FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zdravnik mora presoditi koristi in možno tveganje uporabe cepiva pri osebah s trombocitopenijo ali katero koli motnjo koagulacije, pri kateri je intramuskularno injiciranje kontraindicirano, razen če pričakovane koristi odtehtajo tveganje krvavitve.
English: Fainting can occur following, or even before, any needle injection.
Slovenian: Po injiciranju ali celo pred njim se lahko pojavi omedlevica.
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43
Slovenian: 43. dan Faktor serokonverzije (95-odstotni IZ) 43. dan do 1. dan Stopnja serokonverzije (95-odstotni IZ) 43. dan
English: Pregnancy No data have been generated with Foclivia in pregnant women.
Slovenian: Podatkov o uporabi zdravila Foclivia pri nosečnicah ni.
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti (>1/100, <1/10): rdečica na mestu injiciranja, otekanje na mestu injiciranja, induracija na mestu injiciranja, ekhimoza na mestu injiciranja in bolečina na mestu injiciranja, zvišana telesna temperatura, slabotnost, utrujenost in tresenje Večina teh reakcij navadno izgine v 1 do 2 dneh brez zdravljenja.
English: In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Slovenian: Pri malčkih sta bila eritem in občutljivost na dotik najpogostejši izzvani lokalni reakciji, razdražljivost in neobičajno jokanje pa najpogostejši izzvani sistemski reakciji.
English: 0.05 milligrams
Slovenian: 0,05 miligramov
English: A third (booster) dose of H5N1 vaccine combined with MF59C was administered 6 months onwards after the primary vaccination series.
Slovenian: Obnovitveni odmerek Tretji (obnovitveni) odmerek cepiva proti H5N1 z dodanim MF59C je bil dan po 6 ali več mesecih po primarnem cepljenju.
English: There were fewer reactions after the second dose compared with the first.
Slovenian: Po drugem odmerku je bilo manj neželenih učinkov kot po prvem odmerku.
English: Children (3 to 8 years of age)
Slovenian: Otroci (stari od 3 do 8 let)
English: The incidence of adverse reactions was evaluated in four clinical trials with different influenza strains and formulations (H5N3, H9N2 and H5N1); 3696 adults and elderly subjects were exposed.
Slovenian: Neželeni učinki iz kliničnih preskušanj pri odraslih in starejših osebah (starih 18 let ali več) Pojavnost neželenih učinkov so ocenili v štirih kliničnih preskušanjih z različnimi sevi in formulacijami virusa gripe (H5N3, H9N2 in H5N1); cepivu je bilo izpostavljenih 3.696 odraslih in starejših oseb.
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Slovenian: Neželeni učinki posebnega interesa, stratificirani glede na vrsto poročila (medicinsko potrjeni ali nemedicinsko potrjeni).
English: Content of the pack and other information What Foclivia contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Foclivia
English: Visually inspect the suspension prior to administration.
Slovenian: Suspenzijo pred uporabo preglejte s prostim očesom.
English: “Possible side effects” may affect your ability to drive or use tools or machines.
Slovenian: „Neželeni učinki“, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Slovenian: Če bolnik prejema imunosupresijsko zdravljenje, se lahko zmanjša imunološki odziv.
English: 10 x 10 doses 1 dose (0.5 ml)
Slovenian: 10 x 1 odmerek 1 odmerek (0,5 ml)
English: 1 x single dose (0.5 ml) pre-filled syringe with needle 1 x single dose (0.5 ml) pre-filled syringe without needle 10 x single dose (0.5 ml) pre-filled syringes with needle 10 x single dose (0.5 ml) pre-filled syringe without needle
Slovenian: 1 napolnjena injekcijska brizga z iglo z enkratnim odmerkom (0,5 ml) 1 napolnjena injekcijska brizga brez igle z enkratnim odmerkom (0,5 ml) 10 napolnjenih injekcijskih brizg z iglo z enkratnim odmerkom (0,5 ml) 10 napolnjenih injekcijskih brizg brez igle z enkratnim odmerkom (0,5 ml)
English: Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).
Slovenian: Podatki o tretjem odmerku (obnovitvenem) 6 mesecev po prvem odmerku so omejeni (glejte poglavji 4.8 in 5.1).
English: What Foclivia looks like and contents of the pack
Slovenian: Izgled zdravila Foclivia in vsebina pakiranja
English: Anti-HA antibody
Slovenian: Protitelo proti HA
English: Redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
Slovenian: Rdečica, otekanje, bolečina na mestu injiciranja, modrice, otrditev kože na mestu injiciranja.
English: Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1).
Slovenian: Med njimi je 3.618 oseb prejelo cepivo Foclivia za pripravljenost na pandemijo (A/H5N1) (glejte poglavje 5.1).
English: Foclivia contains sodium and potassium
Slovenian: Zdravilo Foclivia vsebuje natrij in kalij
English: Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks.
Slovenian: Ko odstranite pokrovček konice, na injekcijsko brizgo pritrdite iglo, tako da jo privijate v smeri ure, dokler se ne zaskoči.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Slovenian: Nevrološke bolezni, kot so nevralgija, parestezija, konvulzije in nevritis
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)
Slovenian: Površinski antigeni (hemaglutinin in nevraminidaza)* naslednjega seva virusa influence: A/Vietnam/1194/2004 (H5N1)
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Slovenian: zoženo SMQ „Anafilaktična reakcija“ in zoženo SMQ
English: In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Slovenian: V drugo klinično preskušanje (3. faza) (študija V87P13) so vključili 2.693 zdravih odraslih prostovoljcev, ki je v 3-tedenskem presledku prejelo dva odmerka cepiva, ki vsebuje H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/odmerek z adjuvansom).
English: Foclivia was evaluated in adults (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Slovenian: Zdravilo Foclivia je bilo ocenjeno pri odraslih (starih od 18 do 60 let) in starejših bolnikih (starih več kot 60 let) po razporedu primarnega cepljenja 1, 22. dan.
English: per 0.5 ml dose
Slovenian: na odmerek 0,5 ml
English: How to store Foclivia
Slovenian: Kako uporabljati zdravilo Foclivia
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C. The multidose vial should preferably be used within 24 hours after first withdrawal.
Slovenian: Večodmerno vialo med uporabami vrnite v priporočene pogoje shranjevanja med 2 °C in 8 °C.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Slovenian: - Poročilo z oceno poročevalca se članom CHMP predloži 50. dan. - Poročilo CHMP se izdelovalcu cepiva predloži 55. dan. - Poročanje je prvih 6 mesecev mesečno.
English: Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti (>1/100, <1/10): artralgija in mialgija
English: Muscoskeletal and connective tissue and bone disorders Muscular weakness, pain in extremities.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišična šibkost, bolečine v okončinah
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Slovenian: Zvišana telesna temperatura ≥ 40 °C Vsi drugi neželeni učinki Mladostniki (stari od 9 do 17 let)
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Slovenian: Poleg neželenih učinkov, ugotovljenih v kliničnih preskušanjih, so bili za zdravilo Focetria H1N1v ugotovljeni naslednji neželeni učinki med nadzorom v obdobju trženja:
English: Generalised skin reactions including itching, bumps on the skin or a non-specific rash.
Slovenian: Splošne kožne reakcije, kot so srbenje, bule na koži ali neznačilni izpuščaj.
English: Serologic responses obtained with the HI assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 µg injections.
Slovenian: pridobljen z metodo HI, je pokazal, da je do serološke zaščite prišlo pri 92 % oseb in da se je po dveh 7,5-mikrogramskih injekcijah pri 75 % pojavila serološka konverzija.
English: - Encephalitis:
Slovenian: - Encefalitis:
English: - Guillain-Barré narrow SMQ “Guillain-Barré syndrome”
Slovenian: zoženo SMQ „Vaskulitis“ - Guillain-Barréjev sindrom: zoženo SMQ „Guillain-Barréjev sindrom“ - Demielinacija:
English: PT “Neuritis”
Slovenian: PI „Nevritis“
English: Non-clinical data obtained with Foclivia and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Slovenian: Neklinični podatki, pridobljeni z zdravilom Foclivia in cepivom proti sezonski gripi, ki je vsebovalo adjuvans MF59C.1, na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalne tolerance, plodnosti pri ženskah ter vpliva na sposobnost razmnoževanja in razvoja (do konca obdobja dojenja) ne kažejo posebnega tveganja za človeka.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Slovenian: Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta paralize, znana kot
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Slovenian: Rezultati MN za sev A/Vietnam/1194/2004 kažejo na stopnjo serozaščite 99 % (95-odstotni IZ: 94100), stopnjo serokonverzije v razponu od 97 % (95-odstotni IZ: 91-99) do 99 % (95-odstotni IZ: 96100) in GMR v razponu od 29 (95-odstotni IZ: 25-35) do 50 (95-odstotni IZ: 44-58).
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Slovenian: Neželeni učinki v tednu po cepljenju z zdravilom Focetria H1N1 pri 77 otrocih, starih 3-8 let, in 80 otrocih in mladostnikih, starih 9-17 let, ki so prejeli formulacijo 7,5 µg, so bili, kot sledi:
English: To be administered intramuscularly into the deltoid muscle.
Slovenian: Uporabiti je treba intramuskularno v deltoidno mišico.
English: However, in a pandemic situation, you may still be given the vaccine.
Slovenian: Vendar boste v pandemični situaciji v primeru, da dobite alergijsko reakcijo, še vedno lahko prejeli cepivo, če bo nemudoma na voljo zdravljenje.
English: tiredness, headache, sweating, pain in muscles and joints.
Slovenian: tresenje, utrujenost, glavobol, potenje, bolečine v mišicah in sklepih.
English: Warnings and precautions Talk to your doctor or nurse before having this vaccine:
Slovenian: Opozorila in previdnostni ukrepi Pred cepljenjem se posvetujte z zdravnikom ali medicinsko sestro:
English: - have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Slovenian: - ste alergični na (preobčutljivi za) cepiva proti gripi ali katerokoli sestavino zdravila Foclivia, - ste alergični na jajca, piščančje beljakovine, - ste alergični na katerikoli antibiotik, formaldehid, cetiltrimetilamonijev bromid (CTAB) in polisorbat 80
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section 5.1).
Slovenian: V kliničnih preskušanjih so opazili določeno stopnjo navzkrižne zaščite proti sorodnim različicam virusa H5N1 (glejte poglavje 5.1).
English: It is essentially sodium- and potassium-free.
Slovenian: Zdravilo je v bistvu brez natrija in kalija.
English: 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.
Slovenian: i) državah članicah EU, po številki serije za obdobje poročanja, ii) državah članicah EU kumulativno in iii) ostalih državah.
English: - Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Slovenian: - Razen za tabelo 1 temeljijo vse tabele na številu učinkov (predstavljenih na ravni PI,
English: In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
Slovenian: faze (študija V87P6) so ocenili varnost cepiva proti gripi H5N1 za pripravljenost na pandemijo z dodanim adjuvansom pri otrocih in mladostnikih (za več informacij glejte poglavje 5.1).
English: Adolescents(9-<18 years)
Slovenian: Mladostniki (9-<18 let)
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Slovenian: Bolezni kože in podkožja generalizirane kožne reakcije, vključno s srbenjem, urtikarijo ali nespecifičnim izpuščajem;
English: Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia.
Slovenian: Varnostni podatki pa so na voljo za nosečnice, ki so bile izpostavljene zdravilu Focetria (cepivo proti pandemični gripi H1N1, ki vsebuje adjuvans MF59.1 in je podobno zdravilu Focetria).
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Slovenian: - Predložitev S-PSUR poročevalcu in članom Odbora za zdravila za uporabo v humani medicini
English: Common (>1/100, <1/10): headache
Slovenian: Pogosti (>1/100, <1/10): glavobol
English: In two dose finding studies 78 adults received an adjuvanted pandemic preparedness vaccine (H5N3 or H9N2).
Slovenian: • Podporne študije pri odraslih in starejši populaciji V dveh študijah za določanje odmerka je 78 odraslih oseb prejelo cepivo za pripravljenost na pandemijo (H5N3 ali H9N2) z dodanim adjuvansom.
English: 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.
Slovenian: Pregled za vse spontane primere na državo, stratificirane glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na resnost za obdobje, ki ga poročilo pokriva, ter kumulativno.
English: Seroconversion factor (95%CI)°°
Slovenian: Faktor serokonverzije (95-odstotni IZ)°°
English: Very rare (may affect up to 1 in 10,000 people).
Slovenian: Zelo redki (se lahko pojavijo pri največ 1 cepljeni osebi od 10.000 cepljenih oseb).
English: Foclivia 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 Foclivia takes due account of the officially declared pandemic strain.
Slovenian: Zdravilo Foclivia se lahko trži samo, kadar SZO/EU uradno razglasi pandemijo gripe, pod pogojem,
English: It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.
Slovenian: Na voljo je v napolnjenih injekcijskih brizgah z iglo ali brez nje, ki vsebujejo enkratni odmerek (0,5 ml) za injiciranje, v škatli z 1 ali10 injekcijskimi brizgami.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Slovenian: Anafilaktične (tj. smrtno nevarne) reakcije v anamnezi na katero koli sestavino cepiva ali ostanke jajc v sledovih, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) v cepivu.
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Slovenian: Rezultati MN za A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 57 % (50-64) do 79 % (68-87) in stopnjo serokonverzije v razponu od 55 % (48-62) do 58 % (47-69).
English: Injection 3
Slovenian: 3. injekcija
English: narrow SMQ “Convulsions”
Slovenian: zoženo standardizirano povpraševanje po MedDRA (SMQ) „Konvulzije“
English: Study V87P1 Adults Booster (6 months after 2nd dose
Slovenian: Študija V87P1 starejši obnovitveni odmerek (6 mesecev po 2. odmerku)
English: MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Slovenian: Rezultati mikronevtralizacije (MN) za A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 67 % (60-74) do 85 % (78-90) in stopnjo serokonverzije v razponu od 65 % (58-72) do 83 % (7789).
English: 1.175 milligrams
Slovenian: 1,175 miligramov sorbitantrioleat
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Slovenian: Zvišana telesna temperatura ≥ 38 °C do 38,9 °C
English: 0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Slovenian: 0,5 ml v napolnjeni injekcijski brizgi (steklo vrste I) z batnim zamaškom (iz bromobutilne gume).
English: One dose (0.5 ml) contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hen's eggs from healthy chicken flocks, and adjuvanted with MF59C.1, of strain:
Slovenian: En odmerek (0,5 ml) vsebuje učinkovine: površinski antigeni (hemaglutinin in nevraminidaza), namnoženi v oplojenih kokošjih jajcih iz jat zdravih piščancev, z dodanim adjuvansom MF59C.1, seva virusa influence: A/Vietnam/1194/2004 (H5N1)
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26).
Slovenian: Rezultati MN v študiji V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,01 (1,78-2,26).
English: Common (>1/100, <1/10): sweating
Slovenian: Pogosti (>1/100, <1/10): potenje
English: The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Slovenian: izoliranim v letih 2003 in 2004, ki so kazala določen antigenski odmik v primerjavi z izvirnimi sevi.
English: Suspension for injection in pre-filled syringe.
Slovenian: suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno bela tekočina
English: Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart.
Slovenian: H5N3 (A/Duck/Singapore/97) so uporabili v presledku treh tednov pri treh različnih odmerkih
English: The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratio of HI for anti-HA antibody to H1N1 after administration of one and two 7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months).
Slovenian: Stopnji serozaščite in serokonverzije, izmerjeni z metodo HI, in faktor serokonverzije, izražen kot geometrijska srednja vrednost razmerja HI za protitelo proti HA in H1N1, so po dajanju enega in dveh 7,5 µg odmerkov zdravila Focetria ocenili pri 70 otrocih in mladostnikih (9-17 let), 60 otrocih (3-8 let), 58 otrocih (12-35 mesecev) in 49 dojenčkih (6-11 mesecev).
English: Seroconversion factor(95%CI)**
Slovenian: Faktor serokonverzije (95-odstotni IZ)**
English: Warnings and precautions Talk to your doctor or nurse before having this vaccine.
Slovenian: Opozorila in previdnostni ukrepi Pred cepljenjem se posvetujte z zdravnikom ali medicinsko sestro.
English: Respiratory, thoracic and mediastinal disorders Cough.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
English: 5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
Slovenian: 5,0 ml v viali z desetimi odmerki (steklo vrste I) z zamaškom (iz halobutilne gume).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Foclivia Vsebina pakiranja in dodatne informacije
English: MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Slovenian: Rezultati MN v V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,77 (2,4-3,2).
English: Caution is needed when administrating 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 eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Slovenian: Pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktičnih reakcij) na učinkovino, katero koli pomožno snov, navedeno v poglavju 6.1, na tiomersal in na jajca, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) je treba biti previden.
English: Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Slovenian: S cepivom napolnjeno brizgo pred dajanjem pustite, da se ogreje na sobno temperaturo.
English: From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to that of Foclivia (an MF59C.1 adjuvanted H1N1 pandemic vaccines), the following additional adverse reactions have been reported:
Slovenian: V nadzoru v obdobju trženja interpandemičnih trivalentnih cepiv z adjuvansom, katerih sestava je bila podobna zdravilu Foclivia (cepivu proti pandemski gripi H1N1 z adjuvansom MF59C.1), so poročali o naslednjih dodatnih neželenih učinkih:
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Slovenian: Stopnja serozaščite*, delež serokonverzije* in faktor serokonverzije** za protitelesa proti HA na H5N1 A/turkey/Turkey/05 po 2. odmerku pri odraslih, starih 18-60 let, izmerjeni s testi SRH in HI, so bili, kot sledi:
English: 9.75 milligrams
Slovenian: 9,75 miligramov polisorbat 80