FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with lamivudine-resistant chronic hepatitis B: No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US-174-0121) in which 280 lamivudine-resistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
Croatian: Bolesnici s kroničnim hepatitisom B rezistentnim na lamivudin: Nove nuspojave na tenofovirdizoproksil nisu zabilježene u randomiziranom, dvostruko slijepom ispitivanju (GS-US-174-0121) u kojem je 280 bolesnika rezistentnih na lamivudin 240 tjedana primalo liječenje tenofovirdizoproksilom (n = 141) odnosno liječenje emtricitabinom/tenofovirdizoproksilom (n = 139).
English: Each tablet contains 164 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 164 mg laktoze (u obliku hidrata).
English: • Not for HIV-1 infected children under 12 years of age
Croatian: • nisu za djecu zaraženu virusom HIV-1 mlađu od 12 godina • nisu za djecu zaraženu virusom HBV-a mlađu od 12 godina.
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Croatian: Jedan ispitanik liječen tenofovirdizoproksilom imao je značajno (> 4%) smanjenje BMD-a lumbalne kralježnice u 48. tjednu,
English: Cmin: N/A Velpatasvir: AUC: ↔
Croatian: Efavirenz: AUC: ↔
English: Viread 123 mg tablets are for use in children.
Croatian: Viread 123 mg tablete namijenjene su primjeni u djece.
English: - Viread should not be administered concomitantly with adefovir dipivoxil.
Croatian: - Viread se ne smije primjenjivati istovremeno s adefovirdipivoksilom.
English: In a paediatric study (GS-US-174-0144), genotypic data from paired baseline and on treatment HBV isolates from patients who received tenofovir disoproxil were available for 9 of 10 patients who had plasma HBV DNA > 400 copies/ml.
Croatian: U pedijatrijskom ispitivanju (GS-US-174-0144), podaci o genotipu iz uparenih izolata HBV-a s početka ispitivanja i tijekom liječenja tenofovirdisoproksilom bili su dostupni za 9 od 10 bolesnika s razinom HBV DNK > 400 kopija/ml u 48. tjednu.
English: Table 8: Safety and efficacy parameters in decompensated patients at week 48
Croatian: Tablica 8: Parametri sigurnosti i djelotvornosti u dekompenziranih bolesnika u 48. tjednu
English: If you throw up less than 1 hour after taking Viread, take another dose.
Croatian: Ako ste povraćali u razmaku manjem od 1 sata nakon što ste uzeli Viread, uzmite drugu dozu.
English: How to store Viread
Croatian: Kako čuvati Viread
English: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Croatian: Tablica 8: Procjena mineralne gustoće kostiju na početku ispitivanja, u 72. i 192. tjednu
English: Twenty-five percent (14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.
Croatian: dvadeset pet posto (14 od 56) bolesnika u skupini koja je primala tenofovirdizoproksil i 24% (7 od 29) bolesnika u skupini koja je primala placebo došlo je do HBeAg serokonverzije u 48. tjednu.
English: Viread should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Croatian: Viread se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže tenofovirdizoproksil ili tenofoviralafenamid.
English: You do not need to take another dose if you were sick more than 1 hour after taking Viread.
Croatian: Drugu dozu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sata po uzimanju
English: Musculoskeletal and connective tissue disorders: Uncommon:
Croatian: Poremećaji mišićno-koštanog i vezivnog tkiva:
English: Patients receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Croatian: sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir istovremeno s tenofovirdizoproksilom i pojačanim inhibitorom HIV proteaze potrebno je pratiti nuspojave vezane uz tenofovirdizoproksil.
English: Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in adults or adolescents for whom a solid dosage form is not appropriate.
Croatian: Viread je također dostupan u obliku granula od 33 mg/g za liječenje infekcije virusom HIV-1 i kroničnog hepatitisa B u odraslih u kojih primjena doza u krutom obliku nije prikladna.
English: Each tablet contains 137 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 137 mg laktoze (u obliku hidrata).
English: Table 9: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Croatian: Tablica 9: Procjena mineralne gustoće kostiju na početku ispitivanja, u 72. i 192. tjednu
English: Viread 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Croatian: Viread 245 mg filmom obložene tablete također su indicirane za liječenje adolescenata s infekcijom virusom HIV-1 koji su u dobi od 12 do < 18 godina i imaju rezistenciju na nukleozidne inhibitore reverzne transkriptaze (NRTI) ili toksičnost koja onemogućuje primjenu lijekova prve linije liječenja.
English: Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years who weigh < 17 kg or who are unable to swallow film-coated tablets.
Croatian: Viread je također dostupan u obliku 33 mg/g granula za liječenje pedijatrijskih bolesnika u dobi od 2 do < 12 godina s infekcijom virusom HIV-1 i kroničnim hepatitisom B, tjelesne težine < 17 kg ili koji nisu u stanju progutati filmom obložene tablete.
English: - The other ingredients are ethylcellulose (E462), hydroxypropyl cellulose (E463), mannitol
Croatian: Drugi sastojci su etilceluloza (E462), hidroksipropilceluloza (E463), manitol (E421) i silicijev dioksid (E551).
English: If you have any further questions on the use of this medicine, ask your child's doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku Vašeg djeteta ili ljekarniku.
English: If your child has advanced HIV infection (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started.
Croatian: (AIDS) i ima neku infekciju, u Vašeg se djeteta mogu nakon započinjanja liječenja Vireadom razviti simptomi infekcije i upale ili pogoršanje simptoma postojeće infekcije.
English: If no alternative treatment is available, the dosing interval must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Croatian: interval doziranja mora se prilagoditi, a funkcija bubrega detaljno pratiti (vidjeti dijelove 4.2 i 5.2).
English: Tell your child's doctor before giving Viread.
Croatian: Obavijestite liječnika Vašeg djeteta prije nego što Vaše dijete počne uzimati Viread.
English: The rate of hepatocellular carcinoma was 18% (8/45) in the tenofovir disoproxil group, 7% (3/45) in the emtricitabine plus tenofovir disoproxil group and 9% (2/22) in the entecavir group.
Croatian: Stopa hepatocelularnog karcinoma iznosila je 18% (8/45) u skupini liječenoj tenofovirdizoproksilom, 7%
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Croatian: Nakon 72 tjedna, održana je virološka supresija u bolesnika koji su primali dvostruko slijepo tenofovirdizoproksil nakon čega je slijedilo otvoreno liječenje tenofovirdizoproksilom (skupina tenofovirdizoproksil-tenofovirdizoproksil): 86,5% (45/52) bolesnika u skupini tenofovirdizoproksil-tenofovirdizoproksil imalo je HBV DNK < 400 kopija/ml u 192. tjednu.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 10:
Croatian: Podaci o mineralnoj gustoći kostiju (BMD) iz ispitivanja GS-US-174-0144 sažeto su navedeni u
English: ½ line
Croatian: oznaka za ½
English: The decision to treat paediatric patients (adolescents and children) should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Croatian: Odluka o liječenju pedijatrijskih bolesnika (adolescenata i djece) treba se temeljiti na pažljivom razmatranju potreba pojedinog bolesnika te se trebaju uzeti u obzir trenutne smjernice za liječenje pedijatrijskih bolesnika, uključujući početnu vrijednost histoloških značajki.
English: • Not for children who weigh under 28 kg or 35 kg and over.
Croatian: • nisu za djecu tjelesne težine manje od 28 kg ili 35 kg ili više.
English: Adefovir dipivoxil 10 mg n = 90
Croatian: Adefovirdipivo ksil 10 mg n = 90
English: • pain in the tummy (abdomen) caused by inflammation of the pancreas
Croatian: • bol u trbuhu (abdomenu) uzrokovana upalom gušterače.
English: If you accidentally take too much Viread, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Croatian: Ako slučajno uzmete previše Vireada, možete imati povećani rizik od mogućih nuspojava ovog lijeka (pogledajte dio 4, Moguće nuspojave).
English: NAME OF THE MEDICINAL PRODUCT Viread 33 mg/g granules
Croatian: Viread 33 mg/g granule
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Croatian: Tablica 3: Tablični prikaz nuspojava povezanih s tenofovirdizoproksilom na temelju kliničkih ispitivanja i iskustva nakon stavljanja u promet
English: • HBV paediatric educational brochure
Croatian: • Edukacijsku brošuru za pedijatrijske bolesnike s HBV-om.
English: Viread is also available as 123 mg, 163 mg, 204 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh ≥ 17 and < 35 kg for whom a solid dosage form is appropriate.
Croatian: Viread je također dostupan u obliku filmom obloženih tableta od 123 mg, 163 mg i 204 mg za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B u dobi od 6 do < 12 godina i tjelesne težine ≥ 17 i < 35 kg u kojih je primjena doza u krutom obliku prikladna.
English: Method of administration Viread 204 mg film-coated tablets should be taken once daily, orally with food.
Croatian: Viread 204 mg filmom obložene tablete potrebno je uzimati peroralno s hranom, jedanput na dan.
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients For patients with creatinine clearance 20-29 ml/min: Administration of 65 mg (2 scoops) tenofovir disoproxil 33 mg/g granules once daily is recommended.
Croatian: Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min) i bolesnici na hemodijalizi Za bolesnike s klirensom kreatinina 20-29 ml/min: preporučuje se primjena 65 mg (2 mjerne žličice)
English: • who weigh from 17 kg to less than 22 kg
Croatian: • čija je tjelesna težina od 17 kg do manje od 22 kg
English: Patients with decompensated liver disease: The safety profile of tenofovir disoproxil in patients with decompensated liver disease was assessed in a double-blind active controlled study
Croatian: Bolesnici s dekompenziranom bolešću jetre: Sigurnosni profil tenofovirdizoproksila u bolesnika s dekompenziranom bolešću jetre procijenjen je u dvostruko slijepom kontroliranom ispitivanju s aktivnom kontrolom (GS-US-174-0108) u kojem su odrasli bolesnici liječeni tenofovirdizoproksilom
English: Tenofovir is converted intracellularly to tenofovir monophosphate and to the active component, tenofovir diphosphate.
Croatian: Tenofovir se unutar stanica pretvara u tenofovirfosfat i u djelatni sastojak tenofovirdifosfat.
English: For patients with creatinine clearance 10-19 ml/min: Administration of 33 mg (1 scoop) tenofovir disoproxil 33 mg/g granules once daily is recommended.
Croatian: Za bolesnike s klirensom kreatinina 10-19 ml/min: preporučuje se primjena 33 mg (1 mjerna žličica)
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Croatian: Druge interakcije Interakcije između tenofovirdizoproksila i drugih lijekova navedene su u Tablici 1 ispod (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”, dvaput na dan kao „b.i.d.” i jedanput na dan kao „q.d.”).
English: Ethylcellulose (E462)
Croatian: celuloza, mikrokristalična (E460)
English: PHARMACEUTICAL FORM AND CONTENTS 60 g granules.
Croatian: 60 g granula.
English: Clinical studies in treatment-experienced patients have assessed the anti-HIV activity of tenofovir disoproxil 245 mg against strains of HIV-1 with resistance to nucleoside inhibitors.
Croatian: djelovanje 245 mg tenofovirdizoproksila protiv sojeva virusa HIV-1 s rezistencijom na nukleozidne inhibitore.
English: Tenofovir and tenofovir disoproxil are not metabolised by liver enzymes.
Croatian: Jetreni enzimi ne metaboliziraju tenofovir i tenofovirdizoproksil.
English: • who weigh from 28 kg to less than 35 kg
Croatian: • čija je tjelesna težina od 28 kg do manje od 35 kg
English: One level scoop delivers 1 g of granules which contains 33 mg of tenofovir disoproxil.
Croatian: Jedna ravno napunjena žličica sadrži 1 g granula, koji sadrži 33 mg tenofovirdizoproksila.
English: • Not for children who weigh under 17 kg or 22 kg and over.
Croatian: • nisu za djecu tjelesne težine manje od 17 kg ili 22 kg ili više.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common: rash Rare:
Croatian: Poremećaji kože i potkožnog tkiva: Vrlo često:
English: Each tablet contains 109 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 109 mg laktoze (u obliku hidrata).
English: Method of administration Viread 123 mg film-coated tablets should be taken once daily, orally with food.
Croatian: Viread 123 mg filmom obložene tablete potrebno je uzimati peroralno s hranom, jedanput na dan.
English: Whole body BMD at least 4% decrease
Croatian: Smanjenjeb BMD-a cijelog tijela za najmanje 4%
English: There is insufficient information on the effects of tenofovir in newborns/infants.
Croatian: Nema dovoljno podataka o učinku tenofovira na novorođenčad/dojenčad, stoga se Viread ne bi trebao primjenjivati tijekom dojenja.
English: Use with the supplied dosing scoop.
Croatian: Primijeniti pomoću priložene mjerne žličice.
English: Viread 163 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Croatian: Viread 163 mg tablete su lijek za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: Method of administration Viread 163 mg film-coated tablets should be taken once daily, orally with food.
Croatian: Viread 163 mg filmom obložene tablete potrebno je uzimati peroralno s hranom, jedanput na dan.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: primjena kortikosteroida, konzumiranje alkohola, teška imunosupresija, viši indeks tjelesne mase.
English: Viread should not be administered concomitantly with adefovir dipivoxil.
Croatian: Viread se ne smije istovremeno primjenjivati s adefovirdipivoksilom.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: sofosbuvirom/velpatasvirom ili sofosbuvirom/velpatasvirom/voksilaprevirom povećava koncentraciju tenofovira u plazmi, posebno prilikom istovremene primjene s režimom liječenja HIV-a koji sadrži tenofovirdizoproksil i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.
Croatian: Viread 33 mg/g granule su indicirane u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 u dobi od 2 do < 6 godina i starijih od 6 godina koji imaju rezistenciju na nukleozidne inhibitore reverzne transkriptaze (NRTI) ili toksičnost koja onemogućuje primjenu lijekova prve linije liječenja i u kojih primjena doza u krutom obliku nije prikladna.
English: No data are available to make dose recommendations (see sections 4.2 and 4.4).
Croatian: Budući da nema dostupnih podataka, nije moguće dati preporuku o doziranju (vidjeti dijelove 4.2 i
English: If Viread is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Croatian: Ako se prekine liječenje Vireadom u bolesnika s kroničnim hepatitisom B i s istovremenom infekcijom virusom HIV-a ili bez nje, te je bolesnike potrebno pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: Results through 48 weeks from two randomised, phase 3 double-blind studies comparing tenofovir disoproxil to adefovir dipivoxil in adult patients with compensated liver disease are presented in Table 3 below.
Croatian: Rezultati dobiveni tijekom 48 tjedana iz dva randomizirana, dvostruko slijepa ispitivanja faze III u kojima se uspoređivao tenofovirdizoproksil s adefovirdipivoksilom u odraslih bolesnika s kompenziranom bolešću jetre prikazani su u tablici 3. Ispitivanje GS-US-174-0103 provodilo se na
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/mL rose sharply after they began treatment with open-label tenofovir disoproxil (PLB-tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Croatian: Kod bolesnika koji su primali placebo tijekom dvostruko slijepog perioda, udio bolesnika s HBV DNK < 400 kopija/ml naglo je porastao nakon što su počeli liječenje s otvorenim tenofovirdizoproksilom (skupina PLB-tenofovirdizoproksil): 74,1% (40/54) bolesnika u skupini PLB-tenofovirdizoproksil imalo je HBV DNK < 400 kopija/ml u 192. tjednu.
English: Frequency Tenofovir disoproxil Metabolism and nutrition disorders:
Croatian: Poremećaji metabolizma i prehrane:
English: You do not need to take another tablet if you were sick more than 1 hour after taking Viread.
Croatian: Drugu tabletu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sata po uzimanju
English: • who weigh from 22 kg to less than 28 kg
Croatian: • čija je tjelesna težina od 22 kg do manje od 28 kg
English: Lumbar spine mean (SD) BMD Z-scorea Lumbar spine mean (SD) change from baseline BMD Z-score a
Croatian: Srednja vrijednost (SD) BMD Z-rezultataa lumbalne kralježnice Srednja vrijednost promjene (SD) BMD Z-rezultataa lumbalne kralježnice u odnosu na početak
English: Serology (%) HBeAg loss/seroconversion n/a n/a
Croatian: Serologija (%) HBeAg nestanak/ serokonverzija
English: Viread 245 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Croatian: Viread 245 mg tablete su lijek za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: Viread 163 mg tablets are only suitable for:
Croatian: Viread 163 mg tablete pogodne su samo za:
English: Table 10: Bone Mineral Density Evaluation at Baseline and Week 48
Croatian: Tablica 10: Ocjena mineralne gustoće kostiju na početku ispitivanja i u 48. tjednu
English: The proportion of subjects with ALT normalization at week 192 in the tenofovir disoproxil-tenofovir disoproxil group was 75.8% (25/33) among those who were HBeAg positive at baseline and 100.0% (2 of 2 subjects) among those who were HBeAg negative at baseline.
Croatian: U skupini tenofovirdizoproksil-tenofovirdizoproksil udio bolesnika s normaliziranom razinom ALT-a u 192. tjednu bio je 75,8% (25/33) kod onih koji su na početku bili HBeAg pozitivni, te 100,0% (2 od
English: Viread 245 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Croatian: Viread 245 mg tablete također se primjenjuju za liječenje kroničnog hepatitisa B, infekcije virusom hepatitisa B (HBV).
English: If you throw up less than 1 hour after taking Viread, take another tablet.
Croatian: Ako ste povraćali u razmaku manjem od 1 sata nakon što ste uzeli Viread, uzmite drugu tabletu.
English: Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/mL (69 IU/ml) at Week 48.
Croatian: Odgovor na liječenje tenofovirdizoproksilom bio je usporediv u prethodno neliječenih i prethodno liječenih ispitanika sa 76% (38/50) prethodno neliječnih i 80% (8/10) prethodno liječenih ispitanika koji su postigli HBV DNK < 400 kopija/ml (< 69 IU/ml) u 48. tjednu.
English: • Not for children who weigh under 22 kg or 28 kg and over.
Croatian: • nisu za djecu tjelesne težine manje od 22 kg ili 28 kg ili više.
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Croatian: e 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega je slijedilo 96 tjedana otvorenog ispitivanja.
English: NAME OF THE MEDICINAL PRODUCT Viread 33 mg/g granules Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacija za bolesnika Viread 33 mg/g granule tenofovirdizoproksil
English: Viread 163 mg film-coated tablets are white, round-shaped, film-coated tablets, 10.7 mm in diameter, debossed on one side with “GSI” and on the other side with “200”.
Croatian: Viread 163 mg filmom obložene tablete bijele su, okrugle, filmom obložene tablete, promjera 10,7 mm, s utisnutom oznakom „GSI” na jednoj strani te „200” na drugoj strani.
English: Viread 245 mg tablets are not suitable for the following groups:
Croatian: Viread 245 mg tablete nisu pogodne za sljedeće skupine:
English: Viread 163 mg tablets are not suitable for the following groups:
Croatian: Viread 163 mg tablete nisu pogodne za sljedeće skupine:
English: PLBtenofovir disoproxil
Croatian: PLB-tenofov irdizoproksil
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Starch pregelatinised
Croatian: Jezgra tablete karmelozanatrij, umrežena laktoza hidrat magnezijev stearat (E572)
English: The pharmacokinetics of tenofovir in non-haemodialysis adult patients with creatinine clearance < 10 ml/min and in patients with ESRD managed by peritoneal or other forms of dialysis have not been studied.
Croatian: Farmakokinetika tenofovira nije ispitana u odraslih bolesnika s klirensom kreatinina < 10 ml/min koji nisu na hemodijalizi te u bolesnika s bolešću bubrega u završnoj fazi koji se liječe peritonealnom dijalizom ili drugim oblicima dijalize.