natgillin/translations-raw huggingface dataset:
In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain
Pri odraslih, starejših od 64 let, so bili najpogostejši neželeni učinki po cepljenju bolečina na mestu injiciranja (58,0 %), bolečine v mišicah ( 19,7 %), utrujenost (13,5 %), glavobol (12,4 %) in bolečine v sklepih (10,3 %).
In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows:
V drugi klinični študiji (Q-Pan-H5N1-001) so bili odzivi anti-HA proti A/Vietnam/1194/2004 po uporabi cepiv z adjuvansom AS03 z vsebnostjo 3,75 µg iz A/Indonesia/5/2005 naslednji:
In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
V študiji konsistentnosti (Q-Pan-H5N1-002) je bil dosežen 4-kraten porast titra nevtralizirajočih protiteles v serumu proti A/Vietnam/1194/2004 na dan 42 pri 65,5 % preiskovancev, starih od 18 do 60 let, in pri 24,1 % preiskovancev, starejših od 60 let.
See sections 4.8
Glejte poglavji 4.8 in 5.1.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1):
Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/5/2005 (H5N1):
SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
ZNANSTVENI ZAKLJUČKI IN UTEMELJITEV PRIPOROČILA ZA SPREMEMBO
At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years
Na dan 42 je imelo titer vsaj 1:80 100 % preiskovancev, starih od 18-60 let, in 96,4 % preiskovancev, starih > 60 let.
The suspension is a translucent to off white opalescent suspension, which may sediment slightly.
suspenzija in emulzija za emulzijo za injiciranje Suspenzija je prozorna do sivo bela opalescentna suspenzija, ki lahko rahlo sedimentira.
In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili drugo cepivo proti pandemski gripi (H5N1 A/Indonesia/05/2005, izdelano v Dresdnu v Nemčiji), so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).
This is as long as medical treatment is available straight away, in case you have an allergic reaction.
- Vendar boste v primeru pandemije morda vseeno dobili cepivo, pod pogojem, da je zdravljenje z zdravili nemudoma na voljo, če bi se vam pojavila alergijska reakcija.
The immunological response may be diminished if the patient is undergoing immunosuppressant
Če bolnik prejema imunosupresivno zdravljenje, je imunski odziv lahko manjši.
The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03
zaščito pri vseh kandidatnih cepivih z adjuvansom, v primerjavi s 43-odstotno zaščito pri cepivih brez adjuvansa, kar kaže na korist adjuvansa AS03.
Mix with adjuvant emulsion before use
Pred uporabo zmešajte skupaj z emulzijo adjuvansa.
Seroprotection rate1 Seroconversion rate2
GMT1 Delež serokonverzije2
1seroprotection rate (i.e. proportion of subjects with HI titre ≥ 1:40);
1Delež serološke zaščite (tj. delež preiskovancev s titrom HI ≥ 1:40),
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post
Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po cepljenju priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
ki so podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2.
Redness
razdražljivost
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
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.
Ne glede na to, ali sta bila 6 mesecev prej uporabljena eden ali dva odmerka primarnega cepiva so bili deleži serološke zaščite proti A/Indonesia po odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 > 80 %, deleži serološke zaščite proti A/Vietnam po odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005 pa > 90 %.
Excipient with known effect: the vaccine contains 5 micrograms thiomersal For the full list of excipients see section 6.1.
Pomožne snovi z znanimi učinki: Cepivo vsebuje 5 mikrogramov tiomersala.
Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia
Zelo pogosti: glavobol Občasni: omotica, parestezije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pumarix
IME ZDRAVILA IN POT(I) UPORABE Emulzija adjuvansa za cepivo Pumarix i.m.
Day 180 N=141
180. dan n = 141
Mix into Antigen suspension before use
Pred uporabo zmešajte skupaj s suspenzijo antigena.
Full dose N=29
Polni odmerek n = 29
Detailed information on this medicine is available on the European Medicines Agency web site:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03.
V tem preskusu zaščite so bele dihurje (šest belih dihurjev/skupino) intramuskularno cepili s kandidatnim cepivom, ki je vsebovalo štiri različne odmerke H5N1 antigena (3,75; 1,5; 0,6 in 0,24 µg
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40.
What you need to know before you are given Pumarix
Kaj morate vedeti, preden boste dobili cepivo Pumarix Cepiva Pumarix ne smete dobiti:
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre
3Faktor serokonverzije: razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem.
Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Tel: + 420 2 22 00 11 11 czmail@gsk.com
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005, izdelanega po drugačnem postopku, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004, izdelanega po drugačnem postopku
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
V klinični študiji (D-Pan-H5N1-012) so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA bodisi iz A/Vietnam/1194/2004 bodisi iz Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03.
V tem preskusu zaščite so bele dihurje (šest belih dihurjev/skupino) intramuskularno cepili s kandidatnim cepivom, ki je vsebovalo tri različne odmerke H5N1 antigena (7,5; 3,8 in 1,9 µg HA
- Reporting to be fortnightly for the first 3 months of the pandemic.
- V prvih treh mesecih pandemije naj bo poročanje štirinajstdnevno.
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Turkey/Turkey/1/2005, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz Indonesia/5/2005
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate,
• Pomožne snovi: Pomožne snovi so: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat,
There are no data with Pumarix using the subcutaneous route.
Podatkov o subkutani uporabi cepiva Pumarix ni.
Split influenza virus, inactivated, containing antigen* equivalent to:
Po premešanju 1 odmerek (0,5 ml) vsebuje: razcepljen virus influence, inaktiviran, ki vsebuje antigene, ki ustrezajo:
“How Pumarix is
Kako deluje cepivo Pumarix
In the event of other variation being observed, discard the
Če opazite kakšno drugo spremembo, morate cepivo zavreči.
If any of the side effects below occur, please tell your doctor or nurse
Če se pojavi kateri od spodaj navedenih neželenih učinkov, morate to nemudoma povedati zdravniku ali medicinski sestri.
Pharmacovigilance Plan or risk minimisation activities
Načrt za obvladovanje tveganja (RMP)
PSURs
NP
In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Razen tega pa so eno skupino šestih belih dihurjev cepili s kandidatnim cepivom, ki je vsebovalo 3,75 µg H5N1 + celoten odmerek AS03.
3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
3Faktor serokonverzije: (tj. razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem).
Split influenza virus, inactivated, containing antigen* equivalent to: A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo: uporabljenemu sevu PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 3,75 mikrogramov**na 0,5 ml odmerek
Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%.
A/Turkey/Turkey/1/2005 in A/Indonesia/5/2005 99,2 %.
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Pumarix je na voljo v dveh vsebnikih:
potassium dihydrogen phosphate, potassium chloride, water for injections What Pumarix looks like and contents of the pack The suspension is a translucent to off white opalescent suspension, which may sediment slightly.
Izgled cepiva Pumarix in vsebina pakiranja Suspenzija je prozorna do sivo bela opalescentna suspenzija, ki lahko rahlo sedimentira.
Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest
Občasni: reakcije na mestu injiciranja (kot so modrice, zatrdlina, srbenje in občutek toplote), astenija, bolečina v prsnem košu, splošno slabo počutje
Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Pumarix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Day 21 N=145
n = 145
Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Zelo pogosti: bolečina v sklepih, bolečine v mišicah Občasni: bolečina v hrbtu, okorelost mišično-skeletnega sistema, bolečina v vratu, mišični krči, bolečina v okončinah
Full dose
6 Polni odmerek
Uncommon: may affect up to 1 in 100 people
Občasni:pojavijo se lahko pri največ 1 od 100 oseb
Immune response to A/Vietnam/1194/2004 3 to 5 years
Imunski odziv proti A/Vietnam/1194/2004 21 dni po 2. odmerku
In particular, please tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system.
kortikosteroide ali kemoterapijo za raka), ki vplivajo na imunski sistem.
Full dose N=41
Polni odmerek n = 41
Immune response to A/Indonesia/5/2005
Imunski odziv proti A/Indonesia/5/2005 18-60 let
The per-dose frequency of local and general solicited adverse reactions observed in the groups of children who received two adult (0.5 ml) doses was higher than that observed in the groups of children who received two half adult (i.e. 0.25 ml) doses, except for redness in the 6-9 years of age group.
ki so prejeli dva odmerka za odrasle (0,5 ml), kot v skupinah otrok, ki so prejeli dva polovična odmerka za odrasle ( t.j.
Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash
Bolezni kože in podkožja Pogosti: znojenje
• 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 or sodium deoxycholate.
• če ste kdaj imeli nenadno, življenje ogrožajočo alergijsko reakcijo na katerokoli sestavino tega cepiva (navedene v poglavju 6) ali na karkoli, kar je lahko prisotno v zelo majhnih količinah,
How to store Pumarix Keep this vaccine out of the sight and reach of children.
Shranjevanje cepiva Pumarix Cepivo shranjujte nedosegljivo otrokom!
Instructions for mixing and administration of the vaccine:
Datum in ura mešanja:
NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Navodilo za uporabo Pumarix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Half dose N=44
Polovični odmerek n = 44
General disorders and administration site conditions Very common: pain at the injection site, fatigue
Zelo pogosti: bolečina na mestu injiciranja, utrujenost
Pumarix may be used in lactating women.
Cepivo Pumarix se lahko uporabi v obdobju dojenja.
Product-specific data can be
Drugi viri podatkov
In a clinical study (D-Pan-H5N1-009, -023), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75
V klinični študiji (D-Pan-H5N1-009, -023) so otroci, stari od 3 do 5 in od 6 do 9 let, dvakrat dobili bodisi polni odmerek (0,5 ml) bodisi polovični odmerek (0,25 ml) cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1) na dan 0 in dan 21.
Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Pomožne snovi: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za injekcije suspenzija antigena za injiciranje 50 vial: suspenzija
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
Adjuvans AS03, ki je sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
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) manufactured using a different process and on administration of half a dose of the same 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.
AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1), izdelanega z uporabo drugačnega postopka, in polovičnega odmerka istega cepiva (tj. 1,875 µg HA in pol količine adjuvansa AS03),
Full dose N=42
Polni odmerek n = 42
Half dose N=42
Polovični odmerek n = 42
Full dose N=43
Polni odmerek n = 43
• Being sick, stomach pain, acid indigestion
• slabost, bolečine v želodcu, dispepsija,
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pumarix Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Suspenzija za emulzijo za injiciranje za cepivo Pumarix cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Talk to your doctor or nurse before you are given Pumarix:
Preden dobite cepivo Pumarix, se posvetujte z zdravnikom ali medicinsko sestro:
Half dose N=43
Polovični odmerek n = 43
• Itching, rash
• drgetanje,
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI
See section 6.5 for the
Za število odmerkov v viali glejte poglavje 6.5.
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population
Uporaba cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1),
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
2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra.
After mixing: Use within 24 hours and do not store above 30°C.
Po premešanju: Uporabite v 24 urah.
In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination.
V klinični študiji (Q-Pan-H5N1-010) je bil 15 mesecev po primarnem cepljenju uporabljen obnovitveni odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz
A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
V klinični študiji (D-H5N1-009) so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so v presledku 21 dni prejeli bodisi dva odmerka za odrasle (t.j.
2seroconversion rate (i.e. 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
2Delež serokonverzije: (tj. delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra),
Medicinal product subject to medical prescription.
POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Štirikratno povečanje serumskih titrov nevtralizirajočih protiteles proti A/Indonesia/5/2005 je bilo doseženo pri 76,6 % preiskovancev na dan 21, pri 97,9 % na dan 42 in pri 91,5 % na dan 180; na dan 42 in 180 je imelo 100 % preiskovancev titer vsaj 1:80.
2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4
2Obnovitveni delež serokonverzije: delež preiskovancev, ki so bili seronegativni pred obnovitvenim odmerkom in imajo zaščitni titer po cepljenju ≥ 1:40, ali so bili pred obnovitvenim odmerkom seropozitivni in imajo 4-kraten porast titra.
How Pumarix is given
Kako uporabljati cepivo Pumarix
Induration Pain
Emulzija je belkastega
Split influenza virus, inactivated, containing antigen* equivalent to: *Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 (H5N1)
The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Po mešanju je količina cepiva Pumarix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
Pumarix contains thiomersal
Nevtralizirajoča protitelesa v serumu
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
• dve pakiranji s 25 vialami po 2,5 ml emulzije (adjuvans)
• Diarrhoea, feeling sick
• driska, siljenje na bruhanje.
Gastrointestinal disorders
Delež serokonverzije
The vaccine should be administered in accordance with the recommended posology (see section 3.
Po mešanju je količina cepiva Pumarix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Pumarix").
2seroconversion rate (i.e. 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 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
2Delež serokonverzije: (tj. delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra), 3Faktor serokonverzije: (tj. razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem).
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Podatke, specifične za zdravilo se lahko vrednoti med obdelavo signalov.
Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Viala z emulzijo: natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Pumarix
IME ZDRAVILA IN POT(I) UPORABE
DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
Due date
21. dan