FrancophonIA/ELRC3.0 huggingface dataset:
English: In such cases, death has been attributed to intra-vascular administration of the product or anaphylaxis.
Croatian: U takvim se slučajevima smrt pripisuje intravaskularnoj primjeni proizvoda ili anafilaksiji.
English: Shelf-life after first opening the container: 28 days.
Croatian: Rok uporabe nakon prvog otvaranja spremnika: 28 dana.
English: If you develop symptoms following exposure such as a skin rash or persistent eye irritation, you should seek medical advice and show the package leaflet or the label to the physician.
Croatian: Ako se nakon izlaganja pojave simptomi kao što su osip na koži ili dugotrajna iritacija očiju, potražite savjet liječnika i pokažite mu uputu o VMP ili etiketu.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Croatian: 11. POSEBNI UVJETI ČUVANJA Nemojte čuvati pri temperaturi iznad 25 °C.
English: It has an antimicrobial activity similar to that of ceftiofur against the target pathogens.
Croatian: Antimikrobno djeluje na ciljne patogene slično kao ceftiofur.
English: Once broached, use by…
Croatian: Jednom otvoren upotrijebiti do…
English: Base of the ear administration:
Croatian: Primjena pri bazi uške:
English: Diagram of the head showing the direction for the base of the ear injections administered toward the animal's opposite eye.
Croatian: Slika glave prikazuje smjer prema suprotnom oku kada se daje injekcija u bazu uške.
English: TARGET SPECIES
Croatian: CILJNE VRSTA ŽIVOTINJA
English: Do not use in cases of hypersensitivity to ceftiofur or other beta-lactam antibiotics, or to any of the excipients.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na ceftiofur ili druge beta-laktamske antibiotike ili na bilo koju od pomoćnih tvari.
English: No specific studies have been conducted in breeding cattle.
Croatian: Nikakve konkretne studije nisu vršene na rasplodnim govedima.
English: (<0.2 μg/ml) for the target bacteria isolated in clinical studies for at least 158 hours.
Croatian: U preporučenoj terapeutskoj dozi koncentracije u plazmi bile su više od vrijednosti MIC90 (< 0,2 µg /ml) za ciljnu bakteriju izoliranu u kliničkim studijama najmanje 158 sati.
English: EXPIRY DATE EXP {month/year} Once broached, use by …
Croatian: EXP {mjesec/godina} Jednom otvoren upotrijebiti do …..
English: STATEMENT OF ACTIVE SUBSTANCES Ceftiofur (as crystalline free acid)
Croatian: SASTAV DJELATNIH TVARI Ceftiofur (kao kristalinična slobodna kiselina)
English: • Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae,
Croatian: INDIKACIJE Liječenje bakterijskih bolesti dišnih organa vezanih uz bakterije Actinobacillus pleuropneumoniae,
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramuscular use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, PUT(EVI) I NAČIN PRIMJENE
English: Treatment of acute post-partum (puerperal) metritis in cases where treatment with another antimicrobial has failed.
Croatian: Liječenje akutnog postpartalnog (puerperalnog) metritisa u slučajevima kada liječenje drugim antimikrobnim sredstvima nije uspjelo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/05/2005.
Croatian: Datum prvog odobrenja: 19/05/2005.
English: 1,000 µg/kg Muscle For porcine species the fat MRL relates to ‘skin and fat in natural proportions'
Croatian: Za životinje iz porodice svinja MRL masti odnosi se na “kožu i mast u prirodnim omjerima”.
English: Once broached, use within 28 days.
Croatian: Upotrijebiti u roku od 28 dana nakon otvaranja.
English: Do not use in cases of hypersensitivity to ceftiofur or other β-lactam antibiotics, or to any of the excipients.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na ceftiofur ili druge β-laktamske antibiotike ili na bilo koju od pomoćnih tvari.
English: WITHDRAWAL PERIOD(S) Meat and offal: 71 days.
Croatian: KARENCIJA(E) Meso i jestive iznutrice: 71 dan.
English: Laboratory studies in rats revealed no teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed.
Croatian: Laboratorijske studije na štakorima nisu otkrile teratogeno djelovanje, ali primijećeno je maternotoksično djelovanje (meka stolica) i fetotoksično djelovanje (smanjena težina fetusa).
English: Laboratory studies in rats have shown no evidence of teratogenic effects but maternotoxic (soft faeces) and foetotoxic (reduced foetal weight) effects were observed.
Croatian: Laboratorijske studije na štakorima nisu pružile dokaze teratogenog djelovanja, ali primijećeno je maternotoksično djelovanje (meka stolica) i fetotoksično djelovanje (smanjena težina fetusa).
English: In very rare cases anaphylactic type reactions may occur following administration of the product.
Croatian: U vrlo rijetkim slučajevima nakon primjene proizvoda može doći do reakcija anafilaktičkog tipa.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e))
English: In cattle, ceftiofur is active against the following micro-organisms which are involved in acute postpartum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum; and interdigital necrobacillosis: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
Croatian: Escherichia coli, Arcanobacterium pyogenes i Fusobacterium necrophorum; te interdigitalna nekrobaciloza: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp. i Prevotella spp.
English: Oily vehicle (vegetable origin).
Croatian: Uljne pomoćne tvari (biljnog podrijetla).
English: Treatment of bacterial respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis.
Croatian: • Liječenje bakterijskih bolesti dišnih organa vezanih uz bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis i Streptococcus suis.
English: Increased use, including use of the product deviating from the instructions given above, may increase the prevalence of bacteria resistant to ceftiofur.
Croatian: Povećana primjena, uključujući upotrebu proizvoda koja odstupa od navedenih uputa, može povećati prevalenciju bakterija otpornih na ceftiofur.
English: Cardboard box with one type I glass vial of 50 ml or 100 ml with a chlorobutyl-isoprene rubber stopper and aluminium cap.
Croatian: I od 50 ml ili 100 ml zatvorena s klorbutilnim isoprenskim gumenim čepom i aluminijskom kapicom.
English: It is essential that Naxcel is only administered subcutaneously at the base of ear location in non-edible tissue, in order to comply with the meat withdrawal period.
Croatian: Naxcel se smije primjenjivati samo subkutano u nejestivo tkivo baze uške, kako bi se primijenilo razdoblje karencije mesa.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI I DRUGIH SASTOJAKA
English: Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Croatian: Liječenje septikemije, poliartritisa ili poliserozitisa vezanih uz infekcije bakterijom Streptococcus suis.
English: Shelf life after first opening the vial: 28 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 28 dana.
English: Oily vehicle (vegetable origin): Triglycerides, medium chain Cottonseed oil.
Croatian: Uljne pomoćne tvari (biljnog podrijetla): Trigliceridi, srednjeg lanca
English: • Treatment of septicaemia, polyarthritis or polyserositis associated with Streptococcus suis infection.
Croatian: • Liječenje septikemije, poliartritisa ili poliserozitisa vezanih uz infekcije bakterijom
English: Injection location for the subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear)
Croatian: Mjesto aplikacije za subkutanu primjenu Naxcela u stražnju stranu uške na spoju s glavom (baza uške)
English: th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other antimicrobials.
Croatian: Sustavna primjena cefalosporina širokog spektra (3. i 4. generacija, kao što je, ceftiofur) trebala bi odražavati činjenicu da su oni rezervirani za liječenje kliničkih stanja koja su slabo reagirala na ostala antimikrobna sredstva ili se očekuje da će slabo reagirati na njih.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom proizvodu su dostupne na web stranici Europske agencije za lijekove(http://www.ema.europe.eu/).
English: Antiinfectious agents / Antibiotics
Croatian: Sredstva protiv infekcije/anti biotici µg/kg
English: SC Read the package leaflet before use.
Croatian: s.c. Pročitati uputu o VMP prije primjene.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUTEVI PRIMJENE
English: 5mg ceftiofur/kg bodyweight (equivalent to 1ml of Naxcel per 20kg bodyweight) administered once in the neck by intramuscular injection.
Croatian: 5 mg ceftiofura/kg tjelesne težine (odgovara 1 ml Naxcela na 20 kg tjelesne težine) primijenjeno jedanput u vrat intramuskularnom injekcijom.
English: Dose of 5 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 20 kg bodyweight) administered once in the neck by intramuscular injection.
Croatian: Doza od 5 mg ceftiofura/kg tjelesne težine (odgovara 1 ml Naxcela na 20 kg tjelesne težine) daje se jedanput u vrat intramuskularnom injekcijom.
English: th generation, such as ceftiofur), it should be reflected that these are to be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to more narrow spectrum antimicrobials.
Croatian: Sustavna primjena cefalosporina širokog spektra (3. i 4. generacija, kao što je ceftiofur) trebala bi odražavati činjenicu da su oni rezervirani za liječenje kliničkih stanja koja su slabo reagirala na antimikrobna sredstva užeg spektra ili se očekuje da će slabo reagirati na njih.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL of 100 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica od 100 ml
English: Increased use, including use of the product deviating from the instructions given in the summary of product characteristics (SPC), may increase the prevalence of bacteria resistant to ceftiofur.
Croatian: Povećana primjena, uključujući primjenu proizvoda koja odstupa od uputa iz Sažetka opisa svojstava, može povećati prevalenciju bakterija otpornih na ceftiofur.
English: All mammalian food producing species
Croatian: Sve vrste sisavaca koji se koriste u proizvod nji hrane µg/kg
English: No specific studies have been conducted in pregnant cows or in breeding cattle.
Croatian: Nikakve konkretne studije nisu vršene na steonim kravama ili rasplodnim govedima.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORANI ZA PUŠTANJE SERIJE U PROMET
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/001 (100 ml)
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET EU/2/05/053/001 (100 ml)
English: and Prevotella spp.
Croatian: UPUTA O VMP
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL of 50 ml
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 4.6 (Adverse reactions).
Croatian: Zbog niske toksičnosti ceftiofura u svinja predoziranje obično ne uzrokuje nikakve kliničke znakove, osim prolaznih lokalnih oteklina, kao što je opisano u odjeljku 4.6 (nuspojave).
English: Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Croatian: Pojedinačna supkutana injekcija od 6,6 mg ceftiofura/kg tjelesne težine (ekvivalentno 1 ml Naxcela A na 30 kg tjelesne težine) primijenjena pri bazi uha.
English: Excipient: Oily vehicle (vegetable origin).
Croatian: Pomoćna tvar: Uljna pomoćna tvar (biljnog podrijetla).
English: No specific studies have been conducted in pregnant cows.
Croatian: Nikakve konkretne studije nisu vršene na steonim kravama.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100ml
Croatian: PODACI NA UNUTARNJEM PAKOVANJU BOČICA od 100 ml
English: MARKETING AUTHORISATION NUMBER (S) EU/2/05/053/001-002
Croatian: ODOBRENJA ZA STAVLJANJE U PROMET EU/2/05/053/001-002
English: PACKAGE LEAFLET: Naxcel 100 mg/ml suspension for injection for pigs
Croatian: Naxcel 100 mg/ml suspenzija za injekcije za svinje
English: MRLs
Croatian: i.m.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Ceftiofur 100 mg/ml
Croatian: Ceftiofur 100 mg/ml
English: Subcutaneous administration of Naxcel at the posterior aspect of the ear where it attaches to the head (base of ear).
Croatian: Slika 2. Subkutana primjena Naxcela u stražnju stranu uške na spoju s glavom (baza uške).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs
Croatian: UPUTA O VMP Naxcel 100 mg/ml suspenzija za injekcije za svinje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle
Croatian: UPUTA O VMP Naxcel 200 mg/ml suspenzija za injekcije za goveda
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE U PROMET Ime i adresa proizvođača odgovornog za puštanje serije u promet
English: PACKAGE LEAFLET: Naxcel 200 mg/ml suspension for injection for cattle
Croatian: Naxcel 200 mg/ml suspenzija za injekcije za goveda
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 100 mg/ml suspension for injection for pigs ceftiofur
Croatian: Naxcel 100 mg/ml suspenzija za injekcije za svinje ceftiofur
English: 8 WITHDRAWAL PERIOD(S) Withdrawal period(s):
Croatian: 8 KARENCIJA(E)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Naxcel 200 mg/ml suspension for injection for cattle ceftiofur
Croatian: Naxcel 200 mg/ml suspenzija za injekcije za stoku ceftiofur
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/003
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET EU/2/05/053/003
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/053/001
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET EU/2/05/053/001
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Single subcutaneous injection of 6.6 mg ceftiofur/kg bodyweight (equivalent to 1 ml of Naxcel per 30 kg bodyweight) administered at the base of the ear.
Croatian: Pojedinačna subkutana injekcija od 6,6 mg ceftiofura/kg tjelesne težine (odgovara 1 ml Naxcela na 30 kg tjelesne težine) primijenjena pri bazi uške.
English: Date of first authorisation: 25 July 2016
Croatian: Datum prvog odobrenja: 25. srpnja 2016.
English: • if you think you have hepatitis infection now or have had it in the past.
Croatian: - ako mislite da trenutno imate infekciju hepatitisa ili ste ju imali u prošlosti.
English: 1930 Zaventem, Belgium
Croatian: 1930 Zaventem, Belgija
English: Special handling instructions.
Croatian: Posebne upute za rukovanje.
English: Therefore no dose recommendations can be made in this population.
Croatian: Stoga nije moguće dati preporuku o doziranju u ovoj populaciji.
English: The median number of cycles received for both groups was 4 cycles.
Croatian: Medijan broja primljenih ciklusa u obje skupine bio je 4 ciklusa.
English: Horizon, Honey Lane Hurley, SL66RJ United Kingdom
Croatian: Horizon, Honey Lane Hurley, SL66RJ Ujedinjeno Kraljevstvo
English: These patients should be monitored closely and appropriate precautions taken.
Croatian: Te bolesnike potrebno pomno pratiti i poduzeti odgovarajuće mjere opreza.
English: CI=Confidence Interval
Croatian: CI=Interval pouzdanosti
English: • Haemoglobin ≥ 8 g/dL
Croatian: • Hemoglobin ≥ 8 g/dl
English: The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Croatian: Sigurnost i djelotvornost bortezomiba u djece ispod 18 godina starosti nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Croatian: a Temeljeno na ocjeni Neovisnog ocjenjivačkog povjerenstva (IRC) (samo radiološki podaci).
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Croatian: Injekcija u venu kratko traje, tijekom 3 do 5 sekundi.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BDx group.
Croatian: Medijan trajanja liječenja bio je 13 tjedana za skupinu VDDx i 11 tjedana za BDx skupinu.
English: This includes any side effects not listed in this leaflet.
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: One hundred and twenty seven matched pairs of patients were identified.
Croatian: Identificirano je 127 odgovarajućih parova bolesnika.
English: Do not give by other routes.
Croatian: Nemojte primjenjivati drugim putovima primjene.
English: Hepatitis B Virus (HBV) reactivation and infection
Croatian: Reaktivacija virusa hepatitisa B (HBV) i infekcija
English: #, Blepharitis
Croatian: #, blefaritis
English: Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Croatian: Stoga bolesnici moraju biti oprezni kad upravljaju vozilima ili rade sa strojevima i treba ih savjetovati da ne voze ili rade sa strojevima ako dožive te simptome (vidjeti dio 4.8).
English: This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Croatian: Ovo je preživljenje bilo veće od medijana preživljenja od šest do devet mjeseci koje su očekivali ispitivači savjetnici u populacije sličnih bolesnika.
English: Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Croatian: Bortezomib se ne smije primjenjivati u djece i adolescenata, jer nije poznato kako će lijek utjecati na njih.
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Croatian: Bolesnici koji postignu odgovor ili stabilnu bolest nakon 4 ciklusa ovog kombiniranog liječenja mogu nastaviti primati istu kombinaciju tijekom maksimalno 4 dodatna ciklusa.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Croatian: Temelj za izradu Tablice 7 bila je verzija 14.1 MedDRAe.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Croatian: Medijan preživljenja svih uključenih bolesnika bio je 17 mjeseci (raspon <1 do 36+ mjeseci).
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Croatian: Tablica 14: Sažetak ishoda bolesti u ispitivanjima faze III (APEX) i faze II Faza III
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Croatian: Bolesnici koji postignu potpuni odgovor mogu nastaviti liječenje tijekom najmanje 2 ciklusa nakon prvog dokaza potpunog odgovora, čak i ako to zahtijeva liječenje u više od 8 ciklusa.
English: p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm.
Croatian: a p-vrijednost za hipotezu neinferiornosti u SC skupni ostaje na najmanje 60% stope odgovora u IV skupini.
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paraesthesia) with no pain or loss of function
Croatian: 1. stupanj (asimptomatski; gubitak dubokih tetivnih refleksa ili parestezija) bez bolova ili gubitka funkcije
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Croatian: Međutim, srednje vrijednosti AUC normalizirane prema dozi bile su povećane za približno 60% u bolesnika s umjerenim ili teškim oštećenjem jetre.
English: The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Croatian: Primarna mjera ishoda bio je najbolje potvrđen odgovor na ponovljeno liječenje procijenjen prema EBMT kriterijima.
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Croatian: U šestomjesečnom ispitivanju na štakorima primijećeni su degenerativni učinci i na testise i na jajnike.
English: Do not use Bortezomib Hospira - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Croatian: Nemojte primjenjivati Bortezomib Hospira - ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate određene teške plućne ili srčane tegobe.
English: Table 8 has been generated using Version 16 of the MedDRA.
Croatian: Temelj za izradu tTablice 8 bila je verzija 16 MedDRAe.
English: 39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Croatian: 39 ml/min/1,73 m2, n=9) i teško (CrCL < 20 ml/min/1,73 m2, n=3).
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in Table 8 below.
Croatian: Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u BR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BR-CAP, navedene su u Tablici 8 ispod.
English: Rare side effects (may affect up to 1 in 1,000 people) Blood clot in small blood vessels (thrombotic microangiopathy)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - krvni ugrušak u malim krvnim žilama (trombotička mikroangiopatija)
English: Similar proportions of patients had creatinine clearance ≤ 30 ml/min (3% in each arm).
Croatian: Slični udjeli bolesnika imali su klirens kreatinina ≤ 30 ml/min (3% u svakoj skupini).
English: The AUClast- geometric mean ratio was 0.99 and 90% confidence intervals were
Croatian: AUCtrajanja omjera geometrijske sredine bila je 0,99; a 90% interval pouzdanosti bio je
English: Mannitol (E421)
Croatian: manitol (E421)
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Croatian: Incidencija smrti od “Progresivne bolesti” bila je 18% u supkutanoj skupini i 9% u intravenskoj skupini.
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Croatian: Preporučeno je da bolesnici koji imaju bar parcijalan odgovor prime 2 dodatna ciklusa.
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
Croatian: Antivirusna profilaksa bila je primijenjena u 137 od 240 bolesnika (57%) u BR-CAP skupini.
English: When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Croatian: Kada se bortezomib primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).