FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
Croatian: • Reakcije na mjestu injiciranja poput boli, crvenila, modrica, oticanja i topline (upala), tvrda kvržica (masa)
English: Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders
Croatian: vrućica Manje često Otvrdnuće i osjećaj topline na mjestu injiciranja, bolest nalik gripi, malaksalost Postmarketinško iskustvo s cjepivom Pandemrix (H1N1)v
English: It is not known whether the observed effects would apply to administration of nonadjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals have elapsed since administration of Pandemrix.
Croatian: Nije poznato da li bi se zamijećeni učinak mogao javiti i u slučaju primjene neadjuvantiranog sezonskog cjepiva protiv influence nakon jedne doze cjepiva Pandemrix ili u slučaju da je od primjene cjepiva Pandemrix prošao dulji vremenski period.
English: Angioedema, generalised skin reactions, urticaria
Croatian: Angioedem, generalizirane kožne reakcije, urtikarija
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%).
Croatian: U odraslih osoba u dobi od 18 do 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (87,8%), umor (32,9%), glavobolja (28,1%), artralgija (17,9%), mijalgija (30,0%), drhtanje (19,4%), oticanje na mjestu injiciranja (11,5%) i znojenje (11,3%).
English: In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years.
Croatian: U djece koja su primila dvije doze za odrasle (0,5 ml), stopa seroprotekcije je 12 mjeseci nakon prve doze bila 100% kod djece u dobi od 3-5 godina te 98,0% kod djece u dobi od 6-9 godina.
English: 4according to protocol anti-HA antibody
Croatian: 4prema planu ispitivanja anti-HA protutijelo
English: Children aged less than 6 months
Croatian: Djeca mlađa od 6 mjeseci
English: Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Croatian: Dvanaest mjeseci nakon prve doze zabilježena je stopa seroprotekcije od 85% u obje dobne skupine.
English: Very common Arthralgia, myalgia
Croatian: Artralgija, mijalgija
English: There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months.
Croatian: Iz kliničkih ispitivanja cjepiva Pandemrix (H1N1)v nema podataka o sigurnosti i imunogenosti u djece koja su mlađa od 6 mjeseci.
English: In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
Croatian: U osoba starijih od 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (59,0%), mijalgija (20,6%), umor (17,9%), glavobolja (17,6%) i artralgija (14,3%).
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Croatian: Cjepivo se miješa tako da se pomoću štrcaljke od 5 ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
English: 5.0% 5.4% 1.9% 5.8% NA NA NA NA
Croatian: 5,0% 5,4% 1,9% 5,8% ND ND ND ND
English: Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Croatian: Podaci stoga ukazuju da se Pandemrix može istovremeno primjenjivati s neadjuvantiranim sezonskim cjepivima protiv influence (uz davanje injekcija cjepiva u različite udove).
English: Neuralgia
Croatian: Neuralgija
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Croatian: • Neurološki poremećaji poput encefalomijelitisa (upala središnjeg živčanog sustava), neuritisa
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.
Croatian: Istovremena primjena dva cjepiva nije bila povezana s većim stopama lokalnih ili sistemskih reakcija od onih pri samostalnoj primjeni Pandemrix cjepiva.
English: In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
Croatian: U kliničkom ispitivanju u kojem je neadjuvantirano sezonsko cjepivo protiv influence (Fluarix, kao ranije navedeno) primijenjeno 3 tjedna nakon druge doze cjepiva Pandemrix (razdoblje između primijenjenih doza bilo je 21 dan), zamijećen je smanjen imunološki odgovor na cjepivo Fluarix u usporedbi s ispitanicima koji ranije nisu primili Pandemrix.
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Croatian: Nakon miješanja cjepiva: Nakon miješanja, cjepivo upotrijebiti unutar 24 sata i ne čuvati na temperaturi iznad 25°C.
English: Clinical trials Blood and lymphatic system disorders
Croatian: Klinička ispitivanja Poremećaji krvi i limfnog sustava
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Croatian: Cjepivo treba primijeniti sukladno preporučenom doziranju (vidjeti dio 4.2).
English: It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix.
Croatian: Poželjno je da se neadjuvantirana sezonska cjepiva protiv influence primjene prije prve doze ili s prvom dozom cjepiva Pandemrix.
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLOVOM PISMU
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
Croatian: NAZIV LIJEKA Emulzija za emulziju za injekciju za Pandemrix
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Croatian: Ako je potrebna istovremena primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
English: Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Croatian: mikrograma hemaglutinina ispitivane su u pokusu homolognog opterećenja a doze od 15, 7,5, 3,8 ili 1,75 mikrograma hemaglutinina u pokusu heterolognog opterećenja.
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili medicinskoj sestri.
English: It is recommended to equip the syringe with a 23-G needle.
Croatian: Preporučuje se koristiti štrcaljku s iglom promjera 23-G.
English: Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Croatian: Dvanaest mjeseci nakon prve doze stopa seroprotekcije bila je 100% u svim dobnim i doznim skupinama.
English: Total enrolled subjects2
Croatian: Ukupan broj uključenih ispitanika2
English: Pandemrix contains thiomersal
Croatian: Pandemrix sadrži tiomersal
English: Anaphylaxis, allergic reactions
Croatian: Anafilaksa, alergijske reakcije
English: One dose of 0.25 ml at an elected date.
Croatian: Jedna doza cjepiva od 0,25 ml na odabrani datum.
English: “Possible side effects” may affect the ability to drive or use machines.
Croatian: Neki učinci navedeni u dijelu 4. “Moguće nuspojave” mogu utjecati na Vašu sposobnost upravljanja vozilom ili strojevima.
English: Suspension vial:
Croatian: Bočica sa suspenzijom:
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Croatian: Tvorovi su cijepljeni na nulti i 21. dan, a 49. dana intratrahealnim putem opterećeni su letalnom dozom H5N1/A/Vietnam/1194/04 ili heterolognim
English: What you need to know before you receive Pandemrix
Croatian: Što morate znati prije nego primite Pandemrix Nemojte primiti Pandemrix:
English: Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses.
Croatian: Dvanaest mjeseci nakon prve doze, stopa seroprotekcije u djece koja su primila dvije polovice (0,25 ml) doze bila je 90,2% i 100% u onih koji su primili dvije pune (0,5 ml) doze za odrasle osobe.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Croatian: Svaka doza cjepiva od 0,5 ml (cijela doza) ili od 0,25 ml (pola doze) uvuče se u štrcaljku za injekciju od 1 ml te se primjenjuje u mišić.
English: 21 days after 1st dose
Croatian: 21 dan nakon 1. doze
English: Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).
Croatian: Vaš će liječnik umjesto cjepiva Pandemrix obično preporučiti drugo cjepivo (godišnje trovalentno/četverovalentno cjepivo protiv influence), ali ako trovalentna/četverovalentna cjepiva nisu dostupna, a potrebna Vam je zaštita od gripe uzrokovane A(H1N1)v virusom, Pandemrix može biti jedna od opcija (pogledajte dio Upozorenja i mjere opreza).
English: neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Croatian: (upale živaca) i vrste paralize poznate kao Guillain-Barré-ov sindrom.
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Croatian: Zbog toga se nakon svake doze preporučuje praćenje tjelesne temperature te primjena mjera za snižavanje povišene temperature (poput davanja paracetamola ili drugih lijekova za snižavanje vrućice).
English: One dose of 0.5 ml at an elected date.
Croatian: Jedna doza cjepiva od 0,5 ml na odabrani datum.
English: Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age.
Croatian: Dva klinička ispitivanja procjenjivala su primjenu polovice doze (0,25 ml) ili cijele doze (0,5 ml) za odrasle cjepiva Pandemrix u zdrave djece u dobi od 10 do 17 godina.
English: • Swollen glands in the neck, armpit or groin
Croatian: • Otečene žlijezde na vratu, u pazusima ili preponama
English: Half adult dose4
Croatian: Pola doze za odrasle4
English: Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website.
Croatian: EMEA/H/C/000832/II/0079 objavljenom na internetskim stranicama Europske agencije za lijekove (EMA).
English: 5all subjects seronegative prior to vaccination anti-HA
Croatian: 5svi ispitanici koji su prije cijepljenja bili seronegativni anti-HA protutijelo
English: Children aged 10-17 years
Croatian: Djeca u dobi od 10-17 godina
English: How Pandemrix works
Croatian: Kako Pandemrix djeluje
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Croatian: U prospektivnom kliničkom ispitivanju u kojem se pratio ishod u više od 100 trudnoća nije zabilježen povećan rizik od nuspojava.
English: In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8).
Croatian: U djece dobi od 6 do 35 mjeseci (N=51) koja su primila dvije doze cjepiva od 0.25 ml (polovicu doze za odrasle) s intervalom od 3 tjedna između primijenjenih doza, nakon primjene druge doze zamijećeno je povećanje stope reakcija na mjestu injiciranja, kao i općih simptoma (vidjeti dio 4.8).
English: Pandemrix contains sodium and potassium
Croatian: Pandemrix sadrži natrij i kalij
English: 4according to protocol
Croatian: 4prema planu ispitivanja
English: Rare (≥1/10,000 to <1/1,000)
Croatian: Često (≥1/100 i <1/10) Manje često (≥1/1000 i <1/100) Rijetko (≥1/10 000 i <1/1000) Vrlo rijetko (<1/10 000)
English: See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
Croatian: Za imunološke odgovore na jednu i dvije doze cjepiva Pandemrix (H1N1)v, uključujući i razine antitijela nakon 6 i 12 mjeseci vidjeti dio 5.1.
English: Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Croatian: Šest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije: anti-HA protutijelo
English: Vaccination is not recommended in this age group.
Croatian: U toj dobnoj skupini cijepljenje se ne preporuča.
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
Croatian: A/California/07/2009 (H1N1) iz kojeg je izveden korišten soj NYMC X-179A i.m.
English: Fever (>39°C) axillary
Croatian: Vrućica (>39°C)
English: In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose.
Croatian: Nakon druge doze, osobito su se značajno povećale stope javljanja vrućice (aksilarna temperatura
English: tection rate1 92.7%
Croatian: stopa seroprotekcije1 93,7%
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 50 BOČICA SUSPENZIJE (ANTIGEN)
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Croatian: Pandemrix se smije primijeniti samo u slučajevima kada preporučena godišnja sezonska trovalentna/četverovalentna cjepiva protiv influence nisu dostupna te ako se imunizacija protiv (H1N1)v smatra nužnom (vidjeti dijelove 4.4 i 4.8).
English: Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Croatian: Postmarketinško iskustvo s trovalentnim sezonskim cjepivom protiv influence
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Croatian: Nije poznat klinički značaj titra inhibicije hemaglutinacije (HI) 1:40 u djece.
English: Very common Swelling and pain at the injection site, fatigue, shivering
Croatian: Oticanje i bol na mjestu injiciranja, umor, drhtanje
English: No data are available.
Croatian: Nema dostupnih podataka o primjeni.
English: It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Croatian: Ne preporučuje se koristiti štrcaljku s iglom čiji je promjer veći od 23-G.
English: Month N=24
Croatian: mjesec N=24
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: Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.
Croatian: Podaci dobiveni pri istovremenoj primjeni cjepiva Pandemrix (H1N1)v i neadjuvantiranog sezonskog cjepiva protiv influence (Fluarix, cjepivo s fragmentiranim virionom) u zdravih odraslih osoba u dobi starijoj od 60 godina nije ukazivala na značajnija ometanja imunološkog odgovora na Pandemrix (H1N1)v.
English: There are no data with Pandemrix using the subcutaneous route.
Croatian: Nema podataka o primjeni cjepiva Pandemrix supkutanim putem.
English: NA NA NA NA 21.5% 20.6% 42.1% 45.6%
Croatian: ND ND ND ND 21,5% 20,6% 42,1% 45,6%
English: If a second dose is administered there should be an interval of at least three weeks between the first and the second dose.
Croatian: Ako se primjenjuje druga doza, između prve i druge doze treba proći najmanje tri tjedna.
English: NA NA NA NA 15.4% 14.3% 14.0% 22.8%
Croatian: ND ND ND ND 15,4% 14,3% 14.0% 22,8%
English: NA NA NA NA 27.7% 20.6% 35.1% 49.1%
Croatian: ND ND ND ND 27,7% 20,6% 35,1% 49,1%
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models.
Croatian: U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
English: unexpected severe adverse reactions, adverse events of special interest (AESI).
Croatian: • Prijavljivanje nuspojava prema značaju; tj. fatalne i životno ugrožavajuće nuspojave, teške neočekivane nuspojave, nuspojave od posebnog interesa (AESI).
English: Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Croatian: Molimo da pogledate Informacije o lijeku za cjepivo protiv pandemijske gripe (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano).
English: Month N=10
Croatian: mjesec N=10
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 25 BOČICA S EMULZIJOM (ADJUVANS)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Emulzija adjuvansa za Pandemrix i.m.
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 Twelve months after the first dose, the seroprotection rate was as follows:
Croatian: 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 Dvanaest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije:
English: After mixing, use the vaccine within 24 hours.
Croatian: Nakon miješanja, cjepivo primijenite unutar 24 sata.
English: In the event of other variation being observed, discard the vaccine.
Croatian: U slučaju da primijetite bilo kakvo odstupanje, bacite cjepivo.
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8).
Croatian: Pandemrix se smije primijeniti samo u slučajevima kada preporučena godišnja sezonska trovalentna/četverovalentna cjepiva protiv influence nisu dostupna te ako se imunizacija protiv (H1N1)v smatra nužnom (vidjeti dio 4.8).
English: Antigen suspension for Pandemrix Influenza vaccine
Croatian: Suspenzija antigena za Pandemrix
English: In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
Croatian: U kliničkom ispitivanju (D-Pan-H1N1-009) zdrave djece u dobi od 6 do 35 mjeseci (stratificirane prema dobi u grupe od 6 do 11, 12 do 23 i 24 do 35 mjeseci) odgovor anti-HA protutijela 21 dan nakon prve i druge polovice doze za odrasle (tj. 0,25 ml) ili doze za odrasle (tj. 0,5 ml) cjepiva Pandemrix bio je:
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 sadržaja 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara količini za 10 doza cjepiva (5 ml).
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: How to store Pandemrix
Croatian: Kako čuvati Pandemrix
English: Children aged from 6 months to 9 years
Croatian: Djeca u dobi od 6 mjeseci do 9 godina
English: NA NA NA NA 13.8% 7.9% 15.8% 14.0%
Croatian: ND ND ND ND 13,8% 7,9% 15,8% 14,0%
English: Very common Headache Uncommon Paraesthesia, dizziness
Croatian: Glavobolja Manje često Parestezija, omaglica
English: 20.0% 17.9% 15.1% 32.7% NA NA NA NA
Croatian: 20,0% 17,9% 15,1% 32,7% ND ND ND ND
English: Half adult dose
Croatian: Pola doze za odrasle
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, gentamicin sulfat i natrijev deoksikolat).
English: The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
Croatian: Bočica koja sadrži adjuvans treba se držati u okomitom položaju gornjom stranom okrenuta prema dolje,
English: NA NA NA NA 16.9% 17.5% 22.8% 28.1%
Croatian: ND ND ND ND 16,9% 17,5% 22,8% 28,1%
English: Six months after the first dose, the seroprotection rate was as follows:
Croatian: Šest mjeseci nakon prve doze zabilježene su slijedeće vrijednosti stopa seroprotekcije:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A
Croatian: TVARI fragmentirani virus influence, inaktivirani, sadrži antigen* koji odgovara: 3,75 mikrograma hemaglutanina/doza *Antigen: A/California/07/2009 (H1N1) iz kojeg je izveden korišten soj NYMCX-179A
English: In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 ml doses of Pandemrix (H1N1)v, higher rates of general solicited symptoms (such as fatigue, headache, arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the first dose.
Croatian: U kliničkim ispitivanjima reaktogenosti u odraslih osoba starijih od 18 godina, koje su primile dvije doze cjepiva Pandemrix (H1N1)v od 0,5 ml, opći simptomi (poput umora, glavobolje, artralgije, mijalgije, drhtanja, znojenja i vrućice) zamijećene su u većim stopama nakon druge primljene doze,
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-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
English: Vasculitis with transient renal involvement 1frequency based on estimated attributable risk from epidemiological studies in several European countries (see section 4.4) 2Reported in patients with narcolepsy and as a temporary event following vaccination
Croatian: 1učestalost temeljena na procijenjenom pripisivom riziku iz epidemioloških ispitivanja u nekoliko europskih zemalja (vidjeti dio 4.4)
English: There are no data on co-administration of Pandemrix with other vaccines.
Croatian: Nema podataka o istovremenoj primjeni cjepiva Pandemrix s drugim cjepivima.
English: Total enrolled subjects N=33
Croatian: Ukupan broj uključenih ispitanika N=33