FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/98/006/001 (1,000 doses, vial) EU/2/98/006/002 (2,500 doses, vial) EU/2/98/006/003 (5,000 doses, vial) EU/2/98/006/004 (10,000 doses, vial) EU/2/98/006/005 (10x 1,000 doses, vials) EU/2/98/006/006 (10x 2,500 doses, vials) EU/2/98/006/007 (10x 5,000 doses, vials) EU/2/98/006/008 (10x 10,000 doses, vials) EU/2/98/006/009 (1x 500 doses, vial)
Croatian: EU/2/98/006/002 ( 2500 doza, bočice) EU/2/98/006/003 ( 5000 doza, bočice) EU/2/98/006/004 ( 10000 doza, bočice) EU/2/98/006/005 ( 10x1000 doza, bočice) EU/2/98/006/006 (10 x 2500 doza, bočice)
English: Vials: off-white/cream-coloured pellet Cups: off-white, predominantly sphere shaped
Croatian: Bočice: krem bijela obojana peleta Čašice: krem bijeli, pretežito okrugli oblici
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - Lyophilisate CUPS
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA NALJEPNICA - Liofilizat ČAŠICE
English: Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
Croatian: Vakcina Nobilis IB 4-91 je namijenjena za zaštitu pilića protiv respiratornih znakova bolesti uzrokovanih varijantnim sojem virusa ZBK 4-91 i ne smije se primjenjivati kao zamjena za druga cjepiva, za virus ZB.
English: DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
English: The vaccine virus may spread from vaccinated to non-vaccinated chickens and appropriate care should be taken to separate vaccinated from non-vaccinated.
Croatian: Cjepni virus može se širiti s cijepljenih pilića na necijepljene, pa treba poduzeti odgovarajuće mjere da cijepljeni pilići budu odvojeni od necijepljenih.
English: EU/2/98/006/010 (10x 500 doses, vials) EU/2/98/006/011 (10x 1,000 doses, cups) EU/2/98/006/012 (10x 5,000 doses, cups) EU/2/98/006/013 (10x 10,000 doses, cups EU/2/98/006/014 (10x 2,500 doses, cups)
Croatian: EU/2/98/006/007 ( 10x 5000 doza, bočice) EU/2/98/006/008 ( 10x 10000 doza, bočice) EU/2/98/006/009 ( 1x 500 doza, bočice) EU/2/98/006/010 ( 10 x 500 doza, bočice) EU/2/98/006/011 ( 10x 1000 doza, čašice)
English: A sufficient number of water containers to provide adequate drinking space is essential.
Croatian: Potreban je dovoljan broj posuda s vodom kako bi pilićima osigurali dovoljnu količinu vode za piće, što je vrlo bitno.
English: Cups: off-white, predominantly sphere shaped.
Croatian: Čašice: krem bijeli, pretežito okrugli oblici.
English: Safety and efficacy data are available which demonstrate that Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Croatian: Dostupni su podaci o neškodljivosti i učinkovitosti koji pokazuju da se Nobilis IB 4-91 može primijeniti jednodnevnim pilićima koji su cijepljeni supkutanom ili in ovo primjenom s Innovax-ND-IBD.
English: By adding skimmed milk to the drinking water the vaccine virus retains its activity longer.
Croatian: Dodavanjem obranog mlijeka u vodu za piće poboljšamo aktivnost virusnog cjepiva.
English: QUANTITY OF ACTIVE SUBSTANCE
Croatian: KOLIČINA DJELATNE(IH) TVARI
English: Active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain IB 4-91.
Croatian: Aktivna imunizacija pilića za smanjenje respiratornih znakova zaraznog bronhitisa uzrokovanih varijantnim sojem IB 4-91.
English: Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration.
Croatian: Deseterostruka maksimalna doza, kod svih preporučenih načina i metoda primjene, je sigurna za životinje kojima je proizvod namijenjen.
English: The appropriate number of vials should be opened under the water or the content of the cup(s) should be poured into the water.
Croatian: Odgovarajući broj bočica treba otvoriti pod vodom ili sadržaj čašica uliti u vodu.
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Nobilis IB 4-91 has been shown to be safe in layers and breeders during lay.
Croatian: Pokazalo se da je primjena Nobilis IB 4-91 neškodljiva u nesilica i rasplodnih pilenki u vrijeme nesenja.
English: Active immunisation against avian infectious bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Croatian: Aktivna imunizacija protiv virusa zaraznog bronhitisa kokoši, varijantni soj IB 4-91, koji uzrokuje zarazni bronhitis u kokoši.
English: Broiler: The vaccine can be administered to 1-day-old chicks and older chickens by coarse spray or by intranasal/ocular administration.
Croatian: Pilići: cjepivo možemo dati jednodnevnim pilićima i starijim pilićima, raspršivanjem ili intranazalnom/okularnom primjenom.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or intranasal/ocular administration to commercial chicks from one day of age onwards.
Croatian: Podaci o neškodljivosti i efikasnosti su dostupni i pokazuju da cjepivo može biti kombinirano i primijenjeno s Nobilis IB Ma5 kao sprej ili intranazalna/okularna primjena, konzumnim pilićima od 1
English: Intranasal/ocular administration
Croatian: Intranazalna/okularna primjena:
English: Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥ 3.6 log10 EID50* * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Croatian: Živi, atenuirani virus zaraznog bronhitisa kokoši (ZBK), varijantni soj 4-91: ≥ 3,6 log 10 EID50 * * EID50: 50% embrio infektivna doza: titar virusa koji uzrokuje infekciju u 50% virusom inokuliranih embrija.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Croatian: NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA
English: Drinking water
Croatian: U vodi za piće:
English: The vials should be opened under water or the content of the cup(s) should be poured into the water.
Croatian: Bočice treba otvoriti pod vodom ili sadržaj čašica uliti u vodu.
English: Lyophilisate for oculonasal suspension/use in drinking water
Croatian: Liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće
English: Future layers and breeders: The vaccine can be administered to future layers and breeders from day old onwards via intranasal/ocular route or coarse spray.
Croatian: Buduće nesilice i rasplodni pilići: Cjepivo možemo dati budućim nesilicama i rasplodnim pilićima u dobi od jednog dana i više, intranazalnim/okularnim putem ili raspršivanjem (veće kapljice).
English: In-use shelf life after mixing: 2 hours.
Croatian: Nakon miješanja rok valjanosti: 2 sata
English: Name and address of the manufacturer of the biological active substance Intervet International B.V.
Croatian: Naziv i adresa proizvođača biološki djelatne) tvari
English: Lyophilisate for oculonasal suspension/use in drinking water.
Croatian: Liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće,
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Croatian: 14. RIJEČI “ČUVATI IZVAN DOSEGA
English: Live attenuated infectious bronchitis virus strain 4-91 ≥ 3.6 log10 EID50* per dose *EID50: 50% embryo infective dose
Croatian: Živi, oslabljeni virus zaraznog bronhitisa kokoši, soj 4-91: 3,6 log 10 EID50. * po dozi * EID50: 50% embrio infektivna doza
English: Cardboard box with 10 cups of 2,500 doses.
Croatian: Kutija s 10 čašica od 2500 doza.
English: Coarse spray, oculonasal or in drinking water use.
Croatian: Okulonazalna primjena, raspršivanje ili u vodi za piće.
English: Lyophilisate
Croatian: Liofilizat
English: Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water
Croatian: Nobilis IB 4-91 liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće
English: Nobilis IB 4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens
Croatian: Nobilis IB 4-91, liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće za piliće
English: Oculonasal use, spray or drinking water
Croatian: Okulonazalna primjena, raspršivanje ili u vodi za piće
English: Spray method
Croatian: SAŽETAK OPISA SVOJSTAVA
English: Cardboard box with 10 cups of 5,000 doses.
Croatian: Kutija s 10 čašica od 5000 doza.
English: Cardboard box with 1 or 10 vials of 2,500 doses.
Croatian: Kutija s 1 ili 10 bočica s 2500 doza.
English: Ensure that the nasal drop is inhaled before freeing the bird.
Croatian: Prije nego pilića pustimo, provjerimo da li je kapljica u nosu udahnuta.
English: Cardboard box with 10 cups of 1,000 doses.
Croatian: Kutija s 10 čašica od 1000 doza.
English: Cardboard box with 1 or 10 vials of 500 doses.
Croatian: Kutija s 1 ili 10 bočica s 500 doza.
English: PACKAGE LEAFLET: Nobilis IB4-91 lyophilisate for oculonasal suspension/use in drinking water for chickens
Croatian: UPUTA O VMP Nobilis IB 4-91, liofilizat za okulonazalnu suspenziju / primjenu u vodi za piće za piliće
English: Cardboard box with 10 cups of 10,000 doses.
Croatian: Kutija s 10 čašica od 10000 doza.
English: Cardboard box with 1 or 10 vials of 5,000 doses.
Croatian: Kutija s 1 ili 10 bočica s 5000 doza.
English: Cardboard box with 1 or 10 vials of 1,000 doses.
Croatian: Kutija s 1 ili 10 bočica s 1000 doza.
English: Guideline
Croatian: INDIKACIJE
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI PRIMJENE Raspršivanjem, okulonazalno ili putem vode za piće.
English: Cardboard box with 1 or 10 vials of 10,000 doses.
Croatian: Kutija s 1 ili 10 bočica s 10000 doza.
English: This is expected to help prevent further heart problems.
Croatian: Očekuje se da će to pomoći u sprečavanju daljnjih srčanih problema.
English: Patients also took other medicines
Croatian: Bolesnici su uzimali i
English: The company provided the results of one study involving over 10,000 patients who had had a heart attack.
Croatian: Tvrtka je dostavila rezultate jednog ispitivanja u kojem je obrađeno više od 10 000 bolesnika koji su imali srčani udar.
English: 14 December 2018 EMA/865778/2018 EMEA/H/C/004754
Croatian: EMA/865778/2018 EMEA/H/C/004754
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se nadležnom liječniku.
English: Patients were given canakinumab Novartis at different doses (50, 150 or 300 mg) or placebo (a dummy treatment) once every three months for up to six years.
Croatian: Bolesnicima je dan kanakinumab Novartis u različitim dozama (50, 150 ili 300 mg) ili placebo (prividno liječenje) jednom svaka tri mjeseca u trajanju do šest godina.
English: The main measure of effectiveness was the decrease in the number of serious events such as heart attack, stroke or death.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje broja ozbiljnih stanja kao što su srčani udar, moždani udar ili smrt.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be possible for them to reply to the Agency's concerns within the agreed timeframe.
Croatian: U svojem dopisu kojim je obavijestila Agenciju o povlačenju zahtjeva, tvrtka je navela da ne može odgovoriti na zabrinutosti Agencije unutar dogovorenog vremenskog roka.
English: The beneficial effects seen were considered modest, particularly in patients who also took statins, and were not considered to outweigh the increased risks of serious infections in patients treated with the medicine.
Croatian: Zabilježene koristi smatrane su skromnima, osobito u bolesnika koji su također uzimali statine te se nije smatralo da nadmašuju povećani rizik od ozbiljnih infekcija u bolesnika liječenih tim lijekom.
English: IL-1 beta is part of the immune system (the body's natural defences) and is involved in the inflammatory processes associated with heart and blood vessels problems.
Croatian: IL-1 beta dio je imunološkog sustava (prirodne obrane tijela) i povezan je s upalnim procesima izazvanim problemima sa srcem i krvnim žilama.
English: It was to be available as a solution for injection under the skin in pre-filled pens and pre-filled syringes.
Croatian: Trebao je biti dostupan kao otopina za supkutanu injekciju u napunjenim brizgalicama i štrcaljkama.
English: By attaching to IL-1 beta, canakinumab blocks its activity and reduces inflammation.
Croatian: Vezivanjem na IL-1 betu, kanakinumab blokira njegovu aktivnost i smanjuje upalu.
English: The CHMP also questioned the appropriateness of the measure chosen by the company to select patients and to monitor the effectiveness of canakinumab Novartis.
Croatian: CHMP je također doveo u pitanje primjerenost mjere koju je tvrtka odabrala za selekciju bolesnika i praćenje djelotvornosti kanakinumaba Novartis.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP ocijenio odgovore tvrtke na posljednji niz pitanja, još su uvijek postojale neke nedoumice.
English: The active substance in canakinumab Novartis, canakinumab, is a monoclonal antibody (a type of protein) which has been designed to recognise and attach to interleukin 1 (IL-1) beta.
Croatian: Aktivna tvar u kanakinumabu Novartis, kanakinumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju i vezivanju na interleukin 1 (IL-1) betu.
English: The company informed the CHMP that, while an extension to the above-mentioned study will stop, other studies investigating canakinumab for the treatment of other conditions will continue as planned.
Croatian: Tvrtka je izvijestila CHMP da će se, iako će se produljenje gore navedenog ispitivanja zaustaviti, ostala ispitivanja kanakinumaba za liječenje drugih stanja nastaviti prema planu.
English: How far into the evaluation was the application when it was withdrawn?
Croatian: U kojoj je fazi bila procjena zahtjeva kad je povučen?
English: Canakinumab Novartis was expected to be used to prevent serious events such as stroke, heart attack or death in patients who have already had a heart attack.
Croatian: Očekivalo se da će se kanakinumab Novartis primjenjivati za sprječavanje ozbiljnih stanja kao što su moždani udar, srčani udar ili smrt u bolesnika koji su već imali srčani udar.
English: In particular, the CHMP was of the opinion that the data provided by the company was not robust enough to clearly demonstrate that canakinumab Novartis is effective in all patients who have had a heart attack.
Croatian: CHMP je osobito smatrao da podatci koje je tvrtka dostavila nisu dovoljno čvrsti kao jasni pokazatelji djelotvornosti kanakinumaba Novartis kod svih bolesnika koji su imali srčani udar.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had remaining concerns and was of the provisional opinion that canakinumab Novartis could not have been approved for the prevention of serious heart problems in patients who have already had a heart attack.
Croatian: Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za kanakinumab Novartis za sprječavanje ozbiljnih srčanih problema u bolesnika koji su već imali srčani udar.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of canakinumab Novartis did not outweigh its risks.
Croatian: Stoga je CHMP u vrijeme povlačenja zahtjeva smatrao kako koristi od kanakinumaba Novartis ne nadmašuju rizike koji su s njim povezani.
English: What is canakinumab Novartis?
Croatian: Što je kanakinumab Novartis?
English: On 4 December 2018, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for canakinumab Novartis, for the prevention of serious events such as stroke, heart attack or death in patients who have had a heart attack.
Croatian: Ltd. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP - Committee for Medicinal Products for Human Use) da želi povući zahtjev za stavljanje u promet kanakinumaba Novartis, za sprječavanje ozbiljnih stanja kao što su moždani udar, srčani udar ili smrti u bolesnika koji su imali srčani udar.
English: Canakinumab Novartis is a medicine that contains the active substance canakinumab.
Croatian: Novartis je lijek koji sadržava djelatnu tvar kanakinumab.
English: What was canakinumab Novartis expected to be used for?
Croatian: Za što se kanakinumab Novartis trebao primjenjivati?
English: How does canakinumab Novartis work?
Croatian: Kako kanakinumab Novartis djeluje?
English: commonly used to prevent heart problems, such as statins.
Croatian: druge lijekove, npr. statine, koji se najčešće upotrebljavaju za sprječavanje srčanih problema.
English: EMA/865778/2018
Croatian: Povlačenje zahtjeva za stavljanje u promet kanakinumaba Novartis (kanakinumab humano monoklonsko protutijelo) EMA/865778/2018
English: --1 ≥ 50x106 CD54+ cells/250mL
Croatian: --1 ≥ 50x106 CD54+ stanica /250 mL
English: Strength Pharmaceutical Form Route of Administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: dispersion for infusion Intravenous use Bag
Croatian: Disperzija za infuziju
English: Repeat steps 3 to 7 in the same way until the whole dose has been taken.
Croatian: Ponavljajte korake 3 - 7 na isti način sve dok ne primijenite cijelu dozu.
English: CELSENTRI can be taken with or without food.
Croatian: CELSENTRI se može uzimati s hranom ili bez nje.
English: The results should therefore be interpreted with caution.
Croatian: Rezultate je stoga potrebno oprezno tumačiti.
English: Risk Management plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: Conditions you need to look out for
Croatian: Stanja na koja morate pripaziti
English: When getting up, do so as slowly as possible.
Croatian: Ustajati treba što polaganije.
English: Stop taking CELSENTRI.
Croatian: Prestanite uzimati CELSENTRI.
English: Difference1 (Confidence Interval2)
Croatian: Razlika1 (Interval pouzdanosti2)
English: A risk to the newborn/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenčad/dojenčad.
English: Potential effect on immunity
Croatian: Potencijalni učinak na imunitet
English: The volume of distribution of maraviroc is approximately 194 L.
Croatian: Volumen distribucije maraviroka je približno 194 L.
English: Your liver function may need to be closely monitored.
Croatian: Možda će Vam trebati pažljivo pratiti funkciju jetre.
English: See the diagram and instructions at the end of this section for how to measure and take (or give) a dose of medicine.
Croatian: Pogledajte grafikon i upute na kraju ovog dijela da saznate kako odmjeriti i uzeti (ili dati) dozu lijeka.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Takve se reakcije obično viđaju tijekom prvih tjedana ili mjeseci po početku primjene CART.
English: These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.
Croatian: One su rijetke, a mogu se javiti u do 1 na 1000 osoba koje uzimaju CELSENTRI.
English: Don't take other medicines for the infection without your doctor's advice.
Croatian: Nemojte uzimati druge lijekove za infekciju bez prethodnog savjetovanja s liječnikom.
English: After first opening: 60 days
Croatian: Nakon prvog otvaranja: 60 dana.
English: What CELSENTRI is and what it is used for
Croatian: Što je CELSENTRI i za što se koristi
English: 1Based on GSS.
Croatian: Temeljem GSS.
English: ULN: Upper Limit of Normal
Croatian: GGN: gornja granica normale
English: If you notice any of these symptoms:
Croatian: Ako primijetite bilo koji od tih simptoma:
English: Hold the bottle firmly.
Croatian: Čvrsto držite bocu.
English: This polar metabolite has no significant pharmacological activity.
Croatian: Ovaj polarni metabolit nema značajniju farmakološku aktivnost.
English: Always take or give this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ili dajte ovaj lijek točno onako kako Vam je rekao liječnik.
English: Skin and liver reactions can occur as single events, or in combination.
Croatian: Kožne i jetrene reakcije mogu se javiti kao pojedinačni događaji ili u kombinaciji.
English: This is due to a sudden fall in blood pressure.
Croatian: To je posljedica naglog pada krvnog tlaka.
English: Therefore, CELSENTRI should be used with caution in this population.
Croatian: Stoga CELSENTRI treba primjenjivati uz oprez u toj populaciji.
English: This is particularly important if you are also taking some other medicines (see ‘Other medicines and CELSENTRI' later in section 2).
Croatian: To je osobito važno ako uzimate i neke druge lijekove (pogledajte odlomak 'Drugi lijekovi i CELSENTRI' u nastavku dijela 2.).
English: CELSENTRI contains soya lecithin.
Croatian: CELSENTRI sadrži sojin lecitin.
English: The position of these mutations was not consistent between different isolates.
Croatian: Mjesto ovih mutacija nije bilo isto kod različitih izolata.
English: Do not push too hard and squirt the liquid into the back of the throat, as that could cause choking.
Croatian: Nemojte ga pritisnuti prejako i istisnuti otopinu u stražnji dio grla jer tada može doći do gušenja.
English: Component of a multipack, cannot be sold seperately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: Angina pectoris rare
Croatian: Angina pektoris rijetko
English: Tell your doctor if you notice anything unusual about your own health or your child's health.
Croatian: Obavijestite svog liječnika ako primijetite bilo što neuobičajeno u svezi s Vašim zdravljem ili zdravljem Vašeg djeteta.
English: CELSENTRI should always be taken by mouth.
Croatian: CELSENTRI se uvijek primjenjuje kroz usta.
English: Remove the bottle cap (A).
Croatian: 1. Skinite zatvarač s boce (A).
English: Talk to your doctor about how to avoid infecting other people.
Croatian: Razgovarajte sa svojim liječnikom o tome kako izbjeći prijenos virusa na druge osobe.
English: The date should be written as soon as the bottle has been opened for first use.
Croatian: Datum treba upisati čim se boca otvori za prvu uporabu.
English: Age (years) (Range, years)
Croatian: Dob (godine) (raspon, godine)
English: In case of concomitant antiviral therapy for hepatitis B and/or C, please refer to the relevant product information for these medicinal products.
Croatian: U slučaju istodobne primjene antivirusnih lijekova za hepatitis B i/ili C, molimo obratite pozornost na relevantne informacije o svojstvima tih lijekova.
English: CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps it at a low level.
Croatian: CELSENTRI, kao dio kombinirane terapije, smanjuje količinu virusa u tijelu i održava razinu virusa niskom.
English: For example, if the dose is 15 ml, you need one and a half applicator -full of medicine.
Croatian: Primjerice, ako doza iznosi 15 ml, morate primijeniti jedan i pol aplikator lijeka.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Croatian: CD4 stanice su jedna vrsta bijelih krvnih stanica koje su važne jer pomažu tijelu u borbi protiv infekcije.
English: • telaprevir and boceprevir.
Croatian: • telaprevir i boceprevir
English: The remainder was excreted as metabolites.
Croatian: Ostatak je izlučen u obliku metabolita.
English: If you forget to take or give CELSENTRI
Croatian: Ako ste zaboravili uzeti ili dati CELSENTRI
English: The highest dose administered in clinical studies was 1,200 mg.
Croatian: Najviša primijenjena doza u kliničkim ispitivanjima bila je 1200 mg.