FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer.
Slovenian: Adjuvans: MF59C.1 emulzija olja v vodi, ki vsebuje skvalen kot oljno fazo, stabilizirana s polisorbatom 80 in sorbitantrioleatom v citratnem pufru.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Slovenian: Vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami), eksudativni multiformni eritem.
English: In clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria.
Slovenian: V kliničnem preskušanju se je cepilo 131 odraslih in 123 starejših oseb z dvema odmerkoma 7,5 µg cepiva Focetria.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki alergijske reakcije so lahko srbeč kožni izpuščaj, zasoplost in otekanje obraza ali jezika.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (5 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Viala (5 ml) z več odmerki
English: Rare: anaphylaxis
Slovenian: Redki: anafilaksa
English: Induration was a common reaction in toddlers but was less common in infants.
Slovenian: Zatrdlina je bila pri malčkih pogost neželen učinek, pri dojenčkih pa manj pogost.
English: Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
Slovenian: Nevrološke motnje, kot so encefalomielitis in Guillain-Barréjev sindrom.
English: Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
Slovenian: Rezultati imunogenosti z dvema odmerkoma 7,5 µg cepiva H1N1v Focetria iz kliničnega preskušanja, ki je v teku pri odraslih in starostnikih so prikazani spodaj.
English: If they persist, CONSULT YOUR DOCTOR.
Slovenian: Če ne izginejo, SE POSVETUJTE Z ZDRAVNIKOM.
English: Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Slovenian: Nevrološke motnje kot so zbadanje ali prebijajoča bolečina vzdolž enega ali več živcev, mravljinčenje, krči in nevritis (vnetje živcev).
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Slovenian: Vaskulitis s prehodno prizadetostjo ledvic in eksudativni multiformni eritem.
English: Via Fiorentina, 1 - Siena, Italy.
Slovenian: Via Fiorentina, 1 - Siena, Italija
English: Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for Focetria, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance influenza vaccine h1n1v (surface antigen, inactivated, adjuvanted) is favourable subject to the proposed changes to the product information.
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo Focetria odbor CHMP meni, da je razmerje med koristmi in tveganji zdravila, ki vsebujejo zdravilno učinkovino cepivo proti gripi H1N1v (s površinskimi antigeni, inaktivirano, z adjuvansom), ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: The vaccine should be allowed to reach room temperature before use.
Slovenian: Cepivo mora pred uporabo doseči sobno temperaturo.
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Slovenian: Alergijske reakcije, anafiksa vključno z dispnejo, bronhospazmom, edemom grla, ki so v redkih primerih povzročili šok.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/385/001
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Slovenian: Večina neželenih učinkov je bila blagih in kratkotrajnih in po lastnostih podobnih neželenim učinkom, ki jih povzročajo običajna cepiva proti sezonski gripi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be administered intramuscularly into the deltoid muscle.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Injicirajte intramuskularno v deltoidno mišico.
English: Nervous system disorders Very common: headache Rare: convulsions
Slovenian: Bolezni živčevja Zelo pogosti: glavobol Redki: krči
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila,
English: Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Slovenian: Iz kliničnih študij, v katerih je bila na dan 0 in dan 22 uporabljena različica cepiva Focetria s HA pridobljenim iz A/Vietnam/1194/2004 (H5N1), so na voljo:
English: Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus.
Slovenian: Kaj je cepivo FOCETRIA in za kaj ga uporabljamo Cepivo Focetria je cepivo za preprečevanje gripe, ki jo povzroča virus A(H1N1v) 2009.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Slovenian: Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja)in vrsta paralize, znana kot Guillain-Barréjev sindrom.
English: Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria.
Slovenian: Podatki, pridobljeni pri sočasni uporabi cepiva Focetria H1N1v s cepivom proti sezonski gripi brez adjuvansa pri zdravih odraslih v starostni skupini 18-60 let ne kažejo pomembnega vpliva na imunski odziv na cepivo Focetria.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/385/004
English: Children (3-8 years)
Slovenian: Otroci (3 do 8 let)
English: It is provided in: - a ready-to-use syringe, containing a single dose of 0.5 ml for injection; - vial containing ten doses of 0.5 ml each for injection.
Slovenian: Na voljo je v: - pripravljeni injekcijski brizgi, ki vsebuje en odmerek 0,5 ml za injiciranje; - vsebniku z desetimi odmerki z 0,5 ml za injiciranje.
English: The same study demonstrated that previous administration of adjuvanted or unadjuvanted seasonal influenza vaccines to adults and elderly does not interfere with the immune response to Focetria.
Slovenian: Ista študija je pokazala, da predhodno cepljenje s sezonskimi cepivi proti gripi z ali brez adjuvansa pri odraslih osebah in starostnikih ne kaže pomembnega vpliva na imunski odziv na cepivo Focetria.
English: Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine.
Slovenian: Cepivo Focetria H1N1v se lahko uporabi skupaj s sezonskim cepivom proti gripi brez adjuvansa.
English: Seroprotection rate (95% CI)
Slovenian: Stopnja serološke zaščite (95-% IZ)
English: The vaccine should not be administered intravascularly.
Slovenian: Cepiva se ne sme dajati intravaskularno.
English: Headache, dizziness, somnolence, syncope.
Slovenian: Glavobol, omotičnost, somnolenca, sinkopa.
English: • Studies in adults and elderly
Slovenian: • Študije z odraslimi in starostniki
English: • Post-marketing surveillance
Slovenian: • Nadzor v obdobju trženja zdravila
English: In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Slovenian: Poleg tega so v nadzoru sezonskih trivalentnih cepiv v obdobju trženja v vseh starostnih skupinah in sezonskih trivalentnih cepiv z adjuvansom MF59, katerih sestava je bila podobna cepivu Focetria (površinski antigen, inaktivirano cepivo, z adjuvansom MF59C.1), ki so bila odobrena za uporabo pri starostnikih nad 65 let, so poročali o naslednjih neželenih učinkih:
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Focetria should under no circumstances be administered intravascularly.
Slovenian: Cepivo Focetria se v nobenem primeru ne sme dajati intravaskularno.
English: • Safety and immunogenicity data obtained after administration of one or two doses of Focetria H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults, including the elderly.
Slovenian: • Podatki o varnosti in imunogenosti, dobljeni tri tedne po uporabi enega ali dveh odmerkov cepiva Focetria H1N1v pri zdravih otrocih in mladostnikih v starosti 6 mesecev-17 let in zdravih odraslih oseb, vključno s starostniki.
English: Excipients: thiomersal
Slovenian: Pomožne snovi: tiomersal
English: Uncommon (affects 1 to 10 users in 1,000): Flu like symptoms
Slovenian: Občasni (pojavijo se pri 1 do 10 cepljenih osebah od 1.000 cepljenih oseb): gripi podobni simptomi
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
Slovenian: V kliničnih preskušanjih z različnimi oblikami (H5N3, H9N2 in H5N1) je bilo modelnim cepivom izpostavljenih približno 3400 oseb.
English: Total N=66
Slovenian: Skupno n = 66
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Slovenian: V okviru teh ukrepov lahko imetnik dovoljenja za promet z zdravilom zagotovi nalepke z imenom cepiva in številko serije za vsako pakiranje cepiva.
English: Vial containing ten doses (0.5 ml each) for injection:
Slovenian: Viala z 10 odmerki (vsak po 0,5 ml) za injiciranje:
English: Adults and elderly
Slovenian: Odrasli in starostniki
English: Cardiac disorders Palpitation, tachycardia.
Slovenian: Srčne bolezni Palpitacija, tahikardija.
English: Infants (6 to 11 months of age)
Slovenian: Dojenčki (stari 6 do 11 mesecev)
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Slovenian: Sočasne uporabe ni spremljal večji delež lokalnih ali sistemskih reakcij kot uporaba cepiva Pandemrix samega.
English: Total N=117
Slovenian: Skupno n = 117
English: • Safety and immunogenicity data in healthy children and adolescents aged from 6 months to 17 years and in adults, including the elderly
Slovenian: • Podatke o varnosti in imunogenosti za zdrave otroke in mladostnike v starosti od 6 mescev do 17 let ter odrasle osebe, vključno s starostniki.
English: Clinical studies with Focetria H1N1v currently provide:
Slovenian: Iz kliničnih študij s cepivom Focetria H1N1v so trenutno na voljo:
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 (halobutilna guma).
English: (Manufacturer responsible for monovalent pooled harvests, before final filtration): Novartis Vaccines and Diagnostics S.r.l.
Slovenian: (Izdelovalec, odgovoren za monovalentne zbrane pridelke, pred končnim filtriranjem): Novartis Vaccines and Diagnostics S.r.l.
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Mišična oslabelost, bolečina v udih.
English: Based on the findings of an observational study conducted in >2000 pregnant women, reflecting the use of Focetria in pregnant women, influenza A (H1N1) vaccination with Focetria does not seem to be associated with an increased risk of adverse pregnancy outcomes, especially in the second or third trimesters of pregnancy.
Slovenian: Upoštevajoč poročilo PRAC o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za cepivo Focetria je odbor PRAC sprejel naslednje znanstvene zaključke: Na podlagi rezultatov opazovalne študije uporabe cepiva Focetria pri nosečnicah, opravljene pri >2000 nosečnicah, izgleda, da cepljenje proti influenci A (H1N1) s cepivom Focetria ni povezano z večjim tveganjem neželenih izidov nosečnosti, zlasti v drugem in tretjem trimesečju nosečnosti.
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 pruritusom, urtikarijo ali neznačilnim izpuščajem; angioedem.
English: Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: mialgija
English: Therefore the data indicate that Focetria may be co-administered with non adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Slovenian: Podatki torej kažejo, da je mogoče cepivo Focetria uporabiti hkrati s cepivi proti sezonski gripi brez adjuvansa (vendar je cepivi treba injicirati v različni okončini).
English: Focetria contains
Slovenian: Cepivo Focetria vsebuje
English: Total N=120
Slovenian: Skupno n = 120
English: Elderly: A dose (0.5 ml) of the vaccine and a second dose of 0.5 ml at least three weeks later.
Slovenian: Starostniki: Prejmejo odmerek (0,5 ml) in drugi odmerek 0,5 ml ne prej kot tri tedne po prvem cepljenju.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Slovenian: Kako boste prejeli cepivo FOCETRIA Cepivo vam bo dal zdravnik ali medicinska sestra skladno z uradnimi priporočili.
English: One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Slovenian: En odmerek z 0,5 ml vsebuje: Zdravilne učinkovine: površinski virusni antigeni (hemaglutinin in nevraminidaza), razmnoženi v jajcih, z dodanim adjuvansom MF59C.1, seva:
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Slovenian: Nevrološke motnje kot so nevralgija, parestezija, konvulzije in nevritis.
English: Common (affects 1 to 10 users in 100): Bruising of the skin at the injection site, fever and nausea
Slovenian: Pogosti (pojavijo se pri 1 do 10 cepljenih osebah od 100 cepljenih oseb): modrice na koži na mestu injiciranja, vročina in siljenje na bruhanje
English: Blood and lymphatic system disorders Lymphadenopathy.
Slovenian: Bolezni krvi in limfatičnega sistema Limfadenopatija.
English: Total N=70
Slovenian: Skupno n = 70
English: Data in children and adolescents suggest a slight decrease in reactogenicity after the second dose of the vaccine, with no increase in rates of fever.
Slovenian: Podatki za otroke in mladostnike kažejo rahlo znižanje reaktogenosti po drugem odmerku cepiva brez zvišanja stopnje zvišane telesne temperature.
English: Children 6 months to 35 months:
Slovenian: Otroci od 6 do 35 mescev:
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
Slovenian: Dodatno so se učinki, opisani v nadaljevanju, pojavili v dnevih in tednih po cepljenju s cepivi, ki se uporabljajo vsako leto za preprečevanje gripe in so vsebovala adjuvans ali pa ne. Ti neželeni učinki se lahko pojavijo po uporabi cepiva Focetria.
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Slovenian: Zelo pogosti neželeni učinki pri otrocih in mladostnikih, starih od 3 do 17 let: bolečina, zatrdlina in eritem, utrujenost, mialgija, glavobol in slabotnost.
English: Fertility An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Slovenian: Študija modelnega cepiva H5N1 na živalih ni pokazala vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Pre-filled syringe:
Slovenian: Napolnjena injekcijska brizga:
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Slovenian: Bolezni kože in podkožja Pogosti: potenje Občasni: urtikarija Redki: otekanje oči
English: METHOD OF ADMINISTRATION Gently shake before use.
Slovenian: POSTOPE UPORABE Pred uporabo nežno pretresite.
English: (Manufacturer responsible for final filtration of monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
Slovenian: (Izdelovalec, odgovoren za končno filtriranje monovalentnih zbranih pridelkov): Novartis Vaccines and Diagnostics S.r.l.
English: See section 4.4 for special warnings and special precautions for use.
Slovenian: Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
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 zamaškom na batu (bromobutilna guma).
English: There is no information on administration of the vaccine Focetria with any other vaccines.
Slovenian: O uporabi cepiva Focetria z drugimi cepivi ni podatkov.
English: Very common: pain, induration and erythema, myalgia, headache, sweating, malaise and fatigue
Slovenian: Zelo pogosti: bolečina, zatrdlina in rdečina, mialgija, glavobol, znojenje, slabo počutje in utrujenost.
English: Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Slovenian: Generalizirana kožna reakcija vključno s srbenjem, urtikarijo (koprivico), izpuščajem ali oteklino kože in sluznice.
English: Children aged 6 months to 35 months:
Slovenian: Otroci, stari od 6 do 35 mesecev:
English: Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Slovenian: Večodmerno vialo pred prenosom odmerka (0,5 ml) cepiva v brizgo nežno pretresite.
English: Fever ≥38°C to 38.9°C
Slovenian: Zvišana telesna temperatura ≥38 °C/≥38,9 °C
English: Focetria H1N1v
Slovenian: Cepivo Focetria H1N1v
English: Children and adolescents aged 3-17 years:
Slovenian: Otroci in mladostniki stari 3-17 let:
English: Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Slovenian: Odbor PRAC meni, da so z vidika razpoložljivih podatkov o uporabi cepiva Focetria med nosečnostjo te spremembe informacij o zdravilu potrebne.
English: Focetria can be given at the same time as non-adjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Slovenian: Cepivo Focetria je mogoče dati hkrati s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa, pri čemer se za cepljenje uporabljata nasprotni okončini.
English: General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Slovenian: Zelo pogosto opaženi neželeni učinki na odmerek v starostni skupini od 6 do 35 mesecev so bili razdražljivost, neobičajen jok, zaspanost, driska in sprememba prehranjevalnih navad.
English: Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Slovenian: Poročali so o naslednjih neželenih učinkih v tednu po cepljenju pri 80 dojenčkih, starih 6-11 mesecev, in 82 malčkih, starih 12-35 mesecev, ki so prejeli formulacijo 7,5 µg:
English: When Focetria is given for the first dose, it is recommended that Focetria (and not another vaccine against H1N1v) be given for the complete vaccination course.
Slovenian: Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Focetria (ne drugega cepiva proti virusu H1N1v), dokončajo cepljenje s cepivom Focetria.
English: Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Slovenian: Podatki pri dojenčkih in malčkih, starih 6-35 mesecev, kažejo rahlo zmanjšanje reaktogenosti po drugem odmerku, brez zvišanja stopnje zvišane telesne temperature.
English: Headache, dizziness, drowsiness, fainting.
Slovenian: Glavobol, omotičnost, zaspanost, omedlevica.
English: Very common reactions reported in 233 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Slovenian: Zelo pogosti neželeni učinki pri 233 dojenčkih in malčkih, starih 6 do 35 mesecev: občutljivost, rdečina, razdražljivost, neobičajen jok, zaspanost, driska in sprememba prehranjevalnih navad.
English: H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults,
Slovenian: Focetria (H1N1) pri zdravih otrocih in mladostnikih v starosti 6 mesecev-17 let in zdravih odraslih oseb, vključno s starostniki.
English: Immune response to Focetria H1N1v
Slovenian: Imunski odziv na cepivo Focetria H1N1v
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA VIALO Z DESETIMI ODMERKI
English: Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Slovenian: Podatki pri otrocih in mladostnikih, starih med 3-17 let, kažejo na majhno znižanje reaktogenosti po drugem odmerku, brez zvišanja stopnje zvišane telesne temperature.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA ZA VIALO Z DESETIMI ODMERKI
English: Rare (affects 1 to 10 users in 10,000): Convulsion, eye swelling and anaphylaxis
Slovenian: Redki (pojavijo se pri 1 do 10 cepljenih osebah od 10.000 cepljenih oseb): krči, zabuhlost oči in anafilaksa
English: Most of the reactions were mild in nature and of short duration.
Slovenian: Večinoma so bili neželeni učinki kratkotrajni in blagi.
English: Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Slovenian: Pri otrocih in mladostnikih sta bila zelo pogosta neželena učinka bolečina, otrdlina kože na mestu injiciranja, pordelost na mestu injiciranja, splošno slabo počutje, bolečina mišic, glavobol in utrujenost.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA BRIZGO
English: - If any of the side effects gets serious, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: Total N=88
Slovenian: Skupno n = 88
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181
Slovenian: Površinski virusni antigeni (hemaglutinin in nevraminidaza) * seva: NYMC X-181 pridobljenega iz seva A/California/07/2009 (H1N1)
English: Please consult the Product Information of: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Slovenian: Glejte informacije o cepivu: Cepivo proti pandemski gripi (H5N1) s površinskimi antigeni, inaktivirano, z adjuvansom.