FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 doses 25 doses
Croatian: 5 doza 25 doza
English: 21 days after the second dose of the two dose intramuscular vaccination schedule.
Croatian: 21 dan nakon druge doze dvokratne intramuskularne sheme cijepljenja.
English: To stimulate active immunity against bovine respiratory syncytial virus.
Croatian: Za poticanje aktivne imunosti protiv goveđeg respiratornog sincicijskog virusa.
English: 5 doses
Croatian: 5 doza
English: Primary vaccination (intramuscular injection): One intramuscular injection of 2 ml should be given, followed by a second intramuscular injection of 2 ml given 4 weeks later.
Croatian: Primarno cijepljenje (intramuskularna injekcija): Treba dati jednu intramuskularnu injekciju od 2 ml, nakon čega slijedi druga intramuskularna injekcija od 2 ml koja se daje 4 tjedna kasnije.
English: Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml).
Croatian: Primarno cijepljenje (nazalna uporaba): U svaku nosnicu uprskajte 1 ml (tako da je ukupni volumen 2 ml).
English: Full immunity is established from 21 days after nasal vaccination.
Croatian: Potpuna imunost nastupa 21 dan nakon nazalne primjene.
English: Solvent: Polyethylene (PET) vials of 10 ml or 50 ml, sealed with a bromobutyl rubber stopper and aluminium cap.
Croatian: Otapalo: Bočice od polietilena (PET) od 10 ml ili 50 ml, zatvorene bromobutilnim gumenim čepom i aluminijskom kapicom.
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56.
Croatian: Živi atenuirani goveđi respiratorni sincicijski virus, soj Lym-56.
English: Solvent for NASYM
Croatian: Otapalo za NASYM
English: For the 25 doses vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent.
Croatian: U slučaju bočice s 25 doza nakon suspenzije liofiliziranog praška izvucite svu suspenziju dobivenu iz bočice sa cjepivom i uštrcajte je u bočicu sa preostalim otapalom.
English: Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Sodium chloride
Croatian: Kalijev dihidrogen fosfat Dinatrij fosfat dodekahidrat Natrijev klorid Kalijev klorid Voda za injekcije
English: Peel the top off the aluminium cap on the vial containing the solvent, and withdraw 10 ml.
Croatian: Odlijepite gornji dio s aluminijske kapice na bočici s otapalom i povucite 10 ml.
English: 10 vials of lyophilisate (50 doses) 10 vials of lyophilisate (250 doses)
Croatian: 10 bočica liofilizata (50 doza) 10 bočica liofilizata (250 doza)
English: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: UPUTA O VMP: NASYM liofilizat i otapalo za suspenziju za injekciju ili nazalni raspršivač za goveda NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination.
Croatian: Docjepljivanje: Jedna intramuskularna injekcija od 2 ml trebala bi se primijeniti 6 mjeseci nakon okončanja osnovne sheme cijepljenja, a onda svakih 6 mjeseci nakon zadnjeg docjepljivanja.
English: Inject the 10 ml of solvent into the vial containing the lyophilisate (freeze-dried powder).
Croatian: Ubrizgajte 10 ml otapala u bočicu koja sadrži liofilizat (liofilizirani prašak).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (1x5 doses and 1x25 doses)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija (1x5 doza i 1x25 doza)
English: Phosphate buffer solution
Croatian: Otopina fosfatnog pufera
English: Lyophilisate: Whitish freeze-dried lyophilisate.
Croatian: Liofilizat: Bjelkasti suho smrznuti liofilizat.
English: Phosphate buffer solution Lyophilisate: Whitish freeze-dried lyophilisate.
Croatian: Otopina fosfatnog pufera Liofilizat: Bjelkasti suho smrznuti liofilizat.
English: Solvent: Homogeneous-clear solution.
Croatian: Otapalo: Homogeno bistra otopina.
English: Revaccination: One intramuscular injection of 2 ml should be given 2 months after the primary vaccination, and then every 6 months after the last revaccination.
Croatian: Docjepljivanje: Jednu intramuskularnu injekciju od 2 ml treba dati 2 mjeseca nakon primarnog cijepljenja, a zatim svakih 6 mjeseci nakon posljednjeg docjepljivanja.
English: 21 days after administration of one dose by the nasal route.
Croatian: Početak imunosti: 21 dan nakon davanja jedne doze nazalnim putem.
English: Potassium dihydrogen phosphate Dipotassium phosphate
Croatian: Kalijev dihidrogen fosfat Dikalijev fosfat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for solvent (10 x 10 ml and 10 x 50 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija za otapalo (10x10 ml i 10x50 ml)
English: Shelf life of the solvent: 5 years
Croatian: Rok valjanosti otapala: 5 godina.
English: Reconstitute the vaccine with the corresponding volume of solvent:
Croatian: Rekonstituirajte cjepivo s odgovarajućim volumenom otapala: Broj doza u bočici liofilizata
English: 1 vial of lyophilisate and 1 vial of solvent (5 doses) 1 vial of lyophilisate and 1 vial of solvent (25 doses)
Croatian: VELIČINA PAKOVANJA 1 bočica liofilizata i 1 bočica otapala (5 doza) 1 bočica liofilizata i 1 bočica otapala (25 doza)
English: Nasal use or intramuscular use.
Croatian: Nazalna ili intramuskularna primjena.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for lyophilisate (10 x 5 doses and 10 x 25 doses)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija za liofilizat (10x5 doza i 10x25 doza)
English: Cardboard box with 10 lyophilisate vials of 25 doses.
Croatian: Kartonska kutija s 10 bočica liofilizata s 25 doza.
English: Cardboard box with 10 lyophilisate vials of 5 doses.
Croatian: Kartonska kutija s 10 bočica liofilizata s 5 doza.
English: Lyophilisate (vaccine): 10 ml type I glass vials of 5 or 25 doses, sealed with a bromobutyl rubber stopper and aluminium cap.
Croatian: I od 10 ml s 5 ili 25 doza, zabrtvljene bromobutilnim gumenim čepom i aluminijskom kapicom.
English: 10 vials of solvent (100 ml) 10 vials of solvent (500 ml)
Croatian: VELIČINA PAKOVANJA 10 bočica otapala (100 ml) 10 bočica otapala (500 ml)
English: Each dose of 2 ml contains: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50
Croatian: Svaka doza od 2 ml sadrži: Živi atenuirani goveđi respiratorni sincicijski virus, soj Lym-56 .................... 104.7 - 6.5 CCID50
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I> PROIZVOĐAČODGOVORANZA
English: Laboratorios Hipra, S.A. Avda.
Croatian: Laboratorios Hipra, S.A.
English: Cardboard box with 1 lyophilisate vial of 25 doses and 1 vial of 50 ml of solvent.
Croatian: Kartonska kutija s 1 bočicom liofilizata s 25 doza i 1 bočicom s 50 ml otapala.
English: Laboratorios Hipra, S.A. Carretera C-63 Km 48.300 Polígon Industrial El Rieral, 17170 Amer (Girona) Spain
Croatian: Laboratorios Hipra, S.A. Avda. la Selva 135, 17170 Amer (Girona) Španjolska
English: Cardboard box with 1 lyophilisate vial of 5 doses and 1 vial of 10 ml of solvent.
Croatian: Kartonska kutija s 1 bočicom liofilizata s 5 doza i 1 bočicom s 10 ml otapala.
English: Vial of lyophilisate (5 doses and 25 doses) NAME OF THE VETERINARY MEDICINAL PRODUCT
Croatian: Bočica liofilizata (5 doza i 25 doza)
English: Cardboard box with 10 vials of 10 ml of solvent.
Croatian: Kartonska kutija s 10 bočica s 10 ml otapala.
English: Lyophilisate for suspension for injection or nasal spray
Croatian: Liofilizat za suspenziju za injekciju ili nazalni raspršivač
English: Solvent vials (10 ml and 50 ml) NAME OF THE VETERINARY MEDICINAL PRODUCT
Croatian: Bočice s otapalom (10 ml i 50 ml)
English: Cardboard box with 10 vials of 50 ml of solvent.
Croatian: Kartonska kutija s 10 bočica s 50 ml otapala.
English: Lyophilisate and solvent for suspension for injection or nasal spray.
Croatian: Liofilizat i otapalo za suspenziju za injekciju ili nazalni raspršivač
English: Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 ..... 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Croatian: Živi atenuirani goveđi respiratorni sincicijski virus (BRSV), soj Lym-56 ...... 104.7 - 6.5 CCID50*
English: la Selva 135, 17170 Amer (Girona) Spain
Croatian: 17170 Amer (Girona) Španjolska
English: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle.
Croatian: NASYM liofilizat i otapalo za suspenziju za injekciju ili nazalni raspršivač za goveda.
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Croatian: Živi atenuirani goveđi respiratorni sincicijski virus, soj Lym-56 .................... 104.7 - 6.5 CCID50*
English: Solvent for suspension for injection or nasal spray
Croatian: Otapalo za suspenziju za injekciju ili nazalni raspršivač
English: NASYM lyophilisate for suspension for injection or nasal spray for cattle
Croatian: NASYM liofilizat za suspenziju za injekciju ili nazalni raspršivač za goveda
English: la Selva 135
Croatian: Laboratorios Hipra, S.A. Avda. la Selva 135
English: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle
Croatian: NASYM liofilizat i otapalo za suspenziju za injekcije ili nazalni raspršivač za goveda
English: Powder for concentrate for solution for infusion
Croatian: 140 mg prašak za koncentrat za otopinu za infuziju intravenski bočica (staklo) 1 bočica
English: What else do I need to know?
Croatian: Što još moram znati?
English: What should I do with this card?
Croatian: Što trebam učiniti s ovom karticom?
English: Where can I get more information?
Croatian: Gdje mogu pronaći više informacija?
English: Ask your pharmacist how to throw away medicines that you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: No additional safety signals were identified.
Croatian: Nisu uočeni dodatni sigurnosni signali.
English: Name:_______________________ Doctor's
Croatian: Ime liječnika:__________________________
English: Look out for the following possible signs of infection:
Croatian: Pripazite na sljedeće moguće znakove infekcije:
English: Median TTP:
Croatian: Medijan TTP:
English: In particular, tell your doctor:
Croatian: Osobito je važno da kažete liječniku:
English: • you have ever had or might now have a hepatitis infection.
Croatian: • ako ste ikada imali ili možda trenutno imate infekciju hepatitisom.
English: Survival Time (Months)
Croatian: Vrijeme preživljenja (mjeseci)
English: • if you are taking medicines for high blood pressure.
Croatian: • ako uzimate lijekove za liječenje visokog krvnog tlaka.
English: • you have a severe active infection at the moment
Croatian: • ako trenutno imate tešku aktivnu infekciju
English: Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: Complete remission at 12 and 18 months
Croatian: Potpuna remisija nakon 12 i 18 mjeseci
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Croatian: Ipak, za sada se ne može isključiti mogući rizik za razvoj solidnih tumora.
English: WestEnd Office Building B torony Hungary
Croatian: WestEnd Office Building B torony
English: The safety and efficacy of Ritemvia in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Ritemvia u djece mlađe od 18 godina nisu ustanovljene.
English: Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Croatian: Također, recite liječniku ako ste u prošlosti imali puno infekcija ili ako imate tešku infekciju.
English: These patients should be very closely monitored throughout the first infusion.
Croatian: Te bolesnike treba vrlo pažljivo nadzirati tijekom cijeloga trajanja prve infuzije.
English: • if you think you may have an infection, even a mild one like a cold.
Croatian: • ako mislite da možda imate infekciju, čak i blagu, poput prehlade.
English: Key results from all four studies are summarised in Table 6.
Croatian: Najvažniji rezultati svih četiriju ispitivanja sažeti su u Tablici 6.
English: Ritemvia may also cause changes in laboratory tests carried out by your doctor.
Croatian: Ritemvia može uzrokovati i promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: When should I not have Ritemvia?
Croatian: Kada ne smijem primiti lijek Ritemvia?
English: These reactions are less likely to happen after the second infusion.
Croatian: Manje je vjerojatno da će se te reakcije pojaviti nakon druge infuzije.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Croatian: Rizik od progresije bolesti smanjen je za 46 %, a rizik od relapsa za 51 %.
English: Not known (it is not known how often these side effects happen):
Croatian: Nepoznato (nije poznato koliko se često te nuspojave javljaju):
English: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea
Croatian: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republika Korea
English: 38 months
Croatian: 38 mjeseci
English: Contents of the pack and other information What Ritemvia contains
Croatian: Sadržaj pakiranja i druge informacije Što Ritemvia sadrži
English: Standard tests to investigate mutagenicity have not been carried out, since such tests are not relevant for this molecule.
Croatian: Nisu provedeni standardni testovi za ispitivanje mutagenosti jer takvi testovi nisu relevantni za ovu molekulu.
English: If you have heart disease or angina, these reactions might get worse.
Croatian: Ako imate srčanu bolest ili anginu pektoris, ove se reakcije mogu pogoršati.
English: Rarely, some of these reactions have been fatal.
Croatian: U rijetkim slučajevima neke od tih reakcija imale su smrtni ishod.
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Croatian: Datum prvog odobrenja: 13. srpnja 2017.
English: Tell your doctor immediately if you have any of these symptoms.
Croatian: Odmah obavijestite svog liječnika ako primijetite neki od tih simptoma.
English: * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Croatian: *Na kraju održavanja/opservacije; rezultati završne analize temelje se na medijanu praćenja od 73 mjeseca.
English: - CI = confidence interval.
Croatian: CI = interval pouzdanosti
English: The median follow up of patients was 53 months.
Croatian: Medijan praćenja bolesnika iznosio je 53 mjeseca.
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Croatian: b Razina pouzdanosti od 95,1 % odražava dodatni alfa od 0,001 koji uzima u obzir privremenu analizu djelotvornosti.
English: It also includes your name and doctor's name and phone number on the back.
Croatian: Na poleđini kartice stoji i Vaše ime te ime i broj telefona Vašeg liječnika.
English: The pre-specified non-inferiority margin for the treatment difference was 20%.
Croatian: Prethodno postavljena granica neinferiornosti za razliku između terapija bila je 20 %.
English: Outcome†
Croatian: Ishod†
English: 3 Reactions occurring during or within 24 hours of infusion.
Croatian: 3 Reakcije koje se javljaju tijekom ili u roku od 24 sata od infuzije.
English: It is important that you keep this Alert Card and show it to your partner or caregiver.
Croatian: Važno je da tu karticu nosite sa sobom i pokažete je svom partneru ili skrbniku.
English: Elderly patients (≥ 65 years):
Croatian: Stariji bolesnici (≥ 65 godina)
English: - * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
Croatian: * pretpostavka najgoreg slučaja a Neinferiornost je dokazana jer je donja granica (−3,2 %) veća od prethodno postavljene granice neinferiornosti (−20 %).
English: Post-hoc retrospective laboratory evaluation
Croatian: Post-hoc retrospektivna laboratorijska ocjena
English: There was no cumulative toxicity in terms of infections reported over a 2-year treatment period.
Croatian: Nije zabilježena kumulativna toksičnost u smislu infekcija prijavljenih tijekom dvogodišnje terapije.
English: This medicine may make you more likely to get infections.
Croatian: Ovaj lijek Vas može učiniti podložnijim infekcijama.
English: Duration of response * Disease free survival (DFS)**
Croatian: Trajanje odgovora* Preživljenje bez bolesti (DFS)**
English: Proportion of patients with no erosive change
Croatian: Udio bolesnika bez erozivnih promjena
English: Ritemvia is indicated in adults for the following indications:
Croatian: Ritemvia je indicirana u odraslih u sljedećim indikacijama:
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Croatian: Bolesnicima također treba savjetovati da obavijeste partnera ili njegovatelje o svojoj terapiji, jer oni mogu primijetiti simptome kojih bolesnik nije svjestan.
English: Primary efficacy
Croatian: Primarna djelotvornost
English: The incidence of serious infections was similar in both arms (approximately 12%).
Croatian: Incidencija ozbiljnih infekcija bila je slična u obje liječene skupine (približno 12%).
English: When these symptoms go away, or improve, the infusion can be continued.
Croatian: Kada se ti simptomi povuku ili ublaže, infuzija se može nastaviti.
English: Do not have Ritemvia if you have an active infection or a serious problem with your immune system.
Croatian: Ne smijete primiti lijek Ritemvia ako imate aktivnu infekciju ili ozbiljne poteškoće s imunološkim sustavom.
English: Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Number of subjects at risk
Croatian: Azatioprin 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituksimab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Broj ispitanika pod rizikom
English: This is a type of protein called a “monoclonal antibody”.
Croatian: To je vrsta proteina koji se naziva „monoklonskim protutijelom“.
English: p-value (Wald test, not adjusted)
Croatian: p-vrijednost (Waldov test, bez prilagođavanja)
English: The primary outcome measure was the rate of major relapse at month 28.
Croatian: Primarna mjera ishoda bila je stopa teškog relapsa u 28. mjesecu.
English: Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Croatian: Odmah obavijestite zdravstvenog radnika koji Vam daje infuziju ako primijetite bilo koji od tih simptoma jer će infuziju možda trebati usporiti ili zaustaviti.
English: Your doctor may decide to stop your Ritemvia treatment if these reactions are serious.
Croatian: Liječnik može odlučiti prekinuti liječenje lijekom Ritemvia ako su te reakcije ozbiljne.
English: These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Croatian: Ti su nalazi ponovljeni u 48. tjednu, kada je seropozitivnost na autoantitijela također uzrokovala značajno veću vjerojatnost postizanja odgovora ACR70.
English: Care must be taken to ensure the sterility of prepared solutions.
Croatian: Potrebno je voditi brigu o sterilnosti pripremljene otopine.
English: • tight or painful muscles
Croatian: • napeti ili bolni mišići
English: Most side effects are mild to moderate but some may be serious and require treatment.
Croatian: Nuspojave su većinom blage do umjerene, ali neke mogu biti ozbiljne i zahtijevati liječenje.
English: • infections such as herpes infections and eye infection
Croatian: • infekcije poput herpesa i infekcija oka
English: What Ritemvia looks like and contents of the pack
Croatian: Kako Ritemvia izgleda i sadržaj pakiranja
English: Your doctor may change this, depending on how you respond to the medicine.
Croatian: Liječnik to može promijeniti sukladno Vašem odgovoru na lijek.
English: • if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries.
Croatian: • ako mislite da ćete u bliskoj budućnosti morati primiti neko cjepivo, uključujući ono koje je obavezno prije putovanja u druge zemlje.
English: Other medicines and Ritemvia
Croatian: Drugi lijekovi i Ritemvia
English: You may require additional treatment such as an antihistamine or paracetamol.
Croatian: Možda će Vam trebati dodatno liječenje, npr. antihistaminicima ili paracetamolom.
English: If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Croatian: Ako se iste teške nuspojave pojave i drugi put, treba ozbiljno razmotriti prekid liječenja ovisno o pojedinom slučaju.
English: Azathioprine 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
Croatian: Azatioprin 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituksimab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
English: Very Rare Not known
Croatian: Manje često Rijetko Vrlo rijetko Nepoznato
English: The transient IgM increase usually returned to at least baseline level within 4 months.
Croatian: Prolazno povećanje razine IgM-a obično se vratilo barem na početnu razinu u roku od 4 mjeseca.
English: Do not have Ritemvia if any of the above apply to you.
Croatian: Nemojte primiti lijek Ritemvia ako se nešto od navedenoga odnosi na Vas.
English: • you have a weak immune system
Croatian: • ako imate oslabljen imunološki sustav
English: What are the signs of getting an infection?
Croatian: Koji su znakovi razvoja infekcije?
English: Oncology indications:
Croatian: Onkološke indikacije:
English: Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small.
Croatian: Eksploracijske analize koristi od terapije održavanja pokazale su manje izražen učinak u starijih bolesnika (> 70 godina), no uzorci su bili mali.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia.
Croatian: Ako ste u dobi kada možete zatrudnjeti, Vi i Vaš partner morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom Ritemvia.
English: Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Croatian: Tablica 14 Ishodi vezani uz fizičku funkciju i kvalitetu života u 24. tjednu u Ispitivanju 1
English: It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Croatian: Ostaje nepoznato mogu li rano otkrivanje PML-a i prekid liječenja lijekom rituksimaba dovesti do slične stabilizacije ili poboljšanog ishoda.
English: Treatment start date and contact details
Croatian: Datum početka liječenja i kontaktni podaci
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: <Sadrži 2D barkod s jedinstvenim identifikatorom.>
English: Kaplan-Meier estimate of median time to event (months)
Croatian: Kaplan-Meierova procjena medijana vremena do pojave događaja (mjeseci)
English: These cases occurred in non-approved indications and the majority of patients were HIV positive.
Croatian: Ovi su se slučajevi pojavili kod liječenja u neodobrenim indikacijama, a većina je bolesnika bila HIV pozitivna.
English: Risk reduction
Croatian: Smanjenje rizika