FrancophonIA/ELRC3.0 huggingface dataset:
English: Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years.
Slovenian: Zvišana telesna temperatura se je tudi pogosteje pojavila pri otrocih, starih od 6 do 9 let, kot pri otrocih, starih od 3 do 5 let.
English: It is recommended that subjects who receive a first dose of Pumarix, complete the vaccination course
Slovenian: Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva Pumarix, cepljenje tudi zaključijo s cepivom
English: There is limited information available on the use of vaccine very similar to Pumarix (but manufactured in a different facility) to children aged from 3-9 years who received either two adult doses or two half adult doses given three weeks apart.
Slovenian: O uporabi cepiva, ki je zelo podobno cepivu Pumarix (vendar je izdelano v drugi tovarni) je na voljo malo podatkov pri otrocih starih od 3 do 9 let, ki so prejeli bodisi dva odmerka za odrasle ali dva polovična odmerka za odrasle tri tedne narazen.
English: • Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand
Slovenian: • bolečina v hrbtu ali vratu, mišična okorelost, mišični krči, bolečina v rokah ali nogah.
English: The report shall include the following tables of aggregate data using the agreed templates:
Slovenian: V poročilu bodo v dogovorjenih predlogah vključene naslednje preglednice združenih podatkov:
English: • They will give Pumarix as an injection into a muscle
Slovenian: • Cepivo Pumarix vam bodo injicirali v mišico.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: There is no information available on use in children aged less than 3 years or aged from 10-17 years.
Slovenian: O uporabi pri otrocih, mlajših od 3 let ali starih od 10 do 17 let, ni podatkov.
English: If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine
Slovenian: Če ste predhodno prejeli eden ali dva odmerka podobnega cepiva H5N1z vsebnostjo AS03
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo.
Slovenian: S kliničnimi študijami so ocenili pojavnost neželenih učinkov pri približno 4500 osebah starih 18 let in več, ki so prejele cepivo Pumarix ali placebo.
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains and any safety data relevant
Slovenian: Ta naj vključuje podatke iz potekajočih študij, ali podatke, če so na voljo, dejanske uporabe
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to
Slovenian: Ko bo CHMP odločil, da predaja S-PSUR ni več potrebna, bo v časovnem obdobju, dogovorjenem s poročevalcem, predložen celoten PSUR, ki bo pokrival obdobje od zaključenega obdobja zbiranja podatkov zadnjega rednega PSUR.
English: In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Slovenian: Posledično bo imetnik dovoljenja za promet z zdravilom, takoj po razglasitvi pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) in uporabi pandemskega cepiva, predložil redna posodobljena poročila o varnosti zdravila s pogostnostjo in obliko, ki je definirana, kot
English: One pack of Pumarix consists of:
Slovenian: Eno pakiranje cepiva Pumarix vsebuje:
English: Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih, opravljene s cepivom Pumarix, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: When a dose of 0.5 ml of a similar vaccine was given to children aged 3-9 years, fever occurred more often than when half of this dose (0.25 ml of vaccine) was given.
Slovenian: Če je bil odmerek 0,5 ml podobnega cepiva uporabljen pri otrocih, starih od 3 do 9 let, se je zvišana telesna temperatura pojavila pogosteje, kot če so dobili pol tega odmerka (0,25 ml cepiva).
English: Storage (2ºC-8ºC), do not freeze, protect from light
Slovenian: Shranjujte pri temperaturi 2°C-8°C, ne zamrzujte, zaščitite pred svetlobo.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
English: The anti-HA
Slovenian: Protitelesa anti-HA
English: NA
Slovenian: HA
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘Guillain
Slovenian: • Težave z vašimi možgani in živci, kot je vnetje osrednjega živčevja (encefalomielitis), vnetje živcev (nevritis) ali vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
English: During the pandemic, the applicant will conduct a surveillance on the safety of the vaccine during
Slovenian: Med pandemijo bo vlagatelj z uporabo ustreznega registra izvajal nadzor nad varnostjo cepiva med nosečnostjo.
English: Your doctor or nurse will give you Pumarix.
Slovenian: Cepivo Pumarix vam bo dal zdravnik ali medicinska sestra.
English: Pumarix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Slovenian: Cepivo Pumarix je cepivo za preprečevanje pandemije gripe (influence) pri odraslih, starejših od 18
English: Tell the doctor requesting these tests that you have recently been given Pumarix.
Slovenian: Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Pumarix.
English: Pumarix should under no circumstances be administered intravascularly.
Slovenian: Cepiva Pumarix se v nobenem primeru ne sme injicirati v žilo.
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Slovenian: V kontrolnih skupinah so bili beli dihurji, ki so bili cepljeni samo z adjuvansom in cepivom brez adjuvansa (7,5 mikrogramov HA).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Slovenian: Dokazano je bilo, da je cepivo, pripravljeno za uporabo, pri temperaturi 30°C kemijsko in fizikalno stabilno 24 ur.
English: Persons previously vaccinated with one or two doses of AS03-containing vaccine containing HA derived from a different clade of the same subtype
Slovenian: Osebe, predhodno cepljene z enim ali dvema odmerkoma cepiva z AS03, ki je vsebovalo HA-antigen iz drugega klada istega podtipa
English: Non-clinical data obtained with Pumarix reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Slovenian: Predklinični podatki, pridobljeni s cepivom Pumarix, na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio-fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
English: Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine (H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose.
Slovenian: Klinični podatki otrok, mlajših od 6 let, ki so prejeli dva odmerka drugega cepiva proti pandemski gripi (H5N1, izdelanega v Dresdnu v Nemčiji) kažejo večjo pogostnost zvišane telesne temperature (aksilarno ≥ 38 °C) po uporabi drugega odmerka.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Slovenian: Redna posodobljena poročila o varnosti zdravila (PSUR) Izven obdobja pandemije bo vzdrževana normalna periodičnost in oblika PSUR, s posebnim pregledom neželenih učinkov posebnega pomena (AESI) in možnih neželenih učinkov, povezanih z adjuvansi.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C).
Slovenian: Pripravljeno cepivo lahko shranjujete v hladilniku (2°C - 8°C) ali na sobni temperaturi (25 °C - 30 °C).
English: Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Slovenian: Vsak odmerek (0,5 ml cepiva) izvlecite v 1-ml injekcijsko brizgo in injicirajte intramuskularno.
English: • Adults from 18 years onwards: you will receive two doses of Pumarix.
Slovenian: • Odrasli, starejši od 18 let: prejeli boste dva odmerka cepiva Pumarix.
English: Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet have this capability.
Slovenian: - Če je možno, je potrebno predložiti merilo za razmerje relativnega poročanja signalov za vsak poročani PT (npr. t.i. Proportional reporting ratio (PRR), Information Component (IC) ali Empirical Bayesian Geometric Mean (EBMG)); to ni obvezno, saj vsi imetniki dovoljenja za
English: Immune response to A/Vietnam/1194/2004
Slovenian: Imunski odziv proti A/Vietnam/1194/2004
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Pumarix.
Slovenian: Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Pumarix o tem vseeno posvetujte s svojim zdravnikom.
English: A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180.
Slovenian: Titer 1:80 je bil dosežen pri 95,7 % preiskovancev na dan 21 in 42 ter pri 85,1 % na dan 180.
English: Pumarix consists of two containers:
Slovenian: Cepivo Pumarix je na voljo v dveh vsebnikih:
English: 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.
Slovenian: Uporaba drugega polovičnega odmerka za odrasle ali odmerka za odrasle ni povečala reaktogenosti, razen deležev splošnih simptomov, ki so bili večji po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri mlajših od 6 let.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti:pojavijo se lahko pri več kot 1 od 10 oseb
English: It is recommended to equip the syringe with a needle gauge not larger than 23
Slovenian: Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
English: However, in a pandemic situation, it may be appropriate to give the vaccine provided that facilities for resuscitation should be immediately available in case of need.
Slovenian: Toda v primeru pandemije je lahko vseeno ustrezno dati cepivo pod pogojem, da je nemudoma na voljo vse,
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo letno pregledala vse nove podatke o tem cepivu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Slovenian: Spodaj so našteti neželeni učinki, zabeleženi v kliničnih študijah z modelnim cepivom (za več podatkov o modelnih cepivih glej poglavje 5.1).
English: • Adults from 18 years onwards: you will receive one dose of Pumarix.
Slovenian: • Odrasli, starejši od 18 let: prejeli boste en odmerek cepiva Pumarix.
English: A titre of 1:80 was achieved in 84.2% of subjects aged 18-60 years and in 92.6% of subjects aged >60 years.
Slovenian: Titer 1:80 je bil dosežen pri 84,2 % preiskovancev, starih od 18 do 60 let, in pri 92,6 % preiskovancev, starih > 60 let.
English: Pumarix contains sodium and potassium
Slovenian: Cepivo Pumarix vsebuje natrij in kalij
English: • Pain in the chest
Slovenian: • bolečina v prsnem košu,
English: Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Cepivo Pumarix vsebuje tiomersal Cepivo Pumarix vsebuje konzervans tiomersal in mogoče je, da se vam pojavi alergijska reakcija.
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pumarix
Slovenian: IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Pumarix
English: What Pumarix is and what it is used for
Slovenian: Kaj je cepivo Pumarix in za kaj ga uporabljamo Kaj je cepivo Pumarix in za kaj ga uporabljamo
English: Immune response to A/Indonesia/5/2005 Day 42 N=145
Slovenian: Imunski odziv proti A/Indonesia/5/2005 42. dan n = 145
English: Adverse reactions
Slovenian: Alergijske reakcije
English: 4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
English: The per-dose frequency of adverse reactions was as follows:
Slovenian: Pogostnost neželenih učinkov na prejeti odmerek je bila naslednja:
English: In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Slovenian: V študiji konsistentnosti (Q-Pan-H5N1-002) so bili odzivi anti-hemaglutininskih (anti-HA) protiteles enaindvajset dni in 6 mesecev po drugem odmerku naslednji:
English: From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported:
Slovenian: Po pridobitvi dovoljenja za promet s cepivi z AS03 z vsebnostjo 3,75 µg HA, pridobljenimi iz A/California/7/2009 (H1N1), so bili opisani naslednji neželeni učinki:
English: 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 and sodium
Slovenian: Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, tiomersal ali ostanke (jajčne in piščančje beljakovine, ovalbumin, formaldehid, in natrijev deoksiholat).
English: However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be
Slovenian: Če pa je to potrebno, vam bodo drugo cepivo injicirali v drugo roko.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: They may also happen with Pumarix.
Slovenian: Lahko se pojavijo tudi pri cepivu Pumarix.
English: This can cause skin rashes, joint pain and
Slovenian: Ta lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes).
Slovenian: Navodila za mešanje in injiciranje cepiva: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti na sobni temperaturi.
English: Forty-two days after the booster dose, the seroprotection rate against
Slovenian: Deset dni po obnovitvenem odmerku je bil delež serološke zaščite proti
English: • Shortness of breath
Slovenian: • težko dihanje,
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Slovenian: 3 % preiskovancev, ki so dosegli serumski titer nevtralizirajočih protiteles vsaj 1:80
English: Adults
Slovenian: Otroci
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Slovenian: 2,5 ml Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile
Slovenian: Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali akutno okužbo.
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each
Slovenian: Zato je otroku po vsakem odmerku cepiva priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za njeno znižanje (npr. otroku dati paracetamol ali drugo zdravilo za znižanje zvišane telesne temperature).
English: Day 180 N=353
Slovenian: 180. dan n = 353
English: 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
Slovenian: Po drugem odmerku ni bilo povečanja, ne glede na to, ali so otroci dobili polovični ali celotni odmerek za odrasle, razen nekaterih neželenih učinkov, ki so bili pogostejši po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, mlajših od 6 let.
English: Day 42 N=479
Slovenian: 42. dan n = 479
English: In adults 18 to 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (80.5%), muscle aches (37.2%), fatigue (25.2%), headache (25.1%), joint pain
Slovenian: Pri odraslih, starih od 18 do 64 let, so bili najpogosteje zabeleženi neželeni učinki cepljenja bolečina na mestu injiciranja (80,5 %), bolečine v mišicah (37,2 %), utrujenost (25,2 %), glavobol (25,1 %), bolečine v sklepih (17,7 %) in drgetanje (11,1 %).
English: Serious unexpected reactions (PTs)
Slovenian: Neželeni učinki posebnega pomena (PT) Resninepričakovani neželeni učinki (PT).
English: On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefitrisk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Slovenian: Utemeljitev priporočila za spremembo pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo Pumarix je CHMP mnenja, da je razmerje med koristjo in tveganjem za cepivo, v katerem so zdravilna učinkovina prečiščene antigenske frakcije inaktiviranega razcepljenega viriona A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2, ugodno, ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: No post-marketing surveillance data are available following Pumarix administration.
Slovenian: Podatki o spremljanju cepiva Pumarix po pridobitvi dovoljenja za promet niso na voljo.
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes)
Slovenian: Če pripravljeno cepivo shranjujete v hladilniku, ga je treba vsaj 15 minut pustiti na sobni temperaturi preden izvlečete posamezni
English: Immune response against A/Indonesia/5/2005 (H5N1)
Slovenian: Imunski odziv proti A/Indonesia/5/2005 (H5N1): Odrasli
English: Rue de l'Institut 89 B-1330 Rixensart Belgium
Slovenian: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgija
English: During a pandemic situation (Phase 6 of the WHO global Influenza preparedness plan), bi-weekly "simplified PSUR" accompanied by a summary of vaccine distribution will be provided according to the cRMP guidance (Doc.
Slovenian: Med obdobjem pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) bodo v skladu s smernicami cRMP (doc.ref.EMEA/32706/2007 za pandemijo) predloženi dvotedenski »poenostavljeni PSUR«, ki jim bo priložen povzetek distribucije cepiva.
English: In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Slovenian: V drugi klinični študiji (Q-Pan-H5N1-001) so bili odzivi antihemaglutininskih (anti-HA) protiteles pri preiskovancih, starih od 18-64 let, naslednji:
English: • When new information is received that may impact on the current Safety Specification,
Slovenian: • Po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja.
English: Day 180 N=104
Slovenian: 180. dan n = 104
English: Half dose
Slovenian: 7 Polovični odmerek
English: • Tingling or numbness of the hands or feet
Slovenian: • nespečnost, • mravljinčenje ali odrevenelost v rokah ali nogah,
English: 3.75 micrograms**
Slovenian: (3,75 mikrogramov HA).
English: Clinical studies have evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 in subjects from the age of 18 years onwards following a 0, 21 days schedule.
Slovenian: S kliničnimi študijami so ocenili imunogenost cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA iz A/Indonesia/5/2005 pri preiskovancih, starejših od 18 let po shemi 0, 21 dni.
English: • Reactions where the injection was given such as bruising, a hard lump, itching, warmth
Slovenian: • reakcije na mestu injiciranja kot so modrica, zatrdlina, srbenje, občutek toplote,
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following
Slovenian: Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
English: 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
Slovenian: 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 %).
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: See sections 4.8
Slovenian: Glejte poglavji 4.8 in 5.1.
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1):
Slovenian: Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/5/2005 (H5N1):
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Slovenian: ZNANSTVENI ZAKLJUČKI IN UTEMELJITEV PRIPOROČILA ZA SPREMEMBO
English: At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years
Slovenian: Na dan 42 je imelo titer vsaj 1:80 100 % preiskovancev, starih od 18-60 let, in 96,4 % preiskovancev, starih > 60 let.