FrancophonIA/ELRC3.0 huggingface dataset:
English: Viramune may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Croatian: Viramune se može dozirati u pedijatrijskih bolesnika ili prema tjelesnoj površini (BSA) ili prema tjelesnoj težini kako slijedi: Prema BSA, uz pomoć Mostellerove formule, preporučena peroralna doza u pedijatrijskih bolesnika svih dobi je 150 mg/m2 jednom dnevno tijekom dva tjedna, iza čega slijedi 150 mg/m2 dvaput dnevno.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ako primijetite bilo kakve simptome infekcije ili druge simptome kao što su slabost mišića, slabost koja počinje u rukama i stopalima te se miče prema gore u smjeru trupa tijela, palpitacije, tremor ili hiperaktivnost, molimo, odmah obavijestite liječnika kako bi Vam propisao potrebno liječenje.
English: Fit the plastic adapter onto the open bottle neck by first pressing and then screwing the adapter.
Croatian: Namjestite plastični nastavak na otvoreno grlo boce tako da prvo pritisnete, a zatim navrtite nastavak.
English: These findings are most likely related to nevirapine being a strong inducer of liver enzymes, and not due to a genotoxic mode of action.
Croatian: Ti su nalazi najvjerojatnije posljedica snažne indukcije jetrenih enzima nevirapinom, a ne zbog genotoksičnog učinka.
English: 3 in the Viramune twice daily and efavirenz groups, respectively.
Croatian: 3 u skupini na Viramuneu dvaput dnevno i skupini na efavirenzu.
English: Approximately half of the patients had tenofovir + emtricitabine as their background therapy, with the remaining patients receiving abacavir sulfate + lamivudine or zidovudine + lamivudine.
Croatian: Oko polovine bolesnika primalo je tenofovir + emtricitabin kao osnovnu terapiju, a preostali bolesnici su primali abakavir sulfat + lamivudine ili zidovudin + lamivudin.
English: This is particularly suitable if: - you have problems swallowing tablets - or you are a child weighing less than 50 kg - or you are a child having a body surface area less than 1.25 square metres (your doctor will work out your surface area).
Croatian: To je osobito pogodno: - ako imate probleme s gutanjem tableta - u djece koja teže manje od 50 kg - u djece čija je površina tijela manja od 1,25 kvadratnih metara (liječnik će izračunati površinu tijela).
English: Osteonecrosis: Although the etiology 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 combination antiretroviral therapy (CART).
Croatian: Osteonekroza: Premda je etiologija osteonekroze multifaktorijalna (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, viši indeks tjelesne mase), slučajevi osteonekroze prijavljeni su posebno u bolesnika s uznapredovalom HIV bolešću i/ili nakon dugotrajne izloženosti kombiniranoj antiretrovirusnoj terapiji (tzv. CART).
English: Carefully read the package leaflet of all other HIV medicines you are taking in combination with Viramune.
Croatian: Pažljivo pročitajte uputu o lijeku svih drugih lijekova protiv HIV -a koje uzimate u kombinaciji s Viramuneom.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Croatian: Relevantni primjeri su citomegalovirusni retinitis, opće i/ili fokalne mikobakterijske infekcije i pneumonija koju uzrokuje
English: Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Croatian: Kobicistat, inhibitor citokroma P450 3A, značajno inhibira jetrene enzime kao i druge metaboličke puteve.
English: In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Croatian: Nadalje, opažene koncentracije nevirapina bile su usporedive među dvjema metodama.
English: Viramune is also available as 200 mg tablets for adults (16 years of age and older).
Croatian: Viramune je također dostupan u obliku 200 mg tableta za odrasle osobe (16 godina i stariji).
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: Pored oportunističkih infekcija, također se mogu pojaviti autoimuni poremećaji (stanje koje se javlja kada imunološki sustav napada zdravo tkivo tijela) nakon početka primjene lijekova za liječenje HIV infekcije.
English: If you notice any of these symptoms please inform your doctor.
Croatian: Ukoliko primijetite bilo koji od ovih simptoma, molimo obavijestite svog liječnika.
English: Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
Croatian: Jedan ml oralne suspenzije sadrži 150 mg saharoze, 162 mg sorbitola, 1,8 mg metilparahidroksibenzoata i 0,24 mg propilparahidroksibenzoata.
English: Furthermore, an immediate-release oral suspension dosage form is available for all age groups for a twice daily administration (please refer to the respective Summary of Product Characteristics).
Croatian: Nadalje, oblik doziranja oralne suspenzije s trenutnim oslobađanjem je dostupan za sve dobne skupine za primjenu dvaput dnevno (molimo, referirati se na odgovarajući sažetak opisa svojstava lijeka).
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies (n=2,718).
Croatian: Učestalost je procijenjena iz statističkih proračuna baziranih na ukupnom broju bolesnika izloženih nevirapinu u randomiziranim, kontroliranim kliničkim ispitivanjima (n=2 718).
English: Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
Croatian: Viramune pripada skupini antiretrovirusnih lijekova koji se primjenjuju u liječenju infekcije virusom humane imunodeficijencije (HIV-1).
English: Nevirapine stops reverse transcriptase from working.
Croatian: Nevirapin blokira djelovanje reverzne transkriptaze.
English: For concomitantly administered therapy, the manufacturers recommended dose should be followed.
Croatian: U istodobno primjenjivanoj terapiji, potrebno je slijediti preporuke proizvođača.
English: Viramune is not a cure for HIV infection.
Croatian: Viramune ne dovodi do izliječenja HIV infekcije.
English: Selected demographic and baseline disease characteristics are displayed in Table 1.
Croatian: Odabrana demografska svojstva i početne vrijednosti prikazani su u tablici 1.
English: There are toxicities that require interruption of Viramune therapy (see section 4.4).
Croatian: Postoje toksičnosti koje zahtijevaju prekid terapije Viramuneom (vidjeti dio 4.4).
English: Physicians needing to treat patients co-infected with tuberculosis and using a Viramune containing regimen may consider coadministration of rifabutin instead.
Croatian: Liječnici koji trebaju liječiti bolesnike istodobno inficiranih tuberkulozom koji se liječe Viramuneom mogu, umjesto toga, razmotriti istodobnu primjenu rifabutina.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnici trebaju potražiti medicinski savjet ukoliko osjete bolove u zglobovima, ukočenost zglobova ili teškoće pri kretanju.
English: Autoinduction also results in a corresponding decrease in the terminal phase half-life of nevirapine in plasma from approximately 45 hours (single dose) to approximately 25-30 hours following multiple dosing with 200-400 mg/day.
Croatian: Autoindukcija također rezultira odgovarajućim smanjenjem terminalne faze poluvijeka nevirapina u plazmi s oko 45 sati (jednokratna doza) na oko 25-30 sati nakon višestrukog doziranja 200-400 mg/dan.
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Croatian: Nije potrebna prilagodba doze bolesnicima s blagim do umjerenim oštećenjem jetre (vidjeti dijelove 4.4 i 5.2).
English: Paediatric population Children three years and older and adolescents
Croatian: Pedijatrijska populacija Djeca u dobi tri i više godina i adolescenti
English: Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
Croatian: Rezultati DDI ispitivanja telaprevira s efavirenzom ukazuju na potrebu opreza u istodobnoj primjeni telaprevira s induktorima P450.
English: Make sure that your child's doctor clearly tells you what dose you must give to your child.
Croatian: Budite sigurni da Vam je djetetov liječnik jasno rekao koju dozu morate davati svom djetetu.
English: Randomisation was stratified by screening HIV-1 RNA level (<100,000 copies/ml and >100,000 copies/ml).
Croatian: Randomizacija je stratificirana pomoću probira HIV-1 RNK vrijednosti (<100 000 kopija/ml i >100 000 kopija/ml).
English: Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use nevirapine.
Croatian: Često se opisuju asimptomatska povišenja jetrenih enzima, što ne predstavlja nužno kontraindikaciju za primjenu nevirapina.
English: Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Croatian: Većina iskustava s Viramuneom odnosi se na kombinaciju s nukleozidnim inhibitorima reverzne transkriptaze (NRTI-i).
English: Therefore, patients should be monitored carefully for the appearance of rash during this period.
Croatian: Stoga,bolesnici moraju biti pomno praćeni zbog pojave osipa tijekom tog perioda.
English: Patients should be closely monitored if an isolated rash occurs.
Croatian: Bolesnike treba pomno pratiti u slučaju pojave izoliranog osipa.
English: CONTRACEPTIVES Depomedroxyprogesterone acetate (DMPA) 150 mg every 3 months
Croatian: Depomedroksiprogesteron acetat (DMPA) 150 mg svaka 3 mjeseca
English: The safety and efficacy of Viramune prolonged-release tablets in children aged less than 3 years has not been established.
Croatian: Sigurnost i djelotvornost Viramune tableta s produljenim oslobađanjem u djece u dobi manje od 3 godine nisu ustanovljene.
English: The overall incidence of adverse events was significantly lower (61 patients, or 41 %) in the abacavir group than in the nevirapine group (83 patients, or 54 %) or the efavirenz group (89 patients, or 57 %).
Croatian: Ukupna incidencija nuspojava bila je značajno niža (61 bolesnik, ili 41%) u skupini na abakaviru nego u skupini na nevirapinu (83 bolesnika ili 54%) ili skupini na efavirenzu (89 bolesnika ili 57%).
English: White high density polyethylene (HDPE) bottle with two piece child-resistant closure (outer shell white high density polyethylene, inner shell natural polypropylene) with a low density polyethylene (LDPE) foam liner.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) s dvodijelnim sigurnosnim zatvaračem za djecu (vanjski dio od bijelog polietilena visoke gustoće, unutarnji dio od prirodnog polipropilena), s pjenastim pokrovom od polietilena niske gustoće (LDPE).
English: Combination of other antiretrovirals with single-dose nevirapine attenuates the emergence of nevirapine resistance.
Croatian: Kombinacija drugih antiretrovirusnih lijekova s jednokratnom dozom nevirapina smanjuje pojavnost rezistencije na nevirapin.
English: For adults
Croatian: Za odrasle
English: Decreased blood phosphorus and increased blood pressure were observed in clinical studies with coadministration of tenofovir/emtricitabine.
Croatian: Snižene vrijednosti fosfora u krvi i povišeni krvni tlak su opaženi su u u kliničkim ispitivanjima uz istodobnu primjenu tenofovira/emtricitabina.
English: Viramune must not be readministered to patients who have required permanent discontinuation for clinical hepatitis due to nevirapine.
Croatian: Viramune se ne smije ponovo primjenjivati na bolesnicima kojima je terapija bila trajno prekinuta zbog kliničkog hepatitisa uzrokovanog nevirapinom.
English: Additionally, when postmenopausal hormone therapy is used during administration of nevirapine, its therapeutic effect should be monitored.
Croatian: Nadalje, kada žene u postmenopauzi primjenjuju hormonsku nadomjesnu terapiju tijekom primjene nevirapina, potrebno je pratiti terapijski učinak.
English: Concomitant use of etravirine with nevirapine may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of etravirine.
Croatian: Istodobna primjena etravirina s nevirapinom može izazvati značajno smanjenje koncentracija etravirina u plazmi i gubitak terapijskog učinka etravirina.
English: Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters.
Croatian: Nevirapin: nije bilo značajne razlike u farmakokinetičkim parametrima nevirapina.
English: Cartons containing 2 blister cards (14 tablets).
Croatian: Kutija sadrži 2 blistera (14 tableta).
English: Twenty per cent of patients assigned to nevirapine twice daily and 18% of patients assigned to efavirenz had at least one grade 3 or 4 clinical adverse event.
Croatian: Dvadeset posto bolesnika u skupini na nevirapinu dvaput dnevno i 18% bolesnika na efavirenzu imalo je najmanje jednu kliničku nuspojavu 3. ili 4. stupnja.
English: In an open-label clinical study (ACTG 180) granulocytopenia assessed as medicinal product-related occurred in 5/37 (13.5 %) of patients.
Croatian: U otvorenom kliničkom ispitivanju (ACTG 180) granulocitopenija povezana s lijekom opažena je u 5/37 (13,5%) bolesnika.
English: • are < 8 years of age and weigh 25 kg or more or
Croatian: • < 8 godina starosti i 25 kg ili više ili
English: This is a retrospective multicentre study comparing the 3-year antiviral efficacy of Viramune and efavirenz in combination with stavudine and lamivudine in 2NN patients from week 49 to week 144.
Croatian: U ovoj retrospektivnoj multicentričnoj studiji uspoređena je antivirusna djelotvornost Viramunea i efavirenza u kombinaciji sa stavudinom i lamivudinom tijekom 3 godine u bolesnika koji su sudjelovali u 2NN studiji, od 49. do 144. tjedna.
English: Hepatic-renal failure syndromes have been reported rarely.
Croatian: Rijetko su prijavljeni slučajevi sindroma hepato-renalnog zatajenja.
English: The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
Croatian: Primarni ishod ispitivanja bila je smrt, progresija u sindrom stečene imunodeficijencije (AIDS) ili porast razina HIV1 RNK do 200 kopija ili više po ml.
English: If you stop taking Viramune
Croatian: Ako prestanete uzimati Viramune
English: Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
Croatian: Trenutno dostupni podaci o primjeni nevirapina u trudnica ne ukazuju na potencijal za uzrokovanje malformacija ili fetalnu/neonatalnu toksičnost.
English: You must take Viramune together with other antiretroviral medicines.
Croatian: Viramune se mora uzimati zajedno s drugim antiretrovirusnim lijekovima.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
English: HIV-1 isolates with reduced susceptibility (100-250-fold) to nevirapine emerge in cell culture.
Croatian: Izolati HIV-a-1 sa smanjenom osjetljivošću (100-250 puta) na nevirapin uočeni su u staničnim kulturama.
English: If liver function abnormalities recur, nevirapine should be permanently discontinued.
Croatian: Ako se ponovo pojave abnormalnosti u funkciji jetre, terapija nevirapinom mora se trajno prekinuti.
English: No changes to lamivudine apparent clearance and volume of distribution,
Croatian: Bez promjena vidljivog klirensa i volumena distribucije lamivudina što
English: Viramune tablets are supplied in blisters, with 14, 60 or 120 tablets per carton.
Croatian: Viramune tablete dostupne su u blisterima sa 14, 60 ili 120 tableta po kutiji.
English: In vitro studies with human liver microsomes suggest that oxidative metabolism of nevirapine is mediated primarily by cytochrome P450 isozymes from the CYP3A family, although other isozymes may have a secondary role.
Croatian: In vitro ispitivanja na humanim jetrenim mikrosomima ukazuju da je oksidativni metabolizam nevirapina primarno posredovan izoenzimima iz obitelji CYP3A, iako drugi izoenzimi mogu imati sekundarnu ulogu.
English: Lactose: Viramune tablets contain 636 mg of lactose per maximum recommended daily dose.
Croatian: Laktoza: Viramune tablete sadrže 636 mg laktoze u maksimalnoj preporučenoj dnevnoj dozi.
English: The available pharmacokinetic data suggest that the concomitant use of rifampicin and nevirapine is not recommended.
Croatian: Na temelju dostupnih farmakokinetičkih podataka, ne preporučuje se istodobna primjena rifampicina i nevirapina.
English: Cimetidine: no significant effect on cimetidine PK parameters is seen.
Croatian: Cimetidin: nije viđen značajan učinak na PK-parametre cimetidina.
English: After 14 days, the usual dose is 20 ml (200 mg) twice a day.
Croatian: Nakon 14 dana, uobičajena doza je 20 ml (200 mg) dvaput na dan.
English: Monotherapy with Viramune has been associated with the development of NNRTI resistance.
Croatian: Monoterapija Viramuneom je povezana s razvojem rezistencije na NNRTI.
English: According to paediatric dose recommendations Viramune 400 mg prolonged-release tablets can be also taken by children, following the adult dosing schedule, if they
Croatian: Prema preporukama u pedijatrijskoj primjeni Viramune 400 mg tablete s produljenim oslobađanjem također mogu uzimati djeca, prema režimu doziranja za odrasle, ako imaju
English: Hormonal methods of birth control other than Depo-medroxyprogesterone acetate (DMPA) should not be used as the sole method of contraception in women taking Viramune, since nevirapine might lower the plasma concentrations of these medicinal products.
Croatian: Hormonska kontracepcija, osim one koja se temelji na primjeni depo-pripravaka medroksiprogesteronacetata, ne smije biti jedina metoda kontracepcije u žena koje uzimaju Viramune, s obzirom da nevirapin može sniziti koncentracije tih lijekova u plazmi.
English: One side is embossed with the code “54 193”, with a single bisect separating the “54” and “193”.
Croatian: Jedna strana ima utisnutu oznaku „54 193“, s jednim urezom koji odvaja „54“ i „193“.
English: Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Croatian: U studiji su sudjelovali bolesnici koji su u 48. tjednu 2NN ispitivanja, kada je ispitivanje završeno, još uvijek bili pod aktivnim praćenjem, te su nastavili liječenje u klinici uključenoj u studiju.
English: BSA range (m
Croatian: BSA raspon (m
English: Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day.
Croatian: Nakon višekratnih doza, vršne koncentracije nevirapina izgleda da povećavaju linearnost doza u rasponu od 200 do 400 mg/dan.
English: Dose adjustment of Viramune is not required when co-administered with lopinavir.
Croatian: Prilagodba doze Viramunea nije potrebna pri istodobnoj primjeni s lopinavirom.
English: Methyl and propyl parahydroxybenzoates: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Croatian: Metil i propilparahidroksibenzoati: Viramune oralna suspenzija sadrži metilparahidroksibenzoat i propilparahidroksibenzoat, koji mogu izavati alergijsku reakciju (moguće odgođenu).
English: The difference in nevirapine pharmacokinetics observed when Viramune prolonged-release tablets are dosed under fasted or fed conditions is not considered clinically relevant.
Croatian: Razlika u farmakokinetici nevirapina opažena uz Viramune tablete s produljenim oslobađanjem, u uvjetima natašte i na pun želudac, ne smatra se klinički značajnom.
English: The calculation will include your child's age and body weight, or body surface area.
Croatian: Izračun će uključivati dob Vašeg djeteta i težinu ili površinu tijela.
English: Only a small fraction (< 5 %) of the radioactivity in urine (representing < 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Croatian: Samo mali dio (< 5%) radioaktivnosti u urinu (koji predstavlja <3% ukupne doze) otpada na neizmijenjeni lijek; stoga izlučivanje neizmijenjenog lijeka bubregom ima tek neznatnu ulogu u eliminaciji neizmijenjenog lijeka.
English: Nevirapine AUC  1.20 Nevirapine Cmax  1.20
Croatian: Nevirapin AUC  1,20 Nevirapin Cmax  1,20
English: Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally.
Croatian: Adefovir nije utjecao na neku od čestih CYP izoformi za koje se zna da su uključene u metabolizam lijeka u ljudi te se izlučuje renalnim putem.
English: If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Croatian: Ako su AST ili ALT ≥2,5 x GGN prije ili tijekom liječenja, testovi jetre moraju se pratiti češće na redovitim liječničkim kontrolama.
English: If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Croatian: Ako uzimate ili vam je propisan rifampicin za liječenje tuberkuloze, molimo, obavijestite svog liječnika prije nego uzmete ovaj lijek s Viramuneom.
English: Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Croatian: Viramune oralna suspenzija je dostupna u plastičnim bocama sa suspenzijom za primjenu kroz usta, s 240 ml suspenzije u jednoj boci.
English: Although these may appear normal (for example nappy rash), they might be rashes due to Viramune.
Croatian: Iako se može činiti norm alnim (npr. pelenski osip), takvi osipi mogu biti izazvani Viramuneom.
English: - weigh 50 kg or more
Croatian: - imaju 50 ili više kilograma
English: Viramune 100 mg prolonged-release tablets are yellow, round and biconvex.
Croatian: Viramune 100 mg tablete s produljenimm oslobađanjem su žute, okrugle i bikonveksne.
English: Children three years and older and adolescents
Croatian: Djeca u dobi tri i više godina i adolescenti
English: PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack containing 14 tablets
Croatian: Pakiranje za početak liječenja koje sadrži 14 tableta
English: Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia.
Croatian: Stoga, bolesnici koji istodobno primaju nevirapin i zidovudin, a osobito pedijatrijski bolesnici i bolesnici koji primaju više doze zidovudina ili bolesnici sa slabom rezervom koštane srži, osobito osobe s uznapredovalom HIV-bolešću, su pod povećanim rizikom od granulocitopenije.