FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity reaction
Croatian: - alergijske reakcije
English: Data on concomitant administration of Hexacima with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Croatian: Podaci o istovremenoj primjeni cjepiva Hexacima s polisaharidnim konjugiranim cjepivom protiv pneumokoka nisu pokazali klinički značajnu interferenciju u odgovoru protutijela na svaki od antigena.
English: The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexacima) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study.
Croatian: Učinkovitost kombiniranih cjepiva DTaP i Hib (pentavalentno i heksavalentno, uključujući cjepiva koja sadrže antigen Hib-a iz cjepiva Hexacima) protiv invazivne bolesti
English: Hexacima in vials 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Croatian: 0,5 ml suspenzije u bočici (staklo tip I) s čepom (halobutil).
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Croatian: Hexacima je dostupna u pakiranju koje sadrži 1 ili 10 napunjenih štrcaljki s 1 zasebnom iglom.
English: N = Number of individuals analysed (per protocol set) a: Generally accepted surrogates (PT, FHA) or correlates of protection (other components) b: 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) c: 2, 4, 6 months with hepatitis B vaccination at birth (Colombia) d: Due to an OPV National Immunisation Days in the country, Polio results have not have been analysed e: 8 EU/ml corresponds to 4 LLOQ (Lower Limit Of Quantification in enzyme-linked immunosorbent assay
Croatian: c: 2, 4, 6 mjeseci s cijepljenjem protiv hepatitisa B po rođenju (Kolumbija) d: Zbog nacionalnih dana imunizacije OPV cjepivom u državi, rezultati za polio nisu bili analizirani. e: 8 EU/ml odgovara 4 LLOQ (donja granica kvantifikacije kod enzimskog imunotesta ELISA) LLOQ vrijednost za anti-PT i anti-FHA iznosi 2 EU/ml
English: Without hepatitis B at birth
Croatian: Bez cijepljenja protiv hepatitisa B po rođenju
English: The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
Croatian: 2 i 4 mjeseca starosti bio je sličan onome koji je zapažen mjesec dana nakon primarnog cijepljenja s 2
English: divízia vakcín Sanofi Pasteur Tel.: +421 2 33 100 100
Croatian: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. divízia vakcín Sanofi Pasteur Tel.: +421 2 33 100 100
English: • Common side effects (may affect up to 1 in 10 people) are: - abnormal crying (prolonged crying) - diarrhoea - injection site hardness (induration)
Croatian: • Česte nuspojave (prijavljene u manje od 1 djeteta na 10 djece): - neuobičajeni plač (produženi plač)
English: EXPIRY DATE EXP: MM/YYYY
Croatian: Rok valjanosti: MM/GGGG
English: Bordetella pertussis antigens Pertussis Toxoid
Croatian: Antigeni bakterije Bordetella pertussis Toksoid hripavca (PT)
English: Anti-Polio type 1 (≥ 8 (1/dilution))
Croatian: (≥ 8 (1/razrjeđenje))
English: • If your child gets any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako Vaše dijete dobije bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hexacima suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Injection-site nodule
Croatian: Prijavljivanje nuspojava
English: Very common Injection-site pain, injection-site erythema, injection-site swelling
Croatian: Vrlo često Bol, eritem i oteklina na mjestu injiciranja, razdražljivost,
English: Data on concomitant administration of a booster dose of Hexacima with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Croatian: Podaci o istovremenoj primjeni docjepljivanja cjepivom Hexacima s cjepivom protiv ospica zaušnjaka-rubeole nisu pokazali klinički značajnu interferenciju u odgovoru protutijela na svaki od antigena.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Croatian: poliomijelitisa (inaktiviranog) i Haemophilus influenzae tip b (konjugiranog), adsorbirano DtaP-IPV-HB-Hib
English: • Very common side effects (may affect more than 1 in 10 people) are: - loss of appetite (anorexia) - crying - sleepiness (somnolence) - vomiting - pain, redness or swelling at the injection site - irritability - fever (temperature 38°C or higher)
Croatian: - bol, crvenilo (eritem), oteklina na mjestu uboda - razdražljivost - vrućica (temperatura 38°C ili više)
English: • has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process - after previous administration of Hexacima or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines.
Croatian: - na glutaraldehid, formaldehid, neomicin, streptomicin ili polimiksin B jer se ove tvari koriste u postupku proizvodnje - na prethodno cijepljenje cjepivom Hexacima ili nekim drugim cjepivom protiv difterije, tetanusa, hripavca, poliomijelitisa, hepatitisa B i Hemofilusa influence tip b
English: Hexacima will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Croatian: Hexacima neće spriječiti bolesti prouzročene patogenima koji nisu Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ili Haemophilus influenzae tip b.
English: General disorders and administration site conditions Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines.
Croatian: Nakon primjene cjepiva koja sadrže Haemophilus influenzae tip b mogu se pojaviti edematozne reakcije koje zahvaćaju jedan ili oba donja ekstremiteta.
English: • Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (GuillainBarré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
Croatian: • privremena upala živaca koja uzrokuje bol, paralizu i poremećaj osjeta (Guillain-Barréov sindrom) i jaka bol i smanjena mogućnosti pokretanja nadlaktice i ramena (brahijalni neuritis)
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth ( Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Croatian: † 6, 10, 14 tjedana sa i bez cijepljenja protiv hepatitisa B pri rođenju (Južnoafrička Republika) †† 2, 3, 4 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Finska) ‡ 2, 4, 6 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Meksiko) i s cijepljenjem protiv hepatitisa B po rođenju (Costa Rica i Kolumbija) ‡‡ Serokonverzija: minimalno četverostruko povećanje u usporedbi s razinom prije cijepljenja (prije 1. doze)
English: Marketing Authorisation Holder: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon , France
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet: Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, Francuska
English: † See section c.
Croatian: PRILOG III.
English: No data are available for premature infants.
Croatian: Nema podataka o primjeni u nedonoščadi.
English: Anti-PRP (≥ 0.15 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Argentina, Mexico, Peru) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration <8 EU/ml, then the post-vaccination antibody concentration should be ≥8 EU/ml.
Croatian: †† 2, 3, 4 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Finska) ‡ 2, 4, 6 mjeseci bez cijepljenja protiv hepatitisa B pri rođenju (Argentina, Meksiko, Peru) i s cijepljenjem protiv hepatitisa B po rođenju (Costa Rica i Kolumbija) ‡‡ Serokonverzija: minimalno četverostruko povećanje u usporedbi s razinom prije cijepljenja (prije 1. doze)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Vistor
Croatian: OBLIK
English: Diarrhoea
Croatian: Doziranje
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 1 separate needle.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklo tip I) s čepom klipa (halobutil) i zatvaračem vrha
English: All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth.
Croatian: Bez obzira je li doza cjepiva protiv hepatitisa B dobivena po rođenju, cjepivo se može primijeniti po svim shemama cijepljenja, uključujući raspored 6, 10, 14 tjedana starosti prema programu imunizacije
English: Sanofi Pasteur Europe Tél: 0800 42 43 46
Croatian: Sanofi Pasteur Sp. z o.o. Tel.: +48 22 280 05 00
English: Injection-site induration
Croatian: Otvrdnuće na mjestu injiciranja
English: If your child experiences any of the following side effects, please tell your doctor, nurse or pharmacist.
Croatian: Ako primijetite bilo koju dolje navedenu nuspojavu, obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Croatian: - Brahijalni neuritis i Guillain-Barréov sindrom prijavljivani su nakon primjene cjepiva koje sadrži toksoid tetanusa.
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Croatian: Nederland sanofi-aventis Netherlands B.V.
English: • Uncommon side effects (may affect up to 1 in 100 people) are: - allergic reaction - lump (nodule) at the injection site - high fever (temperature 39.6°C or higher)
Croatian: - čvorić na mjestu uboda, - vrućica (temperatura 39,6°C ili više)
English: Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level
Croatian: Odnosno, koncentracija protutijela nakon cijepljenja treba biti jednaka ili veća (≥) razini prije cijepljenja
English: In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3%
Croatian: Ispitivanja dugoročne trajnosti protutijela induciranih cjepivom nakon različitih primarnih serija cijepljenja dojenčadi/male djece i nakon što je cjepivo protiv hepatitisa B bilo ili nije bilo primjenjeno po rođenju, pokazala su održavanje razina iznad utvrđenih zaštitnih razina ili graničnih vrijednosti protutijela za antigene iz cjepiva (vidjeti Tablicu 3.) Dodatno, pokazalo se da imunost protiv hepatitis B komponente cjepiva traje do dobi od 9 godina, nakon primarne serije cijepljenja koja se sastoji od jedne doze cjepiva protiv hepatitisa B dobivene po rođenju koju slijedi serija od 3 doze za dojenčad u dobi od 2, 4 i 6 mjeseci bez docjepljivanja te nakon toga u dobi malog djeteta gdje je 49,3% cijepljenih imalo protutijela ≥ 10 mIU/ml s geometrijskom srednjom vrijednosti koncentracija od 13,3 (95% CI: 8,82 - 20,0) mIU/ml.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Croatian: poliomijelitisa (inaktiviranog) i Haemophilus influenzae tip b (konjugiranog), adsorbirano.
English: Manufacturer: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France
Croatian: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, Francuska Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, Francuska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Extensive limb swelling†
Croatian: Opsežne otekline ekstremiteta†
English: vaccination at birth
Croatian: po rođenju
English: Hexacima suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Croatian: Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK),
English: Saccharose
Croatian: Proljev
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Croatian: S obzirom na dugu inkubaciju hepatitisa B, postoji mogućnost da je u trenutku cijepljenja prisutna neprepoznata zaraza hepatitisom B. U takvim slučajevima cjepivo možda neće spriječiti infekciju hepatitisom B. Hexacima ne štiti od zaraznih bolesti koje su prouzročene drugim tipovima bakterije Haemophilus influenzae ili drugim uzročnicima meningitisa.
English: The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.
Croatian: Imunokompromitirani pacijenti (bilo zbog bolesti ili liječenja) možda neće razviti očekivani imunološki odgovor.
English: Contents of the pack and other information What Hexacima contains The active substances are per dose (0.5 ml)1: Diphtheria Toxoid not less than 20 IU2
Croatian: Jedna doza1 (0,5 ml) sadrži: • Toksoid difterije
English: 5 Or equivalent antigenic quantity determined by a suitable immunochemical method 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Croatian: Ili ekvivalentna antigenska količina određena primjerenom imunokemijskom metodom
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I
English: This is not considered clinically relevant.
Croatian: To se ne smatra klinički značajnim.
English: This will be done by a healthcare professional.
Croatian: To će učiniti zdravstveni radnik.
English: Best response
Croatian: Najbolji odgovor
English: Therefore no dose recommendations can be made in this population.
Croatian: Stoga se ne mogu dati preporuke za dozu u ovoj populaciji.
English: Some of these effects may be serious.
Croatian: Neke od tih nuspojava mogu biti ozbiljne.
English: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Croatian: Otapanje liofiliziranog praška gotovo je u manje od 2 minute.
English: Day -- -
Croatian: Dan -- -
English: For dose adjustments, see Table 5 below.
Croatian: Za prilagodbe doza vidjeti Tablicu 5 ispod.
English: Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Croatian: Razgovarajte sa svojim liječnikom kada je sigurno ponovno početi s dojenjem nakon što završite liječenje.
English: The educational material shall consist of the following:
Croatian: Edukacijski materijal će se sastojati od sljedećeg:
English: A total of 218 patients were evaluable for response.
Croatian: U ukupno 218 bolesnika bila je moguća procjena odgovora.
English: Some of these events have been fatal.
Croatian: Neki od tih događaja imali su smrtni ishod.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, ali ne mogu se dati preporuke za doziranje.
English: The median number of cycles received for both groups was 4 cycles.
Croatian: Medijan broja ciklusa koje su primile obje skupine bio je 4 ciklusa.
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Croatian: Osamnaest posto bolesnika postiglo je ili je imalo poboljšan odgovor [MR (11 %) ili PR (7 %)] uz kombinirano liječenje.
English: Do not give by other routes.
Croatian: Nemojte primjenjivati drugim putevima primjene.
English: Bzmb=Bortezomib SUN; M=melphalan, P=prednisone
Croatian: Bzmb = Bortezomib SUN; M = melfalan, P = prednizon
English: These results, though not mature, constituted the protocol defined final analysis.
Croatian: Ovi rezultati, iako nisu zreli, sačinjavali su planom ispitivanja definiranu konačnu analizu.
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Croatian: Razmotriti smanjenje doze melfalana za 25 % u sljedećem ciklusu.
English: Median follow-up was 16.3 months.
Croatian: Medijan praćenja iznosio je 16,3 mjeseci.
English: Complete response (CR) was evaluated at the end of Block 1.
Croatian: Kompletni odgovor (engl. complete response, CR) bio je procijenjen na kraju 1. bloka.
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Croatian: a Temeljeno na ocjeni Nezavisnog odbora za procjenu (IRC) (samo radiološki podaci).
English: If, despite these measures, pregnancy occurs, tell your doctor immediately.
Croatian: Ako trudnoća nastupi unatoč ovim mjerama, odmah o tome obavijestite svog liječnika.
English: These patients should be monitored closely and appropriate precautions taken.
Croatian: Te je bolesnike potrebno pomno pratiti i poduzeti odgovarajuće mjere opreza.
English: In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Croatian: U nekoliko slučajeva, bolesnici koji su imali hepatitis B, mogli bi imati ponovnu pojavu hepatitisa, koja može biti smrtonosna.
English: Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Croatian: Dvoje (1 %) bolesnika imalo je teške reakcije; 1 slučaj pruritusa i 1 slučaj crvenila.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Croatian: AST = aspartat aminotransferaza; GGN = gornja granica normalnog raspona.
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Croatian: NCI Common Toxicity Criteria CTCAE v 4.0).
English: * Grouping of more than one MedDRA preferred term.
Croatian: * Grupiranje više od jednog MedDRA preporučenog izraza.
English: Therefore, caution should be used during handling and preparation.
Croatian: Stoga je potreban oprez tijekom rukovanja i pripreme.
English: Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
Croatian: Od 669 uključenih bolesnika, 245 (37 %) bilo je u dobi od 65 godina ili starije.
English: All these target organs have shown partial to full recovery following discontinuation of treatment.
Croatian: Svi ti ciljni organi djelomično su se ili potpuno oporavili nakon prestanka liječenja.
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Croatian: Nemojte voziti niti rukovati alatima ili strojevima ako imate takve nuspojave; čak i ako ih ne osjećate i dalje morate biti na oprezu.
English: Time to first response in CR + PR
Croatian: Vrijeme do prvog odgovora u CR + PR
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 do 18 godina starosti nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
English: The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Croatian: Mehanizam ovog događaja nije poznat, premda djelomično može biti posljedica autonomne neuropatije.
English: The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Samo bočica od 3,5 mg se smije primijeniti supkutano, što je opisano ispod.
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Croatian: Liječenje se primjenjivalo tijekom najviše 9 ciklusa (približno 54 tjedna) i prekinuto je u početnoj fazi zbog progresije bolesti ili neprihvatljive toksičnosti.
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Croatian: 4. stupanj (po život opasne posljedice; indicirana je hitna intervencija) i/ili teška autonomna neuropatija
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzmbDx group.
Croatian: Medijan trajanja liječenja bio je 13 tjedana za skupinu VDDx i 11 tjedana za BzmbDx skupinu.
English: Information on autonomic neuropathy and its contribution to these undesirable effects is limited.
Croatian: Podaci o autonomnoj neuropatiji i njezinom doprinosu tim nuspojavama su ograničeni.
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 kod populacije sličnih bolesnika.
English: Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Croatian: Štoviše, u ispitivanjima na psima bilo je primijećeno blago povećanje korigiranog QT intervala.
English: Day 29 Rest period
Croatian: Dan 29 Period odmora
English: The major metabolic pathway is deboronation to form two deboronated metabolites that subsequently undergo hydroxylation to several metabolites.
Croatian: Glavni metabolički put je deboronacija čime se oblikuju dva deboronirana metabolita koji se nakon toga hidroksiliraju do nekoliko metabolita.
English: MARKETING AUTHORISATION NUMBER EU/1/16/1102/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1102/001
English: Day 8, 11
Croatian: Dan 8, 11
English: Bortezomib should be discontinued if serious reactions occur.
Croatian: Primjena bortezomiba mora se prekinuti ako se pojave ozbiljne reakcije.
English: Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Croatian: Trajanje liječenja (medijan=17 tjedana) i trajanje praćenja (medijan=40 mjeseci) bili su usporedivi u obje liječene skupine.