natgillin/translations-raw huggingface dataset:
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you. 
Pred cepljenjem natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
If vaccination is considered necessary, facilities for resuscitation should be immediately available in case of need (see section 4.4). 
Če se oceni, da je cepljenje vseeno potrebno, je treba zagotoviti opremo za oživljanje, ki mora biti takoj na voljo (glejte poglavje 4.4).
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
Vaš zdravnik ali medicinska sestra vas bosta cepila v skladu z uradnimi priporočili.
Very Rare (<1/10,000) 
Zelo redki (<1/10.000)
A protective immune response may not be induced in all individuals receiving the vaccine (see section 5.1). 
Zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5.1).
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01 
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB01
It is intended to be given before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. 
Namenjeno je uporabi pred naslednjo pandemijo gripe, da preprečimo gripo, ki jo povzroča virus vrste H5N1.
Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy. 
Te reakcije so se pojavile pri bolnikih z več alergijami v anamnezi in bolnikih brez znane alergije.
What you need to know before you receive VEPACEL 
Kaj morate vedeti, preden boste prejeli cepivo VEPACEL
18 - 59 years 
18-59 let
The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more severe. 
Simptomi pandemske gripe so podobni znakom ”navadne” gripe, vendar so običajno hujši.
• Adults, older people, and special risk groups 
• Odrasli, starostniki in skupine s posebnimi tveganji
In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update. 
Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije in začetku uporabe prepandemičnega cepiva pogosteje predajati redna posodobljena poročila o varnosti zdravila v obliki in s pogostnostjo, kot je opisano v "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008) in vseh nadaljnjih dopolnitvah.
What VEPACEL looks like and contents of the pack 
Kaj VEPACEL izgleda in vsebina pakiranja
Date of latest renewal: 04/01/2017 
Datum prve odobritve: 17/02/2012 Datum zadnjega podaljšanja: 04/01/2017
Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses. 
Pandemska in predpandemska cepiva vsebujejo antigene virusa gripe, ki se razlikujejo od antigenov v trenutno prisotnih virusih gripe.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. 
V cepljeni osebi bo imunski sistem (naravni obrambni sistem telesa) proizvedel lastno zaščito (protitelesa) proti bolezni.
Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% Seroconversion factor*** 
Odstotek seronevtralizacije* 52,6 % 85,4 % 17,1 % 72,9 % 3,0 % 68,8 % Odstotek serokonverzije** 9,1 % 31,8 % 16,4 % 72,2 % 9,1 % 65,6 %
If you take any medicines that reduce immunity to infections or have any other type of treatment that affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to the vaccine may be poor. 
Če jemljete zdravila, ki zmanjšajo imunost na okužbe, ali prejemate drugo vrsto terapije, ki vpliva na imunski sistem (kot je radioterapija), boste še vedno lahko cepljeni s cepivom VEPACEL, vendar bo lahko vaš odziv na cepivo oslabljen.
Healthcare providers should carefully consider the potential risks and benefits for each specific patient before prescribing VEPACEL. 
Zdravniki naj skrbno pretehtajo morebitna tveganja in koristi zdravljenja za vsakega bolnika, preden mu predpišejo cepivo VEPACEL.
• Infants, children, and adolescents 
• Dojenčki, otroci in mladostniki
As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated. 
Kot vsa cepiva tudi cepivo VEPACEL morda ne zaščiti vseh cepljenih oseb popolnoma.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed. 
V vseh navedenih primerih, SE POSVETUJTE S SVOJIM ZDRAVNIKOM ALI Z MEDICINSKO SESTRO, saj cepljenje morda ni priporočljivo ali pa ga je treba preložiti.
The use of VEPACEL during pregnancy and lactation may be considered in a pre-pandemic situation, taking into account official recommendations. 
Možnost uporabe cepiva VEPACEL med nosečnostjo in dojenjem se lahko pretehta v predpandemski situaciji ob upoštevanju uradnih priporočil.
9 - 17 years 
9-17 let
No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of age. 
Podatkov o varnosti in učinkovitosti VEPACEL pri otrocih, mlajših od 6 mesecev starosti.
• severe stabbing or throbbing pain along one or more nerves 
• huda bolečina v obliki zbadanja ali utripanje vzdolž enega ali več živcev,
The most frequently occurring side effect was injection- site pain, which was usually mild. 
Najpogostejši neželeni učinek je bila bolečina na mestu injiciranja, ki je bila po navadi blaga.
Trivalent seasonal influenza vaccines 
Trivalentna sezonska cepiva proti gripi
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time. 
ki je določena v 24. členu Uredbe (ES) št. 726/2004, ne bo zadostovala za spremljanje varnosti pandemičnega cepiva, za katerega se v kratkem časovnem obdobju pričakuje visoka stopnja izpostavljenosti.
However, in a pandemic situation, it may be appropriate for you to have the vaccine, provided that appropriate medical treatment is immediately available in case of an allergic reaction. 
V pandemskih razmerah je cepljenje morda vseeno upravičeno, vendar ob zagotovitvi ustrezne medicinske opreme, ki mora biti takoj na voljo za primer alergijske reakcije.
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 bleeding. 
Zato mora zdravnik oceniti koristi in morebitna tveganja cepljenja oseb s trombocitopenijo ali motnjami strjevanja krvi, ki bi povzročile kontraindikacije za intramuskularno injiciranje, razen če morebitni koristni učinki odtehtajo tveganje za krvavitve.
Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines. 
Podatki, pridobljeni z uporabo cepiv proti H5N1, bodo uporabljeni pri oblikovanju strategije cepljenja, ki bo najverjetneje uporabljena za cepivo proti pandemski gripi: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni s cepivi proti H5N1, veljajo tudi za pandemska in predpandemska cepiva.
Tell the doctor requesting the test that you have recently received VEPACEL. 
Povejte zdravniku, ki je naročil preiskavo, da ste bili pred kratkim cepljeni s cepivom VEPACEL.
The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials. 
Varnost cepiva VEPACEL med nosečnostjo in dojenjem ni bila ovrednotena v kliničnih preskušanjih.
Allergic reactions, in rare cases leading to shock, have been reported. 
Poročali so o pojavu alergijskih reakcij, ki so v redkih primerih vodile do šoka.
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or if you have recently received any other vaccine. 
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom.
In case of any particles and/or abnormal appearance, the vaccine should be discarded. 
Če opazite delce in/ali neobičajen izgled, cepivo zavrzite.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive VEPACEL. 
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, ali ste lahko cepljeni s cepivom VEPACEL.
The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people. 
Varnostni profil pri preiskovancih, ki so imunsko kompromitirani in pri bolnikih s kroničnimi bolezenskimi stanji, je podoben kot pri zdravih odraslih in starejših preiskovancih.
The adverse reactions observed are shown in the table below. 
Ugotovljeni neželeni učinki so prikazani v spodnji preglednici.
What VEPACEL is and what it is used for 
Kaj je cepivo VEPACEL in za kaj ga uporabljamo
Side effects observed with flu vaccines given routinely every year In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side effects listed below have occurred. 
Neželeni učinki, ugotovljeni pri cepivih proti gripi, ki se rutinsko uporabljajo vsako leto Neželeni učinki, ki so se pojavili v dneh ali tednih po vsakoletnem rutinskem cepljenju proti gripi, so navedeni v spodnjem seznamu.
This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1). 
Ta indikacija temelji na podlagi podatkov o imunogenosti, pridobljenih pri osebah, starih 6 mesecev ali starejših po uporabi dveh odmerkov cepiva, pripravljenega s sevi podtipa H5N1 (glejte poglavje 5.1).
• allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock 
• alergijske reakcije, vključno z anafilaktičnimi reakcijami, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko vodi do šoka, če ne ukrepamo,
See section 6.6 for administration instructions. 
Glejte poglavje 6.6 uprave.
Immunisation shall be postponed in patients with severe febrile illness or acute infection. 
Cepljenje je treba odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali akutno okužbo.
In the clinical studies conducted in adults and older people most side effects were mild in nature and short term. 
V kliničnih študijah pri odraslih in starostnikih je bila večina neželenih učinkov blagih in kratkotrajnih.
Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) 
Imunogenost pri preiskovancih, ki so imunsko kompromitirani (N=122) ali bolnikih s kroničnimi bolezenskimi stanji (N=123)
A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with VEPACEL. 
Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika glede cepljenja s cepivom
VEPACEL is a vaccine for use in individuals aged 6 months and older. 
VEPACEL je cepivo, ki se uporablja za osebe od 6. meseca starosti naprej.
This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell protein, which are used during the manufacturing process. 
To cepivo lahko vsebuje sledi formaldehida, benzonaze, saharoze, tripsina in beljakovin gostiteljskih celic Vero, ki se uporabljajo pri izdelavi, zato lahko pride do preobčutljivostne reakcije.
Other medicines and VEPACEL 
Druga zdravila in cepivo VEPACEL
• reduced blood pressure, feeling faint (syncope) 
• nižji krvni tlak, izguba zavesti (sinkopa),
The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals. 
Cepivo A/Vietnam/1203/2004 je zagotovilo zaščito pred homolognim virusom, kar je pokazalo 100-odstotno preživetje živali, manjša izguba teže, manjši in krajši dvig telesne temperature, nižja stopnja zmanjšanja števila limfocitov ter zmanjšanje vnetja in nekroze možganov in olfaktornega bulbusa pri skupini cepljenih živali v primerjavi s kontrolnimi živalmi.
The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older people. 
Pojavnost in narava simptomov po prvem in drugem odmerku cepiva sta bili podobni kot pri zdravih odraslih in starejših osebah.
This section describes the clinical experience with the H5N1 vaccine. 
V tem poglavju so opisane klinične izkušnje pri cepljenju s cepivom proti H5N1.
- if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet - section 6) or to any substances that may be present in trace (very low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein. 
- če ste v preteklosti imeli hudo alergijsko reakcijo na katero koli sestavino cepiva VEPACEL (navedene v poglavju 6 na koncu navodila za uporabo) ali katero koli snov, ki je morda prisotna v sledeh (zelo majhnih količinah): formaldehid, benzonaza, saharoza, tripsin, beljakovine gostiteljskih celic Vero.
Adverse Reactions (adults and older people) 
Neželeni učinki (odrasli in starostniki)
Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3). 
Študije cepiv s sevom H5N1 (A/Vietnam/1203/2004 in A/Indonesia/05/2005) na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost, brejost, razvoj zarodka/plodu, kotitev ali postnatalni razvoj (glejte poglavje 5.3).
The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret challenge model. 
Učinkovitost cepiva VEPACEL pri zaščiti pred obolevnostjo in smrtnostjo zaradi okužbe s smrtonosnimi odmerki izredno patogenega virusa ptičje gripe H5N1 je bila ocenjena neklinično na dihurju.
Active immunisation against H5N1 subtype of influenza A virus. 
Aktivna imunizacija proti podtipu H5N1 virusa gripe A.
• low blood platelet count which can result in bleeding or bruising 
• nizka raven trombocitov, ki lahko vodi v krvavitev ali podplutbo.
• vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems) 
• vaskulitis (vnetje žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in ledvične težave),
If necessary, VEPACEL may be given at the same time as normal or specific immunoglobulin into separate limbs. 
Če je potrebno, se lahko cepivo VEPACEL uporabi sočasno s polispecifičnim ali specifičnim imunoglobulinom v različni okončini.
The side effects are generally similar to those related to the flu vaccine. 
Neželeni učinki so po navadi podobni učinkom, ki jih povzroči cepivo proti gripi.
• sudden hearing loss 
• nenadna izguba sluha.
If you are not sure, talk to your doctor or nurse before having this vaccine. 
Če ste negotovi, se pred cepljenjem posvetujte z zdravnikom ali z medicinsko sestro.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/ 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass. 
Cepivo se injicira v mišico nadlakti (deltoidno mišico) ali zgornji predel stegna, odvisno od mišične mase.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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. 
Heterologno poživitveno cepivo so po 12 do 24 mesecih v študiji 3. faze dali tudi osebam, ki so bile imunsko kompromitirane ali pri bolnikih s kroničnimi bolezenskimi stanji.
The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines: 
O naslednjih resnih neželenih učinkih so poročali med spremljanjem interpandemskih trivalentnih cepiv, razmnoženih v jajcih po pridobitvi dovoljenja za promet:
In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule. 
Poleg tega je bila imunogenost ocenjena v študiji 3. faze v skupinah s specifičnim tveganjem, in sicer pri osebah, ki so imunsko kompromitirane (N=122), in bolnikih s kroničnimi bolezenskimi stanji (N=123) po shemi cepljenja 0. in 21. dan.
Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency to provide immediate protection. 
Skupaj s cepivom VEPACEL se ne dajejo imunoglobulini, razen v nujnem primeru za zagotavljanje takojšnje zaščite.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
Pri bolnikih z endogeno ali jatrogeno zmanjšanim imunskim odzivom je protitelesni odziv lahko nezadosten.
The vaccine should never be given into a vein. 
Cepivo se ne sme nikoli dati v žilo.
However, if this cannot be avoided, the other vaccine should not be injected into the same arm used for VEPACEL. 
Če se sočasnemu cepljenju ni mogoče izogniti, drugega cepiva ne smete injicirati v roko, v katero je bilo dano cepivo VEPACEL.
After shaking, the vaccine is a clear to opalescent suspension. 
Ko cepivo pretresete, postane bistra do opalescentna suspenzija.
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection 
FARMACEVTSKA OBLIKA IN VSEBINA Suspenzija za injiciranje
The vaccine is available in a single dose pre-filled syringe. 
Cepivo je na voljo v enoodmerni napolnjeni injekcijski brizgi.
Adults and children from 6 months onwards: 
Odmerjanje Odrasle osebe in otroci, stari 6 mesecev:
Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass. 
Cepivo je treba injicirati intramuskularno, v deltoidno mišico ali anterolateralni predel stegna, odvisno od mišične mase.
Side effects observed with a similar influenza vaccine (Celvapan) The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme: 
Neželeni učinki, ugotovljeni pri podobnem cepivu proti gripi (Celvapan) Neželeni učinki, navedeni v nadaljevanju, so se pojavili pri podobnem cepivu proti gripi (Celvapan) pri odraslih in otrocih v programu cepljenja proti pandemski gripi H1N1:
Adverse Reactions (infants, children and adolescents) 
Neželeni učinki (dojenčki, otroci in mladostniki)
ACTIVE SUBSTANCE A/Vietnam/1203/2004 (H5N1) 
A/Vietnam/1203/2004 (H5N1)
Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1) 
Dojenčki, otroci in mladostniki Odziv imunskega sistema na sev A/Vietnam/1203/2004 (H5N1)
Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion. 
Dihurji, cepljeni z odmerkom 7,5 µg cepiva A/Vietnam/1203/2004, so pokazali visoko stopnjo serokonverzije.
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. 
Dojenčki in otroci, stari od 6 do 35 mesecev: V kliničnem preskušanju je cepivo proti H5N1 prejelo 36 dojenčkov in otrok, starih od 6 do 35 mesecev.
Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity. 
Študije vpliva na sposobnost razmnoževanja in razvoj pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/plodu, kotitev ali postnatalni razvoj.
1 dose (0.5 ml) contains: 
1 odmerek (0,5 ml) vsebuje:
Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, 
Po cepljenju proti gripi je prišlo do lažno pozitivnih rezultatov seroloških testov, ki so bili izvedeni po metodi ELISA za odkrivanje protiteles proti človeškemu virusu imunske pomanjkljivosti 1 (HIV-1),
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Baxter AG
- if you have a bleeding problem or bruise easily. 
- če imate težave s krvavitvami oz. strjevanjem krvi ali vam že pri rahlem udarcu nastanejo modrice.
One dose of 0.5 ml at an elected date. 
En odmerek 0,5 ml naj bo injiciran na izbran datum.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEPACEL suspension for injection 
IME ZDRAVILA IN POT(I) UPORABE VEPACEL suspenzija za injiciranje
- if you have a weakened immune system as for example because of immunosuppressive therapy, e.g. taking of corticosteroids or treatment for cancer. 
- če imate oslabljen imunski sistem, na primer zaradi imunosupresivnega zdravljenja z zdravili,
• injection-site reaction such as irritation, itching, bruising or stiff arm 
• reakcija na mestu injiciranja, kot so draženje, srbenje, podplutba ali otrdelost roke.
21 Days after 2nd Dose 
21 dni po drugem odmerku 21 dni po drugem odmerku
Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase 
Odstotek seronevtralizacije* Odstotek serokonverzije** Faktor serokonverzije*** * titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
* produced in Vero cells ** haemagglutinin 
* pripravljen v celicah Vero **hemaglutinina
Immune system disorders: anaphylactic reaction, hypersensitivity Nervous system disorders: febrile convulsion Skin and subcutaneous tissue disorders: angioedema Muscoluskeletal and connective tissue disorders: pain in extremity 
Bolezni imunskega sistema: anafilaktična reakcija, preobčutljivost Bolezni živčevja: febrilne konvulzije Bolezni kože in podkožja: angioedem
60 years and above Strain A/Indonesia/05/2005 21 Days after 2nd Dose 
60 let in več Sev A/Indonesia/05/2005
VEPACEL should not be given at the same time as immunoglobulins. 
Cepiva VEPACEL ne uporabljajte hkrati z imunoglobulini.
After first opening, the vaccine should be used immediately (within 3 hours maximum). 
Po prvem odprtju cepivo uporabite nemudoma (v največ 3 urah).
• stomach pain, upset stomach 
• bolečine v trebuhu, prebavne motnje,