FrancophonIA/ELRC3.0 huggingface dataset:
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Croatian: Stopa seroprotekcije u djece koja su primila dvije polovice doze (0.25 ml) 180. dana bila je 100%.
English: BATCH NUMBER
Croatian: Ukupan broj
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Croatian: 3faktor serokonverzije: omjer geometrijske srednje vrijednosti titra (GMT) nakon i prije cijepljenja.
English: Pandemrix may be administered in lactating women.
Croatian: Pandemrix se može primjenjivati kod dojilja.
English: Post dose 2
Croatian: Nakon 2. Doze
English: Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Croatian: Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano, adjuvantirano)
English: The neutralising antibody responses were as follows:
Croatian: Odgovori anti-HA protutijela navode se u nastavku:
English: Suspension and emulsion for emulsion for injection.
Croatian: Suspenzija i emulzija za emulziju za injekciju.
English: In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
Croatian: U djece u dobi od 6-35 mjeseci koja su primila dvije doze od 0,25 ml Pandemrixa (H1N1), nakon druge doze u usporedbi s prvom dozom povećan je broj prijavljenih slučajeva boli, crvenila i oticanja na mjestu injiciranja kao i vrućice (>38°C), omamljenosti, razdražljivosti i gubitka apetita.
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Croatian: Kao psihogeni odgovor na injekciju iglom, osobito u adolescenata, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
English: The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Croatian: Miješanjem suspenzije i emulzije dobiva se višedozno cjepivo u bočici.
English: Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Croatian: Sadržaj: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
English: Children aged 3-9 years
Croatian: Djeca u dobi od 3-9 godina
English: Children aged 3 to 9 years
Croatian: Djeca u dobi od 3 do 9 godina
English: Rare: may affect up to 1 in 1,000 people
Croatian: Rijetke: mogu se javiti u manje od 1 na 1000 osoba
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Croatian: Vrućica >38°C Vrućica >39°C
English: Half adult dose (D-Pan-H1N1-023)
Croatian: Pola doze za odrasle (D-Pan-H1N1-023)
English: Uncommon Insomnia
Croatian: Manje često Nesanica
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose (D-Pan-H1N1-023)
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v Pola doze (D-Pan-H1N1-023)
English: Redness Swelling Fever (>38°C) axillary
Croatian: Vrućica (>38°C)
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 nakon 2 doze od 0,5 ml nakon 1 doze od 0,5 ml
English: • Itching, rash
Croatian: • Svrbež, osip
English: Total enrolled subjects N=24
Croatian: Ukupan broj uključenih ispitanika N=24
English: Month 6 N=22
Croatian: 6. mjesec N=22
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) after each dose of Pandemrix.
Croatian: Stoga se nakon svake doze cjepiva Pandemrix u male djece (npr. do oko 6 godina starosti)
English: Total enrolled subjects N=15
Croatian: Ukupan broj uključenih ispitanika N=15
English: anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v >80 godina 12. mjesec nakon 2 doze od 0,5 ml
English: Month 6 N=18
Croatian: 6. mjesec N=18
English: - Verify influenza-specificity of hypocretin-specific CD4 T cells from narcoleptic patients by complementary assays and verify if crossreactive CD4 T cells are found among influenza-specific CD4 T cells from healthy subjects after vaccination with Pandemrix or nonadjuvanted H1N1v vaccine.
Croatian: stanice nađene među CD4 T stanicama specifičnim za influencu zdravih ispitanika nakon cijepljenja cjepivom Pandemrix ili neadjuvantiranim cjepivom H1N1v.
English: Month 12 N=7
Croatian: 12. mjesec N=7
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 (tj. životno ugrožavajuća) reakcija 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: Adults aged 18-60 years
Croatian: 18-60 godina.
English: Month 12 N=5
Croatian: 12. mjesec N=5
English: Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Croatian: Dodatne nuspojave u djece i adolescenata Djeca u dobi od 10-17 godina
English: Post dose
Croatian: Nakon doze
English: If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Croatian: Ako se primjenjuje druga doza od 0,25 ml, između prve i druge doze trebalo bi proći razdoblje od barem tri tjedna.
English: See section 6.5 for the number of doses per vial.
Croatian: Za broj doza u bočici vidjeti dio 6.5.
English: Vascular disorders
Croatian: Prolazna trombocitopenija
English: Total enrolled subjects N=120
Croatian: Ukupan broj uključe nih ispitani ka N=120
English: In two clinical studies in which children aged 3 to 9 years old received two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) of Pandemrix, the anti-HA antibody responses 21 days after the first and the second dose were as follows:
Croatian: U dva klinička ispitivanja u kojima su djeca u dobi od 3 do 9 godina primala dvije doze od 0,25 ml (pola doze za odrasle) ili dvije doze od 0,5 ml (doza za odrasle) Pandemrixa, odgovor anti-HA protutijela 21 dan nakon prve i druge doze bio je:
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v D-Pan H1N1-007
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 anti-HA protutijelo
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 2all subjects seronegative prior to vaccination
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 2svi ispitanici koji su prije cijepljenja bili seronegativni
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Croatian: • jedno pakiranje koje sadrži 50 bočica s 2,5 ml suspenzije (antigen) • dva pakiranja koje sadrži 25 bočica s 2,5 ml emulzije (adjuvans)
English: Post dose 1
Croatian: Nakon 1. doze
English: Month 12 N=31
Croatian: 12. mjesec N=31
English: 1antigenically similar to A/California/7/2009 (H1N1)v-like
Croatian: 1antigenski sličan soju poput A/California/7/2009 (H1N1)v
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Croatian: - jedno pakiranje s 50 bočica (staklo tip I) od 2,5 ml suspenzije s čepom (butil guma).
English: Month 6 N=17
Croatian: 6. mjesec N=17
English: Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Croatian: Suspenzija za emulziju za injekciju za Pandemrix Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano, adjuvantirano)
English: Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Croatian: Trenutno se ne preporučuje cijepljenje djece ove dobne skupine.
English: Injection site reactions (such as inflammation, mass, ecchymosis)
Croatian: Reakcije na mjestu injiciranja (poput upale,
English: GMT.
Croatian: KG
English: Full dose (D-Pan-H1N1-010)
Croatian: Cijela doza (D-Pan-H1N1-010)
English: Very common Sweating increased Uncommon Pruritus, rash
Croatian: Manje često Pruritus, osip
English: Month 6 N=15
Croatian: 6. mjesec N=15
English: The anti-HA antibody responses 21 days after the first and the second dose were as follows:
Croatian: dan nakon prve i druge doze bio je sljedeći:
English: 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Croatian: 2postotak cijepljenika koji su nakon cijepljenja, ako su inicijalno bili seronegativni, postigli titar antitijela ≥32 1/DIL, ili ako su inicijalno bili seropozitivni, postigli titar antitijela ≥ 4 puta onog prije cijepljenja
English: Total subjects4 N=28 [95% CI]
Croatian: Ukupan broj ispitanika4 N=28 [95% CI]
English: • Pain and swelling at the injection site
Croatian: • Bol i oticanje na mjestu injiciranja
English: Post dose 2 N=29
Croatian: doze N=29
English: Month 12 N=14
Croatian: 12. mjesec N=14
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose *propagated in eggs **expressed in microgram haemagglutinin
Croatian: A/California/07/2009 (H1N1) iz kojeg je izveden korišteni soj NYMC X-179A 3,75 mikrograma** po dozi od 0,5 ml
English: • Sleeplessness
Croatian: • Omaglica
English: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Croatian: Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Day 21 N=18
Croatian: 21. dan N=18
English: Immune response to A/California/7/2009 (H1N1)v-like >80 years
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v >80 godina
English: Total enrolled subjects N=67 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=67 [95% CI]
English: 4all subjects seronegative prior to vaccination
Croatian: 4svi ispitanici koji su prije cijepljenja bili seronegativni 5prema planu ispitivanja
English: Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 12-23 mjeseci
English: Total enrolled subjects N=75
Croatian: Seronegativni uključen ih ispitanik a N=75
English: Total enrolled subjects2 N=2 [95% CI]
Croatian: Ukupan broj uključenih ispitanika2 N=2 [95% CI]
English: • Flu-like symptoms
Croatian: • Simptomi poput onih kod gripe
English: • Redness and itching at the injection site
Croatian: • Crvenilo i svrbež na mjestu injiciranja
English: 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
Croatian: 2stopa serokonverzije: udio ispitanika koji su bili seronegativni prije cijepljenja pa su nakon cijepljenja postigli zaštitni titar od ≥1:40, ili koji su bili seropozitivni prije cijepljenja pa su nakon cijepljenja postigli četverostruko povećanje titra;
English: Day 42 N=22
Croatian: 42. dan N=22
English: • Severe stabbing or throbbing pain along one or more nerves
Croatian: • Jaka probadajuća ili pulsirajuća bol uzduž jednog ili više živaca • Snižen broj trombocita što može prouzročiti krvarenje ili nastanak modrica
English: Day 21 N=22
Croatian: 21. dan N=22
English: Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 24-35 mjeseci
English: Total subjects4 N=51 [95% CI]
Croatian: Ukupan broj ispitanika4 N=51 [95% CI]
English: Irritability
Croatian: Omamljenost
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Croatian: KG Zirkustraße 40, D-01069 Dresden
English: Post dose 1 N=30
Croatian: doze N=30
English: antibody
Croatian: protutijelo
English: Uncommon Lymphadenopathy
Croatian: Manje često Limfadenopatija
English: Total enrolled subjects N=60
Croatian: Ukupan broj uključe nih ispitani ka N=60
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Croatian: 1 stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40;
English: Day 42 N=18
Croatian: 42. dan N=18
English: Day 21 N=17
Croatian: 21. dan N=17
English: Month 6 after 1 dose of 0.5 ml
Croatian: 6. mjesec nakon 1 doze od 0,5 ml
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C).
Croatian: U kliničkom ispitivanju reaktogenosti u djece u dobi od 6 do 35 mjeseci, koja su primila ili dvije doze od 0,25 ml (polovica doze za odrasle) ili dvije doze od 0,5 ml (doza za odrasle) (u razmaku od 21 dan) cjepiva Pandemrix (H1N1)v, nakon primjene druge doze zabilježeno je više reakcija na mjestu injiciranja, kao i općih simptoma, nego nakon prve doze, a osobito je učestalije bilo javljanje vrućice
English: Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 61-70 godina
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Croatian: A/California/07/2009 (H1N1) iz kojeg je izveden korišteni soj NYMC X-179A 3,75 mikrograma* AS03 adjuvans sadrži skvalen, DL-α-tokoferol i polisorbat 80 * hemaglutinin
English: Month 12 after 2 doses of 0.5 ml
Croatian: 12. mjesec nakon 2 doze od 0,5 ml
English: Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Croatian: Nakon bilo koje injekcije iglom, a ponekad čak i prije injekcije, može doći do gubitka svijesti (većinom kod adolescenata).
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Croatian: Seronegativni ispitanici prije cijepljenja N=43 [95% CI]
English: - If you get any of side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Vaccine Response
Croatian: Cjepivo protiv influence
English: Seronegative subjects prior to vaccination N=32 [95% CI]
Croatian: Seronegativni ispitanici prije cijepljenja N=32 [95% CI]
English: Day 42 N=17
Croatian: 42. dan N=17
English: Seronegative subjects prior to vaccination N=36 [95% CI]
Croatian: Seronegativni ispitanici prije cijepljenja N=36 [95% CI]
English: Month 12 after 1 dose of 0.5 ml
Croatian: 12. mjesec nakon 1 doze od 0,5 ml
English: Month 6 after 2 doses of 0.5 ml
Croatian: 6. mjesec nakon 2 doze od 0,5 ml
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Croatian: ispitanici prije cijepljenja N=23 [95% CI]
English: NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Croatian: Pandemrix suspenzija i emulzija za emulziju za injekciju.
English: In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Croatian: U kliničkim ispitivanjima reaktogenosti u djece u dobi od 3 do 5 godina i 6 do 9 godina, koja su primila ili dvije doze od 0,25 ml (polovice doze za odrasle) ili dvije doze od 0,5 ml (doza za odrasle) (u razmaku od 21 dan) cjepiva Pandemrix (H1N1)v, učestalost nuspojava prema dozi navedena je u sljedećoj tablici:
English: 20.0% 26.8% 18.9% 26.9% NA NA NA NA
Croatian: 23,3% 17,9% 15,1% 28,8% ND ND ND ND Razdražljivost 20,0% 26,8% 18,9% 26,9% ND ND ND ND Gubitak apetita
English: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Croatian: Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
English: Month 12 N=13
Croatian: 12. mjesec N=13
English: In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
Croatian: U kliničkim ispitivanjima reaktogenosti u djece u dobi od 10 do 17 godina, koja su primila ili dvije doze od 0,5 ml (doza za odrasle) cjepiva ili dvije doze od 0,25 ml (polovice odrasle doze) (s razmakom od 21 dan) cjepiva Pandemrix (H1N1)v, učestalost nuspojava prema dozi navedena je u sljedećoj tablici:
English: Total enrolled subjects N=59
Croatian: Ukupan broj uključe nih ispitani ka N=59
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 12-23 mjeseci
English: Total enrolled subjects N=40 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=40 [95% CI]
English: Seronegative subjects prior to vaccination N=76 [95% CI]
Croatian: Seronegativ ni ispitanici prije cijepljenja N=76 [95% CI]
English: Total enrolled subjects N=41 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=41 [95% CI]
English: Adult dose5 (D-Pan-H1N1-010)
Croatian: Doza za odrasle5 (D-Pan-H1N1-010)
English: Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 6-11 mjeseci
English: Adult dose (D-Pan-H1N1-010)
Croatian: Doza za odrasle (D-Pan-H1N1-010)
English: Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Croatian: Gastrointestinalni simptomi (poput proljeva,
English: Seronegative subjects prior to vaccinatio n N=15 [95% CI]
Croatian: ispitanici prije cijepljenja N=15 [95% CI]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 Half dose
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 Pola doze
English: • Dizziness
Croatian: • Drhtanje
English: Total subjects5 [95% CI]
Croatian: Ukupan broj ispitanika5 [95% CI]
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Pandemrix: • ako ste imali bilo koju alergijsku reakciju, izuzev iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak ovog cjepiva (naveden u dijelu 6), na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid, gentamicinsulfat (antibiotik) ili natrijev deoksikolat.
English: Seronegative subjects prior to vaccination N=37 [95% CI]
Croatian: Seronegativ ni ispitanici prije cijepljenja N=37 [95% CI]
English: Total enrolled subjects N=3 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=3 [95% CI]
English: Total enrolled subjects N=52 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=52 [95% CI]
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 6-11 mjeseci
English: Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Croatian: Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 6-9 godina
English: Total enrolled subjects N=40
Croatian: uključen ih ispitanik a N=40
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 3-5 years
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 3-5 godina
English: Total enrolled subjects N=59 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=59 [95% CI]
English: Sími: +354 530 3700
Croatian: GlaxoSmithKline ehf. Sími: +354 530 3700
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1
English: Post dose 2 N=14
Croatian: doze N=14
English: Total enrolled subjects N=5 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=5 [95% CI]
English: • Fever
Croatian: • Umor
English: Seronegative subjects prior to vaccination N=48 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=48 [95% CI]
English: Seroconversio n rate2
Croatian: Stopa serokonve rzije2
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Croatian: Imunološki odgovor na soj poput A/Netherlands/602/9 (H1N1)v1 6-9 godina
English: Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Croatian: Podaci dobiveni nakon primjene neadjuvantiranog sezonskog cjepiva protiv influence (Fluarix, kao ranije navedeno) tri tjedna prije doze cjepiva Pandemrix (H1N1)v u zdravih odraslih osoba starijih od
English: Seronegative subjects prior to vaccination N=42 [95% CI]
Croatian: Seronegativ ni ispitanici prije cijepljenja N=42 [95% CI]
English: N=34 N = 32 N=30
Croatian: N=14 N=14
English: Suspension and emulsion for emulsion for injection
Croatian: OBLIK I SADRŽAJ Suspenzija i emulzija za emulziju za injekciju
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=29 [95% CI]
English: Seronegative subjects prior to vaccination N=16 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=16 [95% CI]
English: Posology
Croatian: Seronegativni
English: Seronegative subjects prior to vaccination N=7 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=7 [95% CI]
English: Seronegative subjects prior to vaccination N=26 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=26 [95% CI]
English: Package leaflet: Information for the user
Croatian: Sadržaj pakiranja i dodatne informacije
English: Immune response to Pandemrix (H1N1)v
Croatian: Imunološki odgovor na Pandemrix (H1N1)v Odrasli u dobi od 18-60 godina
English: After 1 dose of 0.5 ml
Croatian: nakon 2 doze od 0,5 ml nakon 1 doze od 0,5 ml
English: Seronegative subjects prior to vaccination N=1 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=1 [95% CI]
English: Two clinical studies evaluated the immunogenicity of Pandemrix in healthy subjects aged 18-60 years.
Croatian: Imunogenost cjepiva Pandemrix procjenjivala se u dva klinička ispitivanja na ispitanicima u dobi od
English: Seronegative subjects prior to vaccination N=19 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=19 [95% CI]
English: Seroconversio n factor3
Croatian: Faktor serokonver zije3
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Croatian: Seronegativni ispitanici prije cijepljenja N=35 [95% CI]
English: STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains:
Croatian: Nakon miješanja, 1 doza (0,5 ml) sadrži: fragmentirani virus influence, inaktiviran, sadrži antigen* koji odgovara:
English: Post dose 2 N=16
Croatian: N=15 N=16
English: Total enrolled subjects N=51 [95% CI]
Croatian: Ukupan broj uključenih ispitanika N=15 [95% CI]