FrancophonIA/ELRC3.0 huggingface dataset:
English: - Avoid skin, eye or mucosal contact with the product.
Croatian: - Izbjegavati dodir proizvoda sa kožom, očima i sluznicama.
English: The dosage is: 100 μg of halofuginone / kg bw, once a day for 7 consecutive days; i.e. 2 ml of Kriptazen / 10 kg bw, once a day for 7 consecutive days.
Croatian: Doza je: 100 µg halofuginona / kg t.m., 1x dan 7 uzastopnih dana; na primjer: 2 mL Kriptazen / 10 kg t.m. 1x dan 7 uzastopnih dana.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: Pu l awska 314 PL-02 819 Warszawa Tel.: + 48 22 855 40 46
Croatian: PL-02 819 Warszawa Tel.: + 48 22 855 40 46
English: Contraindications
Croatian: KONTRAINDIKACIJE
English: 3) Remove the protector cap from the tip of the nozzle of the pump.
Croatian: 3) Uklonite zaštitnu kapicu s vrha otvora pumpe.
English: Package with a metering pump:
Croatian: Pakovanje sa mjernom pumpom:
English: Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate.
Croatian: Kartonska kutija u kojoj je boca od 500ml (polietilen visoke gustoće) koja sadržava 490 ml otopine ili boca od 1000 ml koja sadržava 980 ml otopine, začepljena sa čepom od polietilena visoke gustoće, sa ili bez mjerne pumpe, sa aplikacijskom cjevčicom napravljenom od etilen-vinil acetata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone
Croatian: Kriptazen 0,5 mg/ml otopina za primjenu na usta, za telad halofuginon
English: SPECIAL STORAGE CONDITIONS Keep the bottle in the outer carton in order to protect from light.
Croatian: Posebne mjere pri čuvanju Čuvati u originalnom pakovanju radi zaštite od svjetla.
English: Benzoic acid (E 210) Lactic acid (E 270) Tartrazine (E 102) Water, Purified
Croatian: Benzoična kiselina (E 210) Mliječna kiselina (E 270)
English: Incompatibilities
Croatian: Inkompatibilnosti:
English: The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals treated displaying adverse reactions) - Common (more than 1 but less than 10 animals in 100 animals treated) - Uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - Rare (more than 1 but less than 10 animals in 10,000 animals treated) - Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - manje česte (više od 1 ali manje od 10 životinja na 1000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10 000 tretiranih životinja)
English: 1ère avenue - 2065 m - LID
Croatian: VIRBAC 1ère avenue - 2065 m - LID
English: Suomi/Finland VIRBAC
Croatian: Suomi/Finland
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Čuvati u originalnom pakovanju radi zaštite od svjetla.
English: - Wear protective gloves while handling the product.
Croatian: - Pribor za osobnu zaštitu koji se sastoji od zaštitnih rukavica treba koristiti pri rukovanju s veterinarsko-medicinskim proizvodom.
English: Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Croatian: Svaka kutija sadržava plastičnu mjernu pumpu koja isporučuje 4 ml volumena i dvije aplikacijske cjevčice (jedna koja paše na bocu od 500 ml i jedna koja paše na bocu od 1000 ml).
English: Benzoic acid (E 210)
Croatian: Pomoćne tvari: Benzoična kiselina (E 210)
English: Each package also contains a plastic metering pump delivering 4 to 12 ml and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Croatian: Svaka kutija sadržava plastičnu mjernu pumpu koja isporučuje 4-12 ml volumena i dvije aplikacijske cjevčice (jedna koja paše na bocu od 500 ml i jedna koja paše na bocu od 1000 ml).
English: 7) Pull the trigger of the metering pump completely for release of the adequate dose.
Croatian: 7) Povucite polugu pumpe do kraja kako bi primijenili željenu dozu.
English: An increase in the level of diarrhoea has been observed in very rare cases, in treated animals.
Croatian: Pojačavanje proljeva je primijećeno, u vrlo rijetkim slučajevima, kod životinja koje su primile ovaj
English: Cardboard box with a 500 ml bottle containing 490 ml or a 1000 ml bottle containing 980 ml, with or without a dosing pump.
Croatian: Kartonska kutija u kojoj je boca od 500 ml koja sadržava 490 ml otopine ili boca od 1000 ml koja sadržava 980 ml otopine.
English: 5) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Croatian: 5) Pokrenite pumpu nježno povlačeći poluge sve dok se na vrhu otvora ne pojave prve kapi.
English: Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Croatian: Boca bez pumpe: Da bi osigurali pravilno doziranje, uporaba brizgaljke ili bilo kakvog prikladnog uređaja za primjenu kroz usta je neophodna.
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: 4) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Croatian: 4) Pokrenite pumpu nježno povlačeći poluge sve dok se na vrhu otvora ne pojave prve kapi.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Croatian: Cryptosporidium parvum dokazana in vitro, ali i kod umjetno stvorenih i prirodnih infekcija.
English: - Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.
Croatian: - Smanjenje proljeva izazvanih sa Cryptosporidium parvum.
English: [Bottle with a 4 to 12 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Croatian: [Boca sa pumpom od 4-12 ml:] Da bi osigurali pravilno doziranje, treba izabrati pumpu pravilne veličine, koja odgovara težini životinje kod koje se primjenjuje.
English: Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Croatian: Boca s pumpom: Da bi osigurali pravilno doziranje, treba izabrati pumpu pravilne veličine, koja odgovara težini životinje kod koje se primjenjuje.
English: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Croatian: Da bi osigurali pravilno doziranje, uporaba brizgaljke ili bilo kakvog prikladnog uređaja za primjenu kroz usta je neophodna.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
English: Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Pull two or three times, respectively, for administration of the desired volume (8 ml for calves weighing more than 35 kg but less than or equal to 45 kg and 12 ml for calves weighing more than 45 kg but less than or equal to 60 kg).
Croatian: Povucite 2-3 puta za primjenu željene doze (8 ml za tele od 35 - 45 kg i 12 ml za tele od 45 - 60 kg).
English: In new born calves: - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
Croatian: - Prevencija proljeva izazvanih sa Cryptosporidium parvum, na farmama koje imaju povijest kriptosporidioze.
English: Cattle (newborn calves).
Croatian: Goveda (novorođena telad).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: [Bottle without a pump:] To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Croatian: [Boca bez pumpe:] Da bi osigurali pravilno doziranje, uporaba brizgaljke ili bilo kakvog prikladnog uređaja za primjenu kroz usta je neophodna.
English: STATEMENT OF ACTIVE SUBSTANCES Active substance:
Croatian: SASTAV DJELATNIH TVARI Djelatna tvar:
English: PACKAGE LEAFLET: Kriptazen 0.5 mg/ml oral solution for calves NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC 1ère avenue - 2065 m - LID 06516 Carros France
Croatian: UPUTA O VMP Kriptazen 0,5 mg/ml otopina za primjenu na usta, za telad NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
English: [Bottle with a 4 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Croatian: [Boca sa pumpom od 4 ml:] Da bi osigurali pravilno doziranje, treba izabrati pumpu pravilne veličine, koja odgovara težini životinje kod koje se primjenjuje.
English: The apparent volume of distribution is 10 l/kg.
Croatian: Volumen raspodjele je 10 kg.
English: Pharmacokinetic particulars
Croatian: 5.2 Farmakokinetički podaci
English: Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja
English: As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly.
Croatian: Važno je životinjama primijeniti točno propisanu dozu VMP-a, jer se primijenjena dvostruka doza pokazala toksičnom.
English: MARKETING AUTHORISATION HOLDER VIRBAC
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET
English: Special precautions for use
Croatian: 11. POSEBNE MJERE PRI ČUVANJU
English: 5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Croatian: 6) Povucite polugu pumpe do kraja kako bi primijenili dozu od 4 ml otopine.
English: PSUR submission for Kriptazen shall be synchronised and submitted at the same frequency as for the reference product, Halocur.
Croatian: Specifični zahtjevi farmakovigilancije: Podnošenje periodičkih izvješća o neškodljivosti (PSUR) za Kriptazen treba biti usklađeno s učestalošću podnošenja za referentni proizvod Halocur.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use in calves after feeding.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves.
Croatian: Kriptazen 0,5 mg/ml otopina za primjenu kroz usta, za telad.
English: 1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml bottle) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on.
Croatian: 1) Izaberite cjevčicu namijenjenu pravilnoj veličini boce ( kraću za bocu od 490 ml ili dužu za bocu od
English: Muscle Fat
Croatian: Masno tkivo Jetra Bubrezi
English: Pharmacodynamic properties
Croatian: 5.1 Farmakodinamička svojstva
English: PHARMACEUTICAL FORM Oral solution.
Croatian: Farmakološki djelatna tvar
English: 13o χλμ Ε.Ο.
Croatian: VIRBAC HELLAS Α.Ε. 13o χλμ Ε.Ο. Αθηνών - Λαμίας
English: (as lactate salt) Excipients:
Croatian: Novorođena telad:
English: Pharmacologically active substance
Croatian: SASTAV DJELATNIH TVARI
English: EU/1/15/1024/001 Keytruda 50 mg Powder for concentrate for solution for infusion
Croatian: EU/1/15/1024/001 Keytruda 50 mg Prašak za koncentrat za otopinu za infuziju bočica (staklo)
English: EU/1/15/1024/002 Keytruda 25 mg/ml
Croatian: EU/1/15/1024/002 Keytruda 25 mg/m za koncentrat za otopinu za infuziju bočica (staklo) 4 ml
English: The exact cause is not known.
Croatian: Točan uzrok nije poznat.
English: The updated data should be submitted by 31st December
Croatian: Ažurirane podatke potrebno je predati do 31. prosinca 2015.
English: Probability of Survival
Croatian: Vjerojatnost preživljenja
English: Safety and efficacy in elderly patients
Croatian: Sigurnost i djelotvornost u starijih bolesnika
English: The estimated 1-year survival rate was 41%.
Croatian: Procijenjena stopa 1-godišnjeg preživljenja iznosila je 41%.
English: Other forms of interaction
Croatian: Drugi oblici interakcija
English: Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Croatian: Imajte na umu da ti znakovi i simptomi ponekad mogu biti odgođeni pa se mogu razviti tjednima ili mjesecima nakon posljednje doze.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Croatian: Važno je da tu Karticu s upozorenjima nosite sa sobom i da je pokažete svome partneru ili njegovateljima.
English: Appendix V.
Croatian: Dodatku V.
English: ATC code: L01XC17.
Croatian: ATK oznaka: L01XC17.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: The majority of patients were white (93%) and male (76%).
Croatian: Većina bolesnika bili su bijelci (93%) i muškarci (76%).
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Croatian: Vaš će liječnik razgovarati s Vama o tome te će Vam objasniti rizike i koristi liječenja.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: Ove informacije pronaći ćete i u Kartici s upozorenjima za bolesnika koju Vam je dao Vaš liječnik.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Samo za jednokratnu uporabu.
English: Based on this prescribed dose, calculate the total dose to be given.
Croatian: Na temelju te propisane doze izračunajte ukupnu dozu koju treba primijeniti.
English: However, the role of this biomarker (PD-L1 expression) has not been fully elucidated.
Croatian: Međutim, uloga tog biološkog biljega (ekspresije PD-L1) nije posve razjašnjena.
English: Do not try to treat your symptoms with other medicines on your own.
Croatian: Nemojte pokušavati sami liječiti simptome drugim lijekovima.
English: • Details on how to minimise the safety concern through appropriate monitoring and management
Croatian: • Pojedinosti o tome kako minimizirati sigurnosni problem odgovarajućim praćenjem i
English: Treatment modification
Croatian: Modifikacija liječenja
English: Tell your doctor immediately if you have any of these signs or symptoms or if they get worse.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od tih znakova ili simptoma ili ako se oni pogoršaju.
English: Because of the small sample size, no definitive conclusions can be drawn from these data.
Croatian: Budući da se radi o malom uzorku, ne mogu se donijeti konačni zaključci na temelju tih podataka.
English: Stopping your treatment may stop the effect of the medicine.
Croatian: Prekid liječenja mogao bi zaustaviti učinak ovog lijeka.
English: Talk to your doctor if you are not
Croatian: Razgovarajte sa svojim liječnikom ako niste sigurni.
English: No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
Croatian: Sveukupno nisu prijavljene razlike u sigurnosti i djelotvornosti između starijih osoba ( ≥ 65 godina) i mlađih bolesnika (< 65 godina).
English: Median (95% CI) (months)
Croatian: Medijan (95% CI) (mjeseci)
English: Only 4 (0.8%) patients were persistent positive.
Croatian: Samo su 4 bolesnika (0,8%) bila trajno pozitivna.
English: You will receive treatment with Nivolumab BMS in a hospital or clinic, under the supervision of an experienced doctor.
Croatian: Nivolumab BMS ćete primati u bolnici ili klinici, pod nadzorom iskusna liječnika.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje
English: Efficacy results are shown in Table 3.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 3.
English: You will also have blood tests during your treatment.
Croatian: Osim toga, tijekom liječenja će se provoditi i krvne pretrage.
English: Nivolumab BMS should not be frozen.
Croatian: Nivolumab BMS se ne smije zamrzavati.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: This helps increase their activity against the lung cancer cells.
Croatian: Na taj način pojačava njihovo djelovanje protiv stanica raka pluća.
English: None of these patients received high-dose corticosteroids.
Croatian: Nijedan od tih bolesnika nije primao visoke doze kortikosteroida.
English: Before treatment, your doctor will check your general health.
Croatian: Liječnik će prije liječenja provjeriti Vaše opće zdravstveno stanje.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama
English: Baseline characteristics were generally balanced between the two groups.
Croatian: Početne su značajke bile ravnomjerno raspoređene između obje skupine.
English: Take care to ensure aseptic handling when you prepare the infusion.
Croatian: Pobrinite se da osigurate aseptični postupak kod pripreme infuzije.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Croatian: Ako propustite termin, pitajte svog liječnika kada biste mogli dogovoriti termin za sljedeću dozu.
English: docetaxel (n = 137)
Croatian: docetaksel (n = 137)
English: Nivolumab is unlikely to affect your ability to drive or use machines; however, use caution when performing these activities until you are sure that nivolumab does not adversely affect you.
Croatian: Nije vjerojatno da će nivolumab utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima, ali ipak budite oprezni dok izvodite te aktivnosti sve dok ne budete sigurni da nivolumab ne utječe štetno na Vas.
English: The primary efficacy outcome measure was overall survival (OS).
Croatian: Primarna mjera ishoda za djelotvornost bilo je ukupno preživljenje (engl. overall survival, OS).
English: The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Nivolumab BMS u djece mlađe od 18 godina nisu ustanovljene.
English: • Physician educational material • Patient alert card
Croatian: • Edukacijski materijal za liječnike • Karticu s upozorenjima za bolesnika
English: Dose escalation or reduction is not recommended.
Croatian: Ne preporučuje se povećavati ni smanjivati dozu.
English: Nivolumab BMS may cause changes in the results of tests carried out by your doctor.
Croatian: Nivolumab BMS može uzrokovati promjene u nalazima pretraga koje provodi Vaš liječnik.
English: Studies in animals have shown embryofoetal toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na embriofetalnu toksičnost (vidjeti dio 5.3).
English: The PFS was measured by RECIST version 1.1.
Croatian: PFS se određivao prema verziji 1.1. RECIST kriterija.
English: Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Croatian: Budući da se mnogi lijekovi, uključujući protutijela, mogu izlučivati u majčino mlijeko, ne može se isključiti rizik za novorođenčad/dojenčad.
English: Be aware of important symptoms of inflammation.
Croatian: Pripazite na važne simptome upale.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: • Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns:
Croatian: • Relevantne informacije (npr. informacije o ozbiljnosti, težini, učestalosti, vremenu do nastupa i reverzibilnosti nuspojava, prema potrebi) za sljedeće sigurnosne probleme:
English: Other in-use storage time and conditions are the responsibility of the user.
Croatian: Druga vremena i uvjeti čuvanja lijeka u uporabi odgovornost su korisnika.
English: Nivolumab CL increased with increasing body weight.
Croatian: Klirens nivolumaba povećavao se s povećanjem tjelesne težine.
English: Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Croatian: Ne preporučuje se koristiti nivolumab tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju, osim u slučajevima kada klinička korist nadmašuje mogući rizik.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Croatian: Većina njih, uključujući teške reakcije, povukla se nakon uvođenja odgovarajuće medicinske terapije ili prestanka primjene nivolumaba (vidjeti 'Opis odabranih nuspojava' u nastavku).
English: There are no data on the use of nivolumab in pregnant women.
Croatian: Nema podataka o primjeni nivolumaba u trudnica.
English: Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Croatian: Nivolumab BMS se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: Effective contraception should be used for at least 5 months following the last dose of Nivolumab BMS.
Croatian: Učinkovitu kontracepciju treba koristiti najmanje 5 mjeseci nakon posljednje doze lijeka Nivolumab BMS.
English: The Kaplan-Meier curves for OS are shown in Figure 1.
Croatian: Kaplan-Meierove krivulje za OS prikazane su na Slici 1.
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Croatian: Smjernice za trajni prekid liječenja ili odgodu primjene doze opisane su u Tablici 1.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg.
Croatian: Otopina ima pH od približno 6,0 i osmolalnost od približno 340 mOsm/kg.
English: The recommended dose is 3 mg of nivolumab per kilogram of your body weight.
Croatian: Preporučena doza je 3 mg nivolumaba po kilogramu tjelesne težine.
English: Patients were enrolled regardless of their PD-L1 status.
Croatian: Bolesnici su bili uključeni u ispitivanje neovisno o PD-L1 statusu.
English: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Croatian: Nivolumab se proizvodi u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.