FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with a sulphonylurea or with insulin.
Croatian: Bolesnike također treba upozoriti da postoji rizik od razvoja hipoglikemije kad se Janumet uzima u kombinaciji sa sulfonilurejom ili s inzulinom.
English: Patients receiving Janumet in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Croatian: Bolesnici koji Janumet primaju u kombinaciji sa sulfonilurejom ili s inzulinom mogu biti izloženi riziku od razvoja hipoglikemije.
English: There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Croatian: Nisu provedena terapijska klinička ispitivanja s Janumet tabletama, međutim, pokazana je bioekvivalencija lijeka Janumet i istodobne primjene kombinacije sitagliptina i metformina (vidjeti dio 5.2).
English: As metformin and sitagliptin are excreted by the kidney, Janumet should be used with caution as age increases.
Croatian: Budući da se metformin i sitagliptin izlučuju putem bubrega, s povećanjem životne dobi Janumet treba primjenjivati uz oprez.
English: Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Croatian: Nisu provedena farmakokinetička ispitivanja interakcija drugih lijekova s lijekom Janumet; međutim, takva su ispitivanja provedena s djelatnim tvarima, sitagliptinom i metforminom, pojedinačno.
English: Janumet has no or negligible influence on the ability to drive and use machines.
Croatian: Janumet ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken.
Croatian: Za bolesnike koji se prebacuju s istodobne primjene sitagliptina i metformina Za bolesnike koji se prebacuju s istodobne primjene sitagliptina i metformina, liječenje lijekom Janumet mora započeti dosadašnjim dozama sitagliptina i metformina.
English: If a hypersensitivity reaction is suspected, Janumet should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Croatian: Pri sumnji na reakciju preosjetljivosti treba prekinuti liječenje lijekom Janumet, procijeniti koji su drugi mogući uzroci te započeti liječenje dijabetesa drugim lijekovima (vidjeti dio 4.8).
English: A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Croatian: Ispitivanje bioekvivalencije u zdravih ispitanika pokazalo je da su Janumet (sitagliptin/metforminklorid) kombinirane tablete bioekvivalentne istodobnoj primjeni pojedinačnih tableta sitagliptinfosfata i metforminklorida.
English: By inhibiting the DPP-4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Croatian: Inhibicijom DPP-4 enzima, sitagliptin povisuje razine dvaju poznatih aktivnih inkretinskih hormona, peptida-1 nalik glukagonu (engl. glucagon-like peptide-1, GLP-1) i inzulinotropnog polipeptida ovisnog o glukozi (engl. glucose-dependent insulinotropic polypeptide, GIP).
English: Janumet combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Croatian: Janumet sadrži kombinaciju dva antihiperglikemijska lijeka s komplementarnim mehanizmima djelovanja koji poboljšavaju regulaciju glikemije u bolesnika s dijabetesom tipa 2: sitagliptinfosfat, inhibitor dipeptidil peptidaze 4 (DPP-4), i metforminklorid, lijek iz skupine bigvanida.
English: In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Croatian: Osim toga, ovojnica tablete sadrži: poli(vinilni alkohol), makrogol 3350, talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172) i crni željezov oksid (E172).
English: When Janumet is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Croatian: Kad se Janumet primjenjuje u kombinaciji s inzulinom, možda će biti potrebno sniziti dozu inzulina kako bi se smanjio rizik od razvoja hipoglikemije (vidjeti dio 4.4).
English: When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Croatian: Kad se Janumet primjenjuje u kombinaciji sa sulfonilurejom, možda će biti potrebno sniziti dozu sulfonilureje kako bi se smanjio rizik od razvoja hipoglikemije (vidjeti dio 4.4).
English: Hepatic impairment Janumet must not be used in patients with hepatic impairment (see section 5.2).
Croatian: Janumet se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Janumet.
Croatian: Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, prije uzimanja lijeka Janumet obratite se svom liječniku ili ljekarniku.
English: Janumet must therefore not be used in women who are breast-feeding (see section 4.3).
Croatian: Stoga dojilje ne smiju uzimati Janumet (vidjeti dio 4.3).
English: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Croatian: Janumet je indiciran kao dopuna dijeti i tjelovježbi za poboljšanje regulacije glikemije u bolesnika u kojih ista nije odgovarajuće regulirana primjenom najviše podnošljive doze samo metformina ili u onih koji se već liječe kombinacijom sitagliptina i metformina.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Janumet (see section 4).
Croatian: U bolesnika koji su primali Janumet prijavljeni su slučajevi upale gušterače (pankreatitis) (pogledajte dio 4.).
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient--years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Croatian: U prospektivnom randomiziranom ispitivanju (UKPDS) utvrđeni su dugoročni korisni učinci intenzivne kontrole glukoze u krvi u bolesnika s dijabetesom tipa 2. Analiza rezultata u bolesnika s prekomjernom tjelesnom težinom liječenih metforminom, nakon neuspjelog liječenja samo dijetom, pokazala je sljedeće: - značajno smanjenje apsolutnog rizika od bilo koje komplikacije povezane s dijabetesom u skupini liječenoj metforminom (29,8 događaja na 1000 bolesnik-godina) naspram skupine koja je bila samo na dijeti (43,3 događaja na 1000 bolesnik-godina), p=0,0023, naspram objedinjenih podataka za skupine koje su uzimale samo sulfonilureju ili primjenjivale samo inzulin (40,1 događaja na 1000 bolesnik-godina), p=0,0034 - značajno smanjenje apsolutnog rizika od smrtnosti povezane s dijabetesom - metformin: 7,5 događaja na 1000 bolesnik-godina; skupina samo na dijeti: 12,7 događaja na 1000 bolesnik-godina, p=0,017 - značajno smanjenje apsolutnog rizika od ukupne smrtnosti: 13,5 događaja na 1000 bolesnikgodina u bolesnika na metforminu naspram 20,6 događaja na 1000 bolesnik-godina za skupinu samo na dijeti (p=0,011), naspram 18,9 događaja na 1000 bolesnik-godina za objedinjene podatke monoterapijskih skupina na sulfonilureji ili samo na inzulinu (p=0,021) - značajno smanjenje apsolutnog rizika od infarkta miokarda - metformin: 11 događaja na 1000 bolesnik-godina, skupina samo na dijeti: 18 događaja na 1000 bolesnik-godina (p=0,01).
English: For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Croatian: Za različite doze metformina, Janumet je dostupan u jačinama od 50 mg sitagliptina i 850 mg metforminklorida ili 1000 mg metforminklorida.
English: If bullous pemphigoid is suspected, Janumet should be discontinued.
Croatian: Pri sumnji na bulozni pemfigoid treba prekinuti liječenje lijekom Janumet.
English: How to store Janumet
Croatian: Kako čuvati Janumet
English: Janumet is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Croatian: Janumet je također indiciran kao dodatak inzulinu (tj. kao dio trojne kombinirane terapije), a kao dopuna dijeti i tjelovježbi, za poboljšanje regulacije glikemije u bolesnika u kojih stabilna doza inzulina i samo metformin ne omogućavaju odgovarajuću regulaciju glikemije.
English: Talk to your doctor or pharmacist before taking Janumet: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Janumet: - ako imate ili ste imali bolest gušterače (kao što je pankreatitis).
English: Janumet must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4).
Croatian: Primjena lijeka Janumet se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna (vidjeti dijelove 4.3 i 4.4).
English: Janumet is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Croatian: Janumet je indiciran kao dio trojne kombinirane terapije s agonistom receptora za aktivator proliferacije peroksisoma-gama (engl. peroxisome proliferator-activated receptor gamma, PPAR) (tj. tiazolidindionom) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i agonista PPAR.
English: Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Croatian: Ako se razviju laboratorijski nalazi koji odstupaju od normalnih vrijednosti ili klinička bolest (posebno nejasna i loše definirana bolest) u bolesnika s prethodno dobro reguliranim dijabetesom tipa 2 lijekom Janumet, treba odmah potražiti znakove ketoacidoze ili laktacidoze.
English: Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Croatian: Janumet je indiciran u kombinaciji sa sulfonilurejom (tj. kao dio trojne kombinirane terapije) kao dopuna dijeti i tjelovježbi u bolesnika koji nisu odgovarajuće regulirani primjenom najviše podnošljive doze metformina i sulfonilureje.
English: EU/1/08/455/002 EU/1/08/455/003 EU/1/08/455/004 EU/1/08/455/005 EU/1/08/455/006 EU/1/08/455/007 EU/1/08/455/015 EU/1/08/455/017 EU/1/08/455/019 EU/1/08/455/020
Croatian: EU/1/08/455/001 EU/1/08/455/002 EU/1/08/455/003 EU/1/08/455/004 EU/1/08/455/005 EU/1/08/455/006 EU/1/08/455/007 EU/1/08/455/015 EU/1/08/455/017 EU/1/08/455/019 EU/1/08/455/020
English: EU/1/08/455/009 EU/1/08/455/010 EU/1/08/455/011 EU/1/08/455/012 EU/1/08/455/013 EU/1/08/455/014 EU/1/08/455/016 EU/1/08/455/018 EU/1/08/455/021 EU/1/08/455/022
Croatian: EU/1/08/455/008 EU/1/08/455/009 EU/1/08/455/010 EU/1/08/455/011 EU/1/08/455/012 EU/1/08/455/013 EU/1/08/455/014 EU/1/08/455/016 EU/1/08/455/018 EU/1/08/455/021 EU/1/08/455/022
English: See section 2, Do not take Janumet.
Croatian: Nemojte uzimati Janumet.
English: Janumet 50 mg/850 mg film-coated tablets
Croatian: Janumet 50 mg/850 mg filmom obložene tablete
English: Janumet 50 mg/1,000 mg film-coated tablets
Croatian: Janumet 50 mg/1000 mg filmom obložene tablete
English: EU/1/08/455/001 14 film-coated tablets EU/1/08/455/002 28 film-coated tablets EU/1/08/455/003 56 film-coated tablets EU/1/08/455/019 60 film-coated tablets EU/1/08/455/004 112 film-coated tablets EU/1/08/455/005 168 film-coated tablets EU/1/08/455/020 180 film-coated tablets EU/1/08/455/006 196 film-coated tablets EU/1/08/455/007 50 x 1 film-coated tablets EU/1/08/455/015 196 (2 x 98) film-coated tablets EU/1/08/455/017 168 (2 x 84) film-coated tablets
Croatian: EU/1/08/455/001 14 filmom obloženih tableta EU/1/08/455/002 28 filmom obloženih tableta EU/1/08/455/003 56 filmom obloženih tableta EU/1/08/455/019 60 filmom obloženih tableta EU/1/08/455/004 112 filmom obloženih tableta EU/1/08/455/005 168 filmom obloženih tableta EU/1/08/455/020 180 filmom obloženih tableta EU/1/08/455/006 196 filmom obloženih tableta EU/1/08/455/007 50 x 1 filmom obložena tableta EU/1/08/455/015 196 (2 x 98) filmom obloženih tableta EU/1/08/455/017 168 (2 x 84) filmom obloženih tableta
English: EU/1/08/455/008 14 film-coated tablets EU/1/08/455/009 28 film-coated tablets EU/1/08/455/010 56 film-coated tablets EU/1/08/455/021 60 film-coated tablets EU/1/08/455/011 112 film-coated tablets EU/1/08/455/012 168 film-coated tablets EU/1/08/455/022 180 film-coated tablets EU/1/08/455/013 196 film-coated tablets EU/1/08/455/014 50 x 1 film-coated tablets EU/1/08/455/016 196 (2 x 98) film-coated tablets EU/1/08/455/018 168 (2 x 84) film-coated tablets
Croatian: EU/1/08/455/008 14 filmom obloženih tableta EU/1/08/455/009 28 filmom obloženih tableta EU/1/08/455/010 56 filmom obloženih tableta EU/1/08/455/021 60 filmom obloženih tableta EU/1/08/455/011 112 filmom obloženih tableta EU/1/08/455/012 168 filmom obloženih tableta EU/1/08/455/022 180 filmom obloženih tableta EU/1/08/455/013 196 filmom obloženih tableta EU/1/08/455/014 50 x 1 filmom obložena tableta EU/1/08/455/016 196 (2 x 98) filmom obloženih tableta EU/1/08/455/018 168 (2 x 84) filmom obloženih tableta
English: - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Croatian: Nemojte uzimati Janumet: - ako ste alergični na sitagliptin ili metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate jako smanjenu funkciju bubrega - ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti "Rizik od laktacidoze" niže) ili ketoacidozu.
English: Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Croatian: Nositelj odobrenja Merck Sharp & Dohme B.V.
English: Janumet 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Croatian: Janumet 50 mg/1000 mg tablete sitagliptin/metforminklorid
English: Janumet 50 mg/850 mg tablets sitagliptin/metformin HCl
Croatian: Janumet 50 mg/850 mg tablete sitagliptin/metforminklorid
English: This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Janumet (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Janumet, as you may experience low blood sugar levels (hypoglycaemia).
Croatian: - ako imate ili ste imali alergijsku reakciju na sitagliptin, metformin ili Janumet (pogledajte dio 4.).
English: Janumet 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Croatian: Janumet 50 mg/1000 mg filmom obložene tablete sitagliptin/metforminklorid
English: Janumet 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Croatian: Janumet 50 mg/850 mg filmom obložene tablete sitagliptin/metforminklorid
English: Tel: + 386 1 5204 201 msd_slovenia@merck.com
Croatian: +370 5 278 02 47 msd_lietuva@merck.com
English: These medical conditions can increase your chance of getting pancreatitis (see section 4) - if you have type 1 diabetes.
Croatian: Ove bolesti mogu povećati vjerojatnost da dobijete pankreatitis
English: Date of first authorisation: 19 September 2011
Croatian: Datum prvog odobrenja: 19. rujna 2011.
English: 95% confidence interval
Croatian: 95%-tni interval pouzdanosti
English: Your doctor will explain these to you.
Croatian: Liječnik će Vam to pojasniti.
English: Therefore this combination should be used with caution or alternatives should be considered.
Croatian: Stoga se ova kombinacija treba primjenjivati s oprezom ili treba razmotriti alternative.
English: INCIVO with food and drink
Croatian: INCIVO s hranom i pićem
English: Anorectal signs and symptoms
Croatian: Anorektalni znakovi i simptomi
English: If you take more INCIVO than you should
Croatian: Ako uzmete više INCIVA nego što ste trebali
English: What INCIVO is and what it is used for
Croatian: Što je INCIVO i za što se koristi
English: No new safety findings were identified.
Croatian: Nisu identificirani novi sigurnosni
English: Insufficient virologic response
Croatian: Nedostatan virološki odgovor
English: If you are taking INCIVO every 8 hours
Croatian: Ako uzimate INCIVO svakih 8 sati
English: Otherwise, the total treatment duration was 48 weeks.
Croatian: Inače, ukupno trajanje liječenja bilo je 48 tjedna.
English: Please see section ‘Other medicines and INCIVO'.
Croatian: Molimo pogledajte dio “ Drugi lijekovi i INCIVO”.
English: 3 and/or albumin < 3.3 g/dl.
Croatian: 3 i/ili albuminom < 3,3 g/dl.
English: - Heart problems
Croatian: - Srčani problemi
English: Data in the paediatric population are currently not available.
Croatian: Podaci o pedijatrijskoj populaciji trenutno nisu dostupni.
English: The incidence was calculated by the number of patients for each parameter.
Croatian: Incidencija je izračunata na temelju broja bolesnika za svaki parametar.
English: ® HCV test (version 2.0), for use with the High Pure System.
Croatian: ® HCV testa (verzija 2.0), za primjenu uz sustav High Pure System.
English: Always take the tablets with food.
Croatian: Uvijek uzimajte tablete uz hranu.
English: Rifampicin reduces the telaprevir plasma AUC by approximately 92%.
Croatian: Rifampicin smanjuje AUC telaprevira u plazmi za približno 92%.
English: Tell your doctor if you take any of the following medicines:
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova:
English: Telaprevir is approximately 59% to 76% bound to plasma proteins.
Croatian: Približno je 59% do 76% telaprevira vezano za proteine plazme.
English: SJS, TEN, erythema multiforme
Croatian: SJS, TEN, multiformni eritem
English: Therefore, telaprevir should be taken with food.
Croatian: Stoga telaprevir treba uzimati s hranom.
English: Study 106 and Study 107
Croatian: Ispitivanje 106 i Ispitivanje 107
English: Simvastatin is contraindicated due to the predicted marked increase in exposure caused by multiple mechanisms.
Croatian: Simvastatin je kontraindiciran radi predviđenog značajnog povišenja izloženosti uzrokovanog višestrukim mehanizmima.
English: INCIVO tablets should be stored in the original bottle.
Croatian: INCIVO tablete treba čuvati u originalnoj bočici.
English: These may be symptoms of anaemia.
Croatian: To mogu biti simptomi anemije.
English: Clinical comment
Croatian: Klinički komentar
English: Table 9 shows response rates.
Croatian: Tablica 9 pokazuje stope odgovora.
English: Telaprevir may be less effective due to decreased concentrations.
Croatian: Telaprevir može biti manje djelotvoran zbog snižene koncentracije.
English: However, sufficiently high concentrations were not tested for intestinal inhibition to be excluded.
Croatian: Međutim, nisu bile ispitane dovoljno velike koncentracije da bi se mogla isključiti intestinalna inhibicija.
English: After ending treatment, approximately one week may be needed for the inhibition to completely disappear.
Croatian: Nakon završetka liječenja, za potpuni nestank inhibicije može biti potrebno oko tjedan dana.
English: At steady-state, the effective half-life is about 9-11 hours.
Croatian: U stanju dinamičke ravnoteže, efektivno poluvrijeme približno je 9-11 sati.
English: The lowest dose of digoxin should be initially prescribed.
Croatian: Za početak treba propisati najnižu dozu digoksina.
English: Among HIV regimens that can be used (not limited to those below) the following should be taken into account:
Croatian: Od režima koji se mogu koristiti kod HIV-a (nisu ograničeni na niže navedene) u obzir se mora uzeti sljedeće:
English: Patients should be instructed to swallow the tablets whole (e.g. patients should not chew, break or
Croatian: Bolesnike treba uputiti da tablete progutaju cijele (npr. bolesnici ne smiju žvakati, lomiti niti otapati
English: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Bočicu držite čvrsto zatvorenu radi zaštite od vlage.
English: The Physician Leaflet should contain the following key elements:
Croatian: Uputa za liječnika mora sadržavati sljedeće ključne elemente:
English: What you need to know before you take INCIVO
Croatian: Što morate znati prije nego počnete uzimati INCIVO
English: The total daily dose is 6 tablets (2,250 mg).
Croatian: Ukupna dnevna doza je 6 tableta (2250 mg).
English: In rats (but not in dogs), telaprevir caused degenerative changes in testes which were reversible and did not affect fertility.
Croatian: U štakora (ali ne i u pasa) telaprevir je prouzročio degenerativne promjene u testisima koje su bile reverzibilne i nisu utjecale na plodnost.
English: The total dose is 6 tablets per day.
Croatian: Ukupna doza je 6 tableta na dan.
English: These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Croatian: Te se preporuke temelje na ispitivanjima interakcija lijekova (označeno sa *) ili na predviđenim interakcijama zbog očekivane jačine interakcija i mogućnosti ozbiljnih nuspojava ili gubitka djelotvornosti.
English: What INCIVO is and what it is used for What you need to know before you take INCIVO
Croatian: Što je INCIVO i za što se koristi Što morate znati prije nego počnete uzimati INCIVO