FrancophonIA/ELRC3.0 huggingface dataset:
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Flixabi.
Slovenian: Razredčite lahko tako, da iz 250 ml steklenice ali infuzijske vrečke odvzamete tisti volumen 9 mg/ml (0,9 %) raztopine natrijevega klorida za infundiranje, ki ustreza volumnu rekonstituiranega zdravila Flixabi, nato pa vanjo počasi dodajte celoten volumen rekonstituirane raztopine zdravila Flixabi in rahlo premešajte.
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Slovenian: bolečine v prsih, utrujenost, zvišana telesna temperatura, reakcije na mestu injiciranja, mrzlica, edem občasni:
English: Abnormal skin openings • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Flixabi.
Slovenian: • Obvestite zdravnika, če imate na koži nenormalne odprtine (fistule), preden začnete prejemati zdravilo Flixabi.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, so ugotavljali tuberkulozo, bakterijske okužbe vključno s sepso in pljučnico, invazivne glivične, virusne in druge oportunistične okužbe.
English: Discontinuation of Flixabi should be considered if these disorders develop.
Slovenian: Če se pojavijo te motnje, je potrebno razmisliti o ukinitvi zdravila Flixabi.
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Slovenian: • resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen,
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNFblocking agents including infliximab.
Slovenian: Dodatno so v obdobju trženja poročali o primerih hepatospleničnega limfoma celic T pri bolnikih, ki so se zdravili z infliksimabom.
English: Combined
Slovenian: pielonefritis
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Slovenian: Klinični odziv so dosegli pri 21 od 31 (68 %) bolnikov, zdravljenih z infliksimabom v odmerku 5 mg/kg, v primerjavi z 8 od 31 (26 %) bolnikov, ki so prejemali placebo (p = 0,002).
English: • Cervical cancer
Slovenian: • možganska kap
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Slovenian: Velika večina primerov, kjer je bil vpleten infliksimab, se je pojavila pri bolnikih s Crohnovo boleznijo ali ulceroznim kolitisom.
English: • Crohn's disease
Slovenian: • Crohnovo bolezen,
English: Myocardial ischaemia/myocardial infarction.
Slovenian: cianoza, perikardni izliv neznana pogostnost: ishemija miokarda ali miokardni infarkt
English: ACCENT I (week-2 responders) % of Patients
Slovenian: ACCENT I (bolniki z odzivom v 2. tednu) % bolnikov vzdrževalno zdravljenje s placebom (n = 110)
English: • Infection due to a live vaccine because of a weakened immune system.
Slovenian: • začasna izguba vida med infundiranjem ali v roku 2 ur po infundiranju, • okužba zaradi živega cepiva zaradi oslabljenega imunskega sistema.
English: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Slovenian: vrtoglavica, omotica, hipestezija, parestezije občasni:
English: Please read the Flixabi ‘Package Leaflet' carefully before you start using this medicine.
Slovenian: Preden začnete uporabljati to zdravilo, natančno preberite navodilo za uporabo zdravila Flixabi.
English: Tell your doctor straight away if you get signs of infection during treatment with Flixabi.
Slovenian: • Zdravniku takoj povejte, če ste dobili simptome okužbe med zdravljenjem z zdravilom Flixabi.
English: c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Slovenian: ± SDc a Kontrolna skupina: Vsi bolniki so imeli aktivni revmatoidni artritis kljub zdravljenju s stalnimi odmerki metotreksata že 6
English: If a patient does not respond after 2 doses, no additional treatment with Flixabi should be given.
Slovenian: Če se bolnik ne odzove na zdravljenje po 2 odmerkih zdravila, ga ne smete več zdraviti zdravila Flixabi.
English: Discontinuation of Flixabi therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi bistvenimi hematološkimi anomalijami je treba razmisliti o ukinitvi zdravljenja z zdravilom Flixabi.
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Flixabi.
Slovenian: Zdravniku povejte takoj, če se pojavijo simptomi nevrološke bolezni med zdravljenjem z zdravilom Flixabi.
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Flixabi with other agents.
Slovenian: Študije za ovrednotenje fizikalno biokemične združljivosti zdravila Flixabi z drugimi zdravili niso bile izvedene, zato ga ne smete dati sočasno v isti intravenski liniji z drugimi zdravili.
English: How much Flixabi is given
Slovenian: Koliko zdravila Flixabi uporabiti
English: One vial contains 100 mg of infliximab*.
Slovenian: Ena viala vsebuje 100 mg infliksimaba.
English: • Nettle-type rash (hives), itchy rash or dry skin
Slovenian: • koprivnica (urtikarija), srbeč izpuščaj ali suha koža,
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Slovenian: Izkušnje glede varnosti kirurških posegov vključno z artroplastiko pri bolnikih, zdravljenih z infliksimabom, so omejene.
English: If a patient does not respond after 3 doses, no additional treatment with Flixabi should be given.
Slovenian: Če se bolnik ne odzove na zdravilo po 3 odmerkih, ga ne smete več zdraviti zdravilom Flixabi.
English: Reproductive system and breast disorders Uncommon:
Slovenian: Motnje reprodukcije in dojk občasni:
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly and flaky skin
Slovenian: otekle ustnice, ali zadebelitev kože, ali rdeča, krastasta in luskasta koža,
English: Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:  adult patients with active disease when the response to disease-modifying antirheumatic drugs
Slovenian: Zdravilo Flixabi je v kombinaciji z metotreksatom indicirano za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Slovenian: trombocitopenija, limfopenija, limfocitoza redki:
English: Tell your doctor straight away if you get symptoms of low blood counts during treatment with Flixabi.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Flixabi pojavijo simptomi nizkega števila krvnih celic.
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Slovenian: Velika večina teh primerov se je pojavila pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom, večina od teh pri mladostnikih ali mlajših odraslih moških (glejte poglavje 4.4).
English: • Kidney infections
Slovenian: • okužbe ledvic,
English: Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Slovenian: • zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, ki se niso odzvali na celoten in ustrezen ciklus zdravljenja s kortikosteroidom in/ali zdravilom za zaviranje imunske odzivnosti, ali pri tistih, ki ne prenašajo tovrstne terapije ali ki imajo medicinske kontraindikacije zanjo,
English: • Heart attack
Slovenian: • srčni zastoj,
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Flixabi.
Slovenian: Zdravniku povejte takoj, če se med zdravljenjem z zdravilom Flixabi pojavijo novi znaki srčnega popuščanja ali se obstoječi znaki poslabšajo.
English: No dose recommendations can be made (see section 5.2).
Slovenian: Infliksimaba pri teh skupinah bolnikov niso proučevali, zato ni mogoče podati priporočil za odmerjanje (glejte poglavje 5.2)
English: How to store Flixabi
Slovenian: Kako uporabljati zdravilo Flixabi
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Slovenian: limfom, ne-Hodgkinov limfom, Hodgkinova bolezen, levkemija, melanom, rak materničnega vratu neznana pogostnost: hepatosplenični limfom celic T (primarno pri mladostnikih in mlajših odraslih moških s Crohnovo boleznijo ali ulceroznim kolitisom), karcinom Merklovih celic
English: • Rheumatoid arthritis
Slovenian: • revmatoidni artritis,
English: Flixabi should be administered  in combination with methotrexate  or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Slovenian: • ali samostojno pri bolnikih, ki ne prenašajo metotreksata ali pri katerih je metotreksat kontraindiciran.
English: Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Slovenian: Odstotek preiskovancev v klinični remisiji in trajnejši remisiji klinična remisija v 8. tednua klinična remisija v 30. tednua trajnejša remisija (remisija tako v 8. tednu kot v 30. tednu)a
English: Placebo Maintenance (n=99)
Slovenian: ACCENT II (bolniki z odzivom v 14. tednu) vzdrževalno zdravljenje s placebom (n = 99)
English: Clinical response at week 30
Slovenian: Klinični odziva Klinična remisija
English: • Fainting
Slovenian: • omedlevica,
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Flixabi.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Flixabi pojavijo simptomi lupusa.
English: Current administrations:
Slovenian: Preiskave občasni:
English: Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Slovenian: Infliksimab ne reagira navzkrižno s TNFα drugih vrst, le s človeškim in šimpanzovim, zato je malo konvencionalnih predkliničnih podatkov o varnosti infliksimaba.
English: PASI 75 response**
Slovenian: navedba smiselno ni potrebna odziv PASI 75**
English: Name and address of the manufacturer responsible for batch release
Slovenian: PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Gastrointestinal disorders Very common:
Slovenian: pozitiven izvid na avtoprotitelesa redki:
English: b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b Absence of any draining fistulas
Slovenian: 54. teden odziv fistule (%)a popoln odziv fistule (%)b a Zmanjšanje števila fistul z izcedkom za ≥ 50 % glede na stanje na začetku študije v obdobju ≥ 4 tednov.
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Slovenian: Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Flixabi pojavijo simptomi težav z jetri.
English: 6 mg/kg
Slovenian: 6 mg/kg kombinirano
English: • Shortage of blood supply, swelling of a vein
Slovenian: • slaba prekrvavitev, otekanje ven,
English: Patients should be tested for HBV infection before initiating treatment with Flixabi.
Slovenian: Pred začetkom zdravljenja z zdravilom Flixabi morate bolnike testirati na okužbo z virusom hepatitisa B (HBV).
English: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Slovenian: Temu naj sledita dodatni infuziji v odmerku 3 mg/kg, 2 in 6 tednov po prvi infuziji, potem pa na vsakih 8 tednov.
English: In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or  Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re administration' below and section 4.4).
Slovenian: • Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
English: Symptoms included, but were not limited to, dyspnoea, urticaria, facial oedema, and hypotension.
Slovenian: Med simptome so sodili dispneja, urtikarija, obrazni edem in hipotenzija, pojavili pa so se tudi drugi simptomi.
English: • Some patients who have received TNF-blockers, including Flixabi have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Slovenian: • Pri nekaterih bolnikih, ki so prejemali zaviralce TNF, vključno z zdravilom Flixabi, se je pojavila redka oblika raka, ki mu pravimo hepatosplenični limfom celic T. Od teh bolnikov je bila večina najstnikov ali mladih moških in večina je imela Crohnovo bolezen ali ulcerozni kolitis.
English: Under aseptic conditions, reconstitute each Flixabi vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Slovenian: Uporabite brizgo z iglo premera 0,8 mm (21 G) ali tanjšo.
English: • You may get infections more easily when you are being treated with Flixabi.
Slovenian: • Med zdravljenjem z zdravilom Flixabi se lahko poveča dovzetnost za okužbe.
English: * ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Slovenian: ** Odziv PASI 75 iz študije IMPACT ni vključen zaradi majhnega števila N; p < 0,001 za infliksimab v primerjavi s placebom v 24. tednu v študiji IMPACT 2.
English: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Slovenian: nevtropenija, levkopenija, anemija, limfadenopatija občasni:
English: Instructions for use and handling - storage conditions Store at 2°C - 8°C.
Slovenian: Shranjujte pri temperaturi 2 °C-8 °C.
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including infliximab.
Slovenian: Pri bolnikih, ki so jemali zaviralce TNF, vključno z infliksimabom, so poročali o pojavu pancitopenije, levkopenije, nevtropenije in trombocitopenije.
English: Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Zdravilo Flixabi je razredčeno v 9 mg/ml (0,9 %) raztopini natrijevega klorida za infundiranje, kar je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija (glejte poglavje 6.6).
English: Uncommon: may affect up to1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Respiratory, thoracic and mediastinal disorders Very common:
Slovenian: odpoved krvnega obtoka, petehija, vazospazem Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti:
English: • Feeling numb or having a tingling feeling.
Slovenian: • občutek otrplosti ali mravljincev.
English: Transient visual loss occurring during or within 2 hours of infusion.
Slovenian: endoftalmitis neznana pogostnost: prehodna izguba vida, ki nastopi med infundiranjem ali v roku 2 ur po infundiranju
English: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Slovenian: b Vsi odmerki infliksimaba so bili v kombinaciji z metotreksatom in folatom, nekaj tudi s kortikosteroidi in/ali NSAID.
English: • Liver failure
Slovenian: • otekle bezgavke,
English: Bottle (HDPE) 1 bottle of 180 tablets without outer carton
Slovenian: 1 steklenica s 180 tabletami brez zunanje ovojnine
English: Package sizes
Slovenian: Velikosti pakiranj
English: Invented name Strengths Pharmaceutical Forms Route of Administration Packaging
Slovenian: Številke EU Zaščiteno ime Jakosti Farmacevtske oblike
English: Date of first authorisation: 8 December 2016
Slovenian: Datum prve odobritve: 8. december 2016
English: - Risk Management Plan (RMP)
Slovenian: - Načrt za obvladovanje tveganj (RMP)
English: Black/African American
Slovenian: Črnci/Afroameričani
English: Get tested for HIV regularly.
Slovenian: - Redno se testirajte za HIV.
English: NC = not calculated.
Slovenian: n/i = ni izračuna
English: They may want to do more tests to make sure you are still HIV negative.
Slovenian: Morda bo želel opraviti več testov, da se prepriča, da ste še vedno HIV negativni.
English: Always take the dose recommended by your doctor.
Slovenian: - Vedno vzemite odmerek, ki vam ga je priporočil zdravnik.
English: Any signs of inflammation or infection.
Slovenian: - Znaki vnetja ali okužbe.
English: If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.
Slovenian: Če imate hepatitis B ali C, bo zdravnik skrbno razmislil o najboljšem režimu zdravljenja za vas.
English: → Tell your doctor if you are taking any of these medicines.
Slovenian: → Obvestite zdravnika, če jemljete katero koli od teh zdravil.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Slovenian: S seboj imejte pakiranje tablet, da boste lahko opisali, kaj ste zaužili.
English: - Additional risk minimisation measures
Slovenian: - Dodatni ukrepi za zmanjševanje tveganj
English: → Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection
Slovenian: → Nemudoma obvestite zdravnika o vsakem novem ali nenavadnem simptomu potem, ko ste prenehali z zdravljenjem, še posebej o simptomih, ki jih povezujete z okužbo s hepatitisom B.
English: Subjects were followed for 7,830 person-years.
Slovenian: Osebe so bile spremljane 7.830 človeklet.
English: - Reminders for evaluations/counselling at the initial visit and follow-up.
Slovenian: - opozorila na oceno/svetovanje pri prvem obisku in v fazi spremljanja.
English: P-value a, b mITT Analysis
Slovenian: P-vrednost a, b
English: - Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
Slovenian: - Testirajte se za druge spolno prenosljive okužbe, kot sta sifilis in gonoreja.
English: Many HIV tests can miss a recent infection.
Slovenian: - Mnogi diagnostični testi za HIV lahko spregledajo nedavno okužbo.
English: → If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Slovenian: → Če opazite te ali kakršne koli druge simptome vnetja ali okužbe, nemudoma poiščite zdravniško pomoč.
English: Then mix the powder with about 100 mL (half a glass) of water, orange juice or grape juice, and drink immediately.
Slovenian: Nato zmešajte prašek s približno 100 ml (pol kozarca) vode, pomarančnega ali grozdnega soka in nemudoma popijte.
English: → If this applies to you, tell your doctor immediately.
Slovenian: → Če to velja za vas, o tem nemudoma obvestite zdravnika.
English: Not recommended because appropriate dose reductions cannot be achieved with the combination tablet.
Slovenian: Zdravilo se ne priporoča, ker ustreznega znižanja odmerka ni mogoče doseči s kombinirano tableto.
English: Contains also lactose monohydrate.
Slovenian: Vsebuje tudi laktozo monohidrat.
English: Subjects were followed for 4,237 personyears.
Slovenian: Osebe so spremljali 4.237 človek-let.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Slovenian: Pogostnost je definirana kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki neželeni učinki (≥ 1/10.000 do <
English: The incidence of HIV seroconversion is shown in Table 9.
Slovenian: Incidenca serokonverzije HIV je prikazana v preglednici 9.
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Slovenian: Vendar pa so koristi za populacijo mladostnikov pričakovane na podlagi ekstrapolacije podatkov pri odraslih in primerljivih farmakokinetičnih podatkov (glejte poglavje 5.2).
English: → If you think you may have lactic acidosis, get medical help immediately.
Slovenian: → Če menite, da bi lahko imeli laktacidozo, nemudoma poiščite zdravniško pomoč.
English: P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Slovenian: P-vrednosti za URAI se nanašajo na ničelno hipotezo, da se učinkovitost razlikuje med podskupinama (URAI, brez URAI).
English: - Do not share or re-use needles or other injection or drug equipment.
Slovenian: - Ne delite ali ponovno uporabljajte igel ali drugih pripomočkov za injiciranje in za ostale oblike jemanja drog.
English: Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Slovenian: - Laktacidoza (preveč mlečne kisline v krvi) je redek, a potencialno življenjsko nevaren neželeni učinek.
English: Race, N (%)
Slovenian: Spol, N (%)
English: - Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Slovenian: - Ne delite osebnih predmetov, na katerih so lahko kri ali telesne tekočine, kot so zobne ščetke in brivniki.
English: - Reminders to adhere to the dosing schedule - Reminder to attend scheduled clinic visits.
Slovenian: - opozorila za upoštevanje urnika odmerjanja; - opozorila za načrtovane obiske pri zdravniku.
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Slovenian: Zdravljenje hepatitisa B se lahko ponovno uvede, če je ustrezno.
English: Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Slovenian: Študijo so izvedli z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, ki se pričakuje pri bolnikih z okužbo s HCV.
English: Mixed/Other
Slovenian: Mešana/drugo
English: 3, nephrogenic diabetes insipidus
Slovenian: 3, nefrogeni insipidusni diabetes
English: Adults: one tablet each day, where possible, with food.
Slovenian: - Odrasli: ena tableta vsak dan s hrano, če je mogoče.
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Slovenian: Veliko število podatkov pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na malformacije ali feto/neonatalno toksičnost povezane z emtricitabinom in dizoproksiltenofoviratom.
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.
Slovenian: - Uporablja se tudi za zdravljenje okužbe z virusom HIV pri mladostnikih, starih 12 let do manj kot 18 let, s telesno maso vsaj 35 kg, ki so se predhodno že zdravili z drugimi zdravili za zdravljenje okužbe s HIV, ki pa več ne učinkujejo ali so povzročila neželene učinke.