FrancophonIA/ELRC3.0 huggingface dataset:
English: Double dose (N=131)
Croatian: Dvostruka doza (N=131)
English: Seroprotection rate1
Croatian: Stopa seroprotekcije1
English: 21 days after 1st dose N=55
Croatian: 21 dan nakon 1. doze N=55
English: STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži:
English: Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Croatian: Manje često: parestezije, somnolencija, omaglica
English: 21 days after 2nd dose N=48
Croatian: 21 dan nakon 2. doze N=48
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Odgovor protutijela može biti nedostatan u bolesnika koji boluju od endogene ili jatrogene imunosupresije.
English: 6 to 9 years
Croatian: 6 do 9 godina
English: • Feeling tired
Croatian: • osjećaj omaglice
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively.
Croatian: Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije prema soju A/Vietnam/1194/2004 u ispitanika koji su primili cjepivo u razmaku od 6 mjeseci iznosila je 89,6%, a stopa odgovora na cjepivo 95,7%.
English: In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
Croatian: U tom su ispitivanju primijećeni i imunološki odgovori križne reaktivnosti na soj A/Indonesia/5/2005.
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 5,000 subjects 18 years old and above who received Prepandrix containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 µg HA.
Croatian: U kliničkim ispitivanjima je procijenjena incidencija nuspojava u oko 5 000 ispitanika u dobi od 18 i više godina, koji su primili Prepandrix koji sadrži soj A/Vietnam/1194/2004 (H5N1) s najmanje 3,75 µg hemaglutinina.
English: There are no data with Prepandrix using the subcutaneous route.
Croatian: Nema podataka o primjeni cjepiva Prepandrix supkutanim putem.
English: How to store Prepandrix
Croatian: Kako primjenjivati Prepandrix
English: Blood and lymphatic system disorders Common: lymphadenopathy
Croatian: Poremećaji krvi i limfnog sustava
English: It is best to see how Prepandrix affects you before you try these activities.
Croatian: Prije nego počnete s tim aktivnostima, najbolje je provjeriti kako Prepandrix djeluje na Vas.
English: 24 months after vaccination
Croatian: 24 mjeseca nakon cijepljenja
English: AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Croatian: AS03 adjuvans sadrži skvalen, DL-α-tokoferol i polisorbat 80 * hemaglutinin
English: 6 months after vaccination
Croatian: 6 mjeseci nakon cijepljenja
English: Single dose (N=140)
Croatian: Jednostruka doza (N=140)
English: No post-marketing surveillance data are available following Prepandrix administration.
Croatian: Nema podataka iz postmarketinškog praćenja nakon primjene cjepiva Prepandrix.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension and emulsion to be mixed before administration
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Suspenziju i emulziju treba pomiješati prije primjene.
English: At day 42, the anti-HA antibody responses were as follows:
Croatian: Odgovor anti-HA antitijela 42. dana je bio sljedeći:
English: An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart.
Croatian: Produljeni interval doziranja ocijenjen je u ispitivanju D-H5N1-012, u kojem je skupina ispitanika u dobi od 18-60 godina primila dvije doze cjepiva Prepandrix sa sojem A/Vietnam/1194/2004 u razmaku od 6 mjeseci ili 12 mjeseci.
English: Suspension and emulsion for emulsion for injection.
Croatian: OBLIK Suspenzija i emulzija za emulziju za injekciju.
English: 50 vials: emulsion (adjuvant)
Croatian: 50 bočica: suspenzija (antigen) 50 bočica: emulzija (adjuvans)
English: Single dose (N=86)
Croatian: Jednostruka doza (N=86)
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Croatian: - dva pakiranja s 25 bočica (staklo tip I) od 2,5 ml emulzije, s čepom (butil guma).
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Croatian: Volumen dobiven miješanjem 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara količini za 10 doza cjepiva (5 ml).
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
Croatian: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) 3,75 mikrograma** po dozi od 0,5ml
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml)
Croatian: 2,5 ml Nakon miješanja s emulzijom adjuvansa: 10 doza od 0,5 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI fragmentirani virus influence, inaktivirani, sadrži antigen* koji odgovara: 3,75 mikrograma hemaglutinina/doza *Antigen: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Croatian: • ako ste ranije imali iznenadnu životno ugrožavajuću alergijsku reakciju na bilo koji sastojak ovog cjepiva (naveden u dijelu 6) ili na bilo koju tvar koja može biti prisutna u vrlo malim količinama, poput jaja i pilećih proteina, ovalbumina, formaldehida, gentamicinsulfata
English: There are no data on co-administration of Prepandrix with other vaccines.
Croatian: Nema podataka o istodobnoj primjeni cjepiva Prepandrix s drugim cjepivima.
English: There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Croatian: Postoje vrlo ograničeni podaci o sigurnosti i imunogenosti primjene AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz A/Vietnam/1194/2004 (H5N1) te o primjeni pola doze cjepiva (tj. 1,875 µg hemaglutinina i pola količine adjuvansa AS03), na 0. i 21. dan u djece u dobi od
English: 6.5 Nature and contents of container
Croatian: 6.5 Vrsta i sadržaj spremnika Jedno pakiranje sadrži:
English: Split influenza virus, inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: Fragmentirani virus influence, inaktiviran, sadrži antigen koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: Immune response against A/Indonesia/05/2005 (H5N1) In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows: anti-HA antibody
Croatian: Imunološki odgovor na A/Indonesia/05/2005 (H5N1) U kliničkom ispitivanju (Q-Pan-H5N1-001) u kojem su se primjenjivale dvije doze AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005, na 0. i 21. dan kod 140 ispitanika u dobi od 18-60 godina, odgovor anti-HA protutijela bio je sljedeći:
English: No fertility data are available.
Croatian: Ne postoje podaci o utjecaju na plodnost.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Prepandrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Suspenzija antigena za Prepandrix
English: Seroprotection rate
Croatian: Stope seroprotekcije u
English: Month N=38
Croatian: mjesec N=38
English: Month N=47
Croatian: mjesec N=47
English: OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Emulziju prije primjene treba miješati isključivo sa suspenzijom antigena.
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Croatian: Neovisno o tome jesu li 6 mjeseci ranije primili jednu ili dvije doze početnog cjepiva, stopa seroprotekcije prema A/Indonesia bila je >80% nakon doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004, a stopa seroprotekcije prema A/Vietnam bila je >90% nakon doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005.
English: NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Croatian: Uputa o lijeku: Informacije za korisnika Prepandrix suspenzija i emulzija za emulziju za injekciju Prepandemijsko cjepivo protiv influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
English: Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Croatian: Cijela doza otvrdnuće bol crvenilo oticanje vrućica (>38°C) vrućica (>39°C)
English: Double dose N=10
Croatian: Dvostruka doza N=10
English: Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Croatian: Stoga se podaci dobiveni s AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 smatraju značajnim za korištenje AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005.
English: Emulsion vial:
Croatian: Bočica s emulzijom:
English: Caution is needed when administering 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 residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Croatian: Potreban je oprez pri primjeni ovog cjepiva u osoba s poznatom preosjetljivošću (pored anafilaktičke reakcije) na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1, tiomersal i ostatne tvari (jaja i pileće proteine, ovalbumin, formaldehid i natrijev deoksikolat).
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Prepandrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Croatian: Epidemiološka ispitivanja povezana s drugim cjepivom koje sadrži adjuvans AS03 (Pandemrix H1N1, koje se proizvodi na istom mjestu kao i Prepandrix), provedena u nekoliko europskih zemalja,
English: Seroconversion factor3
Croatian: Faktor serokonverzije3
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine
Croatian: Volumen dobiven nakon miješanja 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara količini za 10 doza cjepiva od 0,5 ml
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Croatian: Kao psihogeni odgovor na injekciju s iglom, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
English: 12 months after the 1st dose
Croatian: 12 mjeseci nakon 1. doze
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Serum neutralising antibody
Croatian: Neutralizirajuća protutijela u serumu
English: See section 6.5 for the number of doses per vial.
Croatian: Za broj doza po bočici vidjeti dio 6.5.
English: Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Croatian: U ispitanika D-Pan-H5N1-010 je praćena postojanost imunološkog odgovora.
English: In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) in subjects 18-60 years old, the anti-haemagglutinin (anti-HA) antibody responses were as follows:
Croatian: U kliničkim ispitivanjima imunogenosti AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) u ispitanika starosti od 18-60 godina, odgovori anti-hemaglutinin protutijela (anti-HA) bili su sljedeći:
English: Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
Croatian: U ispitanika D-Pan-H5N1-002 je praćena postojanost imunološkog odgovora.
English: Although an adequate immune response was achieved at day 42 following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), a higher response was observed following two administrations of a double dose of vaccine.
Croatian: Iako je 42. dana nakon dvije primjene jednostruke doze AS03-adjuvantiranog cjepiva koje je sadržavalo 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) postignut adekvatan imunološki odgovor, nakon dvije primjene dvostruke doze cjepiva opaženi odgovor je bio veći.
English: There are currently no data available on the use of Prepandrix in pregnancy.
Croatian: Nema podataka o primjeni cjepiva Prepandrix tijekom trudnoće.
English: The neutralising antibody responses were as follows:
Croatian: Odgovori neutralizirajućih protutijela u serumu bili su sljedeći:
English: Double dose N=92
Croatian: Dvostruka doza N=92
English: • Pain, redness, swelling or a hard lump where the injection was given
Croatian: • glavobolja • bol, crvenilo, oticanje ili otvrdnuće na mjestu davanja injekcije
English: In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21.
Croatian: U drugom ispitivanju, 49 ispitanika u dobi od 18-60 godina primilo je dvije doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005, na 0. i 21. dan.
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
Croatian: 3faktor serokonverzije: omjer geometrijske srednje vrijednosti titra (eng. geometric mean titre (GMT)) nakon i prije cijepljenja.
English: Single dose N=48
Croatian: Jednostruka doza N=48
English: Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Croatian: Imunološki odgovori križne reaktivnosti izazvani AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005 (H5N1)
English: Immune response to A/Indonesia/05/2005
Croatian: Imunološki odgovor na A/Indonesia/05/2005
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Suspenziju prije primjene treba miješati isključivo s emulzijom adjuvansa.
English: The seroprotection at month 6, 12 and 24 were as follows:
Croatian: 6., 12. i 24. mjesecu bile su sljedeće:
English: Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Croatian: U ispitanika D-Pan-H5N1-009 praćena je postojanost imunološkog odgovora.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Croatian: Ovaj adjuvans sadrži skvalen (10,69 miligrama), DL-αtokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
English: Immune response to A/Indonesia/5/2005 6 to 9 years
Croatian: Imunološki odgovor na A/Indonesia/5/2005 6 do 9 godina
English: Single dose N=51
Croatian: Jednostruka doza N=51
English: Full dose (N=35)
Croatian: Cijela doza (N=35)
English: There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Croatian: Neovisno o tome jesu li djeca primila pola doze ili cijelu dozu za odrasle, nije zabilježeno povećanje učestalosti, osim kod nekih nuspojava koje su se javljale češće nakon druge doze, što se osobito odnosi na učestalost vrućice u djece mlađe od 6 godina.
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Croatian: natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
English: Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post-vaccination.
Croatian: Stoga se u male djece (u dobi do približno 6 godina) nakon cijepljenja preporučuje kontrola tjelesne temperature i primjena mjera za snižavanje vrućice (poput antipiretika, prema kliničkoj potrebi).
English: Single dose N=13
Croatian: Jednostruka doza N=13
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Day 21 N=140
Croatian: 21. dan N=140
English: A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the second dose.
Croatian: 79,2% ispitanika, 21 dan nakon druge doze u 95,8% ispitanika i šest mjeseci nakon druge doze u 87,5% ispitanika.
English: Full dose N=35
Croatian: Cijela doza N=35
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.
Croatian: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) i.m.
English: • Sleeplessness
Croatian: • pospanost • nesanica
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Croatian: Primjena AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1)
English: Double dose N=54
Croatian: Dvostruka doza N=54
English: Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
Croatian: Dvanaest i 24 mjeseca nakon cijepljenja, titri neutralizirajućih antitijela bili su sljedeći: Neutralizirajuća protutijela u serumu
English: A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Croatian: U kliničkom ispitivanju (D-H5N1-009) procijenjena je reaktogenost u djece u dobi od 3 do 5, odnosno od 6 do 9 godina, koja su u razmaku od 21 dan primila ili dvije doze za odrasle (tj. 0,5 ml) ili dvije polovice doze za odrasle (tj. 0,25 ml) cjepiva spremnog protiv pandemijske influence (H5N1 A/Vietnam/1194/2004, proizvedeno u Dresdenu u Njemačkoj).
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Croatian: Jedna doza AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005, primijenjena nakon jedne ili dvije doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004.
English: Day 42 N=46
Croatian: 42. dan N=46
English: Full dose (N=41)
Croatian: Cijela doza (N=41)
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
English: Immune response to A/Indonesia/5/2005 3 to 5 years
Croatian: Imunološki odgovor na A/Indonesia/5/2005 3 do 5 godina
English: Read the package leaflet before use
Croatian: Prije uporabe pročitati uputu o lijeku
English: In the event of other variation being observed, discard the vaccine.
Croatian: U slučaju da primijetite nekakvo odstupanje od opisanog, bacite cjepivo.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Prepandrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Emulzija adjuvansa za Prepandrix i.m.
English: Half dose (N=50)
Croatian: Pola doze (N=50)
English: • Itching, rash
Croatian: • svrbež, osip
English: In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004.
Croatian: U kliničkom ispitivanju, djeca u dobi od 3 do 9 godina primila su ili dvije doze za odrasle (0,5 ml) ili dvije polovice doze za odrasle (0,25 ml) sličnog cjepiva koje je sadržavalo soj A/Vietnam/1194/2004.
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Croatian: Anafilaktička reakcija (tj. životno ugrožavajuća) u anamnezi na bilo koji sastojak ovog cjepiva ili na tvari koje se u cjepivu nalaze u tragovima (jaja i pileći proteini, ovalbumin, formaldehid, gentamicin sulfat i natrijev deoksikolat).
English: 12 months after vaccination
Croatian: 12 mjeseci nakon cijepljenja
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Croatian: Imunološki odgovori križne reaktivnosti izazvani AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1):
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Croatian: Prolazne lažno pozitivne reakcije mogu biti posljedica stvaranja
English: The suspension and emulsion vials once mixed form a multidose container.
Croatian: Miješanjem sadržaja bočica suspenzije i emulzije dobiva se višedozni spremnik.
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Croatian: Često: drhtanje, bolest nalik gripi, reakcije na mjestu injiciranja (poput topline, pruritusa) Manje često: malaksalost