeka od propisane, odmah se javite svom liječniku.
The level of digoxin in your blood may need to be checked if taking with Januvia.
Možda će biti potrebno provjeravati razinu digoksina u Vašoj krvi ukoliko se uzima s lijekom Januvia.
There is no experience with doses above 800 mg in clinical studies.
Nema iskustva s dozama većim od 800 mg u kliničkim ispitivanjima.
The usual recommended dose is: one 100 mg film-coated tablet once a day by mouth
Uobičajena preporučena doza je: jedna filmom obložena tableta od 100mg jedanput na dan kroz usta
- an allergic reaction to Januvia (see section 4).
- Alergijsku reakciju na lijek Januvia (pogledajte dio 4).
Method of administration Januvia can be taken with or without food.
Način primjene Januvia se može uzimati s hranom ili bez nje.
What Januvia is and what it is used for What you need to know before you take Januvia How to take Januvia
Što je Januvia i za što se koristi Što morate znati prije nego počnete uzimati lijek Januvia Kako uzimati lijek Januvia
Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Januvia se ne smije primjenjivati u bolesnika s dijabetesom tipa 1 ili za liječenje dijabetičke ketoacidoze.
For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
U odraslih bolesnika s dijabetesom mellitus tipa 2, Januvia je indicirana za poboljšanje regulacije glikemije:
Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "EXP".
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Budući da istodobno uzimanje sitagliptina s punomasnim obrokom nema učinka na farmakokinetiku, Januvia se može uzimati s hranom ili bez nje.
The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Januvia u jednoj ili više podskupina pedijatrijske populacije za dijabetes mellitus tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted.
Posumnja li se na pankreatitis, mora se prekinuti primjena lijeka Januvia i drugih lijekova za koje se sumnja da bi ga mogli izazvati; potvrdi li se akutni pankreatitis, liječenje lijekom Januvia ne smije se ponovno započeti.
What you need to know before you take Januvia
Što morate znati prije nego počnete uzimati lijek Januvia
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
S obzirom da se doza prilagođava temeljem bubrežne funkcije, preporučuje se procijeniti bubrežnu funkciju prije uvođenja lijeka Januvia te periodično nakon toga.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Prolazni fizički znakovi povezani s liječenjem, od kojih neki upućuju na neurotoksičnost, poput disanja otvorenih usta, salivacije, povraćanja bijele pjene, ataksije, drhtanja, smanjene aktivnosti i/ili pogrbljenog držanja tijela, opaženi su kod pasa pri razinama izloženosti otprilike 23 puta većima od razina kliničke izloženosti.
Incidenc e rate per 100 patientyears* N (%)
Stopa incidencije na 100 bolesnikgodina* N (%)
Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Januvia je također indicirana kao dodatak inzulinu (sa ili bez metformina) kada dijeta i tjelovježba uz stabilnu dozu inzulina ne omogućuju odgovarajuću regulaciju glikemije.
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Januvia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Hipoglikemija pri uzimanju u kombinaciji s drugim antihiperglikemijskim lijekovima U kliničkim ispitivanjima lijeka Januvia kao monoterapije ili kao dio kombinirane terapije s lijekovima za koje nije poznato da uzrokuju hipoglikemiju (tj. metforminom i/ili agonistom PPAR), stope prijavljenih hipoglikemija u bolesnika koji su uzimali sitagliptin bile su podjednake onoj u bolesnika koji su uzimali placebo.
In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with a sulphonylurea or with insulin.
Bolesnike se također mora upozoriti na rizik od hipoglikemije kad se Januvia uzima u kombinaciji sa sulfonilurejom ili s inzulinom.
If you stop taking Januvia
Ako prestanete uzimati lijek Januvia
Januvia has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Januvia nije ispitivana u bolesnika s teškim oštećenjem funkcije jetre, te je potreban oprez (vidjeti dio 5.2).
When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Januvia administered concomitantly.
Kada se uzima u kombinaciji s metforminom i/ili agonistom PPAR, mora se zadržati ista doza metformina i/ili agonista PPAR, uz istodobnu primjenu lijeka Januvia.
If you forget to take Januvia
Ako ste zaboravili uzeti lijek Januvia
When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Kada se Januvia uzima u kombinaciji sa sulfonilurejom ili inzulinom, može se razmotriti niža doza sulfonilureje ili inzulina kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
Januvia has no or negligible influence on the ability to drive and use machines.
Januvia ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
U nekih su se bolesnika liječenih metforminom nakon dodavanja sitagliptina javile sljedeće nuspojave: Često (mogu se javiti u do 1 na 10 osoba): nizak šećer u krvi, mučnina, vjetrovi, povraćanje Manje često (mogu se javiti u do 1 na 100 osoba): bol u trbuhu, proljev, zatvor, omamljenost
No dose adjustment for Januvia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Nije potrebna prilagodba doze lijeka Januvia u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (Child-Pugh rezultat ≤ 9).
Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Hipoglikemija je primijećena kad se sitagliptin uzimao u kombinaciji s inzulinom ili sulfonilurejom.