FrancophonIA/ELRC3.0 huggingface dataset:
English: Polyvinyl chloride (PVC)/aluminium foil push through blister units.
Croatian: Blister od polivinilklorid (PVC)/aluminijske folije kroz kojeg se mogu protisnuti tablete.
English: It is not recommended to coadminister efavirenz and Viramune (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1).
Croatian: Ne preporučuje se istodobna primjena efavirenza i Viramunea (vidjeti dio 4.4) zbog dodatne toksičnosti i izostanka koristi u smislu djelotvornosti u odnosu na sam NNRTI (za rezultate 2NN ispitivanja, vidjeti dio 5.1).
English: Nevirapine AUC  1.27 (1.12-1.44) Nevirapine Cmin  1.47 (1.20-1.82) Nevirapine Cmax  1.18 (1.02-1.37)
Croatian: Nevirapin AUC  1,27 (1,12-1,44) Nevirapin Cmin  1,47 (1,20-1,82) Nevirapin Cmax  1,18 (1,02-1,37)
English: Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN.
Croatian: Bolesnici s teškim oštećenjem jetre (Child-Pugh C) ili osobe koje su u fazi prije liječenja imali AST ili ALT > 5 x gornja granica normale (GGN) sve dok se vrijednosti AST/ALT ne stabiliziraju na razini < 5 x GGN.
English: phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin..
Croatian: Ograničeni podaci dostupni iz ispitivanja faze IIA na bolesnicima inficiranih HIV-om pokazali su klinički beznačajno 20% tno smanjenje Cmin tipranavira.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 - 55216 Ingelheim am Rhein Germany
Croatian: KG Binger Strasse 173 - 55216 Ingelheim am Rhein Njemačka
English: Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Croatian: Viramune je indiciran za liječenje odraslih osoba, adolescenata i djece bilo koje dobi inficiranih HIVom.
English: Each prolonged-release tablet contains 100 mg nevirapine.
Croatian: Svaka tableta s produljenim oslobađanjem sadrži 100 mg nevirapina.
English: 55216 Ingelheim am Rhein Germany or
Croatian: 55216 Ingelheim am Rhein Njemačka ili
English: Cases of Viramune overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Croatian: Prijavljeni su slučajevi predoziranja Viramuneom dozama koje variraju od 800 do 6 000 mg na dan do 15 dana.
English: Nevirapine AUC  1.29 (1.19-1.40) Nevirapine Cmin  1.34 (1.21-1.49) Nevirapine Cmax  1.25 (1.14-1.37)
Croatian: Nevirapin AUC  1,29 (1,19-1,40) Nevirapin Cmin  1,34 (1,21-1,49) Nevirapin Cmax  1,25 (1,14-1,37)
English: Nevirapine administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Croatian: Primjena nevirapina u dozama višim od preporučenih može povećati učestalost i ozbiljnost kožnih reakcija, kao što su Stevens-Johnsonov sindrom i toksična epidermalna nekroliza.
English: Zidovudine AUC  0.72 (0.60-0.96) Zidovudine Cmin ND Zidovudine Cmax  0.70 (0.49-1.04)
Croatian: Zidovudin AUC  0,72 (0,60-0,96) Zidovudin Cmin NO Zidovudin Cmax  0,70 (0,49-1,04)
English: Ketoconazole 400 mg QD
Croatian: Ketokonazol 400 mg 1x/ dan
English: Lamivudine 150 mg BID
Croatian: Lamivudin 150 mg 2x/dan
English: If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time.
Croatian: Ako je doza propuštena, a prošlo je više od 8 sati, treba uzeti sljedeću dozu u uobičajeno vrijeme.
English: x Wt
Croatian: x težina
English: It is not recommended to coadminister efavirenz and Viramune (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1 Viramune immediate-release formulations).
Croatian: Ne preporučuje se istodobna primjena efavirenza i Viramunea (vidjeti dio 4.4) zbog dodatne toksičnosti i izostanka koristi u smislu djelotvornosti u odnosu na sam NNRTI (za rezultate 2NN ispitivanja vidjeti dio 5.1 Viramune formulacije s trenutnim oslobađanjem).
English: Blood and lymphatic system disorders Uncommon granulocytopenia Rare anaemia
Croatian: Poremećaji krvi i limfnog sustava Često granulocitopenija
English: If ASAT and ALAT return to baseline values and if the patient had no clinical signs or symptoms of hepatitis, rash, constitutional symptoms or other findings suggestive of organ dysfunction, it may be possible to reintroduce nevirapine, on a case by case basis, at the starting dose regimen of 200 mg/day for 14 days followed by 400 mg/day.
Croatian: Ako se AST i ALT vrate na početne vrijednosti te ako bolesnik nema kliničkih znakova ili simptoma hepatitisa, osipa, općih simptoma ili drugih nalaza koji ukazuju na disfunkciju organa, moguće je ponovo uvesti nevirapin na temelju analize svakog pojedinog slučaja, s početnom dozom od 200 mg/dan u trajanju od 14 dana, iza čega slijedi 400 mg/dan.
English: Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with Viramune use.
Croatian: Primijećena je rabdomioliza u bolesnika s kožnim i/ili jetrenim reakcijama povezanim s primjenom Viramunea.
English: It is very important that your child takes Viramune only once a day for the first 14 days (“lead-in” period).
Croatian: Vrlo je važno da dijete uzima Viramune samo jednom na dan prvih 14 dana (“uvodno” razdoblje).
English: Fluconazole Cmin  0.93 (0.86-1.01) Fluconazole Cmax  0.92 (0.85-0.99)
Croatian: Flukonazol AUC  0,94 (0,88-1,01) Flukonazol Cmin  0,93 (0,86-1,01) Flukonazol Cmax  0,92 (0,85-0,99)
English: The prolonged-release tablets are approximately 9 mm in diameter, debossed with V01 on one side and company symbol on the other side.
Croatian: Tablete s produljenim oslobađanjem imaju promjer oko 9 mm, s utisnutom oznakom V01 na jednoj strani i simbolom tvrtke na drugoj.
English: Viramune is indicated for the treatment of HIV-1 infected adolescents and children three years and above and able to swallow tablets.
Croatian: Viramune je indiciran za liječenje HIV-om inficiranih adolescenata i djece u dobi tri i više godina koji mogu gutati tablete.
English: It is very important that you take only 20 ml of Viramune a day for the first 14 days (“lead-in” period).
Croatian: Važno je da uzimate samo 20 ml Viramunea dnevno prvih 14 dana (”uvodno” razdoblje).
English: Renal impairment: The single-dose pharmacokinetics of nevirapine immediate-release has been compared in 23 patients with either mild (50  CLcr  80 ml/min), moderate (30  CLcr  50 ml/min) or severe renal dysfunction (CLcr  30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr  80 ml/min).
Croatian: Oštećenje bubrega: Farmakokinetika jednokratne doze nevirapina s trenutnim oslobađanjem uspoređivana je na 23 bolesnika s blagom (50 ≤ CLcr < 80 ml/min) (n=8), umjerenom (30 ≤ CLcr < 50ml/min), ili teškom (CLcr < 30ml/min) disfunkcijom bubrega, oštećenjem bubrega ili terminalnom bubrežnom insuficijencijom (ESRD) koja zahtijeva dijalizu, te 8 subjekata s urednom bubrežnom funkcijom (CLcr > 80 ml/min).
English: Stavudine: 30/40 mg BID
Croatian: Stavudin 30/40 mg 2x/dan
English: Instead Viramune 400 mg prolonged-release tablets should be used after the lead-in period.
Croatian: Umjesto toga, nakon uvodnog razdoblja primjenjuju se Viramune 400 mg tablete s produljenim oslobađanjem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/001 [60 tablets]
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/055/001 [60 tableta]
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Croatian: Manje često anafilaktička reakcija Rijetko reakcija na lijek uz eozinofiliju i sistemske simptome
English: Zidovudine 100-200 mg TID
Croatian: Zidovudin 100-200 mg 3x/dan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous).
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadrži 200 mg nevirapina (u bezvodnom obliku).
English: Itraconazole 200 mg QD
Croatian: Itrakonazol 200 mg 1x/dan
English: The anti-HIV-1 activity of nevirapine was antagonized by the anti-HBV medicinal product adefovir and by the anti-HCV medicinal product ribavirin in vitro.
Croatian: Lijekovi protiv hepatitisa B, adefovir i hepatitisa C, ribavirin, in vitro antagoniziraju anti-HIV-1 aktivnost nevirapina.
English: 55216 Ingelheim am Rhein, Germany
Croatian: 55216 Ingelheim am Rhein, Njemačka
English: Atazanavir/r AUC  0.81 (0.65-1.02) Atazanavir/r Cmin  0.41 (0.27-0.60) Atazanavir/r Cmax  1.02 (0.85
Croatian: Atazanavir/r AUC  0,81 (0,65-1,02) Atazanavir/r Cmin  0,41 (0,27-0,60) Atazanavir/r Cmax  1,02 (0,85-1,24) (u usporedbi s 300/100 mg bez nevirapina)
English: Sucrose: Viramune oral suspension contains 150 mg of sucrose per ml.
Croatian: Saharoza: Viramune oralna suspenzija sadrži 150 mg saharoze u 1 ml.
English: The following adverse reactions were identified in other nevirapine studies or by post-marketing surveillance but not observed in the randomised, controlled clinical study 1100.1486.
Croatian: Sljedeće nuspojave prepoznate su u drugim ispitivanjima s nevirapinom ili u postmarketinškom razdoblju praćenja, ali nisu opažene u randomiziranom, kontroliranom kliničkom ispitivanju
English: Nevirapine AUC  1.14 (1.05-1.24) Nevirapine Cmin  1.22 (1.10-1.35) Nevirapine Cmax  1.13 (1.03-1.24)
Croatian: Nevirapin AUC  1,14 (1,05-1,24) Nevirapin Cmin  1,22 (1,10-1,35) Nevirapin Cmax  1,13 (1,03-1,24)
English: drug-drug interaction study of telaprevir with nevirapine has been conducted, however, interaction studies of telaprevir with an NNRTI with a similar metabolic pathway as nevirapine demonstrated reduced levels of both.
Croatian: Međutim, ispitivanja interakcija telaprevira s NNRTI-om sa sličnim metaboličkim putem nevirapinu su pokazala smanjene vrijednosti koncentracije oba lijeka.
English: BLISTER CARTON LABEL
Croatian: NALJEPNICA NA KUTIJI S BLISTERIMA
English: Due to the metabolic pathway of entecavir, no clinically relevant drug-drug interaction is expected.
Croatian: Zbog metaboličkog puta entekavira, ne očekuju se klinički značajne interakcije među lijekovima.
English: If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible.
Croatian: Ako primjetite da ste propustili dozu unutar 8 sati od vremena kad ste ju trebali uzeti, uzmite propuštenu dozu čim je prije moguće.
English: Table 1: Lead-in phase with Viramune immediate-release
Croatian: Tablica 1: Uvodno razdoblje na Viramuneu s trenutnim oslobađanjem Poremećaji krvi i limfnog sustava
English: Uncommon Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal) (0.2 %), angioedema, urticaria
Croatian: Manje često Stevens-Johnsonov sindrom/toksična epidermalna nekroliza (koji mogu biti fatalni) (0,2%), angioedem, urtikarija
English: administered without dose adjustments.
Croatian: prilagodbe doze.
English: It is not recommended to coadminister ketoconazole and Viramune (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena ketokonazola i Viramunea (vidjeti dio 4.4).
English: Common (may affect up to 1 in 10 people): - decreased numbers of white blood cells (granulocytopenia) - allergic reactions (hypersensitivity) - headache - feeling sick (nausea) - vomiting - abdominal pain - loose stools (diarrhoea) - inflammation of the liver (hepatitis) - feeling tired (fatigue) - fever - abnormal liver function tests
Croatian: Često (može se javiti do 1 na 10 osoba): - smanjeni broj bijelih krvnih stanica (granulocitopenija) - alergijske reakcije (preosjetljivost) - glavobolja - mučnina - povraćanje - bol u turbuhu - mekana stolica (proljev) - upala jetre (hepatitis) - osjećaj umora (umor) - vrućica - abnormalni nalazi testova jetrene funkcije
English: Uncommon Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal) (0.6 %), angioedema, urticaria
Croatian: Manje često Stevens-Johnsonov sindrom/toksična epidermalna nekroliza (koji mogu biti fatalni) (0,6%), angioedem, urtikarija
English: The nevirapine postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Croatian: Postmarketinško iskustvo ukazuje da su najozbiljnije nuspojave nevirapina Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, teški hepatitis/zatajenje jetre i reakcija na lijek uz eozinofiliju i sistemskim simptomima, karakterizirane osipom uz konstitucijske simptome poput vrućice, artralgije, mijalgije i limfadenopatije, plus visceralne poremećaje poput hepatitisa, eozinofilije, granulocitopenije i disfunkcije bubrega.
English: It is not recommended to coadminister rifampicin and Viramune (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena rifampicina i Viramunea (vidjeti dio 4.4).
English: - blistering - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - general feelings of illness - abdominal pain - hypersensitivity (allergic) reactions - inflammation of the liver (hepatitis) - if you have severe liver disease - if you have had to stop Viramune treatment in the past because of changes in your liver function - if you are taking a medicine containing the herbal substance St. John's Wort (Hypericum perforatum).
Croatian: - rane u ustima - upala oka - oticanje lica - opće oticanje - nedostatak zraka - bol u mišićima ili zglobovima - opći osjećaj bolesti - bol u trbuhu - reakcije preosjetljivosti (alergijske reakcije) - upala jetre (hepatitis) - ako imate tešku bolest jetre - ako ste morali prekinuti liječenje Viramuneom zbog promjena u funkciji jetre - ako uzimate lijekove koji sadrže biljnu tvar gospinu travu (Hypericum perforatum).
English: NAME OF THE MEDICINAL PRODUCT Viramune 200 mg tablets
Croatian: NAZIV LIJEKA Viramune 200 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Viramune 200 mg tablets nevirapine
Croatian: NAZIV LIJEKA Viramune 200 mg tablete nevirapin
English: Table 4: Summary of lipid laboratory values at baseline (screening) and week 48 - study
Croatian: Tablica 4: Sažetak laboratorijskih početnih vrijednosti lipida (probir) i nakon 48 tjedanaispitivanje 1100.1486
English: NNRTIs Efavirenz 600 mg QD
Croatian: NNRTI-i Efavirenz 600 mg 1x/ dan
English: Patients should be instructed that dose escalation is not to occur if any rash occurs during the two-week lead-in dosing period, until the rash resolves.
Croatian: Bolesnike također treba upozoriti da se u slučaju pojave osipa, tijekom dvotjednog uvodnog razdoblja, doza ne smije postupno povećavati, dok se ne riješi osip.
English: If in doubt ask your child's doctor.
Croatian: Ako imate bilo kakvu dvojbu, upitajte djetetovog liječnika.
English: Yellow, oval, biconvex prolonged-release tablets.
Croatian: Žute, ovalne i bikonveksne tablete s produljenim oslobađanjem.
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2).
Croatian: Viramune je indiciran u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje adolescenata i djece s HIV-1 infekcijom u dobi tri i više godina koji mogu gutati tablete (vidjeti dio 4.2).
English: Nevirapine AUC  1.25 (1.17-1.34) Nevirapine Cmin  1.32 (1.22-1.43) Nevirapine Cmax  1.17 (1.09-1.25)
Croatian: Nevirapin AUC  1,25 (1,17-1,34) Nevirapin Cmin  1,32 (1,22-1,43) Nevirapin Cmax  1,17 (1,09-1,25)
English: Ritonavir 600 mg BID
Croatian: Ritonavir 600 mg 2x/dan
English: Tenofovir and Viramune can be coadministered without dose adjustments.
Croatian: Tenofovir i Viramune mogu se istodobno primjenjivati bez prilagodbe doze.
English: NAME OF THE MEDICINAL PRODUCT Viramune 100 mg prolonged-release tablets
Croatian: NAZIV LIJEKA Viramune 100 mg tablete s produljenim oslobađanjem
English: severe and life-threatening hepatotoxicity) (1.6 %) Uncommon jaundice, hepatitis fulminant (which may be fatal) Skin and subcutaneous tissue disorders Common rash (5.7 %)
Croatian: Često hepatitis (uključujući tešku i po život opasnu hepatotoksičnost) (1,6%) Manje često žutica, fulminantni hepatitis (koji može biti fatalan) Poremećaji kože i potkožnog tkiva
English: It is particularly important that you tell your doctor if you are taking or have recently taken: - St. John's Wort (Hypericum perforatum, medicine to treat depression) - rifampicin (medicine to treat tuberculosis) - rifabutin (medicine to treat tuberculosis) - macrolides e.g. clarithromycin (medicine to treat bacterial infections) - fluconazole (medicine to treat fungal infections) - ketoconazole (medicine to treat fungal infections) - itraconazole (medicine to treat fungal infections) - methadone (medicine used for treatment of opiate addicts) - warfarin (medicine to reduce blood clotting) - hormonal contraceptives (e.g. the “pill”) - atazanavir (another medicine to treat HIV-infection) - lopinavir/ritonavir (another medicine to treat HIV-infection) - fosamprenavir (another medicine to treat HIV-infection) - efavirenz (another medicine to treat HIV-infection) - etravirine (another medicine to treat HIV-infection) - rilpivirine (another medicine to treat HIV-infection) - delavirdine (another medicine to treat HIV-infection) - zidovudine (another medicine to treat HIV-infection) - boceprevir (medicine to treat hepatitis C) - telaprevir (medicine to treat hepatitis C) - elvitegravir/cobicistat (another medicine to treat HIV-infection)
Croatian: Osobito je važno obavijestiti liječnika ako uzimate ili ste nedavno uzeli: - gospinu travu (Hypericum perforatum, lijek za liječenje depresije) - rifampicin (lijek za liječenje tuberkuloze) - rifabutin (lijek za liječenje tuberkuloze) - makrolidi, npr. klaritromicin (lijek za liječenje bakterijskih infekcija) - flukonazol (lijek za liječenje gljivičnih infekcija) - ketokonazol (lijek za liječenje gljivičnih infekcija) - itrakonazol (lijek za liječenje gljivičnih infekcija) - metadon (lijek koji se primjenjuje u liječenju opijatskih ovisnika) - varfarin (lijek za smanjenje zgrušavanja krvi) - hormonske kontraceptive (npr. “pilule”) - atazanavir (drugi lijek za liječenje HIV-infekcije) - lopinavir/ritonavir (drugi lijek za liječenje HIV-infekcije) - fosamprenavir (drugi lijek za liječenje HIV-infekcije) - efavirenz (drugi lijek za liječenje HIV-infekcije) - etravirin (drugi lijek za liječenje HIV infekcije) - rilpivirin (drugi lijek za liječenje HIV infekcije) - delavirdin (drugi lijek za liječenje HIV infekcije) - zidovudin (drugi lijek za liječenje HIV-infekcije) - boceprevir (lijek za liječenje hepatitisa C) - telaprevir (lijek za liječenje hepatitisa C) - elvitegravir/kobicistat (drugi lijek za liječenje infekcije HIV-om)
English: Hepatic impairment
Croatian: ili anafilaktički šok
English: In paediatric patients with renal dysfunction who are undergoing dialysis it is recommended following each dialysis treatment patients receive an additional dose of Viramune oral suspension or immediate-release tablets representing 50% of the recommended daily dose of Viramune oral suspension or immediate-release tablets, which would help offset the effects of dialysis on nevirapine clearance.
Croatian: Pedijatrijskim bolesnicima s disfunkcijom bubrega na dijalizi preproučuje se dodatna doza Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem nakon svake dijalize, što predstavlja 50 % preporučene dnevne doze Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem, što bi pomoglo uklanjanju učinka dijalize na klirens nevirapina.
English: It is not recommended to coadminister boceprevir and Viramune (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena boceprevira i Viramunea (vidjeti dio 4.4).
English: The tablets shall be taken with liquid, and should not be crushed or chewed.
Croatian: Tablete se uzimaju s tekućinom, i ne smiju se drobiti ili žvakati.
English: Fosamprenavir/ritona vir 700/100 mg BID
Croatian: Fosamprenavir/ritonavir 700/100 mg 2x/dan
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 100 mg of nevirapine (as anhydrous).
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta s produljenim oslobađanjem sadrži 100 mg nevirapina (u bezvodnom obliku).
English: Viramune is also available as 200 mg tablets for older children, particularly adolescents, weighing more than 50 kg or having a body surface of more than 1.25 m2.
Croatian: Viramune je također dostupan u obliku 200 mg tableta za stariju djecu, osobito adolescente, koja imaju više od 50 kg težine ili imaju tjelesnu površinu veću od 1,25 m2. Liječnik Vašeg djeteta obavijestit će Vas o ispravnoj dozi za Vaše dijete.
English: No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3).
Croatian: Reproduktivna ispitivanja na gravidnim štakorima i kunićima nisu ukazala na teratogeni potencijal (vidi dio 5.3).
English: Severe rash occurred in 1.4 % and 0.2 % of the Viramune immediate-release and Viramune prolonged-release groups respectively during the randomised phase.
Croatian: Teški osip pojavio se kod 1,4 % u skupinama na Viramuneu s trenutnim oslobađanjem odnosno 0,2% u skupinama na Viramune s produljenim oslobađanjem, tijekom razdoblja randomizacije.
English: Viramune and emtricitabine may be coadministered without dose adjustments.
Croatian: Viramune i emtricitabin se mogu istodobno primjenjivati bez prilagodbe doze.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 400 mg of nevirapine (as anhydrous).
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta s produljenim oslobađanjem sadrži 400 mg nevirapina (u bezvodnom obliku).
English: Cases of overdose with Viramune immediaterelease at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Croatian: Prijavljeni su slučajevi predoziranja Viramuneom s trenutnim oslobađanjem pri dozama koje variraju od 800 do 6 000 mg na dan do 15 dana.
English: Rashes occur alone or in the context of drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Croatian: Osip se pojavljuje samostalno ili u sklopu reakcije na lijek uz eozinofiliju i sistemske simptome, poput, vrućice, artralgije, mijalgije i limpadenopatije, te visceralne bolesti, poput hepatitisa, eozinofilije, granulocitopenije i disfunkcije bubrega.
English: NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension nevirapine
Croatian: Viramune 50 mg/5 ml oralna suspenzija nevirapin
English: Breast-feeding Nevirapine readily crosses the placenta and is found in breast milk.
Croatian: Dojenje Nevirapin dobro prolazi posteljicu, a nađen je i u majčinom mlijeku.
English: The postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/ toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Croatian: Postmarketinško iskustvo ukazuje da su najozbiljnije nuspojave Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, teški hepatitis/zatajenje jetre i reakcija na lijek uz eozinofiliju i sistemskim simptomima poput vrućice, artralgije, mijalgije i limfadenopatije, uz visceralne poremećaje poput hepatitisa, eozinofilije, granulocitopenije i disfunkcije bubrega.