FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
Slovenian: • če ste alergični na katerokoli sestavino ali ostanke v sledeh v cepivu (formaldehid, Benzonaza, saharoza).
English: The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Slovenian: Če je potrebno, se lahko pretehta možnost uporabe cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER med nosečnostjo ob upoštevanju uradnih priporočil.
English: • vomiting, feeling sick, diarrhoea
Slovenian: • bruhanje, slabost, driska,
English: Seroprotection rate*
Slovenian: Odstotek serološke zaščite*
English: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Slovenian: BOLEZNI DIHAL, PRSNEGA KOŠA IN MEDIASTINALNEGA PROSTORA
English: Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Slovenian: Cepivo proti pandemski gripi (H5N1) (celi virioni, inaktivirano, pripravljeno v celični kulturi)
English: Immune system disorders: anaphylactic reaction, hypersensitivity
Slovenian: Bolezni imunskega sistema: anafilaktična reakcija, preobčutljivost Bolezni živčevja: konvulzije
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Slovenian: Vsem dihurjem je bil na 35. dan skozi nos vbrizgan velik odmerek izjemno virulentnega virusa H5N1 seva A/Vietnam/1203/2004, nato pa so bili 14 dni na opazovanju.
English: Common (affects 1 to 10 in 100 vaccinees):
Slovenian: Pogosti (pojavijo se pri 1 do 10 od 100 oseb):
English: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Slovenian: Wilton Park House Wilton Place Dublin 2
English: Seroneutralisation rate**
Slovenian: seronevtralizacije**
English: Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Slovenian: V kliničnem preskušanju je cepivo proti H5N1 prejelo 36 dojenčkov in otrok, starih od 6 do 35 mesecev.
English: The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet.
Slovenian: Učinkovina in pomožne snovi v cepivu PANDEMIC INFLUENZA VACCINE H5N1 BAXTER so navedene v 6. poglavju na koncu navodil za uporabo.
English: AESIs will be defined as follows:
Slovenian: Neželeni učinki posebnega pomena bodo opredeljeni takole:
English: Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton.
Slovenian: Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je belkasta, opalescentna in prosojna tekočina.
English: Very common (affects more than 1 in 10 vaccinees):
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb):
English: • hardness, redness, swelling or minor bleeding at the injection site
Slovenian: • otrdlina, rdečina, oteklina ali manjša krvavitev na mestu injiciranja,
English: Cross-reactive immune response against related H5N1 strains In a phase 3 study in adults (N=270) and older subjects (N=272) after vaccination with the A/Vietnam/1203/2004 strain vaccine the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
Slovenian: V študiji 3. faze pri odraslih (N=270) in pri starejših osebah (n=272) po cepljenju s cepivom seva A/Vietnam/1203/2004 je bil odstotek oseb z navzkrižnimi nevtralizacijskimi protitelesi, izmerjen z mikronevtralizacijo (titer > 20), naslednji:
English: • flu-like illness
Slovenian: • gripi podobna bolezen.
English: GASTROINTESTINAL DISORDERS
Slovenian: Test mikronevtralizacije
English: After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Slovenian: Ko cepivo pretresete, postane sivo bela, opalescentna, prosojna suspenzija.
English: ** ≥ 4-fold increase in MN titer *** geometric mean increase
Slovenian: * titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Slovenian: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspenzija za injiciranje cepivo proti pandemski gripi (H5N1) (celi virioni, inaktivirano, pripravljeno v celični kulturi)
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 and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Slovenian: • Pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomožno snov ali ostanke v sledeh, npr. formaldehid, Benzonaza ali saharozo, je treba biti previden.
English: For PANDEMIC INFLUENZA VACCINE H5N1 BAXTER post-marketing surveillance data are not yet available.
Slovenian: Spremljanje po pridobitvi dovoljenja za promet Za cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER še ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional circumstances”.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je pridobilo dovoljenje za promet v ”izjemnih okoliščinah”.
English: * MN titre ≥ 20
Slovenian: ** titer MN ≥ 20
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - NAPOLNJENA INJEKCIJSKA BRIZGA
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Slovenian: Prav tako so v študiji 3. faze preiskovancem, ki so bili imunsko kompromitirani in bolnikom s kroničnimi bolezenskimi stanji, od 12 do 24 meseca dali heterologni poživitveni odmerek.
English: Common (≥1/100 to <1/10)
Slovenian: Redki (≥1/10.000 do <1/1.000)
English: The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Slovenian: V klinični študiji so poročali o naslednjih neželenih učinkih pri dojenčkih, starih od 6 do 35 mesecev.
English: Nasopharyngitis
Slovenian: MEDIASTINALNEGA
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account of the officially declared pandemic strain.
Slovenian: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se lahko sprosti v promet šele po uradni razglasitvi SZO/EU pandemije gripe pod pogojem, da imetnik dovoljenja za promet z zdravilom
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years and older:
Slovenian: Dojenčki, otroci in mladostniki, stari od 6 mesecev do 17 let, in odrasli od 18. leta starosti naprej: Daje se en odmerek po 0,5 ml.
English: History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Slovenian: Anafilaksija v pretekli anamnezi (če je smrtno nevarna) zaradi preobčutljivosti na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali ostanke v sledeh (npr. formaldehid, benzonaza, saharoza).
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Slovenian: Neželeni učinki posebnega pomena (Adverse Events of Special Interest - AESI), razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega).
English: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Slovenian: BOLEZNI KOŽE IN PODKOŽJA
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Slovenian: Suspenzija za injiciranje 20 večodmernih vial (10 odmerkov na vialo - 0,5 ml na odmerek)
English: • irritation or itching at the injection site, bruising or stiff arm
Slovenian: • draženje ali srbenje na mestu injiciranja, modrice ali otrdelost roke,
English: Seroneutralization rate*
Slovenian: Odstotek seronevtralizacije*
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
Slovenian: Kaj je cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in za kaj ga uporabljamo
English: - Reporting to be monthly for the first 6 months.
Slovenian: (so)poročevalec v 6-mesečnih časovnih razmikih.
English: One single dose pre-filled syringe (containing 0.5ml suspension)
Slovenian: Suspenzija za injiciranje Ena enoodmerna napolnjena injekcijska brizga (ki vsebuje 0,5 ml suspenzije)
English: Contents of the pack and other information What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains Active substance:
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Zdravilna učinkovina:
English: Insomnia Sleep disorder
Slovenian: PSIHIATRIČNE MOTNJE nespečnost motnje spanja pogosti občasni
English: Marketing Authorisation Holder: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Slovenian: Imetnik dovoljenja za promet z zdravilom: Ology Bioservices Ireland LTD
English: Uncommon (affects 1 to 10 in 1,000 vaccinees):
Slovenian: Občasni (pojavijo se pri 1 do 10 od 1.000 oseb):
English: After primary vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Slovenian: Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH, single radial haemolysis) za protitelesa proti HA po prvem cepljenju odraslih, starih med 18 in 59 let, ter starejših oseb, starih 60 let in več, so bili naslednji:
English: • The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Slovenian: • Če se bolnik zdravi z imunosupresivnimi zdravili, je odziv imunskega sistema lahko manjši.
English: • malaise,
Slovenian: • nespečnost,
English: Seroprotection rate* Seroconversion rate** Seroconversion factor***
Slovenian: Odstotek serološke zaščite* Odstotek serokonverzije**
English: Injections of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER and immunoglobulin should be made into separate limbs.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in imunoglobulin injicirajte v različni okončini.
English: • pain at the injection site
Slovenian: • bolečina na mestu injiciranja
English: Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*: A/Vietnam/1203/2004 (H5N1)
Slovenian: cepivo proti gripi H5N1 s celimi virioni, inaktivirano, ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1)
English: * SRH area ≥ 25 mm² ** either SRH area ≥ 25 mm if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Slovenian: * površina SRH ≥ 25 mm² ** bodisi površina SRH ≥ 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine
English: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Slovenian: SKELETNEGA SISTEMA IN VEZIVNEGA TKIVA
English: Very common (≥1/10)
Slovenian: Povzetek neželenih učinkov Zelo pogosti (≥1/10)
English: There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.
Slovenian: Ni informacij o injiciranju cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pod kožo.
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Contents of the pack and other information
Slovenian: Shranjevanje cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Vsebina pakiranja in dodatne informacije
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances be administered intravascularly.
Slovenian: • Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne smete v nobenem primeru injicirati v žilo.
English: • pain in the armpit
Slovenian: • bolečine v trebuhu,
English: The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.
Slovenian: Odziv imunskega sistema na sev A/Vietnam/1203/2004 (H5N1) Imunogenost cepiva cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v kliničnem preskušanju pri otrocih in mladostnikih, starih od 9 do 17 let (N=288), pri otrocih, starih od 3 do 8 let (N=146) ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=33), po shemi cepljenja 0. in 21. dan.
English: What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Slovenian: Kaj morate vedeti preden boste cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by MN assay in immunocompromised subjects and patients with chronic disease conditions were as follows:
Slovenian: Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju preiskovancev, ki so bili imunsko kompromitirani ali bolnikov s kroničnimi bolezenskimi stanji, so bili naslednji:
English: Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Suspenzijo pred dajanjem preglejte s prostim očesom glede delcev in/ali sprememb izgleda in v takšnem primeru cepivo zavrzite.
English: Seroneutralization rate* Seroconversion rate** Seroconversion factor***
Slovenian: Odstotek seronevtralizacije* Odstotek serokonverzije**
English: Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
Slovenian: V študiji toksičnosti pri ponavljajočih odmerkih, ki je bila izvedena na podganah, so predklinične študije pokazale manjše spremembe v vrednostih jetrnih encimov in koncentraciji kalcija.
English: NAME OF THE MEDICINAL PRODUCT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspension for injection
Slovenian: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspenzija za injiciranje
English: >4 mm² *** geometric mean increase
Slovenian: SRH, če je začetni vzorec > 4 mm² *** geometrična sredina povečanja
English: The protective efficacy of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza
Slovenian: Učinkovitost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pri zaščiti pred obolevnostjo in smrtnostjo zaradi okužbe s smrtonosnimi odmerki izredno patogenega virusa ptičje gripe H5N1 je bila ocenjena neklinično na dihurju.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Slovenian: Druga zdravila in cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom.
English: • swollen glands
Slovenian: • otečene žleze,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Influenza vaccine (whole virion, inactivated) containing antigen* A/Vietnam/1203/2004 (H5N1)
Slovenian: Cepivo proti gripi (celi virioni, inaktivirano), ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1)
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Slovenian: Poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 brez adjuvansa je bilo uporabljeno pri otrocih in mladostnikih, starih od 9 do 17 let (N=196), pri otrocih, starih od 3 do 8 let (N=79), ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=25),12 mesecev po primarnem cepljenju z dvema odmerkoma cepiva s sevom A/Vietnam/1203/2004.
English: Once the needle is attached, the vaccine must be administered immediately.
Slovenian: Cepivo morate uporabiti nemudoma po namestitvi igle na brizgo.
English: Malaise
Slovenian: BOLEZNI
English: Trometamol Sodium chloride Water for injections Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol natrijev klorid voda za injekcije polisorbat 80
English: Urticaria
Slovenian: MedDRA
English: How to use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Slovenian: Kako uporabljati cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days.
Slovenian: Na 35. dan je bil dihurjem skozi nos vbrizgan velik odmerek klada 2 virusa H5N1 A/Indonesia/05/2005 ali klada 1 virusa
English: - Demyelination:
Slovenian: - demielinizacija:
English: • runny nose
Slovenian: • izcedek iz nosu,
English: After vaccination, the seroprotection rate, seroconversion rate, and seroconversion factor for anti-HA antibody, as measured by SRH, in, infants, children, and adolescents aged 6 months to 17 years were as follows:
Slovenian: Odstotek serološke zaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni s SRH, za protitelesa proti HA po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji:
English: Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in a clinical study in adults aged 18 - 59 years and subjects aged 60 years and above at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series.
Slovenian: H5N1 BAXTER (sev A/Vietnam/1203/2004) brez adjuvansa so ovrednotili v klinični študiji pri odraslih, starih od 18 do 59 let, in preiskovancih, starih 60 let in več, po 6 mesecih, 12-15 mesecih in 24 mesecih po začetku primarnega zaporedja cepljenja.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se ne daje hkrati z drugimi cepivi.
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Slovenian: Škatla po 20 večodmernih vial (iz stekla vrste I) po 5 ml suspenzije (10 odmerkov po 0,5 ml)
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins.
Slovenian: Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se ne sme uporabljati hkrati z imunoglobulini.
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Slovenian: ozko SMQ ”anafilaktične reakcije”
English: 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.
Slovenian: Vsi spontani neželeni učinki (po organskih sistemih, HLT in PT), ki so se pojavili pri nosečnicah, razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
English: 12 Month Booster
Slovenian: Poživitveni odmerek po 12 mesecih
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Slovenian: Vsi spontani neželeni učinki po starostnih skupinah, organskih sistemih, HLT in PT, razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
Slovenian: • Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne uporabljajte hkrati z drugimi cepivi.
English: PT “Bell's palsy”
Slovenian: PT ”Bellova paraliza”
English: MN Assay
Slovenian: Test MN
English: System Organ Class (SOC)
Slovenian: Razvrstitev organov po sistemu MedDRA
English: Microneutralisation Assay Immunocompromised subjects
Slovenian: Imunsko kompromitirani
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Slovenian: Resni nenavedeni neželeni učinki (po organskih sistemih, HLT in PT), razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
English: Dizziness Headache Crying
Slovenian: draženje oči občasni
English: SKIN AND
Slovenian: INFEKCIJSKE IN
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Slovenian: Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju po 12 do 24 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
English: A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Slovenian: Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika glede cepljenja s cepivom
English: 2nd Dose 1st Dose
Slovenian: 21 dni po 1. odmerku 2. odmerku 1. odmerku 2. odmerku
English: What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of the pack
Slovenian: Izgled cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in vsebina pakiranja
English: Injection site pruritus Axillary pain
Slovenian: NALEPKA - ENOODMERNA NAPOLNJENA INJEKCIJSKA BRIZGA
English: Seroprotection rates (SRH area ≥ 25 mm²) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Slovenian: Odstotki serološke zaščite (površina SRH ≥ 25 mm²) 21 dni po poživitvenem cepljenju po 12 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be used in lactating women.
Slovenian: INFLUENZA VACCINE H5N1 BAXTER se lahko uporablja med dojenjem.
English: An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Slovenian: (High Level Term - HLT) in prednostnem terminu (Preferred Term - PT), razvrščenih v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), ter z navedbo števila poročil o smrtnih primerih za obdobje, ki ga zajema poročilo, in kumulativno.