FrancophonIA/ELRC3.0 huggingface dataset:
English: 1,000 patients) but serious side effect that can be fatal.
Slovenian: 1.000 bolnikov), a resen neželeni učinek, ki je lahko usoden.
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Slovenian: • priporočeni režim spremljanja delovanja ledvic, upoštevajoč prisotnost ali odsotnost dodatnih dejavnikov tveganja za ledvično okvaro;
English: If Viread has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Slovenian: Če je bilo zdravilo Viread predpisano za vašega otroka, veljajo vsi podatki v tem navodilu za uporabo za vašega otroka (v tem primeru berite “vaš otrok” namesto “vi”).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 February 2002
Slovenian: Datum prve odobritve: 5. februar 2002 Datum zadnjega podaljšanja: 14. december 2011
English: • Fill the dosing scoop to the top.
Slovenian: • Merico za odmerjanje napolnite do vrha.
English: The HIV and HBV paediatric educational brochures should contain the following key messages:
Slovenian: Izobraževalni brošuri o pediatričnih bolnikih s HIV in HBV morata vsebovati naslednja ključna sporočila:
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1, 2, myopathy1
Slovenian: osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom)1, 2, miopatija1
English: Although there are limited clinical data on the use of Viread in pregnant women, it is not usually used unless absolutely necessary.
Slovenian: Čeprav so na voljo nezadostni klinični podatki o uporabi zdravila Viread pri nosečnicah, se zdravila Viread ponavadi ne uporablja, razen če je nujno potrebno.
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Slovenian: Dizoproksiltenofovirat se mora jemati s hrano, kajti hrana poviša biološko razpoložljivost tenofovirja (glejte poglavje 5.2).
English: Please refer to the Summaries of Product Characteristics for these medicinal products.
Slovenian: Glejte povzetke glavnih značilnosti za ta zdravila.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Viread in paediatric patients are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdraviloViread pri pediatričnih bolnikih, prejeli paket izobraževalnih gradiv za zdravnika, ki bo vseboval Povzetek glavnih značilnosti zdravila in primerne izobraževalne brošure, kot je navedeno v nadaljevanju:
English: • Measure out the correct number of level scoops of granules into a container.
Slovenian: • Izmerite pravilno število poravnanih meric zrnc in jih dajte v vsebnik.
English: • The importance of regular monitoring of renal function during Viread therapy
Slovenian: • pomembnost rednega spremljanja delovanja ledvic med zdravljenjem z zdravilom Viread;
English: Other medicines and Viread
Slovenian: Druga zdravila in zdravilo Viread
English: * Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis.
Slovenian: * Na splošno velja: 1 odmerek enkrat tedensko pri predpostavljenih treh hemodializah na teden, vsaka po približno 4 ure ali skupno 12 ur.
English: ½ line
Slovenian: ½ črta
English: PHARMACEUTICAL FORM AND CONTENTS 60 g granules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 g zrnc
English: • You must take the granules mixed with food immediately.
Slovenian: • Zrnca, premešana s hrano, morate takoj zaužiti.
English: One gram of granules contains 622 mg mannitol.
Slovenian: En gram zrnc vsebuje 622 mg manitola.
English: What Viread is and what it is used for
Slovenian: Kaj je zdravilo Viread in za kaj ga uporabljamo
English: Mannitol may have a mild laxative effect.
Slovenian: Manitol ima lahko blag odvajalni učinek.
English: Your child's doctor will determine the right dose of Viread granules based on your child's weight.
Slovenian: Otrokov zdravnik bo določil pravilni odmerek zdravila Viread zrnca na podlagi telesne mase vašega otroka.
English: Pharmacokinetic studies have not been performed in children under 2 years.
Slovenian: Farmakokinetične študije niso bile izvedene pri otrocih, mlajših kot 2 leti.
English: Complete response (%)
Slovenian: Popolni odziv (%)a
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Slovenian: 3 Študijo so izvedli z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, ki se pričakuje pri bolnikih z okužbo s HCV.
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij; nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC: J05AF07
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake {Uporabno do}.
English: Simulations suggest that the prolonged dose interval using Viread 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Slovenian: Simulacije nakazujejo, da podaljšani odmerni interval z zdravilom Viread 245 mg filmsko obložene tablete ni optimalen in lahko vodi v povečano toksičnost in možnost nezadostnega odziva.
English: The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing scoop.
Slovenian: Zrnca so na voljo v plastenkah, ki vsebujejo 60 g zrnc, in so pakirana z merico za odmerjanje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Viread in one or more subsets of the paediatric population in HIV and chronic hepatitis B (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Viread za eno ali več podskupin pediatrične populacije za virus HIV in kronični hepatitis B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: For HIV, your child's doctor will prescribe Viread with other antiretroviral medicines.
Slovenian: Za HIV bo otrokov zdravnik zdravilo Viread predpisal skupaj z drugimi protiretrovirusnimi zdravili.
English: Your child must always take the dose recommended by their doctor.
Slovenian: Vaš otrok naj vedno vzame odmerek, ki mu ga je priporočil zdravnik.
English: For dosage see section 3, How to take Viread.
Slovenian: Za odmerjanje glejte poglavje 3 Kako jemati zdravilo Viread.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Slovenian: Tenofovir se primarno izloča preko ledvic tako s filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenoznem vnosu približno 70-80% odmerka izloči nespremenjenega s sečem.
English: These symptoms may indicate that your child's body's improved immune system is fighting infection.
Slovenian: Ti simptomi lahko nakazujejo, da se izboljšani imunski sistem otrokovega telesa bojuje proti okužbi.
English: • Children aged 2 to less than 12 years: The daily dose in children depends on their weight.
Slovenian: • Otroci, stari 2 do manj kot 12 let: Dnevni odmerek za otroke je odvisen od njihove telesne mase.
English: • For ½ scoop: • Fill the dosing scoop up to the “½ line” on the side (see Figure C).
Slovenian: • Napolnite merico za odmerjanje do črte “1/2” ob strani (glejte sliko C).
English: Once daily Scoops of granules
Slovenian: Enkrat dnevno merice zrnc
English: If your child misses a dose, work out how long since they should have taken it.
Slovenian: Če je vaš otrok izpustil odmerek, izračunajte, koliko časa je minilo od takrat, ko bi ga moral vzeti.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every
Slovenian: • laktacidoza (povečana količina mlečne kisline v krvi) je redek (prizadene lahko do 1 od
English: • That use of Viread should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Slovenian: • uporabi zdravila Viread se je treba izogibati pri sočasni oziroma po nedavni uporabi nefrotoksičnih zdravil.
English: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
Slovenian: Vaš zdravnik bo skrbno pretehtal, če vas bo zdravil s kombinacijami tenofovirja in didanozina.
English: Table 1: Dosing for children aged 2 to < 12 years
Slovenian: Preglednica 1: Odmerjanje za otroke, stare 2 do < 12 let
English: If the granules mixture is chewed, it will taste very bitter.
Slovenian: Ob žvečenju ima mešanica zrnc zelo grenak okus.
English: • That a multidisciplinary approach is recommended for the management of paediatric patients
Slovenian: • za obravnavo pediatričnih bolnikov je priporočlljiv multidisciplinarni pristop;
English: Children aged 2 to < 12 years:
Slovenian: Otroci, stari 2 do < 12 let:
English: • Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines that contain didanosine can raise the levels of didanosine in the blood and may reduce CD4 cell counts.
Slovenian: • Druga zdravila, ki vsebujejo didanozin (za okužbe z virusom HIV): Jemanje zdravila Viread skupaj z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša ravni didanozina v krvi in zmanjša število celic CD4.
English: Do not mix the granules with liquids.
Slovenian: Zrnc ne mešajte s tekočinami.
English: Wait and give the next dose at the regular time.
Slovenian: Počakajte in dajte otroku naslednji odmerek ob običajnem času.
English: If you feel dizzy while taking Viread, do not drive or ride a bicycle and do not use any tools or machines.
Slovenian: Če ste v času zdravljenja z zdravilom Viread omotični, ne vozite avtomobila ali kolesa in ne upravljajte z orodji ali stroji.
English: Tenofovir disoproxil at a concentration of 100 µmol/l had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of CYP1A1/2 substrate was observed.
Slovenian: Dizoproksiltenofovirat ni imel pri koncentraciji 100 µmol/l nobenega vpliva na katero koli obliko CYP450 izoformov, izjema je CYP1A1/2, kjer so opazili majhno (6%) toda statistično pomembno zmanjšanje presnove substrata za CYP1A1/2.
English: - The active substance is tenofovir.
Slovenian: - Učinkovina je tenofovir.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Viread.
Slovenian: Krvne preiskave ali simptomi pri nekaterih bolnikih so kazali, da se je njihov hepatitis poslabšal po prenehanju zdravljenja z zdravilom Viread.
English: 245 mg film-coated tablet 12 to < 18 years (n = 8)
Slovenian: 245 mg filmsko obložene tablete 12 do < 18 let (n = 8)
English: If you are older than this and are prescribed Viread, your doctor will monitor you carefully.
Slovenian: Če ste starejši in so vam predpisali zdravilo Viread, vas bo zdravnik skrbno nadzoroval.
English: The effects of tenofovir disoproxil-associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Slovenian: Učinki dizoproksiltenofovirata, povezani z MGK, na dolgoročno zdravje kosti in bodoče tveganje za zlom, trenutno niso znani (glejte poglavje 5.1).
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Slovenian: Huda ledvična okvara: 245 mg dizoproksiltenofovirata vsakih 72-96 ur (odmerjanje dvakrat na teden).
English: 6.5 mg/kg granules 2 to < 12 years (n = 23)
Slovenian: 6,5 mg/kg zrnca 2 do < 12 let (n = 23)
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 30 tablet
English: • That Viread may cause a reduction in BMD and the effects of Viread associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients
Slovenian: • zdravilo Viread lahko povzroči zmanjšanje MGK; učinki zdravila Viread, povezani s spremembo MGK, na dolgoročno zdravje kosti in bodoče tveganje za zlom, pri pediatričnih bolnikih trenutno niso znani;
English: Histological responsea,b (%)
Slovenian: Histologija Histološki odziv (%)b
English: In patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) the daily dose must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo ledvično okvaro (očistek kreatinina < 50 ml/min) je treba dnevni odmerek prilagoditi, delovanje ledvic pa skrbno nadzorovati (glejte poglavji 4.2 in 5.2).
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil expanded access program.
Slovenian: 2 Ta neželeni učinek je bil opredeljen v okviru nadzora v obdobju trženja zdravila, vendar ga v randomiziranih kontroliranih kliničnih študijah ali v podaljšanem programu dostopanja do dizoproksiltenofovirata niso opazili.
English: • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil fumarate-containing products such as Viread
Slovenian: • obstaja povečano tveganje za nastanek ledvične bolezni pri bolnikih, okuženih HIV in HBV, povezano z zdravili, ki vsebujejo dizoproksiltenofovirijev fumarat, kot je zdravilo Viread;
English: • Tell your child's doctor immediately about new or unusual symptoms after your child stops treatment, particularly symptoms you associate with hepatitis B infection.
Slovenian: • Nemudoma obvestite otrokovega zdravnika o vsakem novem ali nenavadnem simptomu potem, ko je vaš otrok prenehal z zdravljenjem, še posebej o simptomih, ki jih povezujete z okužbo s hepatitisom B.
English: However, in exceptional circumstances Viread 245 mg film-coated tablets can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Slovenian: V izjemnih primerih pa se lahko zdravilo Viread 245 mg filmsko obložene tablete zaužije razdrobljeno v najmanj 100 ml vode, pomarančnega ali grozdnega soka.
English: Your child may require blood tests for several months after stopping treatment.
Slovenian: Morda bodo pri vašem otroku potrebne krvne preiskave še več mesecev po prenehanju zdravljenja.
English: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany
Slovenian: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Nemčija
English: In HIV Viread should always be used combined with other medicines to treat HIV infection.
Slovenian: Pri okužbi z virusom HIV je treba zdravilo Viread vedno uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
Slovenian: Varnost in učinkovitost dizoproksiltenofovirata pri otrocih, okuženih s HIV-1, ali otrocih s kroničnim hepatitisom B, starih do 2 leti, nista bili dokazani.
English: No significant pharmacokinetic alteration has been observed in these patients (see section 5.2).
Slovenian: Pomembnih farmakokinetičnih odstopanj pri teh bolnikih niso opazili (glejte poglavje 5.2).
English:  If this applies to your child, tell their doctor immediately and don't give Viread.
Slovenian:  Če to velja za vašega otroka, o tem nemudoma obvestite zdravnika in mu ne dajajte zdravila Viread.
English: They are suitable for:
Slovenian: Primerno je za:
English: If a patient misses a dose of Viread by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Viread za več kot 12 ur in je že skoraj čas za naslednji odmerek, naj bolnik ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: • fatty liver  If you think that you may have any of these serious side effects, talk to your doctor.
Slovenian: • zamaščena jetra  Če menite, da bi lahko imeli katerega koli od teh resnih neželenih učinkov, se posvetujte s svojim zdravnikom.
English: Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your doctor.
Slovenian: Prenehanje zdravljenja z zdravilom Viread lahko zmanjša učinkovitost zdravljenja, ki vam ga je predpisal zdravnik.
English: • breakdown of muscle, muscle pain or weakness Tests may also show:
Slovenian: • razpad mišičnega tkiva, bolečine v mišicah ali mišična oslabelost Preiskave lahko kažejo tudi:
English: If this is unavoidable, your child's doctor will monitor your child's kidney function once a week.
Slovenian: Če je to neizogibno, bo otrokov zdravnik enkrat tedensko nadzoroval funkcijo njegovih ledvic.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).
Slovenian: • mladostniki, stari 12 do manj kot 18 let, s telesno maso vsaj 35 kg: 1 tableta vsak dan s hrano (na primer ob obroku ali prigrizku).
English: Although these doses are not expected to exactly reproduce the pharmacokinetic profile of tenofovir in patients with normal renal function receiving tenofovir disoproxil 245 mg film-coated tablets, they are considered to represent the best balance of benefit and risk for patients with renal impairment.
Slovenian: Ne pričakuje se, da bi ti odmerki natančno ponovili farmakokinetični profil tenofovirja pri bolnikih z normalno ledvično funkcijo, ki so prejemali dizoproksiltenofovirat 245 mg filmsko obložene tablete, temveč se obravnava, da predstavljajo najboljše ravnovesje med koristmi in tveganji za bolnike z ledvično okvaro.
English: • You must not take Viread during pregnancy unless specifically discussed with your doctor.
Slovenian: • Zdravila Viread ne smete jemati med nosečnostjo, razen če ste se o tem posebej dogovorili s svojim zdravnikom.
English: White, taste masked, coated granules.
Slovenian: zrnca Bela obložena zrnca s prikritim okusom.
English: Possible serious side effects: tell your doctor immediately
Slovenian: Možni resni neželeni učinki: nemudoma se posvetujte s svojim zdravnikom
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported, particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Slovenian: Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo CART ali obojim.
English: Viread does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Slovenian: Zdravilo Viread ne zmanjšuje nevarnosti prenosa virusa HBV na druge s spolnim stikom ali okužbo s krvjo.
English: A granules formulation of tenofovir disoproxil is available for patients having difficulty in swallowing film-coated tablets.
Slovenian: Formulacija dizoproksiltenofovirata v obliki zrnc je na voljo za bolnike s težavami s pogoltnjenjem filmsko obloženih tablet.
English: Possible serious side effects: tell your child's doctor immediately
Slovenian: Možni resni neželeni učinki: nemudoma se posvetujte z otrokovim zdravnikom
English: • Not for children and adolescents under 6 years or 12 years and over.
Slovenian: • ni za otroke in mladostnike, stare manj kot 6 let ali več kot 12 let.
English: Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Slovenian: Terapijo mora izvajati zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV in/ali zdravljenjem kroničnega hepatitisa B.
English: Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your child's doctor.
Slovenian: Prenehanje zdravljenja z zdravilom Viread lahko zmanjša učinkovitost zdravljenja, ki ga je otroku predpisal njegov zdravnik.
English: • If you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
Slovenian: • Če ste alergični na tenofovir, dizoproksiltenofovirat ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
English: • increased creatinine in your child's blood
Slovenian: • povišan kreatinin v otrokovi krvi
English: • It is very important to tell your child's doctor if your child is taking other medicines that may damage their kidneys.
Slovenian: • Zelo pomembno je, da otrokovega zdravnika obvestite, če otrok jemlje druga zdravila, ki bi lahko poškodovala njegove ledvice.
English: Tell your child's doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite otrokovega zdravnika ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: • feeling sick (nausea), being sick (vomiting) and stomach pain  If you think that you may have lactic acidosis, contact your doctor immediately.
Slovenian: • občutek siljenja na bruhanje, bruhanje in bolečine v trebuhu  Če menite, da bi lahko imeli laktacidozo, se nemudoma posvetujte s svojim zdravnikom.
English: • Your child must not breast-feed, to avoid passing the virus to the baby in breast milk.
Slovenian: • Vaša hči naj ne doji, da s tem prepreči prenos virusa preko mleka na dojenčka.
English: 11l a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384 due to a protocol defined endpoint, as well as those completing week 384, are included in the denominator.
Slovenian: 11l a Na podlagi algoritma dolgoročne ocenitve (Long Term Evaluation algorithm - LTE) - Bolniki, ki prenehajo sodelovati v študiji kadar koli pred 384. tednom zaradi izida, opredeljenega v protokolu, kot tudi tisti, ki dopolnijo 384 tednov, so vključeni v denominator.
English: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany or
Slovenian: Takeda GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Nemčija ali
English: • That Viread is not recommended for use in paediatric patients with renal impairment
Slovenian: • uporaba zdravila Viread ni priporočljiva pri pediatričnih bolnikih z ledvično okvaro;
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
Slovenian: Bolniki z dekompenzirano jetrno boleznijo: Varnostni profil dizoproksiltenofovirata pri bolnikih z dekompenzirano jetrno boleznijo je bil ocenjen v dvojno slepi aktivno kontrolirani študiji (GS-US
English: As Viread may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Slovenian: Ker lahko zdravilo Viread povzroči ledvično poškodbo, se priporoča nadziranje ledvične funkcije (glejte poglavji 4.4 in 4.8 Povzetek varnostnega profila).
English: The recommended dose is 6.5 mg of tenofovir disoproxil per kilogram of body weight once daily taken with food.
Slovenian: Priporočeni odmerek je 6,5 mg dizoproksiltenofovirata na kilogram telesne mase enkrat dnevno, s hrano.