FrancophonIA/ELRC3.0 huggingface dataset:
English: dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Croatian: Vaš će liječnik možda trebati povećati učestalost krvnih pretraga kako bi provjerio kako se Vaša krv zgrušava. dabigatran eteksilat, koji se koristi za sprječavanje nastanka krvnih ugrušaka ketokonazol, itrakonazol, posakonazol ili vorikonazol, koji se koriste za liječenje gljivičnih infekcija verapamil, diltiazem, nifedipin ili amlodipin, koji se koriste za snižavanje krvnog tlaka rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin ili pravastatin, koji se koriste za snižavanje razine kolesterola u krvi oralne kontraceptive
English: Observed emergent NS5A resistance-associated variants are reported in Table 15.
Croatian: Primijećene varijante NS5A koje su uzrokovale rezistenciju, a pojavile su se tijekom liječenja, prikazane su u Tablici 15.
English: ↔ Warfarin
Croatian: rilpivirin
English: SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level.
Croatian: Stope SVR-a bile su usporedive neovisno o režimu liječenja HIV-a, dobi, rasi, spolu, statusu alela IL28B ili početnoj razini HCV RNK.
English: Do not take Daklinza if you are taking any of the following medicines: phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis dexamethasone, a steroid used to treat allergic and inflammatory diseases medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Croatian: Ne uzimajte lijek Daklinza ako uzimate neki od sljedećih lijekova: fenitoin, karbamazepin, okskabazepin ili fenobarbital, koji se koriste za liječenje epileptičkih rifampicin, rifabutin ili rifapentin, antibiotike koji se koriste za liječenje tuberkuloze deksametazon, kortikosteroid koji se koristi za liječenje alergijskih i upalnih bolesti lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni lijek) Navedeni lijekovi smanjuju učinak lijeka Daklinza pa Vaše liječenje neće biti djelotvorno.
English: * Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2 for 7 patients.
Croatian: ** Ciroza je bila određena biopsijom jetre (METAVIR F4) za 14 bolesnika, FibroScan >14,6 kPa za 11 bolesnika ili rezultat FibroTesta ≥0,75 te indeks omjera aspartat aminotransferaza (AST): trombociti (APRI) >2 za 7 bolesnika.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Daklinza.
Croatian: Nakon što počnete uzimati lijek Daklinza, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bristol-Myers Squibb Pharma EEIG
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC
Croatian: Većina bolesnika (71%, uključujući 98% bolesnika koji nisu odgovorili na prethodno liječenje inhibitorom proteaze) imala je polimorfizam IL-28B rs12979860 koji nije CC
English: Respiratory, thoracic and mediastinal disorders dyspnoea, dyspnoea exertional, cough, nasal diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, dispneja u naporu, kašalj, kongestija proljev, povraćanje, bol u gastroezofagealna konstipacija, suha usta,
English: Ribavirin Dosing Guidelines
Croatian: Smjernice za doziranje ribavirina
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza u bolesnika s bilo kojim stupnjem oštećenja bubrežne funkcije (vidjeti dio 5.2).
English: Very common (may affect more than 1 in 10 people): headache, nausea (feeling sick), fatigue reduction in red blood cells (anaemia) Common (may affect up to 1 in 10 people):
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): smanjen tek svrbež, suha koža, neuobičajeno opadanje ili stanjivanje kose, osip bol u zglobovima; bol u mišićima ili osjetljivost mišića na dodir koja nije posljedica tjelovježbe;
English: * Mainly interferon-based therapy +/-NS3/4 PI. ** Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Croatian: ** Ciroza se utvrđivala biopsijom jetre, vrijednošću > 14,6 kPa izmjerenom uređajem FibroScan ili rezultatom ≥ 0,75 prema FibroTestu i indeksom omjera aspartat aminotransferaze (AST) i trombocita (engl. aspartate aminotransferase: platelet ratio index, APRI) > 2. U 5 se bolesnika status ciroze nije
English: 60 mg tablet orally followed by 100 μg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Croatian: [13C,15N]-daklatazvira od 100 µg, procijenjeni volumen distribucije u stanju dinamičke ravnoteže iznosio je 47 l.
English: Tabulated summary of interactions
Croatian: Tablični prikaz nuspojava
English: Daklinza can be taken with or without a meal.
Croatian: Daklinza se može uzimati neovisno o
English: CP B CP C
Croatian: Bolesnici s cirozom CP stadija C
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir
Croatian: Daklinza 30 mg filmom obložene tablete Daklinza 60 mg filmom obložene tablete daklatazvir
English: Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation,
Croatian: Tablica 9: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom i ribavirinom tijekom 12 tjedana, bolesnici s cirozom i povratom HCV-a nakon presađivanja jetre,
English: Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040
Croatian: Tablica 7: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 24 tjedna, prethodno neliječeni bolesnici s HCV-om genotipa 2 ili 3 u ispitivanju AI444040
English: The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient Emergent daclatasvir resistance-associated substitutions have been shown to persist for 3 years posttreatment and beyond for patients treated with daclatasvir-based regimens.
Croatian: Supstitucija S282T, koja je povezana s rezistencijom na sofosbuvir, pojavila se u samo 1 bolesnika s infekcijom genotipom 3 koji nije postigao SVR12.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks or
Croatian: Daklinza + sofosbuvir tijekom 12 tjedana Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana ili
English: Table 14: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Croatian: Tablica 14: Ishodi liječenja, daklatazvir u kombinaciji s peginterferonom alfa i ribavirinom (pegIFN/RBV), prethodno neliječeni bolesnici s HCV-om genotipa 4 Ispitivanje AI444010
English: Follow guidelines above for haemoglobin 200 mg every other day Discontinue ribavirin
Croatian: Slijediti gore navedene smjernice za hemoglobin 200 mg svaki drugi dan Obustaviti primjenu ribavirina Prilagodba doze, privremen prekid primjene i obustava liječenja
English: Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir.
Croatian: Primjena lijeka Daklinza s verapamilom može dovesti do povećane koncentracije daklatazvira Preporučuje se oprez.
English: Post-Liver Transplant N = 53
Croatian: Bolesnici kojima je presađena jetra N = 53
English: Daklinza + sofosbuvir (without ribavirin) for 24 weeks
Croatian: Daklinza + sofosbuvir (bez ribavirina) tijekom
English: 12 weeks therapy HCV Treatmentnaïve N=101
Croatian: Prethodno neliječeni za HCV N=101
English: One treatment-naïve patient was missing both post-treatment Weeks 12
Croatian: Za jednog prethodno neliječenog bolesnika nedostajali su podaci i iz 12. i iz 24. tjedna nakon liječenja.
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Croatian: Veličina pakiranja: 28 filmom obloženih tableta u perforiranim blisterima djeljivima na pojedinačne Veličina pakiranja: 28 filmom obloženih tableta u neperforiranim kalendarski označenim blisterima.
English: The AUC associated with this dose in males is 19-fold the clinical
Croatian: AUC nakon primjene navedene doze u mužjaka je 19 puta veći od AUC-a nakon primjene preporučene doze za ljude.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije lijekom direktno djelujući antivirotik / DAA, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
Croatian: SVR12 je postignut kod 74% bolesnika u ovom ispitivanju (genotip
English: Bristol-Myers Squibb spol.
Croatian: Bristol-Myers Squibb Kft.
English: s r.o.
Croatian: {MM/GGGG}
English: HORMONAL CONTRACEPTIVES Ethinylestradiol 35 μg once daily for 21 days + norgestimate
Croatian: etinilestradiol 35 μg jedanput
English: Daclatasvir inhibits both viral RNA replication
Croatian: Daklatazvir inhibira i replikaciju virusne RNK i
English: ** One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Croatian: * Bolesnici izgubljeni iz praćenja ** Jedan bolesnik za kojeg se smatralo da nije udovoljavao zahtjevima protokola (bolesnik bez SVR-a) *** Praćene varijante NS5A koje uzrokuju rezistenciju nalazile su se na aminokiselinskim položajima 28, 29,
English: Discontinue Daklinza, peginterferon alfa and ribavirin Discontinue Daklinza, peginterferon alfa and ribavirin
Croatian: Isključiti lijek Daklinza, peginterferon alfa i ribavirin
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3 Treatment-naïve N=101
Croatian: Tablica 12: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 12 tjedana, bolesnici s HCV-om genotipa 3 u ispitivanju ALLY-3
English: CP A
Croatian: 1b
English: All 3 HCV/HIV co
Croatian: Istodobna infekcija HCV-om i HIV-om (ALLY-2)
English: Each film-coated tablet contains 30 mg or 60 mg daclatasvir
Croatian: Jedna filmom obložena tableta sadrži 30 mg ili 60 mg i daklatazvira (u obliku daklatazavir diklorida).
English: ↔ Ethinylestradiol AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
Croatian: ↔ daklatazvir AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70, 0,85) ↔ darunavir AUC: 0,90 (0,73, 1,11)
English: ↑ Daclatasvir AUC: 2.32 (2.06, 2.62) Cmax: 1.46 (1.28, 1.66)
Croatian: ↔ daklatazvir AUC: 1,12 (1,01; 1,26) Cmax: 1,14 (0,98; 1,32)
English: Expected due to inhibition of P-gp by
Croatian: Budući da daklatazvir inhibira P-gp,
English: Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Croatian: ↔ daklatazvir AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94, 1,15) Cmin: 1,56 (1,41; 1,71)
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Croatian: Za preporučene režime liječenja s obzirom na različite genotipove HCV-a, vidjeti dio 4.2. Za virološku i kliničku aktivnost protiv pojedinog genotipa, vidjeti dio 5.1.
English: Inhibition of OATP 1B1 and BCRP by
Croatian: Daklatazvir inhibira OATP1B1 i
English: Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV
Croatian: Bolesnici koji su izvorno randomizirani za primanje placeba i oni u skupini liječenoj daklatazvirom koji u 4. tjednu nisu imali HCV RNK < LLOQ, niti nemjerljive razine HCV RNK u 10. tjednu, nastavili su liječenje kombinacijom pegIFN/RBV do ukupno 48 tjedana liječenja.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets daclatasvir
Croatian: NAZIV LIJEKA Daklinza 30 mg filmom obložene tablete daklatazvir
English: Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatmentexperienced N=24
Croatian: Tablica 13: Ishodi liječenja, daklatazvir u kombinacijs sa sofosbuvirom i ribavirinom tijekom 24 tjedna, bolesnici s HCV-om genotipa 3, i s cirozom u ispitivanju
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets daclatasvir
Croatian: NAZIV LIJEKA Daklinza 60 mg filmom obložene tablete daklatazvir
English: Description of selected adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene umor
English: PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin,
Croatian: Cmin: ↔* ↔ peginterferon alfa daklatazvira pri istodobnoj primjeni s peginterferonom alfa i ribavirinom bili ispitivanju 14-dnevne monoterapije parametara peginterferona alfa u bolesnika koji su primali peginterferon alfa, ribavirin i daklatazvir bile su slične onima u bolesnika koji su primali peginterferon alfa, ribavirin i
English: One patient with HCV genotype 2 infection was missing both post
Croatian: Za jednog bolesnika s infekcijom HCV-om genotipa 2 nedostajali su podaci i iz 12. i iz 24. tjedna nakon liječenja.
English: If you have any questions about your medicines, please ask your doctor or
Croatian: Ako imate bilo kakvih pitanja o tim lijekovima, obratite se svom liječniku ili ljekarniku.
English: Discontinue peginterferon alfa and ribavirin (treatment with Daklinza is complete at week 24) Dose recommendation for concomitant medicines Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4)
Croatian: Isključiti peginterferon alfa i ribavirin (liječenje lijekom Daklinza je završeno u 24. tjednu)
English: Patients received daclatasvir 60 mg once daily, sofosbuvir 400 mg once daily, and ribavirin (600 mg starting dose) for 12 weeks and were monitored for 24 weeks post treatment.
Croatian: Preporuke za istodobnu primjenu peginterferon alfa 180 µg jedanput na tjedan i ribavirin 1000 mg ili 1200 mg na dan u dvije odvojene doze (daklatazvir 60 mg jedanput na dan)
English: Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 60 mg daklatazvira (u obliku daklatazvir diklorida).
English: Fusion inhibitor Enfuvirtide
Croatian: Budući da antifungici inhibiraju
English: if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Croatian: - rifampicin, rifabutin ili rifapentin, antibiotike koji se koriste za liječenje tuberkuloze - deksametazon, kortikosteroid koji se koristi za liječenje alergijskih i upalnih bolesti - lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni pripravak)
English: All 4 patients achieved SVR12.
Croatian: Sva 3 bolesnika istodobno zaražena virusima HCV/HIV postigli su SVR12.
English: Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 30 mg daklatazvira (u obliku daklatazavir diklorida).
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Croatian: (daklatazvir 20 mg jedanput na telaprevir 750 mg svakih 8 sati (daklatazvir 20 mg jedanput na
English: 600 mg daily 400 mg daily 200 mg daily Discontinue ribavirin
Croatian: 600 mg na dan
English: Expected due to CYP3A4 induction by the anticonvulsant:
Croatian: Budući da antimikobakterijski lijekovi induciraju CYP3A4, očekuje se:
English: The relapse rate was around 15%, and similar for patients with Child-Pugh A, B and C. The programmes do not allow for a direct comparison of efficacy between the 12- and 24-week regimens.
Croatian: Programi ne dozvoljavaju direktnu usporedbu djelotvornosti 12-tjednog i 24-tjednog režima liječenja.
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Croatian: IMUNOSUPRESIVI ciklosporin u pojedinačnoj dozi od 400 mg (daklatazvir 60 mg jedanput na dan)
English: Magyarország Bristol-Myers Squibb Kft. Tel.: + 36 1 9206 550
Croatian: Bristol-Myers Squibb spol. s r.o. TEL: +385 1 2078 508
English: Expected due to CYP3A4 induction by
Croatian: Budući da boceprevir inhibira CYP3A4, očekuje se: ↑ daklatazvir
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with efavirenz.
Croatian: Pri istodobnoj primjeni s efavirenzom dozu lijeka Daklinza treba povećati na 90 mg jedanput na dan.
English: CCR5 receptor antagonist Maraviroc
Croatian: Preporuke za istodobnu primjenu etravirin nevirapin
English: ↑ Daclatasvir AUC*: 2.10 (1.95, 2.26)
Croatian: ↔ daklatazvir AUC: ↔* Cmax: ↔* Cmin: ↔*
English: Treatment-naïve
Croatian: Kraj liječenja
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with atazanavir/ritonavir, atazanavir/cobicistat or other strong inhibitors of CYP3A4.
Croatian: Pri istodobnoj primjeni s atazanavirom/ritonavirom, atazanavirom/kobicistatom ili drugim snažnim inhibitorima CYP3A4, dozu lijeka Daklinza treba smanjiti na 30 mg jedanput na dan.
English: ↑ Concentration of statin
Croatian: Rezistencija u staničnoj kulturi
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Broj(EU) odobrenja (Zaštićeno) ime Doza
English: If any of the above apply to you (or you are not sure), talk to your doctor before you are given Ocrevus.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku prije nego što primite Ocrevus.
English: Some of them might be serious
Croatian: Neke od njih mogu biti ozbiljne.
English: Effect on the immune system :
Croatian: Učinak na imunosni sustav:
English: Adults over 55 years old and elderly population
Croatian: Odrasle osobe starije od 55 godina i starije osobe
English: The number of serious infections was too low to draw definitive conclusions.
Croatian: Broj ozbiljnih infekcija bio je premalen da bi se donijeli definitivni zaključci.
English: Do not wait until your next planned infusion.
Croatian: Nemojte čekati do sljedeće planirane infuzije.
English: · you are taking medicines for high blood pressure.
Croatian: · ako uzimate lijekove za visok krvni tlak.
English: The primary analysis is based on all events accrued.
Croatian: Primarna analiza temelji se na svim prikupljenim događajima.
English: Infusion 2 (2 weeks later)
Croatian: 2. infuzija (2 tjedna kasnije)
English: Delayed or Missed Doses
Croatian: Odgođene ili propuštene doze
English: The symptoms can appear suddenly within a few hours, or slowly over several days.
Croatian: Simptomi se mogu pojaviti iznenada, unutar nekoliko sati, ili polako, tijekom nekoliko dana.
English: No increase was observed in PPMS.
Croatian: Porast nije opažen kod PPMS-a.
English: · Keep this leaflet.You may need to read it again.
Croatian: Možda ćete je trebati ponovno pročitati.
English: Contraception for women
Croatian: Kontracepcija za žene
English: * All patients in this analysis had a minimum of 120 weeks of follow-up.
Croatian: * Svi bolesnici u ovoj analizi bili su praćeni tijekom najmanje 120 tjedana.
English: In most cases these are mild reactions but some serious reactions can happen.
Croatian: U većini se slučajeva radi o blagim reakcijama, ali mogu se javiti i neke ozbiljne reakcije.
English: You may not be able to receive Ocrevus.
Croatian: Možda nećete moći primati Ocrevus.
English: This can take from six months to two and a half years, or up to several years in rare cases.
Croatian: Za to može biti potrebno od šest mjeseci do dvije i pol godine, a u rijetkim slučajevima i nekoliko godina.
English: You must not be given Ocrevus:
Croatian: Ne smijete primiti Ocrevus:
English: In rare cases, some of these infections were fatal.
Croatian: U rijetkim su slučajevima neke od tih infekcija imale smrtni ishod.
English: This was sustained throughout the treatment period.
Croatian: Taj se učinak održao tijekom cijelog razdoblja liječenja.
English: · Risk Management Plan (RMP)
Croatian: LIJEKA · Plan upravljanja rizikom (RMP)
English: Treatment of severely immunocompromised patients
Croatian: Liječenje teško imunokompromitiranih bolesnika
English: What is Multiple Sclerosis
Croatian: Što je multipla skleroza
English: Other medicines and Ocrevus
Croatian: Drugi lijekovi i Ocrevus
English: Primary Progressive MS
Croatian: Primarno progresivni MS
English: Animal studies (embryo-foetal toxicity) do not indicate teratogenic effects.
Croatian: Ispitivanja na životinjama (embriofetalna toksičnost) ne ukazuju na teratogene učinke.
English: This is because Ocrevus may lower blood pressure.
Croatian: Naime, Ocrevus može sniziti krvni tlak.
English: Mean number of relapses in the last year
Croatian: Srednji broj relapsa u proteklih godinu dana
English: · you have ever had hepatitis B or are a carrier of the hepatitis B virus.
Croatian: · ako ste ikada imali hepatitis B ili ako ste nositelj virusa hepatitisa B.
English: The safety and efficacy of Ocrevus in children and adolescents aged 0 to 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Ocrevus u djece i adolescenata u dobi od 0 do 18 godina nisu još ustanovljene.
English: A hypersensitivity reaction could also occur (acute allergic reaction to medicinal product).
Croatian: Može se javiti i reakcija preosjetljivosti (akutna alergijska reakcija na lijek).
English: Dose Modifications during Treatment
Croatian: Prilagodbe doze tijekom liječenja
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, ime i broj serije primijenjenog lijeka treba jasno evidentirati.
English: It is a type of protein called a ‘monoclonal antibody'.
Croatian: Radi se o jednoj vrsti proteina koji se zove „monoklonsko protutijelo”.
English: · If you have any further questions, ask your doctor.
Croatian: · Ako imate dodatnih pitanja, obratite se liječniku.
English: What Ocrevus looks like and contents of the pack
Croatian: Kako Ocrevus izgleda i sadržaj pakiranja
English: · Do not use Ocrevus if you are pregnant unless you have discussed this with your doctor.
Croatian: · Nemojte primiti Ocrevus ako ste trudni, osim ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: Please see section 4.2 for populations not studied.
Croatian: Vidjeti dio 4.2 za populacije koje se nisu ispitivale.
English: A risk to neonates and infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenčad i dojenčad.
English: No formal pharmacokinetic study has been conducted.
Croatian: Nije provedeno formalno farmakokinetičko ispitivanje.
English: Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord.
Croatian: Multipla skleroza (MS) zahvaća središnji živčani sustav, osobito živce u mozgu i kralježničnoj moždini.