FrancophonIA/ELRC3.0 huggingface dataset:
English: Boceprevir is partly metabolized by CYP3A4/5.
Croatian: Boceprevir se djelomično metabolizira putem CYP3A4/5.
English: Talk to your doctor or pharmacist before taking Viramune.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Viramune.
English: Mosteller Formula: BSA (m
Croatian: Mostellerova formula: BSA (m
English: Data on potential symptoms of hepatic events were prospectively collected in this study.
Croatian: Podaci o potencijalnim simptomima jetrenih događaja u ovom ispitivanju su prikupljani na prospektivan način.
English: Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude osim onog opaženog u kliničkim ispitivanjima na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide u nekim slučajevima postoji dokaz o učinku liječenja, dok za debljanje nema čvrstog dokaza povezanog s bilo kojim posebnim liječenjem.
English: One case of massive accidental overdose in a newborn was reported.
Croatian: Prijavljen je jedan slučaj teškog slučajnog predoziranja novorođenčeta.
English: ENTRY INHIBITORS Enfuvirtide
Croatian: INHIBITORI ULAZA Enfuvirtid
English: Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications.
Croatian: Opažene su blaga izolirana neutropenija i hiperlaktatemija, koje su spontano nestale unutar jednog tjedna bez kliničkih komplikacija.
English: Always follow the exact instructions given by your child's doctor.
Croatian: Uvijek pratite točne upute liječnika Vašeg djeteta.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease.
Croatian: Duljina trajanja kombinirane antiretrovirusne terapije, primjena kortikosteroida, konzumiranje alkohola, teška slabost imunološkog sustava i viši indeks tjelesne mase mogu biti neki od mnogih rizičnih čimbenika za razvoj ove bolesti.
English: You should therefore remain in regular contact with your doctor.
Croatian: Prema tome, potrebno je biti u redovitom kontaktu s liječnikom.
English: Furthermore, in the case Viramune is used as single dose to prevent vertical transmission of HIV-1 infection, the risk of hepatotoxicity in mother and child cannot be excluded.
Croatian: Nadalje, u slučaju kada se Viramune primjenjuje kao jednokratna doza radi prevencije vertikalnog prijenosa infekcije HIV-om 1, ne može se isključiti rizik od hepatotoksičnosti u majke i djeteta.
English: White to off-white homogenous suspension.
Croatian: Bijela do bjelkasta homogena suspenzija.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako postoje dokazi pogoršanja bolesti jetre u ovih bolesnika, nužno je razmotriti privremen ili trajan prekid liječenja.
English: Viramune oral suspension can be taken by children of all age groups.
Croatian: Viramune oralnu suspenziju mogu uzimati djeca svih dobnih skupina.
English: HIV-1 subtype
Croatian: Podtip HIV-1
English: Cases of jaundice have been reported.
Croatian: Prijavljeni su slučajevi žutice.
English: The maximum volume which can be measured with the dispensing syringe is 5 ml and therefore steps 3-5 must be repeated for dose volumes greater than 5 ml.
Croatian: Maksimalni volumen koji se može izmjeriti dozirnom štrcaljkom je 5 ml te se stoga koraci 3-5 ponavljaju za volumene doze veće od 5 ml.
English: There were no differences based on the formulation taken (immediate-release twice daily or prolonged-release once daily).
Croatian: Nije bilo razlike s obzirom na primjenjivanu formulaciju (trenutno oslobađanje dvaput dnevno ili produljeno oslobađanje jednom dnevno).
English: The plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the paediatric population, but were more variable between patients, particularly in the second month of age.
Croatian: Opažene koncentracije nevirapina u plazmi bile su unutar raspona opaženih u odraslih i u preostalom dijelu pedijatrijske populacije, ali su više varirale između bolesnika, pogotovo u drugom mjesecu života.
English: If you are an adult and choose to use another measuring device (e.g. cup or teaspoon) please make sure that you take the whole dose.
Croatian: Ako ste odrasla osoba i odaberete koristiti drugu mjernu napravu (npr. šalica ili čajna žličica), molimo, budite sigurni da ste uzeli cijelu dozu.
English: Do not chew your tablets.
Croatian: Ne žvačite tablete.
English: Interaction has not been studied.
Croatian: Interakcije nisu ispitivane.
English: The most common clinical toxicity of nevirapine is rash.
Croatian: Najčešća klinička toksičnost nevirapina je osip.
English: The denominator 1,068 includes 55 patients who stopped treatment during the lead in phase and two patients randomized but never treated with randomized dose.
Croatian: Denominator 1 068 uključuje 55 bolesnika koji su prekinuli liječenje tijekom uvodnog razdoblja i dva randomizirana bolesnika koji nisu nikad bili liječeni randomiziranom dozom.
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju istodobne antivirusne terapije za hepatitis B ili C, molimo obratite pozornost na važne infomacije i o tim lijekovima.
English: In addition, Viramune has not been shown to cause glucose disturbances.
Croatian: Nadalje, nije se pokazalo da Viramune izaziva poremećaje glukoze.
English: Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Croatian: Nevirapin je induktor CYP3A i potencijalno CYP2B6, s maksimalnom indukcijom koja se događa unutar 2-4 tjedna nakon početka terapije višestrukom dozom.
English: Careful monitoring of paediatric patients is especially warranted, particularly in the first 18 weeks of treatment, since these patients may be less likely than adults to notice, or report, skin reactions.
Croatian: Naročito se zahtijeva pažljivo praćenje pedijatrijskih bolesnika, osobito u prvih 18 tjedana liječenja, jer postoji manja vjerojatnost da ti bolesnici prijave kožne reakcije nego odrasli bolesnici.
English: Reverse transcriptase is an enzyme that HIV needs in order to multiply.
Croatian: Reverzna transkriptaza je enzim potreban HIV-u radi umnožavanja.
English: Patients 16 years and older
Croatian: Bolesnici u dobi od 16 godina i stariji
English: In these cases, more frequent liver monitoring is required.
Croatian: U ovakvim slučajevima potrebno je češće praćenje jetrenih funkcija.
English: The numerator 793 is the number of patients who were treatment responders at 48 weeks (384 from immediate-release and 409 from prolonged-release treatment groups).
Croatian: Numerator 793 je broj bolesnika koji su odgovorili na liječenje u 48 tjedana (384 iz skupine s trenutnim oslobađanjem i 409 iz skupine s produljenim oslobađanjem).
English: What Viramune contains
Croatian: Što Viramune sadrži
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji se mogu javiti više mjeseci nakon početka liječenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 February 1998
Croatian: Datum prvog odobrenja: 5. veljače 1998.
English: Only take Viramune tablets by mouth.
Croatian: Viramune tablete uzimajte samo kroz usta.
English: Nevirapine concentrations in human cerebrospinal fluid (n = 6) were 45 % ( 5 %) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein.
Croatian: Koncentracije nevirapina u cerebrospinalnom likvoru ljudi (n=6) bile su 45% (± 5%) plazmatskih koncentracija; ovaj omjer otprilike je jednak frakciji koja nije vezana na proteine plazme.
English: Children less than three years old
Croatian: Djeca mlađa od tri godine
English: The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
Croatian: Većina teških osipa dogodila se unutar prvih 6 tjedana liječenja i pojedini slučajevi su zahtijevali hospitalizaciju, a jedan bolesnik je bio podvrgnut kirurškoj intervenciji (vidjeti dio 4.4).
English: The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Croatian: Odabir daljnje terapije nakon Viramunea mora se zasnivati na kliničkom iskustvu i testiranju rezistencije (vidjeti dio 5.1).
English: Overall, there was a comparable incidence of symptomatic hepatic events among men and women enrolled in VERxVE.
Croatian: Zaključno je utvrđena usporediva incidencija simptomatskih jetrenih događaja među muškarcima i ženama uključenima u VERxVE ispitivanje.
English: ANALGESICS/OPIOIDS Methadone Individual Patient Dosing
Croatian: ANALGETICI/OPIOIDI Doziranje metadona za pojedinog bolesnika
English: Nevirapine: compared to historical controls, levels appeared to be unchanged.
Croatian: Nevirapin: u usporedbi s povijesnom kontrolom, razine su nepromijenjene.
English: Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Croatian: Genotipska analiza pokazala je mutacije u HIV-1-RT genu Y181C i/ili V106A ovisno o virusnom soju i staničnoj liniji.
English: Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Croatian: Izloženost klaritromicinu bila je značajno smanjena, a izloženost 14OH metabolitu povećana.
English: In these patients nevirapine must not be restarted.
Croatian: U tih se bolesnika terapija nevirapinom ne smije ponovo započinjati.
English: Distribution: Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Croatian: Distribucija: Nevirapin je lipofilan i u osnovi nije ioniziran pri fiziološkom pH.
English: This herbal substance may stop Viramune from working properly.
Croatian: Ova biljna tvar može zaustaviti pravilno djelovanje Viramunea.
English: These may look like whole tablets, but have not been found to affect the efficacy of nevirapine.
Croatian: Oni mogu izgledati poput cijelih tableta, međutim, ne postoji dokaz o utjecaju ovog na djelotvornost nevirapina.
English: Numerous studies have been performed examining the use of Viramune in regards to perinatal transmission, most notably HIVNET 012.
Croatian: Provedena su brojna ispitivanja primjene Viramunea u smislu perinatalnog prijenosa, a najznačajnije je HIVNET 012.
English: It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop.
Croatian: Važno je nastaviti s ispravnim uzimanjem Viramunea, kao što je prethodno opisano, osim ako Vam liječnik da uputu da prekinete uzimati Viramune.
English: Of these 50 patients, 28 developed resistance to efavirenz and 39 developed resistance to etravirine (the most frequently emergent resistance mutation being Y181C).
Croatian: Od tih 50 bolesnika, 28 je razvilo rezistenciju na efavirenz, a 39 je razvilo rezistenciju na etravirin (s najčešćom mutacijom rezistancije Y181C).
English: This is because some Viramune can remain in the cup or spoon.
Croatian: Ovo je potrebno jer se Viramune može zadržati u šalici ili na žličici.
English: Total cholesterol/HDL
Croatian: Ukupni kolesterol/HDL
English: No clinical data available.
Croatian: Nisu dostupni klinički podaci.
English: Hypersensitivity (allergic) reactions can occur.
Croatian: Može doći do pojave reakcija preosjetljivosti (alergijske reakcije).
English: Children less than three years old.
Croatian: Djeca mlađa od tri godine starosti.
English: All patients received tenofovir + emtricitabine as background therapy.
Croatian: Svi bolesnici primali su tenofovir + emtricitabin kao osnovnu terapiju.
English: * Includes 2 patients who were randomised but never received blinded medicinal products.
Croatian: * Uključuje 2 bolesnika koji su bili randomizirani, ali nikada nisu primili lijekove “naslijepo”.
English: If you are taking oral contraceptives (e.g. „pill“) or other hormonal methods of birth control during treatment with Viramune, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission.
Croatian: Ako uzimate oralne kontraceptive (npr. „pilule“) ili druge hormonske metode kontrole rađanja tijekom liječenja Viramuneom, trebate koristiti barijernu kontracepciju (npr. kondomi) kako bi dodatno spriječili trudnoću i daljnji prijenos HIV-a.
English: This study demonstrated a significant reduction in transmission using single dose nevirapine (13.1 % (n = 310) in the Viramune group, versus 25.1 % (n = 308) in the ultra-short zidovudine group (p = 0.00063)).
Croatian: Ovo ispitivanje je pokazalo značajno smanjenje prijenosa uz jednokratnu dozu nevirapina (13,1 % (n=310) u skupini na Viramuneu u odnosu na 25,1% (n=308) u skupini s ultrakratkom primjenom zidovudina (p=0,00063)).
English: Viramune is also available as tablets.
Croatian: Viremune je također dostupan u tabletama.
English: However, due to the high interpatient variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity.
Croatian: Međutim, zbog velike interindividualne varijabilnosti neki bolesnici imaju veliko povećanje izlaganja rifibutinu pa rizik toksičnosti rifabutina može biti povećan.
English: Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Croatian: Stoga, metabolizam citokroma P450, konjugacija s glukuronidom i izlučivanje glukuronidnih metabolita urinom predstavljaju primarni put biotransformacije i eliminacije nevirapina u ljudi.
English: Asymptomatic GGT elevations are not a contraindication to continue therapy.
Croatian: Asimptomatska povišenja GGT-a nije kontraindikacija za nastavak terapije.
English: During the first 18 weeks of treatment with Viramune it is very important that you and your doctor watch out for signs of liver or skin reactions.
Croatian: Tijekom prvih 18 tjedana liječenja Viramuneom, vrlo je važno da Vi i Vaš liječnik pratite znakove reakcija na jetri i koži.
English: Your doctor might then decide to restart you on a lower dose.
Croatian: Nakon toga, možda će odlučiti o ponovnom početku s nižom dozom.
English: Absorption: Nevirapine is readily absorbed (> 90 %) after oral administration in healthy volunteers and in adults with HIV-1 infection.
Croatian: Apsorpcija: Nakon peroralne primjene nevirapin se dobro apsorbira (>90%) u zdravih dobrovoljaca i odraslih s HIV-1 infekcijom.
English: Granulocytopenia is commonly associated with zidovudine.
Croatian: Granulocitopenija se često povezuje sa zidovudinom.
English: Close monitoring of anticoagulation levels is warranted.
Croatian: Mora se osigurati pomno praćenje antikoagulacijskih razina.
English: A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
Croatian: Povišenje doze itrakonazola mora se razmotriti kada se istodobno primjenjuju ova dva lijeka.
English: If you develop severe liver, skin or hypersensitivity reactions whilst taking Viramune, NEVER TAKE VIRAMUNE again without referring to your doctor.
Croatian: Ako razvijete teške jetrene, kožne ili reakcije preosjetljivosti dok uzimate Viramune, NIKAD NE UZIMAJTE VIRAMUNE ponovno bez savjetovanja s liječnikom.
English: If an alternative measuring device is used (e.g. a dispensing cup or teaspoon for larger doses) it is important that the device is rinsed to ensure complete removal of residual oral suspension.
Croatian: Ako se koristi druga dozirna naprava (npr. dozirna čašica ili čajna žličica za veće doze) važno je isprati napravu kako bi se osiguralo potpuno uklanjanje ostatka oralne suspenzije.
English: Very common (may affect more than 1 in 10 people): - rash
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba): - osip
English: For this reason, and to reduce the risk of HIV transmission, barrier contraception (e.g. condoms) is recommended.
Croatian: Iz tog razloga i radi smanjenja rizika od prijenosa HIV-a, preporučuje se barijerna kontracepcija (npr. kondomi).
English: The simultaneous use of nevirapine (400 mg) plus efavirenz (800 mg) was associated with the highest frequency of clinical adverse events and with the highest rate of treatment failure (53.1 %).
Croatian: Istodobna primjena nevirapina (400 mg) i efavirenza (800 mg) bila je povezana s najvišom učestalošću kliničkih nuspojava i najvišom stopom terapijskog neuspjeha (53,1%).
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Croatian: Klinički ishod ovog primijećenog smanjenja najnižih koncentracija boceprevira nije direktno ocjenjivan.
English: In this study, no Grade 3 or 4 rash was observed in either treatment group.
Croatian: U ovom ispitivanju, nije primijećen osip stupnja 3 ili 4 niti u jednoj liječenoj skupini.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako je dokazano da učinkovita supresija virusa antiretrovirusnim liječenjem značajno smanjuje rizik prijenosa bolesti spolnim putem, preostali rizik se ne može isključiti.
English: The required dose volumes should be measured employing the enclosed dispensing syringe and adapter, as described in steps 1-5 below.
Croatian: Potrebne volumene doziranja potrebno je mjeriti pomoću priložene dozirne štrcaljke i nastavka, kako je opisano u koracima 1-5 u nastavku.
English: Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
Croatian: Pažljivo praćenje terapijske učinkovitosti lijekova koji se metaboliziraju putem P450 preporučuje se kada se uzimaju u kombinaciji s nevirapinom.
English: Delavirdine
Croatian: Delavirdin
English: Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction.
Croatian: Odmah obavijestite liječnika ako dobijete osip ili neku drugu nuspojavu reakcije preosjetljivosti (alergijska reakcija).
English: Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Croatian: Primarni ishodi ispitivanja (postotak bolesnika s neuspjelim liječenjem), sekundarni ishodi ispitivanja i osnovna terapija bili su slični kao i u originalnom 2NN ispitivanju.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: Neki bolesnici koji uzimaju kombiniranu antiretrovirusnu terapiju mogu razviti bolest kostiju koja se naziva osteonekroza (smrt koštanog tkiva uzrokovana gubitkom opskrbe kosti krvlju).
English: If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Viramune.
Croatian: Ako se ikada imali samo blage simptome osipa bez drugih reakcija, molimo, odmah obavijestite liječnika koji će Vam savjetovati je li potrebno prekinuti uzimanje Viramunea.
English: 3 with detectable HIV-1 RNA in plasma (50 or more copies/ml), these conditions should be taken in consideration on therapeutic decision (see section 4.4).
Croatian: 3 s detektabilnim HIV-1 RNK u plazmi (50 ili više kopija/mL), ova stanja moraju biti uzeta u obzir prilikom odluke o terapiji (vidjeti dio 4.4).
English: You should not use Viramune on its own.
Croatian: Viramune se ne smije uzimati sam.
English: Make sure that the syringe is tightly inserted.
Croatian: Budite sigurni da je štrcaljka čvrsto umetnuta.
English: Each bottle contains 240 ml of oral suspension.
Croatian: Svaka boca sadrži 240 ml oralne suspenzije.
English: A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
Croatian: Znatno poboljšanje postotka CD4+ stanica opaženo je tijekom 48. tjedna u obje skupine.
English: In a panel of 2,923 predominantly subtype B HIV-1 clinical isolates, the mean EC50 value was 90nM.
Croatian: U skupini od 2923 kliničkih izolata u kojima je dominirao podtip B HIV-1, srednja vrijednost EC50 bila je 90 nM.
English: When rash occurs it is normally mild to moderate.
Croatian: Ako se osip pojavi, obično je blagog do umjerenog oblika.
English: In study 1100.1526 (TRANxITION) no Grade 3 or 4 clinical hepatic events were observed in either treatment group.
Croatian: U ispitivanju 1100.1526 (TRANxITION) nisu opaženi klinički jetreni događaji stupnja 3 ili 4 niti u jednoj liječenoj skupini.
English: Patients who discontinued treatment during the lead-in period are excluded.
Croatian: Bolesnici koji su prekinuli liječenje tijekom uvodnog razdoblja su isključeni.
English: Taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
Croatian: Uzimanje svih doza u odgovarajuće vrijeme: - uvelike povećava učinkovitost kombinacije antiretrovirusnih lijekova koje uzimate - smanjuju se izgledi za razvoj otpornosti HIV-infekcije na antiretrovirusne lijekove koje uzimate.
English: Interaction
Croatian: Interakcije
English: This is therefore an important period which requires close monitoring by your doctor.
Croatian: To je, znači, važno razdoblje koje zahtijeva pomno liječničko praćenje.
English: Because the clarithromycin active metabolite has reduced activity against Mycobacterium aviumintracellulare complex overall activity against the pathogen may be altered.
Croatian: S obzirom da aktivni metabolit klaritromicina ima smanjenu aktivnost protiv Mycobacterium aviumintracellulare complex, ukupna aktivnost protiv patogena se može promijeniti.
English: Because of the risk of increased exposure to Viramune, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Croatian: Zbog rizika od povećanog izlaganja Viramuneu, nužan je oprez ako se lijekovi primjenjuju istodobno, a bolesnici se moraju pomno pratiti.
English: Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Croatian: Ribavirin ne inhibira enzime citokroma P450 i ne postoje dokazi iz ispitivanja toksičnosti da ribavirin inducira jetrene enzime.
English: The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Croatian: Skupna analiza studija iz programa pedijatrijskih kliničkih ispitivanja AIDS-a (PACTG) protokoli 245, 356, 366, 377, i 403 omogućila je i procjenu pedijatrijskih bolesnika u dobi mlađoj od 3 mjeseca (n=17).
English: There were no significant differences in demographic and baseline characteristics between the treatment groups.
Croatian: Nije bilo značajnih razlika u demografiji i početnim vrijednostima između liječenih skupina.
English: In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Croatian: U ispitivanjima kancerogenosti, nevirapin je inducirao tumore jetre u štakora i miševa.