natgillin/translations-raw huggingface dataset:
Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
PRAC zato glede na dostopne podatke o zvišani telesni temperaturi pri otrocih meni, da so spremembe v informacijah o zdravilu utemeljene.
These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Te antigene je mogoče obravnavati kot "nove" antigene in simulirajo okoliščine, v katerih ciljna populacija za cepljenje še ni bila v stiku z antigenom.
Pumarix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Cepivo Pumarix vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
For storage conditions after mixing of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po mešanju glejte poglavje 6.3.
The European Medicines Agency has deferred the obligation to submit the results of studies with Pumarix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij s cepivom Pumarix pri eni ali več skupinah pediatrične populacije za okužbo z gripo, povzročeno s sevom v cepivu, ali s sevom, sorodnim sevu v cepivu.
At day 42 and six months after the second dose, the anti-HA antibody responses were as follows:
Na dan 42 in šest mesecev po drugem odmerku so bili odzivi protiteles anti-HA naslednji:
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (EC) št.726/2004,
Pumarix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pumarix takes due account of the officially declared pandemic strain.
Cepivo Pumarix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Pumarix upošteva uradno razglašen pandemski sev.
- All tables will be based on number of events (presented on PT level, sorted by System Organ Class
- Vse preglednice bodo temeljile na številu dogodkov (predstavljenih na nivoju PT, razvrščenih po organskih sistemih (System Organ Class - SOC) in ne po številu primerov.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne:
Your doctors know that this might happen and will have emergency treatment
Vaš zdravnik ve, da se to lahko zgodi in bo imel nujna zdravila pripravljena za uporabo.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z vašim zdravnikom ali medicinsko sestro.
Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years.
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.
It is recommended that subjects who receive a first dose of Pumarix, complete the vaccination course
Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva Pumarix, cepljenje tudi zaključijo s cepivom
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.
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.
• Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand
• bolečina v hrbtu ali vratu, mišična okorelost, mišični krči, bolečina v rokah ali nogah.
The report shall include the following tables of aggregate data using the agreed templates:
V poročilu bodo v dogovorjenih predlogah vključene naslednje preglednice združenih podatkov:
• They will give Pumarix as an injection into a muscle
• Cepivo Pumarix vam bodo injicirali v mišico.
Any unused medicinal product or waste material should be disposed of in accordance with local
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
There is no information available on use in children aged less than 3 years or aged from 10-17 years.
O uporabi pri otrocih, mlajših od 3 let ali starih od 10 do 17 let, ni podatkov.
If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine
Če ste predhodno prejeli eden ali dva odmerka podobnega cepiva H5N1z vsebnostjo AS03
Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo.
S kliničnimi študijami so ocenili pojavnost neželenih učinkov pri približno 4500 osebah starih 18 let in več, ki so prejele cepivo Pumarix ali placebo.
This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains and any safety data relevant
Ta naj vključuje podatke iz potekajočih študij, ali podatke, če so na voljo, dejanske uporabe
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
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.
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:
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
One pack of Pumarix consists of:
Eno pakiranje cepiva Pumarix vsebuje:
Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3).
Študije na živalih, opravljene s cepivom Pumarix, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
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.
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).
Storage (2ºC-8ºC), do not freeze, protect from light
Shranjujte pri temperaturi 2°C-8°C, ne zamrzujte, zaščitite pred svetlobo.
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
The anti-HA
Protitelesa anti-HA
NA
HA
• 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
• Težave z vašimi možgani in živci, kot je vnetje osrednjega živčevja (encefalomielitis), vnetje živcev (nevritis) ali vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
During the pandemic, the applicant will conduct a surveillance on the safety of the vaccine during
Med pandemijo bo vlagatelj z uporabo ustreznega registra izvajal nadzor nad varnostjo cepiva med nosečnostjo.
Your doctor or nurse will give you Pumarix.
Cepivo Pumarix vam bo dal zdravnik ali medicinska sestra.
Pumarix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Cepivo Pumarix je cepivo za preprečevanje pandemije gripe (influence) pri odraslih, starejših od 18
Tell the doctor requesting these tests that you have recently been given Pumarix.
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Pumarix.
Pumarix should under no circumstances be administered intravascularly.
Cepiva Pumarix se v nobenem primeru ne sme injicirati v žilo.
Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
V kontrolnih skupinah so bili beli dihurji, ki so bili cepljeni samo z adjuvansom in cepivom brez adjuvansa (7,5 mikrogramov HA).
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Dokazano je bilo, da je cepivo, pripravljeno za uporabo, pri temperaturi 30°C kemijsko in fizikalno stabilno 24 ur.
Persons previously vaccinated with one or two doses of AS03-containing vaccine containing HA derived from a different clade of the same subtype
Osebe, predhodno cepljene z enim ali dvema odmerkoma cepiva z AS03, ki je vsebovalo HA-antigen iz drugega klada istega podtipa
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).
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.
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.
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.
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.
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.
The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C).
Pripravljeno cepivo lahko shranjujete v hladilniku (2°C - 8°C) ali na sobni temperaturi (25 °C - 30 °C).
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Vsak odmerek (0,5 ml cepiva) izvlecite v 1-ml injekcijsko brizgo in injicirajte intramuskularno.
• Adults from 18 years onwards: you will receive two doses of Pumarix.
• Odrasli, starejši od 18 let: prejeli boste dva odmerka cepiva Pumarix.
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.
- 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
Immune response to A/Vietnam/1194/2004
Imunski odziv proti A/Vietnam/1194/2004
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.
Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Pumarix o tem vseeno posvetujte s svojim zdravnikom.
A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180.
Titer 1:80 je bil dosežen pri 95,7 % preiskovancev na dan 21 in 42 ter pri 85,1 % na dan 180.
Pumarix consists of two containers:
Cepivo Pumarix je na voljo v dveh vsebnikih:
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.
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.
Very common: may affect more than 1 in 10 people
Zelo pogosti:pojavijo se lahko pri več kot 1 od 10 oseb
It is recommended to equip the syringe with a needle gauge not larger than 23
Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
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.
Toda v primeru pandemije je lahko vseeno ustrezno dati cepivo pod pogojem, da je nemudoma na voljo vse,
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Evropska agencija za zdravila bo letno pregledala vse nove podatke o tem cepivu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
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).
Spodaj so našteti neželeni učinki, zabeleženi v kliničnih študijah z modelnim cepivom (za več podatkov o modelnih cepivih glej poglavje 5.1).
• Adults from 18 years onwards: you will receive one dose of Pumarix.
• Odrasli, starejši od 18 let: prejeli boste en odmerek cepiva Pumarix.
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.
Titer 1:80 je bil dosežen pri 84,2 % preiskovancev, starih od 18 do 60 let, in pri 92,6 % preiskovancev, starih > 60 let.
Pumarix contains sodium and potassium
Cepivo Pumarix vsebuje natrij in kalij
• Pain in the chest
• bolečina v prsnem košu,
Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Cepivo Pumarix vsebuje tiomersal Cepivo Pumarix vsebuje konzervans tiomersal in mogoče je, da se vam pojavi alergijska reakcija.
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pumarix
IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Pumarix
What Pumarix is and what it is used for
Kaj je cepivo Pumarix in za kaj ga uporabljamo Kaj je cepivo Pumarix in za kaj ga uporabljamo
Immune response to A/Indonesia/5/2005 Day 42 N=145
Imunski odziv proti A/Indonesia/5/2005 42. dan n = 145
Adverse reactions
Alergijske reakcije
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
Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
The per-dose frequency of adverse reactions was as follows:
Pogostnost neželenih učinkov na prejeti odmerek je bila naslednja:
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:
V študiji konsistentnosti (Q-Pan-H5N1-002) so bili odzivi anti-hemaglutininskih (anti-HA) protiteles enaindvajset dni in 6 mesecev po drugem odmerku naslednji:
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:
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:
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
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).
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be
Če pa je to potrebno, vam bodo drugo cepivo injicirali v drugo roko.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
They may also happen with Pumarix.
Lahko se pojavijo tudi pri cepivu Pumarix.
This can cause skin rashes, joint pain and
Ta lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes).
Navodila za mešanje in injiciranje cepiva: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti na sobni temperaturi.
Forty-two days after the booster dose, the seroprotection rate against
Deset dni po obnovitvenem odmerku je bil delež serološke zaščite proti
• Shortness of breath
• težko dihanje,
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
3 % preiskovancev, ki so dosegli serumski titer nevtralizirajočih protiteles vsaj 1:80
Adults
Otroci
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
2,5 ml Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile
Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali akutno okužbo.
Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each
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).
Day 180 N=353
180. dan n = 353
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
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.
Day 42 N=479
42. dan n = 479
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
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 %).
Serious unexpected reactions (PTs)
Neželeni učinki posebnega pomena (PT) Resninepričakovani neželeni učinki (PT).
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.
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.
No post-marketing surveillance data are available following Pumarix administration.
Podatki o spremljanju cepiva Pumarix po pridobitvi dovoljenja za promet niso na voljo.
If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes)
Če pripravljeno cepivo shranjujete v hladilniku, ga je treba vsaj 15 minut pustiti na sobni temperaturi preden izvlečete posamezni
Immune response against A/Indonesia/5/2005 (H5N1)
Imunski odziv proti A/Indonesia/5/2005 (H5N1): Odrasli
Rue de l'Institut 89 B-1330 Rixensart Belgium
GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgija
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.
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.
In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
V drugi klinični študiji (Q-Pan-H5N1-001) so bili odzivi antihemaglutininskih (anti-HA) protiteles pri preiskovancih, starih od 18-64 let, naslednji:
• When new information is received that may impact on the current Safety Specification,
• Po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja.
Day 180 N=104
180. dan n = 104
Half dose
7 Polovični odmerek
• Tingling or numbness of the hands or feet
• nespečnost, • mravljinčenje ali odrevenelost v rokah ali nogah,
3.75 micrograms**
(3,75 mikrogramov HA).
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.
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.
• Reactions where the injection was given such as bruising, a hard lump, itching, warmth
• reakcije na mestu injiciranja kot so modrica, zatrdlina, srbenje, občutek toplote,
In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following
Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih: