natgillin/translations-raw huggingface dataset:
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. 
Po cepljenju proti gripi so opazili lažne pozitivne rezultate seroloških testov, pridobljenih z metodo ELISA za odkrivanje protiteles proti HIV1, virusu hepatitisa C in še zlasti HTLV1.
Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02 Immunogenicity 
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
The most common reactions occurring after vaccine administration were local reactions at injection 
Najpogostejše reakcije po cepljenju so bile lokalne reakcije na mestu vboda.
What IDflu is and what it is used for 
Kaj je cepivo IDflu in za kaj ga uporabljamo
The Western Blot technique disproves the false-positive ELISA test results. 
Tehnika Western Blot je lažne pozitivne rezultate, pridobljene z metodo ELISA, ovrgla.
Keep the syringe in the outer carton in order to protect from light. 
Shranjujte brizgo v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected. 
Cepivo lahko vpliva na rezultate krvnih testov za HIV-1, virus hepatitisa C in HTLV-1.
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER 
2/ SISTEM ZA MIKROINJICIRANJE DRŽITE MED PALCEM IN SREDINCEM
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France 
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Francija
• Vessel inflammation which may result in very rare cases in temporary kidney problems. 
• vnetje žil, ki lahko v zelo redkih primerih povzroči začasne težave z ledvicami
The safety of IDflu has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees received an injection of IDflu. 
Varnost cepiva IDflu je bila ocenjena v 3 odprtih, randomiziranih kliničnih preskušanjih, v katerih je bilo 3.372 oseb cepljenih z zdravilom IDflu.
The needle shielding system is designed to cover the micro-needle after use. 
Sistem za zaščito igle je zasnovan tako, da po uporabi mikro-iglo pokrije.
Seroprotection is generally obtained within 2 to 3 weeks. 
Serozaščita običajno nastopi v 2 do 3 tednih.
Very limited data in immunocompromised patients are available for IDflu. 
Na voljo je zelo malo podatkov o uporabi cepiva IDflu pri imunokompromitiranih bolnikih.
Precautions to be taken before handling or administering the medicinal product For instructions on preparation of the medicinal product before administration, see section 6.6. 
Opozorila glede rokovanja s cepivom in dajanja cepiva Za navodila za uporabo zdravila pred dajanjem glejte poglavje 6.6.
HOW TO USE IDflu 
KAKO UPORABLJATI CEPIVO IDflu
Fertility and toxicity studies to reproduction in females have not identified any specific potential hazard for humans. 
Študije plodnosti in toksičnosti za razmnoževanje niso pokazale posebne nevarnosti za ljudi.
Once the micro-needle has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger. 
Ko mikroiglo vstavite, vzdržujte rahel pritisk na površini kože in injicirajte cepivo s kazalcem, s katerim pritiskate na bat.
Apparent local reactions after intradermal administration were more frequent than after intramuscular administration of an adjuvanted or non-adjuvanted comparator vaccine. 
Očitne lokalne reakcije so bile po tem, ko je bilo cepivo odmerjeno intradermalno, bolj pogoste kot po intramuskularnem cepljenju s primerljivim cepivom ,ki je oziroma ni vsebovalo adjuvansa.
Systemic safety profile of IDflu is similar to the comparator vaccine, adjuvanted or non-adjuvanted, 
Sistemski profil varnosti cepiva IDflu je podoben primerjanemu cepivu z adjuvansom ali brez, ki se
IDflu may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and octoxinol 9, which are used during the manufacturing process (see section 4.3). 
Cepivo IDflu lahko vsebuje sledove jajc kot je ovalbumin ter sledove neomicina, formaldehida in oktoksinola 9, ki se uporabljajo v procesu izdelave zdravila (glejte poglavje 4.3).
* In some cases, local redness lasted up to 7 days. 
* V nekaterih primerih je lokalna pordelost trajala do 7 dni c. možni neželeni dogodki
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data). 
b. povzetek tabelarno prikazanih neželenih učinkov Spodnji podatki so povzetek pogostnosti neželenih učinkov, ki so jih zabeležili v kliničnih preizkušanjih po cepljenju in zajeli po svetu po prihodu cepiva na trg, po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥1/1000 do < 1/100); redki (≥ 1/10000 do
Immunisation should be carried out by intradermal route. 
Način uporabe Imunizacija se izvaja intradermalno.
It is not necessary to shake the vaccine before use. 
Cepiva pred uporabo ni potrebno pretresati.
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France 
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - Francija Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - Francija
1/ REMOVE NEEDLE CAP 
1/ ODSTRANITE POKROV IGLE
EU/1/08/507/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/507/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/507/006 - pack of 20 pre-filled syringes with a Micro-Injection System 
ŠTEVILKA(ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/507/004 - pakiranje z 1 napolnjeno brizgo s sistemom za mikro-injiciranje EU/1/08/507/005 - pakiranje z 10 napolnjenimi brizgami s sistemom za mikro-injiciranje EU/1/08/507/006 - pakiranje z 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
Remove the needle cap from the 
Pokrov igle odstranite s
• It is not necessary to shake the vaccine before use. 
• Cepiva pred uporabo ni potrebno pretresati.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/507/004 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/507/004
• Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin. 
• začasno zmanjšanje števila krvnih delcev, imenovanih trombocitov, ki lahko povzročijo modrice ali krvavenje, prehodno oteklost žlez vratu, pazduhe ali dimelj
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of IDflu. 
V kliničnih preizkusih in v obdobju po prihodu cepiva IDflu na trg so poročali o sledečih neželenih učinkih
IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm). 
Cepivo IDflu se daje v obliki injekcije v zgornjo plast kože (po možnosti v mišico nadlakti).
What IDflu looks like and contents of the pack 
Izgled cepiva IDflu in vsebina pakiranja
The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 
Po cepljenju se trajanje imunosti na homologne seve ali na seve, ki so tesno povezani s sevi cepiva, razlikuje, običajno pa traja od 6 do 12 mesecev.
Other vaccines or medicines and IDflu Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
- If you have an illness with fever or acute infection, the vaccination shall be postponed until 
- če imate bolezen s povišano telesno temperaturo ali akutno okužbo, morate cepljenje prestaviti na kasnejše obdobje, ko si opomorete.
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9. 
Preobčutljivost na zdravilno učinkovino, na katero koli pomožno snov navedeno v poglavju 6.1 ali na katere izmed naslednjih sledov: jajc (ovalbumin, piščančje beljakovine), neomicina, formaldehida in
Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain. 
Zelo pogosti (lahko prizadanejo več kot 1 med 10 cepljenimi) - Na mestu injiciranja: pordelost, otrdelost, otekanje, srbenje in bolečina.
(immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case. 
- Obvestite zdravnika pred cepljenjem, če imate oslabljen imunski sistem (imunosupresija) zaradi bolezni ali zdravil, saj se lahko zgodi, da cepivo v tem primeru ne bo delovalo najbolje.
** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre). 
** Serokonverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40, značilno povečanje = pozitivni titri HI pred cepljenjem in vsaj 4-povečanje titra HI po cepljenju
IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method. 
Cepivo ID flu je tako imunogeno kot primerjalno trivalentno cepivo z adjuvansom (ki vsebuje MF-59) v smislu GMT za vsakega od 3 sevov gripe po metodi SRH in za 2 seva po metodi HI.
Do not use this vaccine after the expiry date which is stated on the carton after EXP. 
Cepiva IDflu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- Other vaccines: IDflu can be given at the same time as other vaccines by using separate limbs. 
- Druga cepiva: cepivo IDflu se lahko daje sočasno z drugimi cepivi, vendar v ločene okončine.
IDflu should under no circumstances be administered intravascularly. 
Cepivo IDflu se pod nobenim pogojem ne sme dajati intravaskularno.
This vaccine is intended for individuals 60 years of age and over. 
To cepivo uporabljajo starejši od 60 let.
The active substances are Influenza virus (inactivated split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA** 
A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09 ............................................................................................................................. 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) ............................................................................................................................. 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ............ 15 mikrogramov HA**
Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock 
Neznani Alergijska reakcija, ki vključuje generalizirano kožno reakcijo kot je urtikaria, anafilaktično reakcijo, angioedem, šok
4/ INJECT USING THE INDEX FINGER 
4/ INJICIRAJTE S KAZALCEM
IDflu is not recommended for use in children and adolescents below 18 years due to insufficient data on safety and efficacy. 
Pediatrična populacija Uporaba zdravila IDflu zaradi pomanjkljivih podatkov o varnosti in učinkovitosti ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
Posology Individuals 60 years of age and over: 0.1 ml. 
Odmerjanje Odrasli starejši od 60 let: 0,1 ml.
With the same hand, push very firmly with the thumb on the plunger to activate the You hear a click and a shield comes out to cover the needle. 
Z isto roko čvrsto pritisnite palec na bat, da aktivirate zaščito igle.
Intradermal 15µg A/H3N2 
Intradermalno 15 µg
1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System 
1 napolnjena brizga (0,1 ml) z mikro-injekcijskim sistemom 10 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom 20 napolnjenih brizg (0,1 ml) z mikro-injekcijskim sistemom
The recommended site of administration is the region of the deltoid. 
Priporočeno mesto cepljenja je predel deltoidne mišice.
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not 
V primeru, da je po cepljenju na mestu vboda prisotna tekočina, ponovno cepljenje ni potrebno.
IDflu is a vaccine.This vaccine is recommended to help to protect you against flu. 
Cepivo se priporoča za zaščito proti gripi.
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria. 
V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite*, serokonverzijo ali značilne stopnje povečanja** in razmerje geometričnega povprečja titrov (GMTR)
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route. 
V randomiziranih primerjalnih preskušanjih faze III je 2606 oseb, starih nad 60 let, prejelo 0,1 ml cepiva IDflu intradermalno, 1089 oseb, starih nad 60 let, pa je prejelo 0,5 ml trivalentno inaktiviranega cepiva gripe po intramuskularni poti.
IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of 
Cepivo IDflu je enako imunogeno kot primerjano trivalentno inaktivirano cepivo gripe, ki se daje intramuskularno, za vse 3 seve gripe pri osebah, starih nad 60 let.
Interference with serological testing: See section 4.5. 
Interferenca s serološkimi testi: glejte poglavje 4.5. 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Justification for not including Braille is accepted. 
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications. 
Cepivo se lahko daje odraslim starejšim od 60 let, še zlasti tistim, pri katerih obstaja povečano
Immunisation shall be postponed in subjects with febrile illness or acute infection. 
Imunizacijo pri osebah s povišano telesno temperaturo ali akutno okužbo je treba preložiti.
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications. 
Zaščita proti gripi pri odraslih starejših od 60 let, še zlasti tistih, pri katerih obstaja povečano tveganje
MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France. 
IMETNIK DOVOLJENJA ZA PROMET Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
• The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system. 
• Sistem za mikro-injiciranje za intradermalno injekcijo je sestavljen iz napolnjene brizge z mikro-iglo (1,5 mm) in s sistemom za zaščito igle.
Reactions of not known frequency (frequency cannot be estimated from the available data) - Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system 
- Alergijske reakcije, vključno kožne reakcije, ki se lahko razširijo po vsem telesu kot izpuščaji, hude alergijske reakcije (anafilaktične reakcije) otekel obraz, jezik ali žrelo, težave pri požiranju, koprivnica in oteženo dihanje (angioedem), okvare obtočil (šok ), zaradi katerih je
In some cases, redness at the injection site lasted up to 7 days. 
V posameznih primerih lahko ostane rdečina na mestu vboda do 7 dni.
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route. 
V randomiziranem primerjalnem preskušanju faze III je 398 oseb, starih 65 in več let, prejelo 0,1 ml cepiva IDflu intradermalno, 397 oseb, starih 65 let in več, pa je prejelo 0,5 ml trivalentnega inaktiviranega cepiva proti gripi z adjuvansom (ki vsebuje MF-59) v enakem odmerku
• The vaccine should be allowed to reach room temperature before use. 
• Pred uporabo počakajte, da doseže cepivo sobno temperaturo.
This vaccine has no or negligible influence on the ability to drive and use machines. 
Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo IDflu nima oziroma zanemarljivo vpliva na sposobnost vožnje in upravljanja s stroji.
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes 
• bolečine na živčnih poteh, konvulzije, povezane s povišano telesno temperaturo, bolezni živčevja, vključno z vnetjem možganov ali hrbtenjače, vnetjem živcev ali Guillain-Barréjev sindrom, ki povzroča izjemno utrujenost in paralizo.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres. 
), stopnje serozaščite med 48,9% in 87,9%, serokonverzija ali značilne stopnje povečanja med 30,0% in 46,9% in GMTR med 3,04 in 5,35 krat nad izhodiščem
- Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system. 
kot so kortikosteroidi (na primer kortizon), zdravila proti raku (kemoterapija), radioterapija ali druga zdravila, ki vplivajo na imunski sistem.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francija.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System 
PODATKI NA ZUNANJI OVOJNINI Pakiranje z 1 ali 10 ali 20 napolnjenimi brizgami s sistemom za mikro-injiciranje
Common reactions (may affect up to 1 in 10 people) - Bruising at the injection site. 
Pogosti (lahko prizadanejo do 1 med 10 cepljenimi) - Modrica na mestu injiciranja
IDflu will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them. 
Po injiciranju cepiva IDflu razvije imunski sistem (naravna obramba telesa) zaščito proti okužbi z Cepivo IDflu pomaga pri zaščiti pred tremi sevi virusov, ki so zajeti v cepivu, in drugimi sevi, ki so tesno povezani z njimi.
• The vaccine should not be used if foreign particles are present in the suspension. 
• Če so v suspenziji prisotni tujki, cepiva ne smete uporabiti.
4.5 Interaction with other medicinal products and other forms of interaction IDflu may be given at the same time as other vaccines. 
Zdravilo IDflu se lahko daje sočasno z drugimi cepivi.
The immunological response may be diminished if the patient is undergoing immunosuppressant 
Če se bolnik zdravi z imunosupresivnimi zdravili, je imunski odziv lahko manjši.
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. 
Pomožne snovi so: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen
Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré 
Bolezni živčevja nevralgija, febrilne konvulzije, nevrološke motnje kot je encefalomielitis in Guillain-Barréjev sindrom Žilne bolezni vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
The following side effects have been reported with other vaccines given to prevent flu. 
V povezavi z drugimi cepivi proti gripi so poročali o naslednjih neželenih učinkih Neželeni učinki, ki
The recommended dose is 0.1 ml for individuals 60 years of age and over. 
Priporočeni odmerek za drasle, starejše od 60 let je 0,1 ml.
IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated) 
IDflu 15 mikrogramov/sev suspenzija za injiciranje Cepivo proti gripi z delci virionov, inaktivirano
Transient thrombocytopenia, transient lymphadenopathy 
Bolezni krvi in limfatičnega sistema prehodna trombocitopenija, prehodna limfadenopatija
- You should tell your doctor before vaccination if you have a poor immune response 
- Obvestite svojega zdravnika, če ste se zdravili z zdravili, ki lahko zmanjšajo vaš imunski odziv,
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom s farmacevtom ali z
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom ali z
0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system. 
opremljeno z batom iz elastomera (klorobutil), s pokrovom konice (termoplastični elastomer in polipropilen) in sistemom za zaščito igle.
Always use this vaccine exactly as your doctor or pharmacist has told you. 
Pri uporabi tega cepiva natančno upoštevajte napotke v tem navodilu ali navodila svojega zdravnika ali farmacevta.
Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain 
A/California/7/2009, NYMC X-179A, ki je podoben sevu A/California/7/2009 (H1N1)pdm09
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see 
4.4 Posebna opozorila in previdnostni ukrepi Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor, za primer anafilaktične reakcije, ki lahko sledi cepljenju (glejte poglavje 4.8).
• Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9. 
(ovalbumin, piščančje beljakovine), neomicin, formaldehid in oktoksinol 9.