FrancophonIA/ELRC3.0 huggingface dataset:
English: The following information is intended for healthcare professionals only: Multidose vial: Vial containing 10 doses (0.5 ml each) for injection.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Jednodozna bočica: 1 bočica sadrži jednu dozu (0,5 ml) za injekciju
English: Water for injections.
Croatian: Tiomersal, Voda za injekcije.
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Croatian: Štrcaljka spremna za primjenu sadrži jednostruku dozu za injekciju od 0,5 ml.
English: From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to Foclivia (an MF59.1 adjuvanted H1N1 pandemic vaccine), the following additional adverse reactions have been reported:
Croatian: Tijekom praćenja nakon stavljanja u promet adjuvantiranih interpandemijskih trovalentnih cjepiva sastava sličnog Focliviji (H1N1 pandemijsko cjepivo adjuvantirano s MF59C.1), prijavljene su sljedeće dodatne nuspojave:
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Croatian: Često (>1/100 i <1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, malaksalost, umor i tresavica
English: Fever ≥ 38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Croatian: Vrućica ≥38°C to 38,9°C Vrućica 39°C to 39,9°C Vrućica ≥ 40° C
English: - have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Croatian: - alergični (preosjetljivi) na cjepiva protiv gripe ili bilo koji sastojak Foclivije, - alergični na jaja, pileću bjelančevinu, - alergični na bilo koji antibiotik, formaldehid, cetiltrimetilamonij bromid (CTAB) i polisorbat 80.
English: It is provided in a vial containing a single dose (0.5 ml) for injection.
Croatian: Isporučena je u bočici koja sadrži jednostruku dozu (0,5 ml) za injekciju.
English: Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3).
Croatian: Trombocitopenija (vrlo rijetki slučajevi su bili ozbiljni, u kojima se broj trombocita spustio na manje od 5000 po mm3)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA ŠTRCALJKU
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects.
Croatian: Dvije doze cjepiva koje sadrži virus H5N1 (A/Vietnam/1194/2004; 7,5 µg hemaglutinina (HA) / doza adjuvantirano) primijenjene su u razmaku od tri tjedna na 156 ispitanika.
English: Seroconversion factor(95%CI)**
Croatian: Čimbenik serokonverzije (95%CI)**
English: How Foclivia is given
Croatian: Kako se daje FOCLIVIA
English: Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Croatian: Prije primjene cjepivo treba ostaviti da dostigne sobnu temperaturu.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-Ha protutijela na virus H5N1 A/turkey/Turkey/05 nakon 2. doze u osoba starijih od 60 godina, izmjereni SRH i HI testovima bili su sljedeći:
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43
Croatian: (95% CI) 43. dan do 1. dan Stopa serokonverzije (95% CI) 43. dan
English: 0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Croatian: 0,5 ml u jednodoznoj bočici (staklo tipa I) s gumenim čepom (halo-butilna guma).
English: Package leaflet: Information for the user Foclivia suspension for injection in multidose container
Croatian: Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju u višedoznom spremniku
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13.
Croatian: Rezultati MN analize za klinička ispitivanja u gornjoj tablici ukazali su na stopu serozaštite od virusa A/turkey/Turkey/05 u rasponu od 27% (17-39) (V87P1) do 39% (32-46) (V87P13) te stopu serokonverzije od 36% (29-43) za studiju V87P13.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-Ha protutijela na virus H5N1 A/Vietnam/1194/2004 izmjereni SRH testovima bili su sljedeći:
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Croatian: Vrućica ≥38°C to 38,9°C Vrućica 39°C to 39,9°C Vrućica ≥ 40° C Bilo koji drugi štetni događaj
English: Single dose vial: 1 vial containing a single dose (0.5 ml) for injection Instructions for administration of the vaccine:
Croatian: Bočica sadrži 10 doza (po 0,5 ml) za injekciju Upute za primjenu cjepiva:
English: All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Croatian: Svi spontani štetni događaji (SOC, HLT, i PT) koje su se javile u trudnica, stratificirani prema vrsti izvještaja (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvještajem i skupno.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA 10-DOZNU BOČICU
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Croatian: 7,5 mikrograma** po dozi od 0,5 ml * umnoženi u oplođenim kokošjim jajima iz jata zdravih kokoši ** izraženo u mikrogramima hemaglutinina.
English: Seroconversion factor (95%CI)°°
Croatian: Čimbenik serokonverzije (95%CI)°°
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA 1-DOZNU BOČICU
English: Very rare (may affect up to 1 in 10,000 people).
Croatian: Vrlo rijetko (može se javiti u najviše 1 od 10 000 osoba).
English: Package leaflet: Information for the user Foclivia suspension for injection in pre-filled syringe
Croatian: Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju u napunjenoj štrcaljki
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Croatian: Rezultati MN analize na virus A/Vietnam/1194/2004 ukazuju na stopu serozaštite i serokonverzije u rasponu od 57% (50-64) do 79% (68-87), odnosno od 55% (48-62) do 58% (47-69).
English: This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Croatian: - Međutim, u pandemijskoj situaciji još uvijek možete primiti cjepivo i to samo ukoliko je medicinski tretman odmah dostupan u slučaju da vam se pojavi alergijska reakcija.
English: MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Croatian: Rezultati mikroneutralizacije (MN) analize na virus A/Vietnam/1194/2004 ukazuju na stope serozaštite i serokonverzije u rasponu od 67% (60-74) do 85% (78-90), odnosno od 65% (58-72) do 83% (77-89).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Croatian: Potreban je oprez pri primjeni cjepiva kod osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar navedenu u dijelu 6.1 i na jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13.
Croatian: A/turkey/Turkey/05 u rasponu od 11% (3-25) (studija V87P1) do 30% (24-37) (studija V87P13) te stopu serokonverzije od 25% (19-31) za studiju V87P13.
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Croatian: Potreban je oprez pri primjeni cjepiva kod osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar navedenu u dijelu 6.1, na tiomersal i na jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
English: The vaccine should be allowed to reach room temperature before use.
Croatian: Prije uporabe cjepivo treba ostaviti da postigne sobnu temperaturu.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by Single Radial Haemolysis (SRH) assay was as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-HA protutijela na virus H5N1 A/Vietnam/1194/2004 u odraslih osoba izmjereni jednosmjernom radijalnom hemolizom (SRH, engl.
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: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
Croatian: H5N1 A/Vietnam/1194/2004 u ispitanika starijih od 60 godina (ograničen broj ispitanika bio je stariji od 70 godina) izmjereni SRH analizom i procijenjeni u dva klinička ispitivanja bili su sljedeći:
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Croatian: a liječnik treba osobe (ili roditelje) obavijestiti o mogućnosti pojave konvulzija (vidjeti dio 4.8).
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
Croatian: Često (>1/100 i <1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, opća malaksalost, umor i tresavica
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Croatian: Svi spontani štetni događaji po dobnoj skupini, prema SOC-u, HLT-u i PT-u, stratificirani prema vrsti izvještaja (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvještajem i skupno.
English: Pandemic Influenza Vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Croatian: Cjepivo protiv pandemijske influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26).
Croatian: Rezultati MN analize u studiji V87P13 pokazali su da je omjer srednje geometrijske vrijednosti (GMR) protiv virusa A/turkey/Turkey/05 bio 2,01 (1,78-2,26).
English: Foclivia was evaluated in adults aged (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Croatian: Foclivia je procijenjena u odraslih osoba (od 18 do 60 godina) i starijih osoba (starijih od 60 godina)
English: A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137).
Croatian: Nuspojave iz kliničkih ispitivanja u djece u dobi od 6 mjeseci do 17 godina Kliničko ispitivanje (Studija V87P6) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 (n=334) nasuprot cjepivu protiv sezonske influence (n=137).
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Croatian: Čimbenik serokonverzije (95%CI)** * izmjereno SRH analizom ≥25 mm2
English: Rare (may affect up to 1 in 1,000 people).
Croatian: Rijetko (može se javiti u najviše 1 od 1000 osoba).
English: Frequency of Adverse reactions in clinical trials and postmarketing surveillance is reported hereunder.
Croatian: Učestalost nuspojava u kliničkim ispitivanjima i istraživanjima nakon stavljanja cjepiva na tržište je navedena ispod.
English: - Active substance:
Croatian: - Djelatna tvar:
English: Adverse reactions from clinical trial in children aged 6 months to 17 years
Croatian: Vrlo česte reakcije prijavljene kod 146 dojenčadi i male djece u dobi od 6 do 35 mjeseci:
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Croatian: Anafilaktička (tj. po život opasna) reakcija u anamnezi, na bilo koji sastojak ovog cjepiva ili na ostatne tvari koje se u cjepivu nalaze u tragovima kao što su jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
English: To be administered intramuscularly into the deltoid muscle.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Intramuskularna primjena u deltoidni mišić.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Croatian: Stopa serozaštite (95%CI)* Stopa serokonverzije (95%CI)* Čimbenik serokonverzije (95%CI)**
English: Common (may affect up to 1 in 10 people).
Croatian: Često (može se javiti u najviše 1 od 10 osoba).
English: Respiratory, thoracic and mediastinal disorders Cough.
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Croatian: HI Stopa serozaštite (95%CI)° Stopa serokonverzije (95%CI)°
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Croatian: Rezultati MN analize u studiji V87P13 pokazali su da je omjer srednje geometrijske vrijednost (GMR) protiv virusa A/turkey/Turkey/05 bio 2,77 (2,4-3,2).
English: Posology
Croatian: Skvalen
English: Study V87P1 21 days after 2nd dose N=84
Croatian: Studija V87P1 21 dan nakon 2. doze N=84
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Croatian: H5N1 A/turkey/Turkey/05 nakon 2. doze u odraslih osoba u dobi od 18 do 60 godina, izmjereni SRH
English: Headache, dizziness, somnolence, syncope.
Croatian: Poremećaji živčanog sustava Glavobolja, omaglica, pospanost, sinkopa.
English: Study V87P13 21 days after 2nd dose N=66
Croatian: Studija V87P13 21 dan nakon 2. doze N=66
English: Study V87P13 21 days after 2nd dose N=69
Croatian: Studija V87P13 21 dan nakon 2. doze N=69
English: Study V87P13 21 days after 2nd dose N=128
Croatian: Studija V87P13 21 dan nakon 2. doze N=128
English: Study V87P1 21 days after 2nd dose N=70
Croatian: Studija V87P1 21 dan nakon 2. doze N=70
English: Foclivia suspension for injection Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Croatian: Foclivia suspenzija za injekciju Cjepivo protiv pandemijske influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
English: Study V87P1 21 days after 2nd dose N=149
Croatian: Studija V87P1 21 dan nakon 2. doze N=149
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)*
Croatian: Stopa serozaštite (95%CI)* Stopa serokonverzije (95%CI)*
English: Study V87P1 21 days after 2nd dose N=37
Croatian: Studija V87P1 21 dan nakon 2. doze N=37
English: Foclivia suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Croatian: Foclivia suspenzija za injekciju Cjepivo protiv pandemijske influence (površinski antigen, inaktivirano, adjuvantirano)
English: Study V87P13 21 days after 2nd dose N=210
Croatian: Studija V87P13 21 dan nakon 2. doze N=210
English: Foclivia injection
Croatian: Foclivia.
English: Foclivia suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Croatian: Foclivia suspenzija za injekciju u višedoznom spremniku Cjepivo protiv pandemijske influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
English: Uncommon: (may affect up to 1 in 100 people).
Croatian: Manje često (može se javiti u najviše 1 od 100 osoba).
English: Study V87P13 21 days after 2nd dose N=143
Croatian: Studija V87P13 21 dan nakon 2. doze N=143
English: Study V87P13 21 days after 2nd dose N=207
Croatian: Studija V87P13 21 dan nakon 2. doze N=207
English: The other ingredients are: thiomersal, sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Croatian: Drugi sastojci su: tiomersal, natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magenzijev klorid heksahidrat, kalcijev klorid dihidrat i voda za injekcije.
English: Foclivia suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Croatian: Foclivia suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv pandemijske influence (površinski antigen, inaktivirano, adjuvantirano)
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Croatian: Drugi sastojci su: natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magenzijev klorid heksahidrat, kalcijev klorid dihidrat i voda za injekcije.
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Croatian: Vrućica ≥ 38°C to 38,9°C Vrućica 39°C to 39,9°C Vrućica ≥ 40° C Bilo koji drugi štetni događaj Adolescenti (9 do 17 godina)
English: Foclivia suspension for injection in multidose container Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Croatian: Foclivia suspenzija za injekciju u višedoznom spremniku Cjepivo protiv pandemijske influence (površinski antigen, inaktivirano, adjuvantirano)
English: Two doses of vaccine containing H9N2 (A/chicken/Hong Kong/G9/97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/dose), were administered four weeks apart.
Croatian: Dvije doze cjepiva koje sadrži virus soja H9N2 (A/chicken/Hong Kong/G9/97) u 4 različita doziranja
English: Vial
Croatian: Dojenje
English: Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate,
Croatian: Kalijev dihidrogen fosfat, Natrijev hidrogenfosfat dihidrat, Magnezijev klorid heksahidrat, Kalcijev klorid dihidrat,
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, thiomersal, water for injections.
Croatian: Natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magenzijev klorid heksahidrat, kalcijev klorid dihidrat, tiomersal, voda za injekcije.
English: While no data is available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia.
Croatian: H1N1 pandemičnim cjepivom adjuvantiranim s MF59C.1 sličnim cjepivu Foclivia, prijavljeni su slučajevi konvulzija praćeni vrućicom ili bez nje.
English: Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Water for injections.
Croatian: Natrijev klorid, kalijev klorid, kalijev dihidrogen fosfat, natrijev hidrogenfosfat dihidrat, magenzijev klorid heksahidrat, kalcijev klorid dihidrat, voda za injekcije.
English: Nervous system disorders
Croatian: Srčani poremećaji
English: Muscoskeletal and connective tissue and bone disorders Muscular weakness, pain in extremities.
Croatian: Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju
English: The full EPAR for Hexyon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Hexyon nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Hexyon is a vaccine.
Croatian: Hexyon je cjepivo.
English: Reactions may be more likely after the first dose than later doses.
Croatian: Izglednije je da će reakcije nastupiti nakon prve doze nego nakon kasnijih doza.
English: It is not intended to provide practical advice on how to use Hexyon.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Hexyon.
English: Why is Hexyon approved?
Croatian: Zašto je Hexyon odobren?
English: Other information about Hexyon
Croatian: Ostale informacije o lijeku Hexyon
English: Hexyon or an appropriate combination of other vaccines can be used for the booster dose.
Croatian: Hexyon ili odgovarajuća kombinacija drugih cjepiva može se koristiti za dodatnu dozu.
English: What measures are being taken to ensure the safe and effective use of Hexyon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hexyon?
English: This is a summary of the European public assessment report (EPAR) for Hexyon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Hexyon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexyon on 17 April 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Hexyon na snazi u Europskoj uniji od 17. travnja 2013.
English: Vaccination with Hexyon should be carried out according to official recommendations.
Croatian: Cijepljenje lijekom Hexyon treba provesti u skladu sa službenim preporukama.