FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Uputa o lijeku: Informacije za korisnika Synflorix suspenzija za injekciju u višedoznom spremniku (4 doze) Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: Anaphylaxis
Croatian: - kolapsu
English: The effect of Synflorix on nasopharyngeal carriage was studied in 2 double-blind randomised studies using an inactive control: in the nested study of FinIP in Finland (5,023 subjects) and in COMPAS (1,700 subjects).
Croatian: FinIP u Finskoj (5023 ispitanika) te u ispitivanju COMPAS (1700 ispitanika).
English: CI Confidence Interval (1) First episode (2) Follow up period for a maximum of 40 months from 2 weeks after third primary dose (3) Not statistically significant by pre-defined criteria (One sided p=0.032).
Croatian: (3) nije statistički značajno prema unaprijed definiranim kriterijima (jednostrana p-vrijednost = 0,032).
English: Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100 Anti-18C 99.3 Anti-19F 96.1 Anti-23F 77.6
Croatian: Anti-18C 99,3 Anti-19F 96,1 Anti-23F 77,6
English: Package leaflet: Information for the user Synflorix suspension for injection Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Uputa o lijeku: Informacije za korisnika Synflorix suspenzija za injekciju Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: Efficacy of Synflorix against first episodes of likely bacterial Community Acquired Pneumonia (CAP) occurring from 2 weeks after the administration of the 3rd dose was demonstrated in the ATP cohort
Croatian: Community Acquired Pneumonia, CAP), koje su se počele javljati 2 tjedna nakon primjene 3. doze, dokazana je u međuanalizi ATP kohorte (p-vrijednost ≤ 0,002) (vođena događajima; primarni cilj).
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane vrlo često gubitak apetita
English: The primary infant series consists of three doses with the first dose given at 2 months of age and with an interval of at least 1 month between doses.
Croatian: pri čemu se prva primjenjuje u dobi od 2 mjeseca, s razmakom od najmanje 1 mjeseca između pojedinih doza.
English: Store in the original package in order to protect from light After first use, the product may be stored in a refrigerator for a maximum of 28 days
Croatian: Nakon prve primjene, cjepivo se može čuvati u hladnjaku najduže 28 dana.
English: Vaccine effectiveness was 6.1% (95% CI: -2.7; 14.1) for the 3+1 schedule and 7.4% (95% CI -2.8; 16.6) for 2+1 schedule for this AOM endpoint in the infant vaccinated cohort.
Croatian: Učinkovitost cjepiva za navedenu mjeru ishoda za AOM u kohorti cijepljene dojenčadi iznosila je 6,1% (95% CI: -2,7; 14,1) za raspored 3+1 te
English: Pneumonia
Croatian: LIJEKA
English: Package leaflet: Information for the user Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Uputa o lijeku: Informacije za korisnika Synflorix suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: IPD Invasive Pneumococcal Disease
Croatian: IPB invazivna pneumokokna bolest UC/DC učinkovitost cjepiva (FinIP) ili djelotvornost cjepiva (COMPAS)
English: ГлаксоСмитКлайн ЕООД Тел.
Croatian: GlaxoSmithKine Biologicals Kft.
English: A different place for the injection will be used for each vaccine.
Croatian: Svako cjepivo u tom slučaju, primjenjuje se na različito ubodno mjesto.
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (2 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Synflorix suspenzija za injekciju u višedoznom spremniku (2 doze) Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Croatian: GlaxoSmithKline Biologicals S.A. 89, Rue de l'Institut BE-1330 Rixensart Belgija
English: For most vaccine serotypes, group comparisons did not suggest any differences in post-primary immune responses between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups, except for a trend towards a lower percentage of subjects reaching OPA titres ≥ 8 and lower OPA GMTs in the HIV+/+ group.
Croatian: osim trenda prema nižem postotku ispitanika koji su postigli OPA titre ≥ 8 i niže OPA GMT-e u skupini HIV+/+.
English: It has also been demonstrated that Synflorix induces an immune response to the cross-reactive serotype 19A with 48.8% (95% CI: 42.9; 54.7) of vaccinees reaching an OPA titre ≥ 8 one month after a booster dose.
Croatian: 48,8% (95% CI: 42,9; 54,7) cijepljenika koji su dostigli OPA titar > 8 jedan mjesec nakon doze docjepljivanja.
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Synflorix suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: may be given from the age of 9 months onwards.
Croatian: Posljednja injekcija (docjepljivanje) se može dati od navršenih 9 mjeseci nadalje.
English: • headache
Croatian: • koprivnjača
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Synflorix suspenzija za injekciju u višedoznom spremniku (4 doze) Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: Immunogenicity data
Croatian: Podaci o imunogenosti
English: Multidose vial 2-dose vial EU/1/09/508/009 4-dose vial EU/1/09/508/012 EU/1/09/508/013
Croatian: Višedozni spremnik 2-dozna bočica EU/1/09/508/009
English: VE Vaccine effectiveness (FinIP) or efficacy (COMPAS) N number of subjects per group
Croatian: U analizi na kraju ispitivanja (ATP kohorta) djelotvornost cjepiva (prve epizode) protiv B-CAP
English: Psychiatric disorders
Croatian: Klinička ispitivanja
English: Similar antibody GMCs and
Croatian: GMC-e protutijela i OPA GMT-e.
English: Infants from 6 weeks to 6 months of age
Croatian: Dojenčad u dobi od 6 tjedana do 6 mjeseci Primarna imunizacija s tri doze
English: 10 doses (0.5 ml)
Croatian: 10 napunjenih štrcaljki 10 doza (0,5 ml)
English: The vaccine efficacy against the first episode of NTHi AOM was 31.1% (95% CI: -3.7; 54.2, not significant).
Croatian: 31,1% (95% CI: -3,7; 54,2, nije značajno).
English: Skin and subcutaneous tissue disorders
Croatian: Tijelo štrcaljke Zatvarač štrcaljke
English: Suspension for injection
Croatian: Synflorix suspenzija za injekciju
English: How Synflorix is given
Croatian: Kako primjenjivati Synflorix Kako se primjenjuje cjepivo
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: (Izmišljeno) ime Doza Farmaceutski oblik Pot primjene Unutranje pakovanje
English: Further information on Azacitidine Celgene can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene.
Croatian: Više informacija o lijeku Azacitidin Celgene dostupno je na internetskim stranicama Agencije:www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene
English: This medicine is the same as Vidaza, which is already authorised in the EU.
Croatian: Ovaj lijek isti je kao lijek Vidaza, koji je već odobren u EU-u.
English: The effect of Azacitidine Celgene was similar in all three diseases.
Croatian: Učinak lijeka Azacitidin Celgene bio je sličan kod svih triju bolesti.
English: The recommended dose of Azacitidine Celgene is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza lijeka Azacitidin Celgene iznosi 75 mg po kvadratnom metru tjelesne površine (izračunato prema visini i tjelesnoj težini bolesnika).
English: It can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Croatian: Lijek se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: If the blood counts fall too low or if the patient develops kidney problems, the next treatment cycle should be delayed or a lower dose should be used.
Croatian: Ako vrijednosti krvne slike bolesnika budu preniske ili ako se kod bolesnika razviju problemi s bubrezima, potrebno je odgoditi sljedeći ciklus terapije ili uvesti manju dozu lijeka.
English: Side effects reported with Azacitidine Celgene are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Azacitidin Celgene pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: It is given as an injection under the skin of the upper arm, thigh or abdomen (tummy) every day for one week, followed by three weeks with no treatment.
Croatian: Daje se injekcijom pod kožu nadlaktice, bedra ili abdomena (trbuha) jednom dnevno tijekom sedam dana, nakon čega slijedi stanka od tri tjedna.
English: What measures are being taken to ensure the safe and effective use of Azacitidine Celgene?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Azacitidin Celgene?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine Celgene have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Azacitidin Celgene nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent').
Croatian: Tvrtka koja proizvodi lijek Vidaza pristala je da se njezini znanstveni podatci upotrijebe za lijek Azacitidin Celgene (tzv. „informirani pristanak”).
English: The most common side effects of Azacitidine Celgene, which may affect more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells), are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Croatian: Najčešće nuspojave lijeka Acitidine Celgene koje se mogu pojaviti u više od 60 % bolesnika s mijelodisplastičnim sindromima, KMML-om ili AML-om (20 do 30 % abnormalnih stanica) su hematološke reakcije uključujući trombocitopeniju (nizak broj trombocita), neutropenija (nizak broj neutrofila, vrste bijelih krvnih stanica) i leukopenija (nizak broj bijelih krvnih stanica), nuspojave povezane s trbuhom i crijevima uključujući mučninu i povraćanje te reakcije na mjestu primjene.
English: Azacitidine Celgene is available as a powder to be made up into a suspension for injection.
Croatian: Lijek Azacitidin Celgene dostupan je kao prašak od kojeg se priprema suspenzija za injekciju.
English: Patients should be given medicines to prevent nausea (feeling sick) and vomiting before receiving Azacitidine Celgene.
Croatian: Bolesnicima je potrebno dati lijekove za sprječavanje mučnine (slabosti) i povraćanja prije nego što prime lijek Azacitidin Celgene.
English: The European Medicines Agency decided that Azacitidine Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Azacitidin Celgene nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The active substance in Azacitidine Celgene, azacitidine, belongs to the group ‘antimetabolites' and can be incorporated into the genetic material of cells (RNA and DNA) instead of their natural building-block, cytidine.
Croatian: Djelatna tvar u lijeku Azacitidin Celgene, azacitidin, ubraja se u skupinu „antimetabolita” i može se ugraditi u genetski materijal stanica (RNK i DNK) umjesto njihove prirodne temeljne sastavnice citidina.
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML who were unlikely to go on to have a stem cell transplant.
Croatian: Prvo je ispitivanje obuhvatilo 358 odraslih osoba s mijelodisplastičnim sindromima srednjeg do visokog rizika, KMML-om ili AML-om, za koje nije bilo izgledno da će se podvrgnuti transplantaciji matičnih stanica.
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Croatian: • AML-a koji se razvio iz mijelodisplastičnog sindroma, a koštana srž sadrži od 20 do 30 % abnormalnih stanica;
English: In the second study, which involved 488 patients with AML who could not have haematopoietic stem cell transplantation and whose bone marrow contained more than 30% abnormal cells, patients receiving Azacitidine Celgene survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Croatian: U drugom su ispitivanju, koje je obuhvaćalo 488 bolesnika s AML-om koji se nisu mogli podvrgnuti transplantaciji hematopoetskih matičnih stanica i čija je koštana srž sadržavala više od 30 % abnormalnih stanica, bolesnici koji su primili lijek Azacitidin Celgene živjeli u prosjeku 10,4 mjeseci u usporedbi s onima koji su primili konvencionalnu terapiju i živjeli 6,5 mjeseci.
English: What is Azacitidine Celgene and what is it used for?
Croatian: Što je Azacitidin Celgene i za što se koristi?
English: Azacitidine Celgene (azacitidine)
Croatian: Azacitidin Celgene (azacitidin)
English: As for all medicines, data on the use of Azacitidine Celgene are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Azacitidin Celgene kontinuirano se prate.
English: For more information about using Azacitidine Celgene, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Azacitidin Celgene pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Croatian: Azacitidin Celgene primjenjuje se kada se koštana srž sadrži 10 do 29 % abnormalnih stanica i ne proizvodi velik broj bijelih krvnih stanica;
English: This helps to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Croatian: Time se rješavaju problemi sazrijevanja i rasta novih krvnih stanica u koštanoj srži koje su uzrok mijelodisplastičnih poremećaja i ubijaju kancerogene stanice pri leukemiji.
English: Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
Croatian: Azacitidin Celgene primjenjuje se u bolesnika sa srednjim do visokim rizikom pogoršanja stanja do AML-a ili smrti;
English: In this study, patients receiving Azacitidine Celgene survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Croatian: U tom su ispitivanju bolesnici koji su primili lijek Azacitidin Celgene živjeli u prosjeku 24,5 mjeseci u usporedbi s onima koji su primili konvencionalnu terapiju i živjeli 15 mjeseci.
English: An overview of Azacitidine Celgene and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Azacitidin Celgene i zašto je odobren u EU-u
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Croatian: • mijelodisplastičnih sindroma, skupine bolesti kod kojih koštana srž proizvodi premalo krvnih stanica.
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Croatian: • kronične mijelomonocitne leukemije (KMML-a, vrste raka koja zahvaća bijele krvne stanice naziva monociti).
English: Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Croatian: Lijek Azacitidin Celgene koristi se za liječenje odraslih osoba koje se ne mogu podvrgnuti transplantaciji hematopoetskih matičnih stanica (kada bolesnik prima matične stanice kako bi koštana srž ponovno mogla proizvoditi zdrave krvne stanice), a boluju od sljedećih bolesti:
English: Other information about Azacitidine Celgene
Croatian: Ostale informacije o lijeku Azacitidin Celgene
English: Why is Azacitidine Celgene authorised in the EU?
Croatian: Zašto je lijek Azacitidin Celgene odobren u EU-u?
English: The patients' bone marrow contained up to 30% abnormal cells.
Croatian: Koštane srži bolesnika sadržavale su do 30 % abnormalnih stanica.
English: In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).
Croatian: U nekim slučajevima mijelodisplastični sindromi mogu dovesti do akutne mijeloične leukemije (AML-a, vrste raka koja zahvaća bijele krvne stanice naziva mijeloične stanice).
English: Azacitidine Celgene contains the active substance azacitidine.
Croatian: Azacitidin Celgene sadrži djelatnu tvar azacitidin.
English: Azacitidine Celgene was shown to be more effective than conventional care in extending survival in two main studies.
Croatian: U dva glavna ispitivanja utvrđeno je da je lijek Azacitidin Celgene učinkovitiji od konvencionalne terapije kada je riječ o produljenju preživljenja.
English: What are the risks associated with Azacitidine Celgene?
Croatian: Koji su rizici povezani s lijekom Azacitidin Celgene?
English: • AML, when the bone marrow has more than 30% abnormal cells.
Croatian: • AML-a pri kojem koštana srž ima više od 30 % abnormalnih stanica.
English: Azacitidine Celgene must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Croatian: Azacitidin Celgene se ne smije primjenjivati u bolesnika s uznapredovalim rakom jetre i žena koje doje.
English: For the full list of side effects and restrictions of Azacitidine Celgene, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Azacitidin Celgene potražite u uputi o lijeku.
English: How does Azacitidine Celgene work?
Croatian: Kako djeluje Azacitidin Celgene?
English: How is Azacitidine Celgene used?
Croatian: Kako se Azacitidin Celgene primjenjuje?
English: What benefits of Azacitidine Celgene have been shown in studies?
Croatian: Koje su koristi od lijeka Azacitidin Celgene utvrđene u ispitivanjima?
English: Side effects were similar in AML patients with more than 30% abnormal cells.
Croatian: Nuspojave kod bolesnika s AML-om koji imaju više od 30 % abnormalnih stanica bile su slične.
English: The full EPAR for Kogenate Bayer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Kogenate Bayer nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Croatian: Reakcije preosjetljivosti na koži (svrbež, koprivnjača i osip) mogu se često pojaviti (u 1 do10 bolesnika na 100), ali rijetko se pojavljuju ozbiljne alergijske reakcije (u 1 do 10 bolesnika na 10 000).
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Croatian: Oktokog alfa proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: tvori se od stanica u koje je uveden gen (DNK) kako bi mogle proizvoditi tu tvar.
English: Kogenate Bayer octocog alfa
Croatian: Kogenate Bayer oktokog alfa
English: The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Croatian: Glavna mjera djelotvornosti tijekom ispitivanja bio je broj primjena lijeka potrebnih kako bi se zaustavilo svako novo krvarenje.
English: The main measure of effectiveness was the doctor's assessment of how well bleeding was stopped.
Croatian: Glavna mjera djelotvornosti bila je procjena liječnika o uspješnosti zaustavljanja krvarenja.
English: Stopping bleeding was assessed as ‘excellent' in all 15 patients.
Croatian: U svih 15 pacijenata zaustavljanje krvarenja ocijenjeno je kao „odlično”.
English: This is a summary of the European public assessment report (EPAR) for Kogenate Bayer.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Kogenate Bayer.
English: Kogenate Bayer is intended for either short-term or long-term use.
Croatian: Kogenate Bayer je predviđen za kratkotrajnu ili dugotrajnu primjenu.
English: The dose and duration of treatment depend on whether it is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Croatian: Doza i trajanje liječenja ovise o tome primjenjuje li se za liječenje ili sprječavanje krvarenja ili tijekom kirurškog zahvata, kao i o razinama faktora VIII u bolesnika, o stupnju hemofilije, jačini i mjestu krvarenja te stanju i tjelesnoj težini bolesnika.
English: Kogenate Bayer is similar to another medicine that was previously authorised in the EU called Kogenate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Croatian: Lijek Kogenate Bayer sličan je drugom lijeku prethodno odobrenom u EU-u pod nazivom Kogenate, no proizvodi se na drugačiji način, tako da u njemu ne postoje proteini ljudskog podrijetla.
English: Because of this, Kogenate Bayer has been compared with Kogenate to show that the two medicines are equivalent.
Croatian: Zbog toga je lijek Kogenate Bayer uspoređen s lijekom Kogenate kako bi se dokazalo da su ta dva lijeka jednakovrijedna.
English: What measures are being taken to ensure the safe and effective use of Kogenate Bayer?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kogenate Bayer?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kogenate Bayer have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Kogenate Bayer nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Commission granted a marketing authorisation valid throughout the EU for Kogenate Bayer on 4 August 2000.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Kogenate Bayer u promet koje vrijedi na prostoru Europske unije od 4. kolovoza 2000.
English: Kogenate Bayer must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Croatian: Kogenate Bayer ne smije se upotrebljavati u osoba koje su preosjetljive (alergične) na ljudski koagulacijski faktor VIII, proteine miša ili hrčka ili na bilo koji drugi sastojak.
English: The Agency decided that Kogenate Bayer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je zaključila da koristi lijeka Kogenate Bayer nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: In such cases, a specialised haemophilia centre should be contacted.
Croatian: U tim slučajevima bolesnici se trebaju obratiti specijaliziranom centru za liječenje hemofilije.