natgillin/translations-raw huggingface dataset:
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.
Stoga se nakon svake doze preporučuje kontrola tjelesne temperature i provođenje mjera za njezino snižavanje (poput davanja paracetamola ili drugih lijekova za snižavanje vrućice).
* propagated in eggs ** haemagglutinin
* umnožen na jajima ** hemaglutinin
In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Uz to, 44,8% odnosno 56,1% ispitanika iz odgovarajućih doznih skupina imalo je četverostruki porast titra neutralizirajućih protutijela u serumu od 0. do 42. dana, a na 42. dan je 96,6% odnosno 100% ispitanika imalo titar od najmanje 1:80.
The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
Stopa seroprotekcije, stopa serokonverzije nakon docjepljivanja i faktor docjepljivanja protiv A/Indonesia/5/2005, 21 dan nakon docjepljivanja, bili su redom 100%, 99,7% i 123,8.
In addition, all subjects had neutralising antibody titres of at least 1:80.
Uz to, svi ispitanici imali su titar neutralizirajućih protutijela od najmanje 1:80.
Before the vaccine is given, the two parts will be mixed together.
Prije primjene cjepiva, dvije komponente moraju se međusobno pomiješati.
The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Primjena druge polovice doze ili cijele doze za odrasle nije pojačala reaktogenost, osim za stope općih simptoma koje su bile veće nakon druge doze, osobito stope vrućice u djece mlađe od 6 godina.
Prepandrix is not intended to be given at the same time as some other vaccines.
Prepandrix nije namijenjen za istodobnu primjenu s drugim cjepivima.
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
U svakom pokusu, četiri skupine po šest tvorova imunizirano je intramuskularno AS03-adjuvantiranim cjepivom koje sadrži hemaglutinin dobiven iz soja H5N1/A/Vietnam/1194/04 (NIBRG-14).
The suspension is a colourless light opalescent liquid.
Suspenzija je bezbojna, blago opalescentna tekućina.
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.
Cjepivo se priprema tako da se pomoću štrcaljke od 5ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
Immune system disorders Anaphylaxis, allergic reactions
Anafilaksija, alergijske reakcije
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemijsko cjepivo protiv influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
Day 180 N=138
180. dan N=138
Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
Imunološki odgovor na A/Vietnam/1194/2004 (D42) 61 do 70 godina
The anti-HA responses were as follows:
Odgovori anti-HA protutijela su bili sljedeći:
After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titre and 98-100% had a titre of at least 1:80.
Nakon dvije doze primijenjene u razmacima od 21 dan ili 6 mjeseci, 96,0% ispitanika imalo je četverostruki porast titra neutralizirajućih protutijela u serumu, a 98-100% imalo je titar od najmanje
The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Pripremljeno cjepivo je bjelkasta do žućkasta mliječna homogena emulzija.
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Nakon miješanja s emulzijom adjuvansa: 10 doza od 0,5 ml
Keep this vaccine out of the sight and reach of children.
Kako čuvati Prepandrix Čuvajte ovo cjepivo izvan pogleda i dohvata djece.
Against A/Vietnam 21 days after boosting with A/Vietnam N=46
anti-HA protutijelo protiv A/Vietnam 21 dan nakon docjepljivanja s A/Vietnam N=46
These side effects may also happen with Prepandrix.
Te nuspojave mogu se pojaviti i s cjepivom Prepandrix.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE KOJE SADRŽI 1 PAKIRANJE S 50 BOČICA SUSPENZIJE I 2 PAKIRANJA S
Prepandrix may be used in lactating women.
Prepandrix se može primjenjivati kod žena koje doje.
The seroprotection rates 6, 12 and 24 months after vaccination were as follows:
Stope seroprotekcije 6, 12 i 24 mjeseca nakon cijepljenja su bile sljedeće:
Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Vrlo ograničeni podaci u seronegativnih ispitanika >80 godina (N=5) pokazali su da nitko od ispitanika nije postigao seroprotekciju nakon dvije primjene jednostruke doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1).
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 pratilo više od 100 trudnoća nije zabilježen povećan rizik od nuspojava.
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Drugi sastojci su: polisorbat 80, oktoksinol 10, tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, magnezijev klorid, voda za injekcije
6-9 years
6-9 godina
Active immunisation against H5N1 subtype of Influenza A virus.
Aktivna imunizacija protiv virusa influence tipa A, podtipa H5N1.
3 to 5 years
3 do 5 godina
Month N=35
mjesec N=35
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Ako je potrebna istodobna primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela primjene na tvorovima.
21 days after 2nd dose
21 dan nakon 2. doze
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix
NAZIV LIJEKA Emulzija za emulziju za injekciju za Prepandrix
Double dose (N=81)
Dvostruka doza (N=81)
BATCH NUMBER Lot:
13. BROJ SERIJE Lot
How Prepandrix works
Kako djeluje Prepandrix
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
2 četverostruko povećanje titra neutralizirajućih protutijela u serumu 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
Poremećaji kože i potkožnog tkiva Često: ekhimoza na mjestu injiciranja, pojačano znojenje Manje često: pruritus, osip
3-5 years
3-5 godina
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.
Tvorovi su cijepljeni na 0. i 21. dan, a 49. dana intratrahealnim putem opterećeni su letalnom dozom H5N1/A/Vietnam/1194/04 ili heterolognim H5N1/A/Indonesia/5/05.
Double dose (N=131)
Dvostruka doza (N=131)
Seroprotection rate1
Stopa seroprotekcije1
21 days after 1st dose N=55
21 dan nakon 1. doze N=55
STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains:
NAVOĐENJE DJELATNE(IH) TVARI Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži:
Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Manje često: parestezije, somnolencija, omaglica
21 days after 2nd dose N=48
21 dan nakon 2. doze N=48
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Odgovor protutijela može biti nedostatan u bolesnika koji boluju od endogene ili jatrogene imunosupresije.
6 to 9 years
6 do 9 godina
• Feeling tired
• osjećaj omaglice
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.
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%.
In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
U tom su ispitivanju primijećeni i imunološki odgovori križne reaktivnosti na soj A/Indonesia/5/2005.
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.
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.
There are no data with Prepandrix using the subcutaneous route.
Nema podataka o primjeni cjepiva Prepandrix supkutanim putem.
How to store Prepandrix
Kako primjenjivati Prepandrix
Blood and lymphatic system disorders Common: lymphadenopathy
Poremećaji krvi i limfnog sustava
It is best to see how Prepandrix affects you before you try these activities.
Prije nego počnete s tim aktivnostima, najbolje je provjeriti kako Prepandrix djeluje na Vas.
24 months after vaccination
24 mjeseca nakon cijepljenja
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
AS03 adjuvans sadrži skvalen, DL-α-tokoferol i polisorbat 80 * hemaglutinin
6 months after vaccination
6 mjeseci nakon cijepljenja
Single dose (N=140)
Jednostruka doza (N=140)
No post-marketing surveillance data are available following Prepandrix administration.
Nema podataka iz postmarketinškog praćenja nakon primjene cjepiva Prepandrix.
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension and emulsion to be mixed before administration
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Suspenziju i emulziju treba pomiješati prije primjene.
At day 42, the anti-HA antibody responses were as follows:
Odgovor anti-HA antitijela 42. dana je bio sljedeći:
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.
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.
Suspension and emulsion for emulsion for injection.
OBLIK Suspenzija i emulzija za emulziju za injekciju.
50 vials: emulsion (adjuvant)
50 bočica: suspenzija (antigen) 50 bočica: emulzija (adjuvans)
Single dose (N=86)
Jednostruka doza (N=86)
- 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).
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 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara količini za 10 doza cjepiva (5 ml).
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) 3,75 mikrograma** po dozi od 0,5ml
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
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)
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)
• 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.
• 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
There are no data on co-administration of Prepandrix with other vaccines.
Nema podataka o istodobnoj primjeni cjepiva Prepandrix s drugim cjepivima.
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.
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
6.5 Nature and contents of container
6.5 Vrsta i sadržaj spremnika Jedno pakiranje sadrži:
Split influenza virus, inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Fragmentirani virus influence, inaktiviran, sadrži antigen koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
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
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:
No fertility data are available.
Ne postoje podaci o utjecaju na plodnost.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Prepandrix
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Suspenzija antigena za Prepandrix
Seroprotection rate
Stope seroprotekcije u
Month N=38
mjesec N=38
Month N=47
mjesec N=47
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Emulziju prije primjene treba miješati isključivo sa suspenzijom antigena.
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.
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.
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Uputa o lijeku: Informacije za korisnika Prepandrix suspenzija i emulzija za emulziju za injekciju Prepandemijsko cjepivo protiv influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Cijela doza otvrdnuće bol crvenilo oticanje vrućica (>38°C) vrućica (>39°C)
Double dose N=10
Dvostruka doza N=10
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.
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.
Emulsion vial:
Bočica s emulzijom:
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 i natrijev deoksikolat).
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.
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,
Seroconversion factor3
Faktor serokonverzije3
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
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
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Kao psihogeni odgovor na injekciju s iglom, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
12 months after the 1st dose
12 mjeseci nakon 1. doze
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Serum neutralising antibody
Neutralizirajuća protutijela u serumu
See section 6.5 for the number of doses per vial.
Za broj doza po bočici vidjeti dio 6.5.
Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
U ispitanika D-Pan-H5N1-010 je praćena postojanost imunološkog odgovora.
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:
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:
Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
U ispitanika D-Pan-H5N1-002 je praćena postojanost imunološkog odgovora.
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.
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.
There are currently no data available on the use of Prepandrix in pregnancy.
Nema podataka o primjeni cjepiva Prepandrix tijekom trudnoće.
The neutralising antibody responses were as follows:
Odgovori neutralizirajućih protutijela u serumu bili su sljedeći:
Double dose N=92
Dvostruka doza N=92
• Pain, redness, swelling or a hard lump where the injection was given
• glavobolja • bol, crvenilo, oticanje ili otvrdnuće na mjestu davanja injekcije
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.
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.
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
3faktor serokonverzije: omjer geometrijske srednje vrijednosti titra (eng. geometric mean titre (GMT)) nakon i prije cijepljenja.
Single dose N=48
Jednostruka doza N=48
Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Imunološki odgovori križne reaktivnosti izazvani AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Indonesia/05/2005 (H5N1)
Immune response to A/Indonesia/05/2005
Imunološki odgovor na A/Indonesia/05/2005
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Suspenziju prije primjene treba miješati isključivo s emulzijom adjuvansa.
The seroprotection at month 6, 12 and 24 were as follows:
6., 12. i 24. mjesecu bile su sljedeće:
Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
U ispitanika D-Pan-H5N1-009 praćena je postojanost imunološkog odgovora.
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-αtokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
Immune response to A/Indonesia/5/2005 6 to 9 years
Imunološki odgovor na A/Indonesia/5/2005 6 do 9 godina
Single dose N=51
Jednostruka doza N=51
Full dose (N=35)
Cijela doza (N=35)
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.
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.
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije