natgillin/translations-raw huggingface dataset:
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity. 
Podatki od nosečnic, cepljenih z različnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, pa niso pokazali malformacij ali toksičnosti cepiva za plod ali novorojenčka.
The vaccine is a clear to opalescent, translucent suspension. 
Cepivo je bistra do opalescentna, prosojna suspenzija.
One dose of 0.5 ml at an elected date. 
En odmerek 0,5 ml na izbran datum.
A dose (0.5 ml) of the vaccine will be given. 
Prejeli boste en odmerek (0,5 ml) cepiva.
2nd Dose 
2. odmerku
There are no safety, immunogenicity or efficacy data to support interchangeability of Celvapan with other (H1N1)v vaccines. 
Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Celvapan z drugimi cepivi proti (H1N1)v.
• Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest 
• Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
Side effects from clinical studies in adults and older people 
Neželeni učinki iz kliničnih študij pri odraslih in starostnikih
Animal reproductive toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity. 
Študije toksičnosti za razmnoževanje na živalih ne kažejo škodljivih učinkov glede plodnosti samic, razvoja zarodka in ploda ter predporodne in poporodne toksičnosti.
Uferstrasse 15 
Baxter AG Uferstrasse 15
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh, depending on the muscle mass. 
Cepivo je treba injicirati intramuskularno, najbolje v deltoidno mišico oziroma v anterolateralni del stegna, odvisno od mišične mase osebe.
Preferred MedDRA Term 
Prednostni izraz MedDRA
• The MAH shall agree with Member States on the provision of a targeted communication to health care professionals which should address the following: 
• Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljnega obveščanja za zdravnike, ki mora obravnavati naslednje:
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
A minor infection such as a cold should not be problem, but your doctor or nurse should advise whether you could still be vaccinated with Celvapan. 
Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika ali medicinske sestre glede cepljenja s cepivom Celvapan;
12 to 35 months 
od 12 do 35 mesecev
The dose recommendations take into account available data from clinical studies in healthy subjects who received two doses of Celvapan (H1N1)v. 
Priporočila za odmerjanje upoštevajo dostopne podatke potekajočih kliničnih študij pri zdravih preiskovancih, ki so dobili dva odmerka cepiva Celvapan (H1N1)v.
In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy adults and older people, subjects with a weakened immune system and patients with long-term conditions, the safety profile was similar to that in healthy adults. 
V študiji s podobnim cepivom proti gripi (ki je vsebovalo cepilni sev H5N1), v katero so bili vključeni zdravi odrasli in starostniki, preiskovanci z oslabljenim imunskim sistemom in bolniki z dolgotrajnimi boleznimi, je bil varnostni profil podoben kot pri zdravih odraslih.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
Frequency1 
Pogostnost1
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome. 
Nevrološke motnje, kot so encefalomielitis, nevritis in Guillain-Barréjev sindrom.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA
• Side effects observed during post-marketing surveillance 
• Neželeni učinki, opaženi v obdobju trženja cepiva
The following adverse reactions were reported at a higher frequency category than in 
Naslednji neželeni učinki so bili opaženi z večjo pogostnostjo kot v
• The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Celvapan. 
• Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravstvenim delavcem omogočili stalen dostop do posodobljenih
After first opening the vial is to be used within a maximum of 3 hours. 
Po prvem odprtju uporabite vialo v največ 3 urah.
• you have a bleeding condition or a bleeding problem or you bruise easily. 
• če imate težave s krvavitvami ali zlahka dobite podplutbe.
Ask your pharmacist what to do with medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Whole virion influenza vaccine, inactivated, containing antigen of strain*: 7.5 micrograms** 
Cepivo proti gripi s celimi inaktiviranimi virusi, ki vsebuje antigen seva*: 7,5 mikrograma**
4.7 Effects on ability to drive and use machines Some undesirable effects mentioned under section 4.8 “Undesirable effects” may affect the ability to 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Na sposobnost vožnje in upravljanja s stroji lahko vplivajo določeni neželeni učinki, ki so navedeni
Crude vaccine effectiveness of one dose of pandemic vaccine among children was 100% (95% 
Neobdelana učinkovitost cepiva z enim odmerkom pandemskega cepiva pri otrocih je bila 100 % (95-odstotni interval zaupanja: 70-100 %).
Pandemic vaccine effectiveness against the medically-attended influenza like illness (ILI) with laboratory-confirmation as A(H1N1)v, was assessed for the vaccination campaign in Jersey 2009/2010 in a case control study (test-negative design). 
Učinkovitosti pandemskega cepiva proti gripi podobni bolezni z medicinsko oskrbo in laboratorijsko potrditvijo A(H1N1)v so ugotavljali med cepilno kampanjo 2009/2010 v Jerseyu v obliki študije primerov in kontrol (negativna testna zasnova).
There were no reported vaccine failures in either of these paediatric age groups. 
V nobeni pediatrični starostni skupini niso ugotovili neuspešnih cepljenj.
The safety profile in healthy subjects > 60 years of age, in immune-compromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects. 
Varnostni profil pri zdravih osebah, starejših od 60 let, imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi je bil podoben kot pri zdravih osebah.
* MN titre ≥ 1:40 ** > 4-fold increase in MN titre *** geometric mean increase 
* titer MN ≥1:40 ** >4-kratno povečanje titra MN *** geometrična sredina povečanja
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
From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the following serious adverse reactions have been reported: 
Med spremljanjem trivalentnih cepiv proti sezonski gripi izdelanih na jajcih po pridobitvi dovoljenja za promet so poročali o naslednjih resnih neželenih učinkih:
The vaccine may be used during breast-feeding. 
Cepivo Celvapan lahko dobite med dojenjem.
Younger children 6 months to 9 years received Celvapan, while older children from 9 to 18 years of age received an adjuvanted split pandemic vaccine. 
Manjši otroci, stari od 6 mesecev do 9 let, so prejeli cepivo Celvapan, večji otroci, stari od 9 do 18 let, so prejeli pandemsko cepivo z razcepljenim virionom in adjuvansom.
• Safety and immunogenicity data in special risk groups (immunocompromised and 
• Podatki o varnosti in imunogenosti pri skupinah s posebnim tveganjem (imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi).
It is recommended that subjects who receive a first dose of Celvapan, complete the vaccination course with Celvapan (see section 4.4). 
Priporočljivo je, da osebe, ki prejmejo prvi odmerek cepiva Celvapan, cepljenje tudi zaključijo s cepivom Celvapan (glejte poglavje 4.4).
• Clinical trials with a version of Celvapan containing a H5N1 vaccine strain 
• Klinična preskušanja z različico cepiva Celvapan, ki vsebuje sev cepiva proti H5N1
“Possible side effects” may affect your ability to drive or use 
Nekateri učinki, ki so navedeni v poglavju 4 »Možni neželeni učinki«, lahko vplivajo na vašo sposobnost vožnje in upravljanja s stroji.
When Celvapan is given for the first dose, it is recommended that Celvapan (and not another vaccine against (H1N1)v) be given for the complete vaccination course. 
Če je za prvi odmerek uporabljeno cepivo Celvapan, je priporočljivo, da se cepljenje tudi dokonča s cepivom Celvapan (in ne z drugim cepivom proti (H1N1)v).
In such cases, you should be aware that the side effects may be more intense. 
V takih primerih se morate zavedati, da so neželeni učinki
If any of these side effects occur, please tell your doctor or nurse immediately. 
Če se pojavi katerikoli od teh neželenih učinkov, nemudoma obvestite svojega zdravnika ali medicinsko sestro.
• generalized skin reactions including urticaria (hives) 
• splošne kožne reakcije, kot je urtikarija (koprivnica);
*Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, cyanosis, pyrexia, flushing, angioedema, and urticaria Musculoskeletal and connective tissue disorders: 
*Takšne reakcije se lahko kažejo z dihalno stisko, hipotenzijo, tahikardijo, tahipnejo, cianozo, zvišano telesno temperature, vročinskimi oblivi, angioedemom in urtikarijo.
Following a 12-month booster vaccination with a licensed trivalent virosomal influenza vaccine for the 2010/2011 Northern hemisphere influenza season, seroprotection rates, seroconversion rates and serconversion factors (compared to pre-booster antibody levels) for the H1N1 component as measured by SRH and MN assays were as follows: 
Po cepljenju z 12-mesečnim poživitvenim odmerkom s trivalentnim cepivom proti gripi z dovoljenjem za promet za sezono gripe na severni polobli v l. 2010/2011 so bili odstotki serozaščite, serokonverzije in faktorji serokonverzije (v primerjavi z ravnmi protiteles pred poživitvenim odmerkom) za komponento H1N1, izmerjeni s testoma SRH in MN, naslednji:
• vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney 
• vaskulitis (vnetje krvnih žil, ki lahko povzroči kožni izpuščaj, sklepne bolečine in težave z ledvicami),
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling 
Med znake alergijske reakcije sodijo srbeč kožni izpuščaj, težko dihanje in otekanje
Celvapan (H1N1)v to healthy children aged 6 months to 17 years. 
Celvapan (H1N1)v zdravim otrokom, starim od 6 mesecev do 17 let.
Neuralgia, paraesthesia, transient thrombocytopenia. 
Nevralgija, parestezije, prehodna trombocitopenija
20 multidose vials (10 doses per vial - 0.5 ml per dose) 
20 večodmernih vial (10 odmerkov na vialo - 0,5 ml na odmerek)
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection. 
Vsak odmerek cepiva po 0,5 ml potegnite v brizgo za injiciranje.
All subjects 
Vsi preiskovanci
From clinical studies limited immunogenicity and safety data are available for Celvapan (H1N1)v in healthy adult and older subjects and in children (see section 4.4, 4.8, and 5.1). 
Iz kliničnih študij je bilo pridobljeno malo podatkov o imunogenosti in varnosti cepiva Celvapan (H1N1)v pri odraslih, starostnikih in otrocih (glejte poglavja 4.4, 4.8. in 5.1).
Celvapan should under no circumstances be administered intravascularly. 
Cepiva Celvapan ne smete v nobenem primeru injicirati v žilo.
There were fewer reactions after the second dose of the vaccine compared with the first dose. 
Po drugem odmerku cepiva je bilo manj neželenih učinkov kot po prvem.
What Celvapan looks like and contents of the pack Celvapan is a clear to opalescent, translucent liquid. 
Izgled cepiva Celvapan in vsebina pakiranja Cepivo Celvapan je bistra do opalescentna in prosojna tekočina.
If you are not sure, talk to your doctor or nurse before having this vaccine. 
Če ste negotovi, se pred cepljenjem posvetujte s svojim zdravnikom ali medicinsko sestro.
Pandemic Observational Study with Celvapan (H1N1)v 
Pandemska opazovalna študija s cepivom Celvapan (H1N1)v
Celvapan (H1N1)v to healthy adults aged 18 years and older. 
Celvapan (H1N1)v zdravim odraslim osebam, starim vsaj 18 let.
Adults aged 18 years and older 
Odrasli, stari vsaj 18 let
Alterations in calcium metabolism have not been examined in human clinical studies. 
Spremembe presnove kalcija niso bile raziskane v kliničnih študijah pri
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, restlessness, irritability, crying and drowsiness were common. 
Pri otrocih, starih od 6 do 35 mesecev, so zelo pogosto poročali o motnjah spanja in zvišani telesni temperaturi, pogosto pa o izgubi apetita, nemirnosti, razdražljivosti, jokanju in zaspanosti.
The vaccine should never be 
Cepiva nikoli ne smete dobiti v veno.
After first opening, the product should be used immediately. 
Zdravilo uporabite nemudoma po prvem odprtju.
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. 
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden se cepite s cepivom Celvapan.
A second dose of the vaccine should be given after an interval of at least three weeks. 
Drugi odmerek cepiva je treba dati po časovnem razmiku najmanj treh tednov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Cepivo proti gripi z inaktiviranimi virusi, ki vsebuje antigen seva*:
One pack of Celvapan contains 20 multidose vials of 5 ml suspension for injection for 10 doses. 
Eno pakiranje cepiva Celvapan vsebuje 20 večodmernih vial po 5 ml suspenzije, za
The use of Celvapan may be considered during pregnancy if this is thought to be necessary, taking into 
Če menite, da je potrebno, lahko cepivo Celvapan uporabljate tudi v času nosečnosti, ob upoštevanju
Hypersensitivity reactions, including anaphylaxis, have been reported following CELVAPAN vaccination (see section 4.8). 
Pri uporabi cepiva Celvapan so se pojavile preobčutljivostne reakcije, vključno z anafilakso (glejte poglavje 4.8).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT večodmerna viala (10 odmerkov po 0,5 ml)
Very common: Injection site pain, injection site redness, muscle pain 
Zelo pogosti: bolečine na mestu injiciranja, pordelost na mestu injiciranja, bolečine v mišicah
Other sources of information 
Dodatne informacije);
Very common: Pain and redness where the injection was given, aching muscles Uncommon: Influenza like illness 
Zelo pogosti: bolečine in pordelost na mestu injiciranja, bolečine v mišicah Občasni: gripi podobna bolezen
There is no information on administration of the vaccine Celvapan with other vaccines. 
Ni podatkov o uporabi cepiva Celvapan z drugimi cepivi.
OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Cepiva ne smete injicirati v žilo.
Specifically, headache, vertigo (spinning feeling), cough, feeling sick, vomiting, diarrhoea, pain in the arms or legs and tiredness were observed commonly in children and adolescents. 
Glavobol, vrtoglavica, kašelj, slabo počutje, bruhanje, driska, bolečine v rokah ali nogah in utrujenost so bili pri otrocih in mladostnikih
• Post-marketing surveillance 
• Spremljanje po pridobitvi dovoljenja za promet
Safety data after the first and second vaccination suggest a similar safety profile to that reported for the influenza vaccines 
Podatki o varnosti po prvem in drugem cepljenju kažejo podoben varnostni profil kot pri cepivih proti gripi s sevom H5N1.
Additionally, in the case of the 9 to 17 year olds pain at the injection site was very common. 
Poleg tega so bile bolečine na mestu injiciranja pri otrocih in mladostnikih, starih od 9 do 17 let, zelo
SRH Assay 
Test SRH
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. 
Če bolnik prejema imunosupresivno zdravljenje, je imunski odziv lahko manjši.
Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy. 
Takšne reakcije so je pojavile tako pri osebah z več alergijami v anamnezi, kot tudi pri
Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects and patients with chronic disease conditions. 
Klinična preskušanja z različico cepiva Celvapan, ki vsebuje sev cepiva proti H5N1 (glejte poglavje 5.1) so opravili pri približno 3700 osebah (v starosti med 18. in 60. letom in več) ter pri skupinah s posebnim tveganjem s po približno 300 preiskovanci, in sicer pri imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi.
This is a multidose container. 
V enem pakiranju je več odmerkov.
Clinical Adverse Reactions (H1N1)v Studies System Organ Class (SOC) 
Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih cepiva (H1N1)v Organski sistem (SOC)
MN 
Test MN
The vaccine should be allowed to reach room temperature before use. 
Pred cepljenjem počakajte, da cepivo doseže sobno temperaturo.
An updated RMP should be submitted: • At the request of the European Medicines Agency; 
Posodobljen RMP je treba predložiti:
Clinical studies in which a version of Celvapan containing HA derived from A/Vietnam/1203/2004 (H5N1) was administered at day 0 and at day 21 provide: 
Klinične študije, v katerih so na dan 0 in dan 21 uporabili različico cepiva Celvapan s HA iz seva A/Vietnam/1203/2004 (H5N1), dajejo naslednje informacije:
However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. 
Če pa menite, da je hkratno cepljenje z drugimi cepivi potrebno, je treba cepiva injicirati v različni okončini.
(A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/foetal development, parturition or post-natal 
Študije vpliva na sposobnost razmnoževanja in razvoja pri živalih z uporabo cepiv s sevom H5N1 (A/Vietnam/1203/2004 in A/Indonesia/05/2005) niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/ploda, kotitev ali postnatalni razvoj
The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people. 
Spodaj navedeni neželeni učinki so se pojavljali pri uporabi cepiva Celvapan (H1N1)v v kliničnih študijah pri odraslih, vključno s starostniki.
The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v. 
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, poročani pri odraslih in starejših osebah so bili primerljivi s cepivom Celvapam (H1N1)v.
• severe stabbing or throbbing pain along one or more nerves • low blood platelet count which can result in bleeding or bruising 
• huda zbadajoča ali pulzirajoča bolečina vzdolž enega ali več živcev,
Vasculitis with transient renal involvement. 
Vaskulitis s prehodno prizadetostjo ledvic.
Clinical studies with Celvapan (H1N1)v currently provide: 
Klinične študije s cepivom Celvapan (H1N1)v trenutno dajejo naslednje informacije:
METABOLISM AND NUTRITION DISORDERS 
PRESNOVNE IN PREHRANSKE MOTNJE
Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v Results from a clinical study done on marketed vaccine confirmed the safety profile as observed in the clinical studies. 
Rezultati klinične študije, opravljene s cepivom, ki je bilo na trgu, so potrdili varnostni profil, ugotovljen v kliničnih študijah.
• if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan or to any of the substances that may be present in trace amounts as follows: formaldehyde, 
• če ste v preteklosti imeli nenadno, življenjsko ogrožujočo alergijsko reakcijo na katerokoli sestavino cepiva Celvapan ali katerokoli od naslednjih snovi, ki so lahko prisotne v sledeh v cepivu: formaldehid, Benzonaza, saharoza.
Children and adolescents aged 5 to 17 years: 
Otroci in mladostniki od 5 do 17 let:
Possible side effects Like all medicines, Celvapan can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi cepivo Celvapan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
1st Dose 
1. odmerku
Children aged 6 to 35 months 
Otroci, stari od 6 do 35 mesecev
Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm) 
Vaš zdravnik ve, da do tega lahko pride, in bolečine v rokah in/ali nogah (v večini primerov so poročali o bolečinah v roki, v katero je
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• 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 
• nevrološke motnje, kot je encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev)
The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older (N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children aged 6 to 35 months (N = 68) following a 0, 21 day schedule. 
Imunogenost cepiva, ki vsebuje 7,5 μg HA iz seva A/California/07/2009 (H1N1)v brez adjuvansa, so ovrednotili v kliničnih preskušanjih pri odraslih osebah, starih vsaj 18 let (N=200), pri otrocih in mladostnikih, starih od 3 do 17 let (N=102) ter pri dojenčkih in majhnih otrocih, starih od 6 do 35 mesecev (N=68), z režimom na dan 0 in 21.
Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 
cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
SPECIAL STORAGE CONDITIONS Store in refrigerator. 
POSEBNA NAVODILA ZA SHRANJEVANJE
CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated) 
CELVAPAN suspenzija za injiciranje cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
Infants and children aged 6-35 months 
Dojenčki in otroci, stari od 6 do 35 mesecev
Non-Clinical data obtained with Celvapan containing a H5N1 vaccine strain demonstrated alterations in liver enzymes and calcium levels in repeat dose toxicity studies in rats. 
V študiji toksičnosti večkratnih odmerkov, ki je bila izvedena na podganah, so predklinični podatki, dobljeni s cepivom Celvapan, ki vsebuje sev cepiva proti H5N1, pokazali spremembe v vrednostih jetrnih encimov in koncentraciji kalcija.
There are no data on co-administration of Celvapan with other vaccines. 
Podatkov o sočasni uporabi cepiva Celvapan z drugimi cepivi ni.
Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below. 
Neželeni učinki, ki so jih ugotovili v pediatričnih kliničnih preskušanjih cepiva CELVAPAN (H1N1)v, so navedeni v spodnji preglednici.