FrancophonIA/ELRC3.0 huggingface dataset:
English: From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the following serious adverse reactions have been reported:
Slovenian: Med spremljanjem trivalentnih cepiv proti sezonski gripi izdelanih na jajcih po pridobitvi dovoljenja za promet so poročali o naslednjih resnih neželenih učinkih:
English: The vaccine may be used during breast-feeding.
Slovenian: Cepivo Celvapan lahko dobite med dojenjem.
English: 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.
Slovenian: 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.
English: • Safety and immunogenicity data in special risk groups (immunocompromised and
Slovenian: • Podatki o varnosti in imunogenosti pri skupinah s posebnim tveganjem (imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi).
English: It is recommended that subjects who receive a first dose of Celvapan, complete the vaccination course with Celvapan (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki prejmejo prvi odmerek cepiva Celvapan, cepljenje tudi zaključijo s cepivom Celvapan (glejte poglavje 4.4).
English: • Clinical trials with a version of Celvapan containing a H5N1 vaccine strain
Slovenian: • Klinična preskušanja z različico cepiva Celvapan, ki vsebuje sev cepiva proti H5N1
English: “Possible side effects” may affect your ability to drive or use
Slovenian: Nekateri učinki, ki so navedeni v poglavju 4 »Možni neželeni učinki«, lahko vplivajo na vašo sposobnost vožnje in upravljanja s stroji.
English: 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.
Slovenian: 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).
English: In such cases, you should be aware that the side effects may be more intense.
Slovenian: V takih primerih se morate zavedati, da so neželeni učinki
English: If any of these side effects occur, please tell your doctor or nurse immediately.
Slovenian: Če se pojavi katerikoli od teh neželenih učinkov, nemudoma obvestite svojega zdravnika ali medicinsko sestro.
English: • generalized skin reactions including urticaria (hives)
Slovenian: • splošne kožne reakcije, kot je urtikarija (koprivnica);
English: *Such reactions have been manifested by respiratory distress, hypotension, tachycardia, tachypnea, cyanosis, pyrexia, flushing, angioedema, and urticaria Musculoskeletal and connective tissue disorders:
Slovenian: *Takšne reakcije se lahko kažejo z dihalno stisko, hipotenzijo, tahikardijo, tahipnejo, cianozo, zvišano telesno temperature, vročinskimi oblivi, angioedemom in urtikarijo.
English: 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:
Slovenian: 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:
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney
Slovenian: • vaskulitis (vnetje krvnih žil, ki lahko povzroči kožni izpuščaj, sklepne bolečine in težave z ledvicami),
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling
Slovenian: Med znake alergijske reakcije sodijo srbeč kožni izpuščaj, težko dihanje in otekanje
English: Celvapan (H1N1)v to healthy children aged 6 months to 17 years.
Slovenian: Celvapan (H1N1)v zdravim otrokom, starim od 6 mesecev do 17 let.
English: Neuralgia, paraesthesia, transient thrombocytopenia.
Slovenian: Nevralgija, parestezije, prehodna trombocitopenija
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Slovenian: 20 večodmernih vial (10 odmerkov na vialo - 0,5 ml na odmerek)
English: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Slovenian: Vsak odmerek cepiva po 0,5 ml potegnite v brizgo za injiciranje.
English: All subjects
Slovenian: Vsi preiskovanci
English: 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).
Slovenian: 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).
English: Celvapan should under no circumstances be administered intravascularly.
Slovenian: Cepiva Celvapan ne smete v nobenem primeru injicirati v žilo.
English: There were fewer reactions after the second dose of the vaccine compared with the first dose.
Slovenian: Po drugem odmerku cepiva je bilo manj neželenih učinkov kot po prvem.
English: What Celvapan looks like and contents of the pack Celvapan is a clear to opalescent, translucent liquid.
Slovenian: Izgled cepiva Celvapan in vsebina pakiranja Cepivo Celvapan je bistra do opalescentna in prosojna tekočina.
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Slovenian: Če ste negotovi, se pred cepljenjem posvetujte s svojim zdravnikom ali medicinsko sestro.
English: Pandemic Observational Study with Celvapan (H1N1)v
Slovenian: Pandemska opazovalna študija s cepivom Celvapan (H1N1)v
English: Celvapan (H1N1)v to healthy adults aged 18 years and older.
Slovenian: Celvapan (H1N1)v zdravim odraslim osebam, starim vsaj 18 let.
English: Adults aged 18 years and older
Slovenian: Odrasli, stari vsaj 18 let
English: Alterations in calcium metabolism have not been examined in human clinical studies.
Slovenian: Spremembe presnove kalcija niso bile raziskane v kliničnih študijah pri
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Slovenian: 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.
English: In children aged 6 to 35 months disturbed sleep and fever were very common, and decreased appetite, restlessness, irritability, crying and drowsiness were common.
Slovenian: 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.
English: The vaccine should never be
Slovenian: Cepiva nikoli ne smete dobiti v veno.
English: After first opening, the product should be used immediately.
Slovenian: Zdravilo uporabite nemudoma po prvem odprtju.
English: Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden se cepite s cepivom Celvapan.
English: A second dose of the vaccine should be given after an interval of at least three weeks.
Slovenian: Drugi odmerek cepiva je treba dati po časovnem razmiku najmanj treh tednov.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Cepivo proti gripi z inaktiviranimi virusi, ki vsebuje antigen seva*:
English: One pack of Celvapan contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
Slovenian: Eno pakiranje cepiva Celvapan vsebuje 20 večodmernih vial po 5 ml suspenzije, za
English: The use of Celvapan may be considered during pregnancy if this is thought to be necessary, taking into
Slovenian: Če menite, da je potrebno, lahko cepivo Celvapan uporabljate tudi v času nosečnosti, ob upoštevanju
English: Hypersensitivity reactions, including anaphylaxis, have been reported following CELVAPAN vaccination (see section 4.8).
Slovenian: Pri uporabi cepiva Celvapan so se pojavile preobčutljivostne reakcije, vključno z anafilakso (glejte poglavje 4.8).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT večodmerna viala (10 odmerkov po 0,5 ml)
English: Very common: Injection site pain, injection site redness, muscle pain
Slovenian: Zelo pogosti: bolečine na mestu injiciranja, pordelost na mestu injiciranja, bolečine v mišicah
English: Other sources of information
Slovenian: Dodatne informacije);
English: Very common: Pain and redness where the injection was given, aching muscles Uncommon: Influenza like illness
Slovenian: Zelo pogosti: bolečine in pordelost na mestu injiciranja, bolečine v mišicah Občasni: gripi podobna bolezen
English: There is no information on administration of the vaccine Celvapan with other vaccines.
Slovenian: Ni podatkov o uporabi cepiva Celvapan z drugimi cepivi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Cepiva ne smete injicirati v žilo.
English: 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.
Slovenian: Glavobol, vrtoglavica, kašelj, slabo počutje, bruhanje, driska, bolečine v rokah ali nogah in utrujenost so bili pri otrocih in mladostnikih
English: • Post-marketing surveillance
Slovenian: • Spremljanje po pridobitvi dovoljenja za promet
English: Safety data after the first and second vaccination suggest a similar safety profile to that reported for the influenza vaccines
Slovenian: Podatki o varnosti po prvem in drugem cepljenju kažejo podoben varnostni profil kot pri cepivih proti gripi s sevom H5N1.
English: Additionally, in the case of the 9 to 17 year olds pain at the injection site was very common.
Slovenian: Poleg tega so bile bolečine na mestu injiciranja pri otrocih in mladostnikih, starih od 9 do 17 let, zelo
English: SRH Assay
Slovenian: Test SRH
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Slovenian: Če bolnik prejema imunosupresivno zdravljenje, je imunski odziv lahko manjši.
English: Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Slovenian: Takšne reakcije so je pojavile tako pri osebah z več alergijami v anamnezi, kot tudi pri
English: 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.
Slovenian: 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.
English: This is a multidose container.
Slovenian: V enem pakiranju je več odmerkov.
English: Clinical Adverse Reactions (H1N1)v Studies System Organ Class (SOC)
Slovenian: Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih cepiva (H1N1)v Organski sistem (SOC)
English: MN
Slovenian: Test MN
English: The vaccine should be allowed to reach room temperature before use.
Slovenian: Pred cepljenjem počakajte, da cepivo doseže sobno temperaturo.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Slovenian: Posodobljen RMP je treba predložiti:
English: 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:
Slovenian: 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:
English: However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Slovenian: Če pa menite, da je hkratno cepljenje z drugimi cepivi potrebno, je treba cepiva injicirati v različni okončini.
English: (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
Slovenian: 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
English: The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people.
Slovenian: Spodaj navedeni neželeni učinki so se pojavljali pri uporabi cepiva Celvapan (H1N1)v v kliničnih študijah pri odraslih, vključno s starostniki.
English: The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v.
Slovenian: Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, poročani pri odraslih in starejših osebah so bili primerljivi s cepivom Celvapam (H1N1)v.
English: • severe stabbing or throbbing pain along one or more nerves • low blood platelet count which can result in bleeding or bruising
Slovenian: • huda zbadajoča ali pulzirajoča bolečina vzdolž enega ali več živcev,
English: Vasculitis with transient renal involvement.
Slovenian: Vaskulitis s prehodno prizadetostjo ledvic.
English: Clinical studies with Celvapan (H1N1)v currently provide:
Slovenian: Klinične študije s cepivom Celvapan (H1N1)v trenutno dajejo naslednje informacije:
English: METABOLISM AND NUTRITION DISORDERS
Slovenian: PRESNOVNE IN PREHRANSKE MOTNJE
English: 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.
Slovenian: Rezultati klinične študije, opravljene s cepivom, ki je bilo na trgu, so potrdili varnostni profil, ugotovljen v kliničnih študijah.
English: • 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,
Slovenian: • 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.
English: Children and adolescents aged 5 to 17 years:
Slovenian: Otroci in mladostniki od 5 do 17 let:
English: Possible side effects Like all medicines, Celvapan can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi cepivo Celvapan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 1st Dose
Slovenian: 1. odmerku
English: Children aged 6 to 35 months
Slovenian: Otroci, stari od 6 do 35 mesecev
English: Pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Slovenian: 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
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Slovenian: • nevrološke motnje, kot je encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev)
English: 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.
Slovenian: 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.
English: Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Slovenian: cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
English: SPECIAL STORAGE CONDITIONS Store in refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE
English: CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Slovenian: CELVAPAN suspenzija za injiciranje cepivo proti gripi (H1N1)v (s celimi inaktiviranimi virusi, pridobljenimi iz celic Vero)
English: Infants and children aged 6-35 months
Slovenian: Dojenčki in otroci, stari od 6 do 35 mesecev
English: 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.
Slovenian: 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.
English: There are no data on co-administration of Celvapan with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Celvapan z drugimi cepivi ni.
English: Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below.
Slovenian: Neželeni učinki, ki so jih ugotovili v pediatričnih kliničnih preskušanjih cepiva CELVAPAN (H1N1)v, so navedeni v spodnji preglednici.
English: Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are listed in the table below.
Slovenian: Neželeni učinki, ki so jih ugotovili v kliničnih preskušanjih cepiva Celvapan (H1N1)v pri zdravih odraslih osebah in starostnikih, so navedeni v spodnji preglednici.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Slovenian: Pri bolnikih z endogeno ali jatrogeno zmanjšanim imunskim odzivom je protitelesni odziv
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Slovenian: Škatla s po 20 večodmernimi vialami (iz stekla vrste I) po 5 ml suspenzije (10 odmerkov po 0,5 ml)
English: Frequency 9 - 17 years 3 - 8 years 6 - 35 months
Slovenian: 3 - 8 let 6 - 35 mesecev
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Slovenian: Pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomožno snov ali ostanke v sledeh, npr. formaldehid, benzonazo ali saharozo, je treba
English: Children and adolescents 3 to 17 years of age
Slovenian: Otroci in mladostniki od 3 do 17 let starosti
English: Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Slovenian: Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) proti bolezni.
English: Children and adolescents 6 months to 17 years of age In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan.
Slovenian: V klinični študiji so bile pogostnosti in vrste neželenih učinkov po prvem in drugem odmerku cepiva v osnovi podobne kot pri odraslih in starostnikih, ki so prejeli cepivo Celvapan.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Celvapan suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Uncommon:
Slovenian: Izdelovalec:
English: See section 6.5 for the number of doses per vial.
Slovenian: Število odmerkov na vialo je navedeno v poglavju 6.5.
English: If you get any of the side effects talk to your doctor.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom.
English: Children and adolescents aged 6 months to 17 years of age:
Slovenian: Otroci in mladostniki, stari od 6 mesecev do 17 let:
English: Immune response against a version of Celvapan containing A/H5N1 vaccine strains The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 - 59 years (N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule.
Slovenian: Imunogenost cepiva, ki vsebuje 7,5 µg HA brez adjuvansa, izdelanega s sevom A/Vietnam/1203/2004, je bila ocenjena v dveh kliničnih študijah pri odraslih, starih od 18 do 59 let (n=312), in pri starejših osebah, starih 60 let ali več (n=272), in sicer po shemi cepljenja na prvi in 21. dan.
English: In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101).
Slovenian: • Klinična preskušanja cepiva Celvapan (H1N1)v V klinični študiji so odmerek 7,5 µg cepiva Celvapan (H1N1)v dajali odraslim osebam, starim od 18 do 59 let (N= 101) in starostnikom, starejšim od 60 let (N=101).
English: In the clinical studies, most side effects were mild in nature and short term.
Slovenian: V kliničnih študijah je bila večina neželenih učinkov
English: • you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose.
Slovenian: • če ste imeli kdaj v preteklosti kakršnokoli drugo alergijsko reakcijo (poleg nenadne, življenjsko ogrožajoče alergijske reakcije) na katerokoli sestavino cepiva, formaldehid, Benzonazo ali saharozo (glejte poglavje 6.
English: The following adverse reactions were reported at a higher frequency category than in the
Slovenian: Naslednji neželeni učinki so bili opaženi z večjo pogostnostjo kot v drugih kliničnih študijah:
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.
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children aged 6 to 35 months was as follows:
Slovenian: Perzistenca protiteles proti HA 180 dni in 360 dni po prvem odmerku cepiva, izmerjena z enkratno radialno hemolizo (SRH) in testom mikronevtralizacije (MN) po cepljenju dojenčkov in majhnih otrok, starih med 6 in 35 mesecev je bila naslednja:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE