natgillin/translations-raw huggingface dataset:
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.
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.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
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.
21 days after 1st dose
21 dan nakon 1. doze
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).
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).
neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
(upale živaca) i vrste paralize poznate kao Guillain-Barré-ov sindrom.
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.
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).
One dose of 0.5 ml at an elected date.
Jedna doza cjepiva od 0,5 ml na odabrani datum.
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.
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.
• Swollen glands in the neck, armpit or groin
• Otečene žlijezde na vratu, u pazusima ili preponama
Half adult dose4
Pola doze za odrasle4
Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website.
EMEA/H/C/000832/II/0079 objavljenom na internetskim stranicama Europske agencije za lijekove (EMA).
5all subjects seronegative prior to vaccination anti-HA
5svi ispitanici koji su prije cijepljenja bili seronegativni anti-HA protutijelo
Children aged 10-17 years
Djeca u dobi od 10-17 godina
How Pandemrix works
Kako Pandemrix djeluje
There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
U prospektivnom kliničkom ispitivanju u kojem se pratio ishod u više od 100 trudnoća nije zabilježen povećan rizik od nuspojava.
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).
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).
Pandemrix contains sodium and potassium
Pandemrix sadrži natrij i kalij
4according to protocol
4prema planu ispitivanja
Rare (≥1/10,000 to <1/1,000)
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)
See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
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.
Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Šest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije: anti-HA protutijelo
Vaccination is not recommended in this age group.
U toj dobnoj skupini cijepljenje se ne preporuča.
A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
A/California/07/2009 (H1N1) iz kojeg je izveden korišten soj NYMC X-179A i.m.
Fever (>39°C) axillary
Vrućica (>39°C)
In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose.
Nakon druge doze, osobito su se značajno povećale stope javljanja vrućice (aksilarna temperatura
tection rate1 92.7%
stopa seroprotekcije1 93,7%
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 50 BOČICA SUSPENZIJE (ANTIGEN)
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).
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).
Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Postmarketinško iskustvo s trovalentnim sezonskim cjepivom protiv influence
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Nije poznat klinički značaj titra inhibicije hemaglutinacije (HI) 1:40 u djece.
Very common Swelling and pain at the injection site, fatigue, shivering
Oticanje i bol na mjestu injiciranja, umor, drhtanje
No data are available.
Nema dostupnih podataka o primjeni.
It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Ne preporučuje se koristiti štrcaljku s iglom čiji je promjer veći od 23-G.
Month N=24
mjesec N=24
2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml
2,5 ml Nakon miješanja s emulzijom adjuvansa: 10 doza od 0,5 ml
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.
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.
There are no data with Pandemrix using the subcutaneous route.
Nema podataka o primjeni cjepiva Pandemrix supkutanim putem.
NA NA NA NA 21.5% 20.6% 42.1% 45.6%
ND ND ND ND 21,5% 20,6% 42,1% 45,6%
If a second dose is administered there should be an interval of at least three weeks between the first and the second dose.
Ako se primjenjuje druga doza, između prve i druge doze treba proći najmanje tri tjedna.
NA NA NA NA 15.4% 14.3% 14.0% 22.8%
ND ND ND ND 15,4% 14,3% 14.0% 22,8%
NA NA NA NA 27.7% 20.6% 35.1% 49.1%
ND ND ND ND 27,7% 20,6% 35,1% 49,1%
The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models.
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
unexpected severe adverse reactions, adverse events of special interest (AESI).
• Prijavljivanje nuspojava prema značaju; tj. fatalne i životno ugrožavajuće nuspojave, teške neočekivane nuspojave, nuspojave od posebnog interesa (AESI).
Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Molimo da pogledate Informacije o lijeku za cjepivo protiv pandemijske gripe (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano).
Month N=10
mjesec N=10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 25 BOČICA S EMULZIJOM (ADJUVANS)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Emulzija adjuvansa za Pandemrix i.m.
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:
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 Dvanaest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije:
After mixing, use the vaccine within 24 hours.
Nakon miješanja, cjepivo primijenite unutar 24 sata.
In the event of other variation being observed, discard the vaccine.
U slučaju da primijetite bilo kakvo odstupanje, bacite cjepivo.
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).
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).
Antigen suspension for Pandemrix Influenza vaccine
Suspenzija antigena za Pandemrix
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:
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:
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).
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).
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
- dva pakiranja s 25 bočica (staklo tip I) od 2,5 ml emulzije s čepom (butil guma).
How to store Pandemrix
Kako čuvati Pandemrix
Children aged from 6 months to 9 years
Djeca u dobi od 6 mjeseci do 9 godina
NA NA NA NA 13.8% 7.9% 15.8% 14.0%
ND ND ND ND 13,8% 7,9% 15,8% 14,0%
Very common Headache Uncommon Paraesthesia, dizziness
Glavobolja Manje često Parestezija, omaglica
20.0% 17.9% 15.1% 32.7% NA NA NA NA
20,0% 17,9% 15,1% 32,7% ND ND ND ND
Half adult dose
Pola doze za odrasle
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).
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).
The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
Bočica koja sadrži adjuvans treba se držati u okomitom položaju gornjom stranom okrenuta prema dolje,
NA NA NA NA 16.9% 17.5% 22.8% 28.1%
ND ND ND ND 16,9% 17,5% 22,8% 28,1%
Six months after the first dose, the seroprotection rate was as follows:
Šest mjeseci nakon prve doze zabilježene su slijedeće vrijednosti stopa seroprotekcije:
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
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
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.
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,
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Ovaj adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
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
1učestalost temeljena na procijenjenom pripisivom riziku iz epidemioloških ispitivanja u nekoliko europskih zemalja (vidjeti dio 4.4)
There are no data on co-administration of Pandemrix with other vaccines.
Nema podataka o istovremenoj primjeni cjepiva Pandemrix s drugim cjepivima.
Total enrolled subjects N=33
Ukupan broj uključenih ispitanika N=33
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Stopa seroprotekcije u djece koja su primila dvije polovice doze (0.25 ml) 180. dana bila je 100%.
BATCH NUMBER
Ukupan broj
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
3faktor serokonverzije: omjer geometrijske srednje vrijednosti titra (GMT) nakon i prije cijepljenja.
Pandemrix may be administered in lactating women.
Pandemrix se može primjenjivati kod dojilja.
Post dose 2
Nakon 2. Doze
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano, adjuvantirano)
The neutralising antibody responses were as follows:
Odgovori anti-HA protutijela navode se u nastavku:
Suspension and emulsion for emulsion for injection.
Suspenzija i emulzija za emulziju za injekciju.
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.
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.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Kao psihogeni odgovor na injekciju iglom, osobito u adolescenata, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Miješanjem suspenzije i emulzije dobiva se višedozno cjepivo u bočici.
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Sadržaj: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
Children aged 3-9 years
Djeca u dobi od 3-9 godina
Children aged 3 to 9 years
Djeca u dobi od 3 do 9 godina
Rare: may affect up to 1 in 1,000 people
Rijetke: mogu se javiti u manje od 1 na 1000 osoba
Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Vrućica >38°C Vrućica >39°C
Half adult dose (D-Pan-H1N1-023)
Pola doze za odrasle (D-Pan-H1N1-023)
Uncommon Insomnia
Manje često Nesanica
Immune response to A/California/7/2009 (H1N1)v-like Half dose (D-Pan-H1N1-023)
Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v Pola doze (D-Pan-H1N1-023)
Redness Swelling Fever (>38°C) axillary
Vrućica (>38°C)
Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
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
• Itching, rash
• Svrbež, osip
Total enrolled subjects N=24
Ukupan broj uključenih ispitanika N=24
Month 6 N=22
6. mjesec N=22
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.
Stoga se nakon svake doze cjepiva Pandemrix u male djece (npr. do oko 6 godina starosti)
Total enrolled subjects N=15
Ukupan broj uključenih ispitanika N=15
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v >80 godina 12. mjesec nakon 2 doze od 0,5 ml
Month 6 N=18
6. mjesec N=18
- 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.
stanice nađene među CD4 T stanicama specifičnim za influencu zdravih ispitanika nakon cijepljenja cjepivom Pandemrix ili neadjuvantiranim cjepivom H1N1v.
Month 12 N=7
12. mjesec N=7
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.
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).
Adults aged 18-60 years
18-60 godina.
Month 12 N=5
12. mjesec N=5
Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Dodatne nuspojave u djece i adolescenata Djeca u dobi od 10-17 godina
Post dose
Nakon doze
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Ako se primjenjuje druga doza od 0,25 ml, između prve i druge doze trebalo bi proći razdoblje od barem tri tjedna.
See section 6.5 for the number of doses per vial.
Za broj doza u bočici vidjeti dio 6.5.
Vascular disorders
Prolazna trombocitopenija
Total enrolled subjects N=120
Ukupan broj uključe nih ispitani ka N=120
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:
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:
Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v D-Pan H1N1-007
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 anti-HA protutijelo
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 2all subjects seronegative prior to vaccination
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 2svi ispitanici koji su prije cijepljenja bili seronegativni
• one pack containing 50 vials of 2.5 ml suspension (antigen)
• jedno pakiranje koje sadrži 50 bočica s 2,5 ml suspenzije (antigen) • dva pakiranja koje sadrži 25 bočica s 2,5 ml emulzije (adjuvans)
Post dose 1
Nakon 1. doze
Month 12 N=31
12. mjesec N=31
1antigenically similar to A/California/7/2009 (H1N1)v-like
1antigenski sličan soju poput A/California/7/2009 (H1N1)v
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
- jedno pakiranje s 50 bočica (staklo tip I) od 2,5 ml suspenzije s čepom (butil guma).
Month 6 N=17
6. mjesec N=17
Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Suspenzija za emulziju za injekciju za Pandemrix Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano, adjuvantirano)
Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Trenutno se ne preporučuje cijepljenje djece ove dobne skupine.
Injection site reactions (such as inflammation, mass, ecchymosis)
Reakcije na mjestu injiciranja (poput upale,
GMT.
KG
Full dose (D-Pan-H1N1-010)
Cijela doza (D-Pan-H1N1-010)
Very common Sweating increased Uncommon Pruritus, rash
Manje često Pruritus, osip
Month 6 N=15
6. mjesec N=15
The anti-HA antibody responses 21 days after the first and the second dose were as follows:
dan nakon prve i druge doze bio je sljedeći:
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
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
Total subjects4 N=28 [95% CI]
Ukupan broj ispitanika4 N=28 [95% CI]
• Pain and swelling at the injection site
• Bol i oticanje na mjestu injiciranja
Post dose 2 N=29
doze N=29
Month 12 N=14
12. mjesec N=14
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
A/California/07/2009 (H1N1) iz kojeg je izveden korišteni soj NYMC X-179A 3,75 mikrograma** po dozi od 0,5 ml
• Sleeplessness
• Omaglica
Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Day 21 N=18
21. dan N=18
Immune response to A/California/7/2009 (H1N1)v-like >80 years
Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v >80 godina
Total enrolled subjects N=67 [95% CI]
Ukupan broj uključenih ispitanika N=67 [95% CI]
4all subjects seronegative prior to vaccination
4svi ispitanici koji su prije cijepljenja bili seronegativni 5prema planu ispitivanja
Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Imunološki odgovor na soj poput A/California/7/2009 (H1N1)v 12-23 mjeseci
Total enrolled subjects N=75
Seronegativni uključen ih ispitanik a N=75
Total enrolled subjects2 N=2 [95% CI]
Ukupan broj uključenih ispitanika2 N=2 [95% CI]
• Flu-like symptoms
• Simptomi poput onih kod gripe
• Redness and itching at the injection site
• Crvenilo i svrbež na mjestu injiciranja