natgillin/translations-raw huggingface dataset:
For instructions on mixing of the medicinal product before administration, see section 6.6.
Za navodila o mešanju zdravila pred uporabo glejte poglavje 6.6. 4.3 Kontraindikacije
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
2 4-kratno povečanje serumskih titrov nevtralizirajočih protiteles 3 % preiskovancev, ki so dosegli serumski titer nevtralizirajočih protiteles vsaj 1:80
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
POSTOPEK IN POT(I) UPORABE ZDRAVILA intramuskularna uporaba.
What Adjupanrix is and what it is used for
Kaj je cepivo Adjupanrix in za kaj ga uporabljamo Kaj je cepivo Adjupanrix in za kaj ga uporabljamo
Serum neutralising antibody
Serumska nevtralizirajoča protitelesa
• Feeling tired
• glavobol, • občutek utrujenosti,
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
Količina, dobljena z mešanjem 1 viale suspenzije (2,5 ml) in 1 viale emulzije (2,5 ml), ustreza 10 odmerkom z 0,5 ml cepiva.
The emulsion is a whitish to yellowish homogeneous milky liquid.
Emulzija je belkasta do rumenkasta homogena mlečna tekočina.
Immune response against A/Vietnam/1194/2004 (H5N1):
Imunski odziv proti A/Vietnam/1194/2004 (H5N1):
Month N=47
mesec n=47
The suspension and emulsion vials once mixed form a multidose container.
Viala, v kateri zmešate suspenzijo in emulzijo, je večodmerni vsebnik.
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Pomožne snovi so: polisorbat 80, oktoksinol 10, tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, magnezijev klorid in voda za injekcije.
In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili podobno cepivo, ki je vsebovalo A/Indonesia/05/2005, so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja,
There are limited safety and immunogenicity data available on the administration of Adjupanrix 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.
Pri otrocih, starih od 3 do 9 let, je malo podatkov o varnosti in imunogenosti cepiva Adjupanrixin polovičnega odmerka istega cepiva (tj. 1,875 µg HA in pol količine adjuvansa AS03), uporabljenih na dan 0 in 21.
Month 6 N=40
mesec 6 n=40
The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows:
Deleži serološke zaščite 6, 12, 24 in 36 mesecev po prvem odmerku so bili:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPPRABE C.
• Other ingredients:
• Pomožne snovi:
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml.
Immune response against A/Indonesia/05/2005 (H5N1)
Imunski odziv proti A/Indonesia/05/2005 (H5N1)
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-vaccination.
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).
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.
Zato je otroku po vsakem odmerku cepiva priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za njeno znižanje, če je zvišana (npr. otroku dati paracetamol ali drugo zdravilo za znižanje zvišane telesne temperature).
An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Pregled vseh spontano prijavljenih primerov na državo, stratificiranih po vrsti prijave (medicinsko potrjena ali ni medicinsko potrjena) in resnosti, za obdobje, ki ga zajema poročilo, in kumulativno.
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
Če pa je to potrebno, vam bodo drugo cepivo injicirali v drugo roko.
50 vials: suspension (antigen) 50 vials: emulsion (adjuvant)
50 vial: suspenzija (antigen)
What Adjupanrix is and what it is used for Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Cepivo Adjupanrix uporabljamo za preprečevanje pandemije gripe pri odraslih, starejših od 18 let.
In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses.
V klinični študiji so otroci, stari od 3 do 9 let, prejeli dvakrat bodisi odmerek za odrasle (0,5 ml) bodisi polovični odmerek za odrasle (0,25 ml).
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 na 42. dan 4-kraten porast titrov nevtralizirajočih protiteles v serumu 44,8 % in 56,1 % preiskovancev in titer vsaj 1:80 96,6 % in 100 % preiskovancev.
Your doctor or nurse will give you Adjupanrix.
S cepivom Adjupanrix vas bo cepil zdravnik ali medicinska sestra.
- Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
- Razpored (periodičnost) morata imetnik dovoljenja za promet in (so)poročevalec pregledovati v
The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Pripravljeno cepivo je belkasta do rumenkasta homogena mlečna tekoča emulzija.
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) Skin and subcutaneous tissue disorders
Občasni: prebavni simptomi (kot so driska, bruhanje, bolečine v trebuhu, navzea)
Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
Odzivi anti-HA proti A/Indonesia/05/2005 so bili po uporabi cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 naslednji:
3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
3% preiskovancev, ki so dosegli titer nevtralizirajočih protiteles v serumu vsaj 1:80
To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Za umestitev poročila o varnosti v kontekst mora biti vključen povzetek o distribuciji cepiva, ki mora obsegati podatke o številu odmerkov cepiva, distribuiranega v:
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 Adjupanrix.
S klinično študijo (D-H5N1-009) so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so dobili v presledku 21 dni bodisi dva odmerka za odrasle (tj. 0,5 ml) bodisi dva polovična odmerka za odrasle (tj. 0,25 ml) cepiva Adjupanrix.
They may also happen with Adjupanrix.
Ti neželeni učinki se lahko pojavijo tudi pri cepivu Adjupanrix.
In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the anti-HA antibody responses at day 42 were as follows:
Pri preiskovancih, starih od 3 do 5 in od 6 do 9 let, ki so dvakrat dobili bodisi polni bodisi polovični odmerek cepiva z adjuvansom AS03 in z vsebnostjo 3,75 µg HA, pridobljenega iz A/Vietnam/1194/2004 (H5N1), so bili odzivi anti-HA protiteles na 42. dan naslednji:
Single dose (N=86)
Enojni odmerek (n=86)
Very rare: may affect less than 1 in 10,000 people
Zelo redki: pojavijo se lahko pri manj kot 1 od 10.000 oseb
Double dose N=10
Dvojni odmerek n=10
The per-dose frequency of adverse reactions was as follows:
Pogostnost navedenih neželenih učinkov glede na odmerek je bila naslednja:
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Če se bolnik zdravi z imunosupresivnimi oblikami zdravljenja, je imunski odziv lahko manjši.
After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Po dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005, uporabljenih na dan 0 in 21 pri 140 preiskovancih, starih od 18 do 60 let, je bil odziv anti-HA protiteles proti A/Vietnam/1194/2004 naslednji:
The seroprotection rates were 16.3% and 4.7% at months 12 and 24, respectively.
16,3 % in 24. mesec 4,7 %.
- Encephalitis:
- encefalitis:
Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Posebej zanimivi neželeni učinki (AESI), stratificirani po vrsti prijave (medicinsko potrjena ali ni medicinsko potrjena).
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
PODATKI NA PRIMARNI OVOJNINI PAKIRANJE S 50 VIALAMI SUSPENZIJE
In particular, 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.
How Adjupanrix works
Kako deluje cepivo Adjupanrix
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Ta adjuvans vsebuje skvalen (10,69 miligramov), DL-αtokoferol (11,86 miligramov) in polisorbat 80 (4,86 miligramov).
The vaccine should be administered in accordance with the recommended posology (see section 3 “How Adjupanrix is given”).
Po mešanju je količina cepiva Adjupanrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Adjupanrix").
Full dose N=35
Polni odmerek n=35
Single dose (N=140)
Enojni odmerek (n=140)
21 days after 2nd dose N = 924
21 dni po drugem odmerku n=924
The seroprotection rates 6, 12 and 24 months after vaccination were as follows:
Deleži serološke zaščite 6, 12 in 24 mesecev po cepljenju so bili:
Double dose N=92
Dvojni odmerek n=92
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 bili 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 %.
Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Navzkrižni imunski odziv na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005 (H5N1)
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient of Adjupanrix (listed in section 6) or 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, življenjsko ogrožajoče alergijske reakcije) na katerokoli sestavino cepiva Adjupanrix (navedene v poglavju 6), ali na tiomersal, jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
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.
Na 42. dan je bil po dvakratni uporabi enega odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1) sicer dosežen ustrezen imunski odziv, vendar so po dvakratni uporabi dvojnega odmerka cepiva opazili večji odziv.
In 297 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Pri 297 preiskovancih, starejših od 60 let, sta bila deleža serološke zaščite anti-HA protiteles in serokonverzije proti A/Indonesia/05/2005 na 42. dan po dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 23 %, dejavnik serokonverzije pa je bil 2,7.
21 days after 2nd dose N = 48
21 dni po drugem odmerku n=48
How to store Adjupanrix
Kako uporabljati cepivo Adjupanrix
Full dose (N=41)
Polni odmerek (n=41)
Adjupanrix should not be given
S cepivom Adjupanrix ne smete biti cepljeni
The seroprotection rate at month 6, 12 and 24 were as follows:
Deleži serološke zaščite 6., 12. in 24. mesec so bili:
Double dose N=54
Dvojni odmerek n=54
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 Adjupanrix 6 months or 12 months apart.
V študiji D-H5N1-012 so raziskali podaljšan presledek med odmerki: skupina preiskovancev, starih od 18 do 60 let, je v tej študiji dobila dva odmerka cepiva Adjupanrix v presledku
Half dose N=36
Polovični odmerek n=36
Half dose (N=50)
Polovični odmerek (n=50)
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Adjupanrix
IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Adjupanrix
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 19. oktober 2009
Immune response to A/Indonesia/5/2005 6 to 9 years
Imunski odziv proti A/Indonesia/5/2005 6 do 9 let
Single dose N=13
Enojni odmerek n=13
Name and address of the manufacturer of the biological active substance
ODGOVOREN ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke zdravilne učinkovine
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
3Faktor serokonverzije: razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 in vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1)
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Adjupanrix
IME ZDRAVILA Suspenzija za emulzijo za injiciranje za cepivo Adjupanrix
All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Vsi spontano prijavljeni neželeni učinki (SOC, HLT, PT) pri nosečnicah, stratificirani po vrsti prijave (medicinsko potrjena ali ni medicinsko potrjena), za obdobje, ki ga zajema poročilo, in kumulativno.
Full dose (N=35)
Polni odmerek (n=35)
Single dose N=51
Enojni odmerek n=51
Half dose (N=44)
Polovični odmerek (n=44)
Adverse reactions reported are listed according to the following frequency: Frequencies are reported as:
Seznam neželenih učinkov Opisani neželeni učinki so navedeni po naslednjih skupinah pogostnosti:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
PODATKI NA PRIMARNI OVOJNINI PAKIRANJE S 25 VIALAMI EMULZIJE
Half dose N=38
Polovični odmerek n=38
3.75 micrograms**
3,75 mikrogramov** * namnožen v jajcih ** hemaglutinin
Single dose N=48
Enojni odmerek n=48
In a different study (D-Pan-H5N1-007) 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 študiji (D-Pan-H5N1-007) pri 50 preiskovancih, starih od 18 do 60 let, so bili deleži serološke zaščite anti-HA protiteles 21 dni po drugem odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 20 % proti A/Indonesia/5/2005, 35 % proti A/Anhui/01/2005 in 60 % proti A/Turkey/Turkey/1/2005.
Day 42 N=46
42. dan n=46
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti, da dosežeta na sobno temperaturo.
Common: ecchymosis at the injection site, sweating increased
Pogosti: ekhimoza na mestu injiciranja, močnejše znojenje Občasni: srbenje, izpuščaj
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.
Anafilaktična reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali zaostanke v sledeh (jajčni in piščančji proteini, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
Full dose N=27
Polni odmerek n=27
Official batch release
• Uradna sprostitev serije:
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Pogosti: drgetanje, gripi podobna bolezen, reakcije na mestu injiciranja (kot so občutek toplote,
A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the second dose.
79,2 % preiskovancev, 21 dni po drugem odmerku pri 95,8 % in 6 mesecev po drugem odmerku pri
Full dose N=26
Polni odmerek n=26
Day 21 N=140
21. dan n=140
Immune response to A/Indonesia/05/2005
Imunski odziv proti A/Indonesia/05/2005
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.
V drugi študiji je 49 preiskovancev, starih od 18 do 60 let, na dan 0 in 21 dobilo dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005.
Full dose (N=26)
Polni odmerek (n=26)
Immune response to A/Vietnam/1194/2004 3 to 5 years
Imunski odziv proti A/Vietnam/1194/2004 3 do 5 let
In another clinical study (D-Pan-H5N1-010), 297 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 (D-Pan-H5N1-010) je 297 preiskovancev, starejših od 60 let (razdeljenih 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 iz A/Vietnam/1194/2004 (H5N1) na dan 0 in 21.
All subjects achieved a neutralising antibody titre of at least 1:80 against each of the two strains regardless of the HA type in the vaccine and the previous number of doses.
Ne glede na tip HA v cepivu in število prejšnjih odmerkov so vsi preiskovanci dosegli titer nevtralizirajočih protiteles vsaj 1:80 proti vsakemu od obeh sevov.
Single dose N=91
Enojni odmerek n=91
In addition, all subjects had neutralising antibody titres of at least 1:80.
Poleg tega so imeli vsi preiskovanci titre nevtralizirajočih protiteles vsaj
Immune response to A/Vietnam/1194/2004 6 months after vaccination
Imunski odziv proti A/Vietnam/1194/2004 6 mesecev po cepljenju
Half dose N=37
Polovični odmerek n=37
Half dose
Polovični odmerek za odrasle
STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Vsebina: Adjuvans AS03, sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
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 preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40; 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;
7 days after 2nd dose N = 47
7 dni po drugem odmerku n=47
Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Preiskovance v D-Pan-H5N1-010 so spremljali glede trajanja imunskega odziva.
However, in the case this needle size would not be available, a 21-G needle might be used.
Če ta velikost igle ni na voljo, se lahko uporabi igla 21-G. Da lažje izvlečemo celotno vsebino, je treba vialo z adjuvansom držati obrnjeno na glavo.
Full dose (N=34)
Polni odmerek (n=34)
No post-marketing surveillance data are available following Adjupanrix administration.
• Spremljanje cepiva po pridobitvi dovoljenja za promet Podatki o spremljanju cepiva Adjupanrix po pridobitvi dovoljenja za promet niso na voljo.
Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Preiskovance v D-Pan-H5N1-009 so spremljali glede trajanja imunskega odziva.
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.
5.000 preiskovancih, starih 18 let in več, ki so prejeli cepiva z vsaj 3,75 mikrograma HA/AS03.
• Pain, redness, swelling or a hard lump where the injection was given
• bolečina, rdečina, oteklina ali zatrdlina na mestu injiciranja,
Immunisation should be carried out by intramuscular injection.
Cepivo je treba injicirati v mišico.
Adjupanrix may be used in lactating women.
Cepivo Adjupanrix se lahko uporabi v obdobju dojenja.