FrancophonIA/ELRC3.0 huggingface dataset:
English: INCIVO is not recommended for use in children and adolescents younger than 18 years of age because the safety and efficacy has not been established in this population.
Croatian: INCIVO se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina zato što u ovoj populaciji nije utvrđena djelotvornost i sigurnost njegove primjene.
English: Effect on concentration of INCIVO or concomitant medicinal product and possible mechanism
Croatian: Učinak na koncentraciju INCIVA ili istodobno primijenjenog lijeka i mogući mehanizam
English: The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body.
Croatian: Inhibitor NS3-4A proteaze smanjuje količinu virusa hepatitisa C u Vašem tijelu.
English: Telaprevir is primarily metabolised in the liver.
Croatian: Telaprevir se prvenstveno metabolizira u jetri.
English: Proton pump inhibitors can be used without dose modification.
Croatian: Inhibitori protonske pumpe mogu se primjenjivati bez prilagodbe doze.
English: The recommended total duration of treatment for patients who have received a liver transplant is 48 weeks.
Croatian: Preporučeno ukupno trajanje liječenja za bolesnike s transplantiranom jetrom je 48 tjedana.
English: INCIVO has only been used in a limited number of patients of 65 years or older.
Croatian: INCIVO se primjenjivao samo kod ograničenog broja bolesnika u dobi od 65 godina starosti ili starijih.
English: The SVR rate for Black patients was 62% (45/73).
Croatian: Stopa SVR u bolesnika crnačke rase bio je 62% (45/73).
English: Permanently discontinue INCIVO immediately.
Croatian: Odmah trajno prekinuti primjenu INCIVA.
English: Caution should be used and dose reduction for amlodipine should be considered.
Croatian: Potreban je oprez i treba razmotriti smanjenje doze amlodipina.
English: The time dependency indicates that inhibition of CYP3A4 may be intensified during the first 2 weeks of treatment.
Croatian: Ovisnost o vremenu upućuje da inhibicija CYP3A4 može biti pojačana tijekom prva 2 tjedna liječenja.
English: Do not drive or operate machines if you feel faint or have problems with your vision while taking INCIVO.
Croatian: Nemojte voziti niti upravljati strojevima ako osjećate da biste se mogli onesvijestiti ili imati probleme s vidom
English: Other enzymes are also involved in the metabolism such as aldo-ketoreductases and other proteolytic enzymes.
Croatian: U metabolizmu također sudjeluju i drugi enzimi poput aldo-ketoreduktaza i ostalih proteolitičkih enzima.
English: Via C. Janssen IT-04100 Borgo San Michele Latina, Italy
Croatian: Janssen IT-04100 Borgo San Michele Latina, Italija
English: Neither telaprevir nor its major metabolite caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation.
Croatian: Ni telaprevir ni njegov glavni metabolit nisu prouzročili oštećenje DNK kad su se ispitivali standardnom baterijom testova mutageneze u prisutnosti i odsutnosti metaboličke aktivacije.
English: Refer to section 4.4, Laboratory tests.
Croatian: Vidjeti dio 4.4, Laboratorijski nalazi.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use INCIVO are provided with a healthcare professional educational pack containing the following:
Croatian: Nositelj odobrenja osigurat će da svi liječnici od kojih se očekuje da će propisivati ili primjenjivati INCIVO dobiju edukacijski paket za zdravstvene djelatnike koji sadrži:
English: These may be symptoms of anaemia (decrease in your red blood cells);
Croatian: To mogu biti simptomi anemije (smanjenja broja crvenih krvnih stanica);
English: Do not use INCIVO in combination with any of the following medicines as they may increase the risk of severe side effects, and/or affect the way INCIVO or the other medicine works:
Croatian: Nemojte uzimati INCIVO u kombinaciji s bilo kojim od sljedećih lijekova, jer oni mogu povećati rizik od teških nuspojava i/ili utjecati na način djelovanja INCIVA ili drugih lijekova:
English: Maximum plasma concentrations after a single dose of telaprevir are generally achieved after 4 - 5 hours.
Croatian: Maksimalne koncentracije telaprevira u plazmi nakon jednokratne doze obično se postignu nakon 4 - 5 sati.
English: If you have both hepatitis C virus infection and human immunodeficiency virus infection, and are taking efavirenz, the recommended dose regimen is 3 tablets of INCIVO every 8 hours with food.
Croatian: Ako imate infekciju virusom hepatitisa C i infekciju virusom humane imunodeficijencije, i uzimate efavirenz, preporučeni režim doziranja je 3 tablete INCIVA svakih 8 sati uz hranu.
English: Make sure that you check the following points and tell your doctor treating your hepatitis C virus (HCV) if any of these apply to you.
Croatian: Svakako pročitajte sljedeće točke i obavijestite liječnika kod kojega liječite hepatitis C (HCV), ako se nešto od navedenog odnosi na Vas.
English: Treatment of overdose with INCIVO consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja INCIVOM sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova i promatranje kliničkog statusa bolesnika.
English: Haemoglobin values gradually improve after completion of INCIVO dosing.
Croatian: Vrijednosti hemoglobina postupno se poboljšavaju nakon završetka liječenja INCIVOM.
English: In INCIVO clinical experience, less than 0.1% of patients had Stevens-Johnson Syndrome (SJS).
Croatian: U kliničkom iskustvu s INCIVOM manje od 0,1% bolesnika dobilo je Stevens-Johnsonov sindrom (SJS).
English: 168 film-coated tablets (4 bottles containing 42 tablets each) The bottles are not to be distributed individually.
Croatian: 168 filmom obloženih tableta (4 bočice od kojih svaka sadrži 42 tablete) Bočice nisu namijenjene pojedinačnoj distribuciji.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: INCIVO may affect other medicines or other medicines may affect INCIVO.
Croatian: INCIVO može utjecati na druge lijekove ili drugi lijekovi mogu utjecati na INCIVO.
English: Increased dose of zolpidem may be required to maintain efficacy.
Croatian: Može biti potrebno povisiti dozu zolpidema, da bi se održala djelotvornost.
English: Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration.
Croatian: Liječnik će Vam izmjeriti količinu virusa u krvi u 4. i 12. tjednu liječenja kako bi odredio trajanje
English: Transfusion rates over the whole study period were 4.6% and 1.6%, respectively.
Croatian: Stope transfuzije tijekom trajanja cijelog ispitivanja iznosile su 4,6% u prvoj i 1,6% u drugoj skupini.
English: INCIVO must always be taken together with food.
Croatian: INCIVO se uvijek mora uzimati s hranom.
English: However, patients treated with peginterferon alfa-2b experienced more frequent viral breakthrough, and were less likely to meet the criteria for shortened total treatment duration (see section 5.1).
Croatian: Međutim, bolesnici liječeni peginterferonom alfa-2b češće su imali virusni proboj i bilo je manje vjerojatno da će zadovoljiti kriterije skraćenog trajanja ukupnog liječenja (vidjeti dio 5.1).
English: Pregnancy precautions for men and women
Croatian: Mjere zaštite od trudnoće za muškarce i žene
English: ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i kategoriji učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100) i rijetko (≥ 1/10 000 do < 1/1000).
English: The total treatment duration was determined based on the patients' individual on-treatment viral response.
Croatian: Ukupno trajanje liječenja bilo je određeno na temelju bolesnikovog individualnog virološkog odgovora na liječenje.
English: to treat psychiatric conditions (neuroleptics)
Croatian: za liječenje psihijatrijskih stanja (neuroleptici)
English: Therefore, INCIVO is not recommended in these patients (see sections 4.2 and 5.2).
Croatian: Stoga se INCIVO ne preporučuje u ovih bolesnika (vidjeti dijelove 4.2 i 5.2).
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AE11.
Croatian: Farmakoterapijska skupina: antivirusni lijekovi izravnog učinka, ATK oznaka: J05AE11.
English: However, when fed via milk from telaprevir-treated dams, body weight gain of rat pups was lower than normal (likely due to taste aversion).
Croatian: Međutim, kad su bili hranjeni mlijekom ženki koje su primale telaprevir, porast tjelesne težine mladunčadi štakora bio je manji od normalnog (vjerojatno zbog neugodnog okusa).
English: You must always take INCIVO with food as this is important to get the right levels of medicine in your body.
Croatian: Uvijek morate uzimati INCIVO uz hranu, što je važno za postizanje odgovarajuće razine lijeka u tijelu.
English: Dose reduction for parenterally administered midazolam should be considered, especially if more than a single dose of midazolam is administered.
Croatian: Potrebno je razmotriti smanjenje doze parenteralno primijenjenog midazolama, osobito ako se primjenjuje više od jednostruke doze midazolama.
English: The plastic bottle comes with a child resistant cap and should be opened as
Croatian: Plastična bočica ima sigurnosni zatvarač za djecu i treba ju otvarati na sljedeći
English: Telaprevir did not have any teratogenic potential in rat or mouse.
Croatian: Telaprevir nije imao nikakvog teratogenog potencijala u štakora ili miša.
English: At week 12, INCIVO dosing ended and patients continued on standard therapy only.
Croatian: U 12. tjednu završila je primjena INCIVA i bolesnici su nastavili uzimati samo standardnu terapiju.
English: It may appear at any time after start of treatment, although the majority of cases appeared between six and ten weeks after the start of treatment with INCIVO.
Croatian: DRESS se može pojaviti u bilo koje vrijeme nakon početka liječenja, premda se u većini slučajeva pojavio između šestog i desetog tjedana od početka liječenja INCIVOM.
English: If trazodone is used with telaprevir, the combination should be used with caution and a lower dose of trazodone should be considered.
Croatian: Ako se trazodon primjenjuje s telaprevirom, kombinaciju treba primjenjivati s oprezom i razmotriti nižu dozu trazodona.
English: Do not take INCIVO if you are allergic to telaprevir or any of the other ingredients of this medicine
Croatian: Nemojte uzimati INCIVO ako ste alergični na telaprevir ili neki drugi sastojak ovog lijeka (naveden
English: When co-administration is required, high doses of itraconazole (> 200 mg/day) or ketoconazole (> 200 mg/day) are not recommended.
Croatian: Kada je potrebna istodobna primjena, ne preporučuju se visoke doze itrakonazola (> 200 mg/dan) ili ketokonazola (> 200 mg/dan).
English: Your doctor may request additional monitoring during your INCIVO treatment.
Croatian: Liječnik može zatražiti dodatno praćenje za vrijeme dok se liječite INCIVOM.
English: In rats and dogs, telaprevir was associated with a reversible reduction of red blood cell parameters accompanied by a regenerative response.
Croatian: U štakora i pasa telaprevir je bio povezan s reverzibilnim smanjenjem parametara crvenih krvnih stanica popraćenim regenerativnim odgovorom.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take INCIVO.
Croatian: Liječnik će procijeniti težinu bolesti vaše jetre prije nego što odluči možete li uzimati INCIVO.
English: Do not remove this desiccant from the bottle.
Croatian: Nemojte uklanjati sredstvo za sušenje iz bočice.
English: More than 90% of rashes were of mild or moderate severity.
Croatian: Više od 90% osipa bilo je blage do umjerene težine.
English: Animal studies are insufficient with respect to human reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu dovoljna za procjenu reproduktivne toksičnosti u ljudi (vidjeti dio 5.3).
English: CYP3A4 is partly responsible for the metabolism of telaprevir.
Croatian: CYP3A4 je djelomično odgovoran za metabolizam telaprevira.
English: Some patients may experience fainting or problems with vision during INCIVO treatment.
Croatian: Neki bolesnici mogu imati nesvjestice ili probleme s vidom za vrijeme liječenja INCIVOM.
English: The median recovery of the administered radioactive dose was approximately 82% in the faeces, 9% in exhaled air and 1% in urine.
Croatian: Medijan izmjerene radioaktivne doze iznosio je približno 82% u stolici, 9% u izdahnutom zraku i 1% u mokraći.
English: There are other uses for sildenafil and tadalafil.
Croatian: Postoje druge svrhe primjene sildenafila i tadalafila.
English: No clinical studies have been performed in paediatric patients.
Croatian: Nisu provedena klinička ispitivanja u pedijatrijskih bolesnika.
English: INCIVO is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: INCIVO se ne preporučuje tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Increased systemic exposures are expected if telaprevir is combined with drugs highly metabolised by this enzyme.
Croatian: Povišene sistemske izloženosti očekuju se ako se telaprevir kombinira s lijekovima koji se u velikom opsegu metaboliziraju preko ovog enzima.
English: INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'.
Croatian: INCIVO sadrži tvar koja se zove telaprevir i pripada skupini lijekova koji se nazivaju ”inhibitori NS3-4A proteaze”.
English: • Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components.
Croatian: • Stupnjevanje i zbrinjavanje osipa i teških kožnih reakcija, osobito s obzirom na kriterije za nastavak ili prekid primjene telaprevira i drugih komponenti liječenja.
English: Telaprevir is extensively metabolised in the liver, involving hydrolysis, oxidation, and reduction.
Croatian: Telaprevir se opsežno metabolizira u jetri putem hidrolize, oksidacije i redukcije.
English: HCV sequencing data were not available for 16 (7%) patients.
Croatian: Podaci o nukleotidnim sljedovima genoma HCV-a nisu bili dostupni za 16 (7%) bolesnika.
English: ANALGESICS alfentanil fentanyl
Croatian: ANALGETICI alfentanil fentanil
English: These are recommended baseline values for initiation of INCIVO combination treatment: - Haemoglobin: ≥ 12 g/dl (females); ≥ 13 g/dl (males)
Croatian: Slijede preporučene početne vrijednosti za početak kombiniranog liječenja s INCIVOM: - hemoglobin: ≥ 12 g/dl (žene); ≥ 13 g/dl (muškarci)
English: phenytoin*
Croatian: fenitoin*
English: Two months after completion of INCIVO treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control.
Croatian: Dva mjeseca nakon završetka liječenja INCIVOM, hormonska kontracepcija ponovno je prikladna kao jedna od dvije potrebne učinkovite metode kontrole začeća.
English: Therefore, you and your partner must use two other birth control methods during the time you are taking INCIVO and for 2 months after stopping this medicine.
Croatian: Stoga Vi i Vaš partner morate koristiti dvije nehormonske metode kontrole začeća tijekom uzimanja INCIVA i 2 mjeseca nakon prestanka liječenja tim lijekom.
English: Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
Croatian: Ribavirin se može ponovno početi primjenjivati uz prilagodbu doze prema smjernicama za ribavirin.
English: For additional information, see sections 4.5 and 4.6.
Croatian: Za dodatne informacije, vidjeti dijelove 4.5 i 4.6.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove
English: Tell your doctor if you have had other problems with your liver such as liver failure.
Croatian: Obavijestite svog liječnika ako ste imali druge probleme s jetrom, kao što je zatajenje jetre.
English: Nagyenyed u. 8-14 H-Budapest, 1123
Croatian: 8-14 H-Budapest, 1123
English: Concomitant use may result in loss of therapeutic effect of telaprevir.
Croatian: Istodobna primjena može rezultirati gubitkom terapijskog učinka telaprevira.
English: Following administration of a single oral dose of 750 mg
Croatian: Nakon primjene jednokratne peroralne doze od 750 mg
English: Your doctor will decide on the appropriate dose regimen for you.
Croatian: Liječnik će odlučiti o tome koji je raspored uzimanja lijeka prikladan za Vas.
English: C-telaprevir in healthy subjects, 90% of total radioactivity was recovered in faeces, urine and expired air within 96 hours post-dose.
Croatian: C-telaprevira u zdravih ispitanika, 90% ukupne radioaktivnosti otkrilo se u stolici, mokraći i izdahnutom zraku u razdoblju od 96 sati nakon doziranja.
English: You must carefully read the information under Rash in section 4 Possible Side Effects.
Croatian: Pažljivo pročitajte informacije o osipu u dijelu 4. Moguće nuspojave.
English: Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO
Croatian: Obavijestite svoga liječnika ako imate infekciju hepatitis B, kako bi mogao odlučiti je li INCIVO odgovarajući lijek za Vas.
English: Pregnancy and contraception requirements
Croatian: Trudnoća i potrebna kontracepcija
English: A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing.
Croatian: Smanjenje vrijednosti hemoglobina javlja se u prva 4 tjedna liječenja, pri čemu se najniže vrijednosti postižu na kraju liječenja INCIVOM.
English: Your doctor will monitor your early response to treatment and how much virus is in your blood.
Croatian: Vaš rani odgovor na liječenje i količinu virusa u krvi.
English: Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
Croatian: Fatalni slučajevi prijavljeni su u bolesnika s progresivnim osipom i sistemskim simptomima koji su nastavili primati INCIVO u kombiniranom liječenju nakon prepoznavanja ozbiljnih kožnih reakcija.
English: Push the plastic screw cap down while turning it counter clockwise.
Croatian: Pritisnite plastični zatvarač s navojem prema dolje dok ga okrećete u smjeru suprotnom od kazaljke na satu.
English: C - telaprevir and VRT-127394 towards total radioactivity recovered in faeces was 31.8% and 18.7%, respectively.
Croatian: C - telaprevira i VRT-127394 u odnosu na ukupnu dozu radioaktivnosti izmjerenu u stolici iznosili su 31,8% i 18,7%.
English: The food is important to get the right levels of medicine in your body.
Croatian: Hrana je potrebna kako bi se postigla potrebna razina lijeka u tijelu.
English: This difference is likely due to the higher genetic barrier for the V36M and R155K substitutions for genotype 1b than genotype 1a.
Croatian: Ova je razlika vjerojatno posljedica više genetske barijere za V36M i R155K supstitucije za genotip 1b nego za genotip 1a.
English: Unless your doctor tells you to stop, continue taking INCIVO in order to ensure that your medicine continues to work against the virus.
Croatian: Ako Vam liječnik nije rekao da prestanete s uzimanjem, nastavite uzimati INCIVO kako bi se osiguralo daljnje djelovanje lijeka na virus.
English: Tadalafil for treatment of erectile dysfunction can be used with caution at a single dose not exceeding 10 mg dose in 72 hours and with increased monitoring for tadalafil associated adverse events.
Croatian: Tadalafil za liječenje erektilne disfunkcije može se primjenjivati uz oprez u jednokratnoj dozi koja ne prelazi 10 mg u 72 sata i uz pojačano praćenje nuspojava povezanih s tadalafilom.
English: However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
Croatian: Međutim, preporučuje se kliničko praćenje, jer će u nekih bolesnika možda trebati prilagoditi dozu metadona tijekom terapije održavanja.
English: Telaprevir and its major metabolite are excreted in rat milk (see section 5.3).
Croatian: Telaprevir i njegov glavni metabolit izlučuju se u mlijeko ženki štakora (vidjeti dio 5.3).
English: Atazanavir/ritonavir: this combination is associated with a high frequency of hyperbilirubinaemia/icterus.
Croatian: Atazanavir/ritonavir: ova kombinacija je povezana s visokom učestalošću hiperbilirubinemije/ikterusa.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Croatian: Bolesnike koji uzimaju estrogene kao nadomjesnu hormonsku terapiju treba klinički pratiti zbog znakova deficijencije estrogena.
English: Mild rash: localised skin eruption and/or a skin eruption with a limited distribution (up to several isolated sites on the body)
Croatian: Blagi osip: lokalizirana erupcija na koži i/ili erupcija na koži ograničene proširenosti (na najviše nekoliko izoliranih mjesta na tijelu)
English: Your doctor may stop your treatment.
Croatian: Vaš liječnik može prekinuti primjenu lijeka.
English: Close monitoring of metformin efficacy and safety is recommended when starting or stopping INCIVO in patients receiving metformin.
Croatian: Preporučuje se brižno praćenje djelotvornosti i sigurnosti metformina kada se započinje ili prekida primjena lijeka INCIVO u bolesnika koji primaju metformin.
English: Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed.
Croatian: Interakcije između telaprevira i antiretrovirusnih lijekova za HIV su česte, te se preporuke iz tablice 2, u dijelu 4.5, moraju pažljivo slijediti.
English: Other enzymes are also involved in the metabolism (see section 5.2).
Croatian: U njegovom metabolizmu također sudjeluju i drugi enzimi (vidjeti dio 5.2).
English: Table 2: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Croatian: Tablica 2: INTERAKCIJE S DRUGIM LIJEKOVIMA
English: The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%).
Croatian: Stopa odgovora u skupini Pbo/PR bila je viša nego kod one koja je zabilježena u ostalim kliničkim ispitivanjima dvostrukog liječenja peginterferonom (povijesne stope SVR < 36%).
English: Hormonal contraceptives may be continued but may not be reliable during INCIVO dosing and for up to two months following cessation of INCIVO (see section 4.5).
Croatian: Hormonska kontracepcija može se nastaviti, ali ne mora biti pouzdana tijekom uzimanja INCIVA i do dva mjeseca nakon prestanka liječenja INCIVOM (vidjeti dio 4.5).
English: In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme.
Croatian: In vitro ispitivanja s rekombinantnim UGT1A3 pokazuju da telaprevir može inhibirati ovaj enzim.
English: Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with INCIVO due to potentially life-threatening adverse events or potential loss of therapeutic effect to INCIVO.
Croatian: Vidjeti dio 4.3 za popis lijekova koji su kontraindicirani za primjenu uz INCIVO zbog potencijalo po život opasnih nuspojava ili zbog potencijalnog gubitka terapijske djelotvornosti INCIVA.