FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are allergic to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na tenofoviralafenamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: This may stop your medicines from working properly, or may make any side effects worse.
Croatian: To može onemogućiti pravilno djelovanje lijekova ili može pogoršati nuspojave.
English:  If this applies to you, do not take Vemlidy and tell your doctor immediately.
Croatian: Ako se ovo odnosi na Vas, nemojte uzimati Vemlidy i odmah obavijestite svog liječnika.
English: 90 (3 bottles of 30) film-coated tablets.
Croatian: 90 (3 boce po 30) filmom obloženih tableta.
English: Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Croatian: Tenofovir ima aktivnost koja je specifična za virus hepatitisa B i virus humane imunodeficijencije (HIV-1 i HIV-2).
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 30 filmom obloženih tableta te kutije koje sadrže 90 (3 boce po 30) filmom obloženih tableta.
English: Central laboratory ULN for ALT are as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males ≥ 69 years; ≤ 34 U/L for females 18 to < 69 years and ≤ 32 U/L for females ≥ 69 years.
Croatian: GGN središnjeg laboratorija za ALT iznosi: ≤ 43 U/l za muškarce u dobi od 18 do < 69 godina i ≤ 35 U/l za muškarce ≥ 69 godina; ≤ 34 U/l za žene 18 do < 69 godina ≤ 32 U/l za žene ≥ 69 godina.
English: If you feel dizzy when taking Vemlidy, do not drive and do not use any tools or machines.
Croatian: Ako osjećate omaglicu prilikom uzimanja lijeka Vemlidy, nemojte voziti ni koristiti alate ili strojeve.
English: What Vemlidy is and what it is used for What you need to know before you take Vemlidy How to take Vemlidy
Croatian: Što je Vemlidy i za što se koristi Što morate znati prije nego počnete uzimati Vemlidy Kako uzimati Vemlidy
English: • Talk to your doctor if you also have HIV.
Croatian: • Obavijestite liječnika i ako imate HIV.
English: A risk to the breast-fed newborns/infants cannot be excluded; therefore, Vemlidy should not be used during breast-feeding.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče, stoga se lijeka Vemlidy ne smije primjenjivati tijekom dojenja.
English: Vemlidy film-coated tablets should be taken with food.
Croatian: Filmom obložene tablete lijeka Vemlidy trebaju se uzimati s hranom.
English: Vemlidy may interact with other medicines.
Croatian: Vemlidy može stupiti u interakcije s drugim lijekovima.
English: Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Croatian: Odrasli i adolescenti (u dobi od 12 godina i stariji tjelesne težine od najmanje 35 kg): jedna tableta jedanput na dan.
English: Vemlidy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Croatian: Vemlidy je dostupan u bocama od 30 tableta (sa sredstvom za sušenje od silikagela koji mora biti u boci kako bi se zaštitile tablete).
English: The binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Croatian: Vezanje tenofoviralafenamida za ljudske proteine plazme u uzorcima prikupljenim tijekom kliničkih ispitivanja iznosilo je otprilike 80%.
English: It is not an inhibitor or inducer of CYP3A in vivo.
Croatian: Nije ni inhibitor ni induktor enzima CYP3A in vivo.
English: The binding of tenofovir to human plasma proteins is less than 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Croatian: Vezanje tenofovira za ljudske proteine plazme je manje od 0,7% i neovisno je o koncentracijama u rasponu od 0,01 do 25 µg/ml.
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Croatian: • Obavijestite liječnika ili ljekarnika ako ste imali bolest bubrega ili su testovi pokazali da imate probleme s bubrezima.
English: Non-clinical studies in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Croatian: Nekliničkim je ispitivanjima na štakorima i psima dokazano da su kosti i bubreg primarni ciljni organi toksičnosti.
English: Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Croatian: Tenofovir se učinkovito uklanja hemodijalizom uz koeficijent ekstrakcije od približno 54%.
English: After Week 96, patients either remained on their original blinded treatment or received open-label Vemlidy.
Croatian: Nakon 96. tjedna bolesnici su ili ostali na svom izvornom zaslijepljenom liječenju ili su otvoreno primali lijek Vemlidy.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vemlidy in one or more subsets of the paediatric population in the treatment of chronic hepatitis B (see sections 4.2 and 5.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Vemlidy u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog hepatitisa B (vidjeti dijelove 4.2 i 5.2 za informacije o pedijatrijskoj primjeni).
English: If you take more Vemlidy than you should
Croatian: Ako uzmete više lijeka Vemlidy nego što ste trebali
English: If you accidentally take more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Croatian: Ako ste nehotično uzeli više od preporučene doze lijeka Vemlidy, možete biti izloženi povećanom riziku od nuspojava povezanih s ovim lijekom (vidjeti dio 4, Moguće nuspojave).
English: Effects on drug levels.a,b Mean ratio (90% confidence interval) for AUC, Cmax, Cmin
Croatian: Učinci na razine lijeka.a,b Srednja vrijednost omjera (interval pouzdanosti od 90%) za AUC, Cmax, Cmin
English: What Vemlidy looks like and contents of the pack
Croatian: Kako Vemlidy izgleda i sadržaj pakiranja
English: -3.6% (95% CI = -9.8% to 2.6%)
Croatian: -3,6% (95% CI = -9,8% do 2,6%)
English: Differences in pharmacokinetics according to gender were not considered to be clinically relevant.
Croatian: Razlike u farmakokinetici prema spolu nisu smatrane klinički relevantnima.
English: Treatment outcomes of Study 108 and Study 110 through Week 48 are presented in Table 3 and Table 4.
Croatian: Ishodi liječenja Ispitivanja 108 i Ispitivanja 110 do 48. tjedna prikazani su u Tablici 3 i Tablici 4.
English: Do not give this medicine to children who are under 12 years old or weigh less than 35 kg.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 12 godina ili onoj tjelesne težine manje od 35 kg.
English: As a result, the amounts of Vemlidy or other medicines in your blood may change.
Croatian: Kao rezultat toga može doći do promjene količina lijeka Vemlidy ili drugih lijekova u krvi.
English: 1.8% (95% CI = -3.6% to 7.2%)
Croatian: 1,8% (95% CI = -3,6% do 7,2%)
English: • Wind (flatulence)
Croatian: • vjetrovi (flatulencija)
English: • Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness.
Croatian: • Obratite se liječniku prije prestanka uzimanja lijeka Vemlidy iz bilo kojeg razloga, a osobito ako imate nuspojave ili drugu bolest.
English: If you stop taking Vemlidy, you will need regular health checks and blood tests for several months to check your hepatitis B infection.
Croatian: Ako prestanete uzimati Vemlidy, nekoliko ćete mjeseci morati ići na redovite zdravstvene preglede i obavljati krvne pretrage kako bi se provjerilo stanje infekcije hepatitisom B.
English: Vemlidy does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination.
Croatian: Vemlidy ne smanjuje rizik od prijenosa hepatitisa B na druge osobe spolnim kontaktom ili kontaminacijom krvlju.
English: It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes.
Croatian: Nije poznato je li tenofoviralafenamid inhibitor drugih enzima UGT.
English: Patients must be advised that Vemlidy does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Croatian: Bolesnike se mora upozoriti da Vemlidy ne sprječava rizik od prijenosa HBV-a na druge osobe spolnim kontaktom ili kontaminacijom krvlju.
English: Treatment discontinuation Treatment discontinuation may be considered as follows (see section 4.4):
Croatian: Prekid liječenja Prekid liječenja može se razmatrati u sljedećim slučajevima (vidjeti dio 4.4):
English: • Talk to your doctor before you restart taking Vemlidy tablets.
Croatian: • Razgovarajte s liječnikom prije nego što ponovno počnete uzimati tablete lijeka Vemlidy.
English: The mechanism of tumour formation in mice and potential relevance for humans is uncertain.
Croatian: Mehanizam formiranja tumora u miševa i potencijalna važnost tog mehanizma za ljude nisu poznati.
English: In patients with hepatitis B, Vemlidy controls the infection by stopping the virus from multiplying.
Croatian: U bolesnika s hepatitisom B, Vemlidy kontrolira infekciju zaustavljajući umnožavanje virusa.
English: EU/1/16/1154/001 30 film-coated tablets EU/1/16/1154/002 90 (3 bottles of 30) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1154/001 30 filmom obloženih tableta EU/1/16/1154/002 90 (3 boce po 30) filmom obloženih tableta
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
Croatian: Spontane egzacerbacije kroničnog hepatitisa B relativno su česte, a karakteriziraju ih prolazna povećanja vrijednosti alanin aminotransferaze (ALT) u serumu.
English: Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors; ATC code: J05AF13.
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu, nukleozidni i nukleotidni inhibitori reverzne transkriptaze, ATK oznaka: J05AF13.
English: Increased ALT
Croatian: Povećani ALT
English: Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus.
Croatian: Hepatitis B je infekcija koja zahvaća jetru, a uzrokuje je virus hepatitisa B.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Croatian: Terapiju treba započeti liječnik s iskustvom u liječenju kroničnog hepatitisa B.
English: There is insufficient information on the effects of tenofovir in newborns/infants.
Croatian: Nema dovoljno podataka o učincima tenofovira na novorođenčad/dojenčad.
English: Animal studies do not indicate harmful effects of tenofovir alafenamide on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke tenofoviralafenamida na plodnost.
English: HIV ANTIRETROVIRAL AGENTS - CCR5 RECEPTOR ANTAGONIST Maraviroc
Croatian: ANTIRETROVIRNUSNI LIJEKOVI ZA LIJEČENJE HIV-A -ANTAGONISTI CCR5 RECEPTORA Maravirok
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Croatian: Sredstvo za sušenje od silikagela nalazi se u zasebnoj vrećici ili spremniku i ne smije se progutati.
English: Tenofovir alafenamide exposures are dose proportional over the dose range of 8 to 125 mg.
Croatian: Izloženost tenofoviralafenamidu proporcionalna je dozi u rasponu doza od 8 do 125 mg.
English: A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Croatian: Dugoročna ispitivanja kancerogenosti nakon peroralne primjene u miševa pokazala su nisku incidenciju duodenalnih tumora, za koje se smatra da su vjerojatno povezani s visokim lokalnim koncentracijama u probavnom sustavu pri korištenju visokih doza od 600 mg/kg/dan.
English: The mean age was 38 years, 64% were male, 82% were Asian, 17% were White and < 1% (5 subjects) were Black.
Croatian: Prosječna dob bila je 38 godina; 64% ispitanika bili su muškarci, 82% Azijati, 17% bijelci, a < 1% (5 ispitanika) crnci.
English: Nucleoside naïvec Nucleoside experienced No Virologic data at Week 48
Croatian: Prethodno liječeni nukleozidom Bez viroloških podataka u 48. tjednu
English: After initiating antiviral therapy, serum ALT may increase in some patients.
Croatian: Nakon početka antivirusne terapije vrijednost ALT-a u serumu u nekih se bolesnika može povećati.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Croatian: Potencijalni rizik nefrotoksičnosti kao posljedice kronične izloženosti niskim razinama tenofovira zbog doziranja tenofoviralafenamida ne može se isključiti (vidjeti dio 5.3).
English: The drug interactions described are based on studies conducted with tenofovir alafenamide, or are potential drug interactions that may occur with Vemlidy.
Croatian: Opisane interakcije lijekova utemeljene su na ispitivanjima provedenima s tenofoviralafenamidom ili se odnose na potencijalne interakcije lijekova do kojih može doći pri korištenju lijeka Vemlidy.
English: Each bottle contains silica gel desiccant and polyester coil.
Croatian: Svaka boca sadrži sredstvo za sušenje od silikagela i poliestersku vaticu.
English: Vemlidy met the non-inferiority criteria in achieving HBV DNA less than 29 IU/mL when compared to tenofovir disoproxil fumarate.
Croatian: Vemlidy je ispunio kriterije neinferiornosti u postizanju vrijednosti HBV DNK manje od 29 IU/ml u odnosu na tenofovirdizoproksilfumarat.
English: What you need to know before you take Vemlidy Do not take Vemlidy
Croatian: Što morate znati prije nego počnete uzimati Vemlidy Nemojte uzimati Vemlidy
English: ALT Normalised ALT (Central lab)b
Croatian: Normalizirani ALT (središnji laboratorij)b
English: The primary efficacy endpoint in both studies was the proportion of patients with plasma HBV DNA levels below 29 IU/mL at Week 48.
Croatian: Primarna mjera ishoda djelotvornosti u oba je ispitivanja bio udio bolesnika s razinama HBV DNK u plazmi manjima od 29 IU/ml u 48. tjednu.
English: Before starting treatment and during treatment, your doctor may order blood tests to monitor how your kidneys work.
Croatian: Prije početka ili tijekom liječenja liječnik će možda zatražiti krvne pretrage da bi pratio rad bubrega.
English: If you forget to take Vemlidy
Croatian: Ako ste zaboravili uzeti Vemlidy
English: Regular reassessment is recommended after treatment discontinuation to detect virological relapse.
Croatian: Nakon prekida liječenja preporučuju se redoviti pregledi radi otkrivanja virološkog recidiva.
English: The EC50 (50% effective concentration) values for tenofovir alafenamide ranged from 34.7 to 134.4 nM, with an overall mean EC50 of 86.6 nM.
Croatian: Vrijednosti EC50 (50% učinkovite koncentracije) za tenofoviralafenamid kretale su se od 34,7 do 134,4 nM, a ukupna srednja vrijednost
English: In some patients with advanced liver disease or cirrhosis, this could be life-threatening.
Croatian: U nekih bolesnika s uznapredovalom bolešću jetre ili cirozom to može biti opasno po život.
English: It is important not to miss a dose of Vemlidy.
Croatian: Važno je da ne propustite uzeti dozu lijeka Vemlidy.
English: Talk to your doctor if you are taking:
Croatian: Druge vrste lijekova Obavijestite liječnika ako uzimate:
English: Effect of tenofovir alafenamide on other medicinal products
Croatian: Učinak tenofoviralafenamida na druge lijekove
English: You must continue to take precautions to avoid this.
Croatian: Da biste to spriječili, morate nastaviti poduzimati mjere opreza.
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4).
Croatian: • U bolesnika pozitivnih na HBeAg koji nemaju cirozu liječenje se treba primjenjivati najmanje 6 - 12 mjeseci nakon potvrde HBe serokonverzije (gubitak HBeAg i gubitak HBV DNK s detekcijom anti-HBe) ili do HBs serokonverzije ili do gubitka djelotvornosti (vidjeti dio 4.4).
English: If you are not sure whether you have HIV, your doctor should offer you HIV testing before you start taking Vemlidy for hepatitis B.
Croatian: Ako niste sigurni imate li HIV, liječnik će Vam prije početka uzimanja lijeka Vemlidy radi liječenja hepatitisa B ponuditi testiranje na HIV.
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Croatian: Tenofoviralafenamid nije inhibitor humane uridin-difosfat-glukuronoziltransferaze (UGT) 1A1 in vitro.
English: How to store Vemlidy
Croatian: Kako čuvati Vemlidy
English: The use of Vemlidy once daily in patients with CrCl ≥ 15 mL/min but < 30 mL/min and in patients with CrCl < 15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data and on modelling and simulation.
Croatian: Upotreba lijeka Vemlidy jedanput na dan u bolesnika s CrCl ≥ 15 ml/min, ali < 30 ml/min te u bolesnika s CrCl < 15 ml/min koji su na hemodijalizi utemeljena je na vrlo ograničenim farmakokinetičkim podacima te modeliranju i simulaciji.
English: There are no data on the safety and efficacy of Vemlidy in HBV infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
Croatian: Nema podataka o sigurnosti i djelotvornosti lijeka Vemlidy u bolesnika zaraženih HBV-om koji imaju dekompenziranu bolest jetre i rezultat po klasifikaciji Child-Pugh-Turcotte (CPT) > 9 (tj. stadij C).
English: Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
Croatian: U bolesnika s bolešću jetre koji hepatitis B liječe pomoću lijekova za liječenje virusnih infekcija postoji veći rizik od teških i potencijalno smrtonosnih komplikacija bolesti jetre.
English: However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Croatian: No tenofovirdizoproksilfumarat smanjio je stopu preživljenja i težinu mladunčadi u perinatalnim i postnatalnim ispitivanjima toksičnosti pri dozama toksičnim za majku.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Croatian: U slučaju predoziranja bolesnik se mora nadzirati zbog moguće pojave toksičnosti (vidjeti dio 4.8).
English: The safety and efficacy of Vemlidy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Vemlidy u djece mlađe od 12 godina ili tjelesne težine < 35 kg nisu još ustanovljene.
English: In patients who are co-infected with HBV and HIV, Vemlidy should be co-administered with other antiretroviral agents to ensure that the patient receives an appropriate regimen for treatment of HIV (see section 4.5).
Croatian: U bolesnika s istodobnom infekcijom HBV-om i HIV-om Vemlidy treba davati istodobno s ostalim antiretrovirusnim lijekovima kako bi se osiguralo da bolesnik dobiva odgovarajući režim liječenja HIV-a (vidjeti dio 4.5).
English: In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
Croatian: 48. tjednu (N = 20) i 96. tjednu (N = 72) u tim izolatima nisu identificirane supstitucije aminokiselina povezane s otpornošću na Vemlidy (genotipske i fenotipske analize).
English: Co-administration guidance for the treatment of hepatitis C should be followed (see section 4.5).
Croatian: Potrebno je slijediti smjernice za istodobnu primjenu za liječenje hepatitisa C (vidjeti dio 4.5).
English: The adverse reactions are listed below by body system organ class and frequency based on the Week 96 analysis.
Croatian: Nuspojave su navedene u nastavku prema klasifikaciji organskih sustava i učestalosti nuspojava na temelju analize u 96. tjednu.
English: • Periodic Safety Update reports
Croatian: • Periodička izvješća o neškodljivosti
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Croatian: Metabolizam je glavni put eliminacije tenofoviralafenamida u ljudi, kojim se eliminira > 80% oralne doze.
English: Vemlidy can cause dizziness.
Croatian: Vemlidy može uzrokovati omaglicu.
English: No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Croatian: Nisu utvrđene nikakve klinički relevantne razlike u farmakokinetici prema dobi ili etničkoj pripadnosti.
English: • Take steps to avoid getting pregnant during treatment with Vemlidy.
Croatian: • Poduzmite mjere za sprječavanje trudnoće tijekom liječenja lijekom Vemlidy.
English: Patients should be informed that dizziness has been reported during treatment with Vemlidy.
Croatian: Bolesnike treba informirati da je tijekom liječenja lijekom Vemlidy prijavljena omaglica.
English: Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Croatian: Proljev, povraćanje, mučnina, bol u abdomenu, distenzija abdomena, flatulencija
English: In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Croatian: U bolesnika s teškim oštećenjem funkcije jetre ukupne koncentracije tenofoviralafenamida i tenofovira u plazmi su niže od onih uočenih u osoba s normalnom funkcijom jetre.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Croatian: Medijan poluvijeka tenofoviralafenamida i tenofovira u plazmi iznosi 0,51 odnosno 32,37 sata.
English: It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Croatian: Preporučuje se ne dojiti kako bi se spriječio prijenos tenofoviralafenamida ili tenofovira na dijete putem majčina mlijeka.
English: Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Croatian: Filmom obložene tablete lijeka Vemlidy su žute boje i okrugle, s utisnutim (ili označene sa) „GSI” na jednoj strani i „25” na drugoj strani tablete.
English: No human data on the effect of Vemlidy on fertility are available.
Croatian: Nema dostupnih podataka o učinku lijeka Vemlidy na plodnost u ljudi.
English: However, in animal studies it has been shown that tenofovir is secreted into milk.
Croatian: No tijekom ispitivanja na životinjama pokazalo se da se tenofovir izlučuje u mlijeko životinja.
English: b Adjusted by baseline plasma HBV DNA categories and oral antiviral treatment status strata.
Croatian: b. Prilagođeno prema kategorijama početne vrijednosti HBV DNK u plazmi i statusu liječenja oralnim antivirusnim lijekovima.
English: • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
Croatian: • U bolesnika negativnih na HBeAg koji nemaju cirozu liječenje se treba primjenjivati najmanje do HBs serokonverzije ili do pojave dokaza o gubitku djelotvornosti.
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Croatian: Tenofoviralafenamid nije inhibitor enzima CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6 in vitro.