natgillin/translations-raw huggingface dataset:
In addition, an updated RMP should be submitted
Poleg tega je posodobljen načrt za obvladovanje tveganja treba predložiti
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Delež serološke zaščite proti A/Indonesia je bil 21 dni po obnovitvenem cepljenju 92% in 180. dan 69,2 %.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv6 (dated March 2009) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici RMPv6 (marec 2009) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
• Increased sweating, shivering, flu-like symptoms
• močnejše znojenje, drgetanje, gripi podobni simptomi.
The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A).
Cepivo zmešate tako, da z injekcijsko brizgo izvlečete vsebino viale z emulzijo (Viala B) in jo dodate v vialo s suspenzijo (Viala A).
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
Izven pandemicnega obdobja se bodo periodicna porocila o varnosti zdravila (PSUR) predajala v obicajni obliki in casovnih obdobjih.
A second dose of 0.5 ml should be given after an interval of at least three weeks.
Drugi odmerek 0,5 ml morajo prejeti najmanj 3 tedne po prvem odmerku.
Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Imunski odziv na A/Indonesia/5/2005 shema 0, 6 mesecev 7 dni po drugem odmerku n=47
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
Občasni (pojavijo se lahko pri do 1 od 100 odmerkov cepiva): • Generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Po premešanju en odmerek (0,5 ml) vsebuje 3,75 mikrogramov hemaglutinina naslednjega seva virusa gripe:
The mixed vaccine is a whitish emulsion.
Zmešano cepivo je belkasta emulzija.
• Narrowing or blockage of blood vessels with kidney problems
• Zoženje ali zapora krvnih žil z ledvičnimi težavami.
Acute severe febrile illness.
Hujša akutna bolezen z zvišano telesno temperaturo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03.
S kliničnimi študijami so ocenili pojavnost spodaj navedenih neželenih učinkov pri približno 5.000 preiskovancih, starih 18 let in več, ki so prejeli cepiva z vsaj 3,75 mikrograma HA/AS03.
After the addition of the emulsion to the suspension, the mixture should be well shaken.
Potem, ko emulzijo dodate suspenziji, morate mešanico dobro pretresti.
Suspension for emulsion for injection 50 vials: suspension
Suspenzija za emulzijo za injiciranje 50 vial: suspenzija
Neuralgia, convulsions, transient thrombocytopenia.
Nevralgija, konvulzije, prehodna trombocitopenija.
Immunisation should be postponed.
V tem primeru je treba cepljenje odložiti.
Blood and lymphatic system disorders Common: lymphadenopathy
Bolezni krvi in limfatičnega sistema Pogosti: limfadenopatija
Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Imunski odziv proti A/Vietnam/1194/2004 shema 0, 21 dni shema 0, 6 mesecev
Split influenza virus inactivated, containing antigen* equivalent to:
Inaktivirane delce virusa gripe z vsebnostjo antigena*, ki ustreza:
Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Zelo pogosti: glavobol Občasni: parestezije, somnolenca, omotica
Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Če ste noseči, mislite, da ste noseči, nameravate zanositi ali dojite to povejte svojemu zdravniku.
• Diarrhoea, vomiting, stomach pain, feeling sick
• driska, bruhanje, bolečine v želodcu, siljenje na bruhanje.
After two doses administered 6 months apart all subjects had a titre of at least 1:80.
Po dveh odmerkih uporabljenih v razmaku 6 mesecev so vsi preiskovanci imeli titer vsaj 1:80.
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Viala A: večodmerna viala z antigenom (suspenzija) Viala B: večodmerna viala z adjuvansom (emulzija)
QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Po premešanju 1 odmerek (0,5 ml) vsebuje:
Emulsion for emulsion for injection 25 vials: emulsion
Emulzija za emulzijo za injiciranje 25 vial: emulzija
After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Po dveh odmerkih apliciranih 21 dni ali 6 mesecev narazen je 96,0 % preiskovancev imelo 4-krat večji titer nevtralizacijskih protiteles v serumu in 98-100 % preiskovancev je imelo titer vsaj 1:80.
The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21.
180. dan je bila serološka zaščita preiskovancev, starejših od 60 let, 52,9%, če so prejeli na dan 0 in 21. dan dva enojna odmerka in 69,5%, če so prejeli dva dvojna odmerka.
The suspension is a colourless light opalescent liquid.
Suspenzije je brezbarvna, rahlo opalescentna tekočina.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).
Indikacija temelji na podatkih o imunogenosti pri zdravih prostovoljcih, starejšiih od 18 let, po cepljenju z dvema odmerkoma cepiva, pripravljenega iz A/VietNam/1194/2004 NIBRG-14 (H5N1) (glejte poglavje 5.1).
A 4-fold increase in serum neutralising antibody titres from day 0 was observed in 85.7% at day 42 and 72% at day 180.
Od dneva 0 so 4-kraten porast titra nevtralizirajočih protiteles v serumu ugotovili 42. dan pri 85,7 % oseb, 180. dan pri 72 % oseb.
Against A/Vietnam 21 days after boosting with A/Vietnam
anti-HA protitelesa Proti A/Vietnam 21 dni po obnovitvi Proti A/Indonesia 21 dni po obnovitvi z A/Vietnam n = 46
To be mixed with Vial A before administration
Pred uporabo zmešajte skupaj z vialo A
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses (2.5 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 odmerkov (2,5 ml)
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40.
To be mixed with Vial B before administration
Pred uporabo zmešajte skupaj z vialo B
Based on very limited data, adults aged >80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Na podlagi zelo omejenih podatkov kaže, da lahko odrasli, starejši od 80 let, potrebujejo za doseganje imunskega odziva dvojni odmerek cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg na izbrani datum in znova po presledku vsaj treh tednov (glejte poglavje 5.1).
Very common (these may occur with more than 1 in 10 doses of the vaccine):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva):
The needle used for withdrawal must be replaced by a needle suitable for intramuscular
Pred aplikacijo morate iglo, ki ste jo uporabili pri izvleku cepiva, zamenjati z iglo, primerno za
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Če jemljete katerokoli zdravilo, ki zmanjšuje imunost proti okužbam, ali se zdravite s katerokoli drugo obliko zdravljenja, ki vpliva na imunski sistem (npr. obsevanje), ste s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg lahko cepljeni, vendar pa je odziv na cepivo lahko slabši.
However, if coadministration with another vaccine is considered to be essential, the vaccines should be injected into separate limbs.
Če je sočasno cepljenje nujno, je treba drugo cepivo injicirati v drugo okončino.
3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
3Obnovitveni dejavnik: razmerje geometrijske sredine (GMS) titra po obnovitvenem odmerku in GMS titra pred obnovitvenim odmerkom.
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper (butyl rubber).
- dve pakiranji s 25 vialami (steklo tipa I) po 2,5 ml emulzije (10 x 0,25 ml odmerki) z zamaškom iz butilne gume.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Navzkrižni imunski odziv na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1):
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
• dve pakiranji s 25 vialami po 2,5 ml emulzije (adjuvans) za 10 odmerkov
If any of these side effects occur, please tell your doctor or pharmacist immediately.
Če opazite katerikoli neželeni učinek od the, nemudoma obvestite svojega zdravnika ali farmacevta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE S 50 VIALAMI SUSPENZIJE
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with suspension before administration
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Emulzijo morate pred uporabo zmešati izključno s suspenzijo.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Po premešanju cepiva: Po premešanju morate cepivo uporabiti v 24 urah.
• Warmth, itching or bruising at the injection site
• občutek toplote, srbenje ali modrica na mestu injiciranja.
0, 6 months schedule
6.3 Rok uporabnosti
In the event of either being observed, discard the vaccine.
Če opazite eno ali drugo, morate cepivo zavreči.
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, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov, tiomersal ali zaostanke (jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Bolezni prebavil Občasni: prebavni simptomi (kot so driska, bruhanje, bolečine v trebuhu, navzea)
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Preden obe komponenti zmešate skupaj, morate pustiti, da se emulzija in suspenzija segrejeta na sobno temperaturo.
Read all of this leaflet carefully before you start receiving this vaccine.
Pred cepljenjem natančno preberite navodilo!
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.
Poleg tega je imelo v posameznih odmernih skupinah 4-kraten porast titrov nevtralizirajočih protiteles v serumu od dneva 0 do 42. dneva 44,8% in 56,1% preiskovancev in titer vsaj 1:80 96,6% in 100% preiskovancev.
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
Eno pakiranje vsebuje: - eno pakiranje s 50 vialami (steklo tipa I) po 2,5 ml suspenzije (10 x 0,25 ml odmerki) z zamaškom iz butilne gume.
• one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
• eno pakiranje s 50 vialami po 2,5 ml suspenzije (zdravilna učinkovina) za 10 odmerkov
Follow up of 50 subjects aged 18-60 years who had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 at 0 and 21 days showed that 84% were seroprotected (HI titre ≥1:40) at day 42 compared with 54% at day 180.
Spremljanje 50 preiskovancev, starih od 18 do 60 let, cepljenih z dvema odmerkoma cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 na dan 0 in 21, je pokazalo, da je bilo 42. dan serološko zaščitenih (titer HI ≥ 1:40) 84 % in 180. dan 54 %.
- This vaccine has been prescribed for you.
- Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
• če se je pri vas kdaj pojavila nenadna, smrtno nevarna alergijska reakcija na katerokoli sestavino cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg (navedena so na koncu tega navodila) ali na katerokoli od naslednjih snovi, ki so lahko prisotne v manjših količinah: jajčne ali piščančje proteine,
If you are older than 80 years of age, you may receive two double injections of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Če ste starejši od 80 let boste morda prejeli dve dvojni injekciji cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg.
However, if this cannot be avoided, the other vaccine will be injected into the other arm. Any side effects that occur may be more severe.
Če pa se sočasni uporabi ni mogoče izogniti, je treba drugo cepivo injicirati v drugo roko.
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate(KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), water for injections
Pomožne snovi so: polisorbat 80, oktoksinol 10, tiomersal, natrijev klorid (NaCl), natrijev hidrogenfosfat (Na2HPO4), kalijev dihidrogenfosfat (KH2PO4), kalijev klorid (KCl), magnezijev
• Sleepiness
• nespečnost
Seroconversion factor3
Faktor serokonverzije 3
• Pain, redness, swelling or a hard lump at the injection site
• bolečina, rdečina, oteklina ali zatrdlina na mestu injiciranja.
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 4fold increase in titre;
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.
In the first few weeks after vaccination with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg the results of these tests may not be correct.
V prvih nekaj tednih po cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg so lahko rezultati teh preiskav napačni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE S 25 VIALAMI EMULZIJE
The second dose should be given after an interval of at least three weeks.
Drugi odmerek morate prejeti najmanj tri tedne po cepljenju s prvim odmerkom.
In another clinical study, 152 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
V drugi klinični študiji je 152 preiskovancev, starejših od 60 let (stratificiranih v skupine od 61 do 70, 71 do 80 ter > 80 let), dobilo ali en ali dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1) na dan 0 in 21.
• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, smrtno nevarne alergijske reakcije) na katerokoli sestavino cepiva, tiomersal, jajčne ali piščančje proteine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat (glejte
The double injections will be given in opposite arms.
Dvojni injekciji boste dobili vsako v eno roko.
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (antiHA) antibody responses were as follows:
V kliničnih študijah, ki so pri preiskovancih v starosti od 18 do 60 let ocenile imunogenost cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1), so bili odzivi protiteles na anti-hemaglutinin (anti-HA) naslednji:
• if you have problems with your immune system, since your response to the vaccine may then be
• če imate težave z imunskim sistemom.
EU/1/08/478/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/478/001
In a different study in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
V drugi klinični študiji je pri 50 preiskovancih, starih od 18 do 60 let, 21 dni po drugem odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 bil delež serološke zaščite 20% proti A/Indonesia/5/2005, 35% proti A/Anhui/01/2005 in 60% proti A/Turkey/Turkey/1/2005.
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 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 4fold increase in titre;
1Delež serološke zaščite: delež oseb s titrom inhibicije hemaglutinacije (HI) ≥ 1:40; 2Delež serokonverzije: delež oseb, ki so bile pred cepljenjem seronegativne in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bile pred cepljenjem seropozitivne in imajo 4-kraten porast titra; 3Faktor serokonverzije : razmerje med geometrično sredino (GMS) titra po cepljenju in GMS titra pred cepljenjem.
However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Pandemrix instead of two doses that are required in previously unvaccinated individuals.
Celotno cepljenje s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg obsega dva odmerka.V primeru uradno razglašene pandemije gripe pa lahko dobijo osebe, predhodno cepljene z enim ali dvema odmerkoma cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg, ki je vsebovalo HA-antigen iz drugega gruče (clade) istega podtipa gripe, kot je pandemični sev, en sam odmerek cepiva Pandemrix namesto dveh odmerkov, ki sta potrebna za predhodno necepljene osebe.
The vial should be shaken prior to each administration.
Vialo morate pretresti pred vsako aplikacijo cepiva.
Common (these may occur with up to 1 in 10 doses of the vaccine):
Pogosti (pojavi se lahko pri do 1 od 10 odmerkov cepiva):
Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Pri 87°% in 67°% od 87 preiskovancev je bil titer nevtralizirajočih protiteles vsaj 1:40 in 1:80.
Split influenza virus, inactivated, containing antigen equivalent to A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Inaktivirani delci virusa gripe z vsebnostjo antigena, ki ustreza A/VietNam/1194/2004 (H5N1) podobnemu sevu (NIBRG-14)
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Občasni (pojavi se lahko pri do 1 od 100 odmerkov cepiva):
In a clinical study, 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 so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno bodisi iz A/Vietnam/1194/2004 bodisi Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
N=49
z A/Indonesia n = 49
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
As with all vaccines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg may not fully protect all persons who are vaccinated.
Kot druga cepiva tudi cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg je treba uporabljati v skladu z uradnimi smernicami.