FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP did not agree that the data presented by the company were sufficient to support the claim that cabazitaxel and docetaxel should be considered the same active substance.
Croatian: CHMP se nije složio da su podatci koje je tvrtka dostavila dostatni da bi poduprli tvrdnju da se kabazitaksel i docetaksel trebaju smatrati istom djelatnom tvari.
English: The company informed the CHMP that there are no ongoing clinical trials with Cabazitaxel Teva in the EU.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja lijeka Cabazitaxel Teva koja su u tijeku u EUu.
English: Based on these findings, the CHMP was of the opinion that it cannot be concluded that cabazitaxel and docetaxel do not differ significantly with regard to safety and effectiveness.
Croatian: Na temelju tih nalaza CHMP je smatrao da se ne može zaključiti da nema značajnih razlika u sigurnosti i učinkovitosti kabazitaksela i docetaksela.
English: This means that Cabazitaxel Teva was intended to be similar to a ‘reference medicine' containing the same active substance and already authorised in the European Union.
Croatian: To znači da je Cabazitaxel Teva trebao biti sličan „referentnom lijeku” koji sadrži istu djelatnu tvar i već je odobren u Europskoj uniji (EU).
English: Refusal of the marketing authorisation for Cabazitaxel Teva (cabazitaxel)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Cabazitaxel Teva (kabazitaksel)
English: What is Cabazitaxel Teva?
Croatian: Što je Cabazitaxel Teva?
English: The company made reference to two medicines, Jevtana (containing cabazitaxel) and Taxotere (containing docetaxel, see below for more details).
Croatian: Tvrtka se pozvala na dva lijeka, lijek Jevtana (sadrži kabazitaksel) i lijek Taxotere (sadrži docetaksel, više pojedinosti dostupno je u nastavku).
English: Cabazitaxel Teva was to be used when the cancer had spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Croatian: Lijek Cabazitaxel Teva trebao se primjenjivati u slučaju kad se rak proširio (metastazirao) na ostale dijelove tijela unatoč terapijama za sprječavanje stvaranja testosterona ili nakon kirurškog odstranjenja testisa (kastracija).
English: On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Cabazitaxel Teva, koji je namijenjen liječenju raka prostate.
English: Cabazitaxel also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Croatian: Kabazitaksel također djeluje na ostale stanice, poput krvnih i živčanih stanica, što može prouzročiti nuspojave.
English: Cabazitaxel Teva was to be used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Croatian: Lijek Cabazitaxel Teva trebao se primjenjivati u kombinaciji s prednizonom ili prednizolonom (protuupalni lijekovi) u bolesnika koji su prethodno liječeni docetakselom (drugi lijek protiv raka).
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26. travnja 2019.
English: Cabazitaxel belongs to the group of cancer medicines known as ‘taxanes'.
Croatian: Kabazitaksel pripada skupini lijekova protiv raka pod nazivom „taksani”.
English: The company claimed that cabazitaxel is a derivative of docetaxel, and that the active substances do not differ significantly in their safety and effectiveness.
Croatian: Tvrtka je tvrdila da je kabazitaksel derivat docetaksela te da nema značajnih razlika u sigurnosti i učinkovitosti tih djelatnih tvari.
English: How does Cabazitaxel Teva work?
Croatian: Kako djeluje Cabazitaxel Teva?
English: Cabazitaxel Teva is a cancer medicine that contains the active substance cabazitaxel.
Croatian: Teva je lijek protiv raka koji sadrži djelatnu tvar kabazitaksel.
English: This is because Cabazitaxel Teva is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: Teva daje infuzijom u venu te tako djelatna tvar dospijeva izravno u krvotok.
English: Cabazitaxel Teva is expected to work in the same way as the reference medicine, Jevtana.
Croatian: Lijek Cabazitaxel Teva trebao je djelovati na jednak način kao i referentni lijek Jevtana.
English: Cabazitaxel Teva was expected to be used to treat men with prostate cancer, a cancer that affects the prostate gland (which produces the liquid in semen).
Croatian: Lijek Cabazitaxel Teva trebao se primjenjivati u liječenju muškaraca s rakom prostate (žlijezda koja stvara tekućinu u sjemenu).
English: Although cabazitaxel is a derivative of docetaxel, laboratory studies have shown that cabazitaxel and docetaxel have different properties, for example cabazitaxel can cross the blood-brain barrier while docetaxel cannot.
Croatian: Iako je kabazitaksel derivat docetaksela, laboratorijska ispitivanja pokazala su da kabazitaksel i docetaksel imaju različita svojstva.
English: Thus Taxotere cannot be used to support the application for Cabazitaxel Teva and the CHMP recommended that Cabazitaxel Teva be refused marketing authorisation.
Croatian: Stoga se lijek Taxotere ne može koristiti kao potpora zahtjevu za lijek Cabazitaxel
English: If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.
Croatian: Ako je potreban još jedan ciklus tretiranja, razdoblje između dvaju ciklusa mora biti najmanje tri mjeseca.
English: Egg production may also be affected.
Croatian: Također su mogući učinci na proizvodnju jaja.
English: The full EPAR for Exzolt can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Exzolt nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Exzolt is added to drinking water on two occasions, seven days apart.
Croatian: Exzolt se dodaje u vodu za piće u dva navrata, u razmaku od sedam dana.
English: Why is Exzolt approved?
Croatian: Zašto je Exzolt odobren?
English: Sufficient Exzolt is added to ensure the required dose is present in the volume of water that the chickens will consume in one day.
Croatian: Dodaje se dostatna količina VMP-a Exzolt kako bi se osigurala potrebna doza u količini vode koju će kokoši popiti u jednom danu.
English: What is Exzolt and what is it used for?
Croatian: Što je Exzolt i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the EU for Exzolt on 18 August 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Exzolt na snazi u Europskoj uniji od 18/08/2017.
English: While handling the product people must not eat, drink or smoke.
Croatian: Osobe koje rukuju ovim VMP-om ne smiju pušiti, jesti niti piti tijekom primjene.
English: Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers.
Croatian: VMP Exzolt smanjio je broj tekuti za više od 99 % u pilenki i rasplodnih kokoši te više od 98 % u nesilica.
English: The withdrawal period for eggs from chickens treated with Exzolt is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za jaja kokoši liječenih VMP-om Exzolt iznosi „nula” dana, drugim riječima, nema obveznog perioda čekanja.
English: Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house.
Croatian: VMP Exzolt ispitivan je u terenskom ispitivanju kojim je bilo obuhvaćeno devet farmi s infestacijom crvenom tekuti, od kojih je svaka farma imala dva slična kokošinjca, svaki s 550 do 100 000 kokoši.
English: The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.
Croatian: Djelotvornost VMP-a trajala je od šest tjedana do osam mjeseci, ovisno o duljini ciklusa proizvodnje i učinkovitosti farmi u sprečavanju reinfestacije tekutima u kokošinjcima.
English: It is not intended to provide practical advice on how to use Exzolt.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Exzolt.
English: It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.
Croatian: VMP djeluje ometajući način na koji se signali prenose među živčanim stanicama (neurotransmisija) u živčanom sustavu parazita, što rezultira paralizom i ugibanjem tekuti.
English: Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts).
Croatian: Infestacije crvenom tekuti mogu prouzročiti nadraženost i nemir ptica, kljucanje perja i anemiju (nizak broj crvenih krvnih stanica).
English: What are the risks associated with Exzolt?
Croatian: Koji su rizici povezani s VMP-om Exzolt?
English: Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens.
Croatian: Exzolt je veterinarsko-medicinski proizvod koji se primjenjuje za liječenje infestacije crvenom tekuti (Dermanyssus gallinae) u pilenki (mladih kokoši), rasplodnih kokoši i nesilica.
English: This means it kills parasites such as mites that feed on the skin of animals.
Croatian: To znači da ubija parazite koji se hrane na koži životinja, kao što je tekut.
English: The withdrawal period for meat from chickens treated with Exzolt is 14 days.
Croatian: Razdoblje karencije za meso kokoši liječenih VMP-om Exzolt iznosi 14 dana.
English: Since the veterinary medicine may be slightly irritating to skin and/or eyes, contact with skin, eyes and mucous membranes (moist body surfaces, such as the lining of the mouth) should be avoided.
Croatian: Budući da ovaj VMP može biti blago nadražujući za kožu i/ili oči, potrebno je izbjegavati kontakt s kožom, očima i sluznicom (vlažne površine tijela, kao što je sluznica usne šupljine).
English: The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide'.
Croatian: Djelatna tvar u VMP-u Exzolt, fluralaner, djeluje kao „ektoparaziticid”.
English: Fluralaner kills mites by acting on their nervous system after they have ingested the chicken's blood.
Croatian: Fluralaner ubija tekut nakon što se nahranila krvlju kokoši tako što djeluje na njihov živčani sustav.
English: Poultry red mite is a parasite that feeds on the blood of hens.
Croatian: Crvena tekut parazit je koji se hrani krvlju kokoši.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Exzolt nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Exzolt.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za veterinarsko-medicinski proizvod Exzolt.
English: Exzolt contains the active substance fluralaner.
Croatian: Exzolt sadržava djelatnu tvar fluralaner.
English: One of the houses on each of the farms was treated with Exzolt, the other house was left untreated.
Croatian: U jednom kokošinjcu na svakoj farmi provedeno je liječenje VMP-om Exzolt, a u drugom nije provedeno liječenje.
English: Exzolt is available as a solution for use in drinking water and can only be obtained with a prescription.
Croatian: VMP Exzolt dostupan je kao otopina za primjenu u vodi za piće i izdaje se samo na veterinarski recept.
English: What benefits of Exzolt have been shown in studies?
Croatian: Koje su koristi VMP-a Exzolt utvrđene u ispitivanjima?
English: Other information about Exzolt?
Croatian: Ostale informacije o VMP-u Exzolt
English: How is Exzolt used?
Croatian: Kako se Exzolt koristi?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Exzolt, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u Exzolt, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For practical information about using Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Exzolt vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Hands and contacted skin should be washed after use of the medicine.
Croatian: Nakon primjene VMP-a potrebno je oprati ruke i kožu koja je bila u dodiru s proizvodom.
English: How does Exzolt work?
Croatian: Kako djeluje Exzolt?
English: - Risk management plan (RMP)
Croatian: - Plan upravljanja rizikom (RMP)
English: Date of first authorisation: 28 April 2017
Croatian: Datum prvog odobrenja: 28. travnja 2017.
English: Shelf life after first opening of the bottle: 2 months.
Croatian: Rok valjanosti nakon prvog otvaranja boce: 2 mjeseca.
English: Adults: one tablet each day, where possible, with food.
Croatian: - Odrasli: jedna tableta svaki dan, kad god je to moguće s hranom.
English: See Table 1.
Croatian: Vidjeti Tablicu 1.
English: less frequently.
Croatian: Manje često:
English: Stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Croatian: - Prestanak uzimanja tableta može smanjiti učinkovitost terapije protiv HIV-a koju Vam je preporučio liječnik.
English: - No virus analysed contained the K65R or K70E mutation.
Croatian: - Nijedan analizirani virus nije sadržavao mutaciju K65R ili K70E.
English: - It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Croatian: - Također se primjenjuje za liječenje HIV-a u adolescenata u dobi od 12 do navršenih 18 godina koji imaju najmanje 35 kg te su već liječeni drugim lijekovima za HIV koji više nisu učinkoviti ili su izazvali nuspojave.
English: Blisters OPA/Alu/PE+DES/ - Aluminium blisters.
Croatian: OPA/Al/PE+DES/ - Aluminijski blisteri.
English: Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.
Croatian: - Adolescenti u dobi od 12 do navršenih 18 godina koji imaju najmanje 35 kg: jedna tableta svaki dan, kad god je to moguće s hranom.
English: Elderly: No dose adjustment is required (see section 5.2).
Croatian: Starije osobe: Nije potrebna prilagodba doziranja (vidjeti dio 5.2).
English: Adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Croatian: Odrasli i adolescenti u dobi od 12 godina i starijih, tjelesne težine najmanje 35 kg: jedna tableta, jedanput na dan.
English: to older people.
Croatian: Starije osobe
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment, and should be monitored during use as in adults (see above).
Croatian: Funkciju bubrega (klirens kreatinina i fosfate u serumu) treba procijeniti prije liječenja i treba je pratiti tijekom primjene kao i u odraslih osoba (vidjeti gore).
English: A multidisciplinary approach is recommended to weigh the benefit/risk balance of the use of emtricitabine/tenofovir, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation on a case by case basis.
Croatian: Preporučuje se multidisciplinarni pristup kako bi se odredio omjer koristi i rizika primjene emtricitabina/tenofovira, odlučilo o prikladnom praćenju tijekom liječenja (uključujući odluku o prekidu liječenja) i razmotrila potreba za dodatnim liječenjem od slučaja do slučaja.
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Croatian: Osam od 89 bolesnika (9,0%) prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima.
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Croatian: Štoviše, reverzibilnost toksičnosti za bubrege ne može se sa sigurnošću utvrditi.
English: ANTI-INFECTIVES Antiretrovirals Protease inhibitors
Croatian: ANTIINFEKTIVNI LIJEKOVI Antiretrovirusni lijekovi Inhibitori proteaze
English: Table 2: Interactions between the individual components of emtricitabine/tenofovir disoproxil and other medicinal products
Croatian: Tablica 2: Interakcije između pojedinačnih komponenti emtricitabin/tenofovirdizoproksila i drugih lijekova
English: 28 film-coated tablets: EU/1/17/1182/001 84 film-coated tablets: EU/1/17/1182/003
Croatian: 28 filmom obloženih tableta: EU/1/17/1182/001 84 filmom obložene tablete: EU/1/17/1182/003
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Croatian: poluvrijeme eliminacije tenofovira iznosi približno 12 do 18 sati.
English: Adults with renal impairment:
Croatian: Odrasle osobe s oštećenjem funkcije bubrega:
English: If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Tenofovir disoproxil Krka d.d.
Croatian: Ako ostanete trudni ili planirate trudnoću, posavjetujte se s liječnikom o potencijalnim koristima i rizicima liječenja lijekom Emtricitabine/Tenofovir disoproxil Krka d.d. po Vas i dijete.
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disproxil in the paediatric population with HIV-1 infection.
Croatian: Liječenje infekcije virusom HIV-1 u pedijatrijskoj populaciji Nisu provedena klinička ispitivanja emtricitabina/tenofovirdizoproksila u pedijatrijskoj populaciji zaraženoj virusom HIV-1.
English: - Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in virus from 21/29 (72%) patients in the comparative group.
Croatian: - Genotipska rezistencija na efavirenz, pretežno mutacija K103N, razvila se kod virusa u 13/19 (68%) bolesnika iz skupine emtricitabin/tenofovirdizoproksil/efavirenz te kod virusa u 21/29 (72%) bolesnika u usporednoj skupini.
English: vancomycin (for bacterial infection) interleukin-2 (to treat cancer) cidofovir (for viral infection) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Croatian: - foskarnet (za virusnu infekciju) - ganciklovir (za virusnu infekciju) - pentamidin (za infekcije) - vankomicin (za bakterijsku infekciju) - interleukin-2 (za liječenje raka) - cidofovir (za virusnu infekciju) - nesteroidne antiinflamatorne (protuupalne) lijekove (NSAIL, za ublažavanje boli u kostima ili mišićima)
English: Administration every 48 hours is recommended based on modelling of single-dose pharmacokinetic data for emtricitabine and tenofovir disoproxil in non-HIV infected subjects with varying degrees of renal impairment (see section 4.4).
Croatian: Primjena svakih 48 sati preporučuje se na temelju modela farmakokinetičkih podataka za pojedinačnu dozu emtricitabina i tenofovirdizoproksila u ispitanika koji nisu zaraženi virusom HIV-a, s različitim stupnjevima oštećenja funkcije bubrega (vidjeti dio 4.4).
English: HIV-1infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Croatian: Bolesnici zaraženi virusom HIV-1 i s otprije postojećim poremećajem funkcije jetre, uključujući kronični aktivni hepatitis, imaju povećanu učestalost abnormalnosti funkcije jetre tijekom kombinirane antiretrovirusne terapije (engl. combination antiretroviral therapy, CART), pa ih treba pratiti u skladu sa standardnom praksom.
English: If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Krka d.d., whether or not you also have HIV.
Croatian: Ako imate HBV, postoji ozbiljan rizik od tegoba s jetrom kada prestanete uzimati Emtricitabine/Tenofovir disoproxil Krka d.d., bez obzira na to imate li i HIV.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be lifethreatening.
Croatian: U nekih se bolesnika s uznapredovalom bolešću jetre ili cirozom jetre ne preporučuje prekid liječenja, jer to može dovesti do pogoršanja hepatitisa, koje može biti životno ugrožavajuće.
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Emtricitabine/Tenofovir disoproxil Krka d.d.
Croatian: U osoba starijih od 65 godina veća je vjerojatnost da imaju smanjenu funkciju bubrega, pa je stoga potrebno primijeniti oprez kad se Emtricitabine/Tenofovir disoproxil Krka d.d. primjenjuje u starijih osoba.
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Krka d.d., contact your doctor or nearest emergency department for advice.
Croatian: Ako slučajno uzmete veću dozu lijeka Emtricitabine/Tenofovir disoproxil Krka d.d. od preporučene, obratite se svom liječniku ili najbližoj hitnoj službi.
English: 30 film-coated tablets: EU/1/17/1182/002 90 (3 x 30) film-coated tablets: EU/1/17/1182/004
Croatian: 30 filmom obloženih tableta: EU/1/17/1182/002 90 (3 x 30) filmom obloženih tableta: EU/1/17/1182/004
English: As of week 144: - The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Croatian: Počevši od 144. tjedna: - Mutacija M184V/I razvila se u 2/19 (10,5%) izolata analiziranih u bolesnika iz skupine emtricitabin/tenofovirdizoproksil/efavirenz, te u 10/29 (34,5%) izolata analiziranih u bolesnika iz skupine lamivudin/zidovudin/efavirenz (p-vrijednost < 0,05, Fisherov egzaktni test koji uspoređuje skupinu emtricitabin+tenofovirdizoproksil sa skupinom lamivudin/ zidovudin među svim bolesnicima).
English: should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Croatian: Emtricitabine/Tenofovir disoproxil Krka d.d. se smije koristiti samo u osoba s klirensom kreatinina (CrCl) < 80 mL/min ako se smatra da su moguće koristi veće od mogućih rizika.
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost emtricitabina/tenofovirdizoproksila u djece mlađe od 12 godina nisu ustanovljene.