FrancophonIA/ELRC3.0 huggingface dataset:
English: Immunogenicity data obtained in a limited number of children aged 6-35 months show that there is a further immune response to a second half-dose of 0.25 ml administered after an interval of three weeks.
Slovenian: Podatki o imunogenosti, pridobljeni pri majhnem številu otrok, starih od 6 do 35 mesecev, kažejo dodaten imunski odziv na drugi odmerek 0,25 ml, uporabljen po presledku treh tednov.
English: per 0.5 ml dose
Slovenian: na 0,5 ml odmerek
English: This section describes the clinical experience with HUMENZA following administration of one or two vaccine doses (0.5 ml or 0.25 ml) at a 3-week interval.
Slovenian: To poglavje opisuje klinične izkušnje pri cepljenju z enim ali dvema odmerkoma cepiva (0,5ml ali 0,25 ml) z 3 tedenskim intervalom med cepljenji.
English: A mean body weight loss of 20% was recorded in control group 4 days after infection.
Slovenian: V kontrolni skupini so 4 dni po okužbi v povprečju zabeležili 20-odstotno izgubo telesne mase.
English: In children from 3 to 8 years of age, the most frequent reactions were injection site pain and injection site erythema.
Slovenian: Pri otrocih, starih od 3 do 8 let, so bile najpogostejše reakcije bolečina na mestu injiciranja in eritem na mestu injiciranja.
English: There are no safety, immunogenicity or efficacy data to support interchangeability of HUMENZA with other H1N1 pandemic vaccines.
Slovenian: Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost zdravila HUMENZA z drugimi pandemskimi cepivi proti H1N1.
English: A challenge ferret study showed vaccine similar protection after one or two human doses based on lung macroscopic examination, body weight loss (as indicator of disease after challenge) and viral loads in lungs and in the upper respiratory tract.
Slovenian: Pri provokacijskem testu z belim dihurjem je pokazalo cepivo podobno zaščito po enem ali dveh človeških odmerkih na podlagi makroskopske pljučne preiskave, izgube telesne mase (kot kazalnik bolezni po provokaciji) in količine virusa v pljučih in zgornjih dihalnih poteh.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Slovenian: Cepivo vsebuje tiomersal (organska živosrebrova spojina) kot konzervans, ki lahko povzroči preobčutljivostne reakcije (glejte poglavje 4.4).
English: Very limited data in children aged 6 to 35 months (N=96) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8.).
Slovenian: Zelo omejeni podatki pri otrocih, starih od 6 do 35 mesecev (n = 96), ki so dobili dva odmerka 0,25 ml (polovični odmerek za odrasle) v presledku 3 tednov med odmerkoma, kažejo večji delež reakcij na mestu injiciranja in splošnih simptomov (glejte poglavje 4.8.).
English: Like all medicines, HUMENZA can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi cepivo HUMENZA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: After mixing, store in a refrigerator and use within 24 hours.
Slovenian: Po premešanju shranjujte v hladilniku in uporabite v 24 urah.
English: What HUMENZA contains
Slovenian: Kaj vsebuje zdravilo HUMENZA
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Slovenian: Toda, če tega ni mogoče preprečiti, je treba drugo cepivo dati v drugo okončino.
English: Groups of 7 ferrets were immunized intramuscularly (IM) with one human dose of HUMENZA (3.8 µg of HA and full dose AF03) (at D21) or 2-dose administration of one human dose at 3-week intervals (at D0 and D21) and compared to a control group (AF03 adjuvant diluted in PBS).
Slovenian: so imunizirali skupine po 7 dihurjev z enim človeškim odmerkom cepiva HUMENZA (3,8 µg HA) in polnim odmerkom AF03 (pri D21) ali 2-odmerkoma, ki odgovarjata enemu humanemu odmerku v 3-tedenskih intervalih (pri D0 in D21) in jih primerjali s kontrolno skupino (adjuvans AF03 razredčen v PBS).
English: Pharmacovigilance The MAH will submit the results of the GBS surveillance
Slovenian: Farmakovigilanca Imetnik dovoljenja za promet z zdravilom bo predložil rezultate študije spremljanja GBS.
English: Overall, local and systemic reactions were less frequently observed in children from 6 to 35 months of age than in children from 3 to 8 years, except fever which was more frequently observed in children from 6 to 23 months.
Slovenian: V splošnem so bile lokalne in sistemske reakcije manj pogoste pri otrocih od 6 do 35 mesecev starosti, kot pri otrocih, starih od 3 do 8 let, razen zvišane telesne temperature, ki je bila pogostejša pri otrocih, starih od 6 do 23 mesecev.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 7.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 7.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Blood and lymphatic system disorders: Transient thrombocytopenia, transient lymphadenopathy
Slovenian: Bolezni krvi in limfatičnega sistema: Prehodna trombocitopenija, prehodna limfadenopatija
English: Tell the doctor requesting these tests that you have recently been given HUMENZA.
Slovenian: Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom HUMENZA.
English: Nervous system disorders - Very common: headache
Slovenian: Bolezni živčevja - Zelo pogosti: glavobol
English: * propagated in eggs ** expressed in microgram haemagglutinin
Slovenian: * namnožen v jajcih ** izražen v mikrogramih hemaglutinina
English: Prior to each administration, the multidose vial should be gently shaken by at least 5 rotating movements.
Slovenian: Pred vsakim apliciranjem morate večodmerno vialo nežno stresti z vsaj 5 krožnimi gibi.
English: In order to keep the traceability of the product received by each vaccinee the name of the vaccine and the lot number should be recorded by using the stickers provided in the pack containing both the antigen and adjuvant vials.
Slovenian: Zaradi zagotovitve sledljivosti prejetega cepiva ob vsakem cepljenju je treba zabeležiti ime cepiva in serijsko številko na oznako, ki je priložena v pakiranju, ki vsebuje viali z adjuvansom in antigenom.
English: The volume of HUMENZA after mixing is at least 6 ml and allows the withdrawal of several doses (multidose vial).
Slovenian: Količina cepiva HUMENZA po mešanju je vsaj 6 ml in zadošča za izvlek več odmerkov (večodmerna viala).
English: 2nd dose
Slovenian: 2. odmerek
English: The immunogenicity 21 days after each half-dose (0.25 ml) of HUMENZA in term of the seroprotection rate, the seroconversion rate and the seroconversion factor, using HI method, were as follows:
Slovenian: Imunogenost 21 dni po vsakem polovičnem odmerku (0,25 ml) cepiva HUMENZA v smislu deleža serozaščite, deleža serokonverzije in faktorja serokonverzije po metodi HI so bili sledeči:
English: Independently of the cohort safety study (9,000 subjects), the MAH commits to implement a post-licensure prospective clinical safety study (N=3,000 subjects from 6 months of age).
Slovenian: Neodvisno od študij varnosti kohorte se je imetnik dovoljenja za promet obvezal, da bo izvedel predvideno klinično študijo o varnosti zdravila po prihodu na trg (N = 3.000 udeleženih v starosti 6 mesecev).
English: In the different age groups, there are limited data (adults aged 18 to 60 years), very limited data (adults aged 61 years and over, children aged 6 months to 17 years) or no data (children aged less than 6 months) with HUMENZA as detailed in sections 4.4, 4.8 and 5.1.
Slovenian: Za nekatere starostne skupine je o cepljenju s cepivom Humenza malo podatkov (odrasli, stari od 18 do 60 let), zelo malo podatkov (odrasli, starejši od 61 let in otroci od 6 mesecev do 17 let) ali jih sploh ni (otroci, mlajši od 6 mesecev), kot je podrobno opisano v poglavjih 4.4, 4.8 in 5.1
English: The severity of the local and systemic reactions was mainly from grade 1 (mild) to grade 2 (moderate).
Slovenian: Resnost lokalnih in sistemskih reakcij je bila večinoma 1. stopnje (blage) do 2. stopnje (zmerne).
English: Instructions for mixing the vaccine:
Slovenian: Navodila za mešanje cepiva:
English: Each vaccine dose of 0.5 ml or 0.25 ml (half-dose) is withdrawn with a new sterile syringe for injection and administered intramuscularly.
Slovenian: Vsak odmerek cepiva (0,5 ml ali 0,25 ml (polovični odmerek)) posrkajte z novo sterilno injekcijsko brizgo in ga aplicirajte intramuskularno.
English: These side effects may occur with HUMENZA.
Slovenian: Ti neželeni učinki se lahko pojavijo s cepivom HUMENZA.
English: There are no data on administration of AF03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Slovenian: Ni podatkov o cepljenju s cepivi z adjuvansom AF0-3, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemsko ali pandemsko uporabo.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Very rare: - Skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash.
Slovenian: Zelo redki: - Kožne reakcije, ki se lahko razširijo po vsem telesu in vključujejo srbenje kože (pruritus,
English: In ferrets administered with one or two doses of HUMENZA, a significant reduction of lung damages (4 % or 1 % of affected lung, respectively) and of lung viral loads (more than 4 log10 reduction) was achieved resulting in 86% (6 out of 7 ferrets) or 100% of ferrets with no detectable virus in lungs, respectively.
Slovenian: Pri dihurjih, ki so dobili en ali dva odmerka cepiva HUMENZA, so opazili značilno nižjo poškodbo pljuč (4 % oz. 1 % prizadetih pljuč) in količine virusa v pljučih (zmanjšanje za več kot 4 log10), kar pomeni 86 % (6 od 7 dihurjev) oz. 100 % dihurjev brez zaznavnega virusa v pljučih.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur SA
English: The reproductive and developmental toxicity studies conducted in rats and rabbits with AF03 did not show any effects on female fertility, pregnancy, embryofetal development or early postnatal development.
Slovenian: Študije vpliva na sposobnost razmnoževanja in razvoja z AF03 pri podganah in kuncih ne kažejo vpliva na plodnost pri samicah, brejost, razvoj embria-zarodka in zgodnji postnatalni razvoj.
English: Pharmacovigilance The MAH commits to update the observational study protocol to screen for auto-antibodies those patients presenting visual or ocular events during the study followup.
Slovenian: Farmakovigilanca Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo posodabljal protokol opazovalnih študij za presejalne raziskave za oceno avtoprotiteles pri tistih bolnikih, ki so v fazi sledenja po študiji imeli težave z vidom ali očmi.
English: Percentages of subjects who reported the following adverse reactions after each dose are provided by age group in the table below:
Slovenian: Odstotki oseb, ki so poročali o naslednjih neželenih učinkih po vsakem odmerku, so razvrščeni po starostnih skupinah v naslednji tabeli:
English: Children below 6 months of age: Vaccination is currently not recommended in this age group.
Slovenian: Otroci, mlajši od 6 mesecev: Cepljenje v tej starostni skupini trenutno ni priporočeno.
English: - Vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
Slovenian: - Vnetje žil (vaskulitis), ki lahko povzroči kožni osip in v zelo redkih primerih prehodne težave z
English: C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
Slovenian: C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA
English: Rabbits dosed with vaccine, or with AF03 adjuvant alone, showed a slight increase of apoptosis / necrosis in the lachrymal tissues at doses higher than the human dose.
Slovenian: Pri kuncih je injiciranje cepiva ali samo adjuvansa AF03 povzročilo nekoliko zvišano apoptozo/nekrozo lakrimalnega tkiva pri odmerkih, ki so bili višji od odmerkov pri človeku.
English: Elderly 71 to 80 years of age
Slovenian: Starejše osebe, stare od 71 do 80 let
English: Vascular disorders: Vasculitis associated in very rare cases with transient renal involvement
Slovenian: Žilne bolezni: Vaskulitis, v zelo redkih primerih povezan s prehodno prizadetostjo ledvic
English: Musculoskeletal and connective tissue disorders - Very common: myalgia
Slovenian: Bolezni mišično-skeletnega sistema - Zelo pogosti: mialgija
English: The rate of grade 3 (severe) reactions was overall low (from 6.5 to 8.3% in children from 6 to 11 months of age and from 8.3 to 12.5% in children from 12 to 35 months of age).
Slovenian: Pojav reakcij 3. stopnje (hude) reakcije je bil v splošnem majhen (od 6,5 do 8,3 % pri otrocih od 6 do 11 mesecev starosti in od 8,3 do 12,5 % pri otrocih od 12 do 35 mesecev starosti..
English: For storage conditions after opening, see section 6.3.
Slovenian: Za pogoje shranjevanja odprtega cepiva glejte poglavje 6.3.
English: 4.6 Pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje
English: Skin and subcutaneous tissue disorders: Generalised skin reactions including pruritus, urticaria or non-specific rash
Slovenian: Bolezni kože in podkožja: Generalizirane reakcije kože, vključno s pruritisom, urtikarijo ali nespecifičnim izpuščajem
English: Available non clinical data obtained with the vaccine HUMENZA or with the same vaccine but with another strain (A/H5N1) revealed no special hazard for humans based on conventional repeat dose toxicity studies, reproductive and developmental toxicity studies and an investigative pneumopathology study.
Slovenian: Predklinični podatki, pridobljeni s cepivom HUMENZA ali z enakim cepivom, a drugim sevom (A/H5N1) na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja ter raziskovalnih pnevmopatoloških študij ne kažejo posebnega tveganja za človeka.
English: One half-dose of 0.25 ml at an elected date.
Slovenian: En polovični 0,25-ml odmerek na izbrani datum.
English: The vaccine will be injected into a muscle, preferably in the upper arm or the front of the thigh (depending on the muscle mass).
Slovenian: Cepivo se injicira v mišico, priporočeno v zgornji del roke ali v prvi del stegna (odvisno od mišične mase).
English: Immunisation should be carried out by intramuscular injection (IM) preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Slovenian: Cepljenje je treba opraviti z intramuskularnim injiciranjem, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
English: The vaccine is mixed by withdrawing with a sterile syringe and needle the entire content of the antigen vial and adding it into the adjuvant vial.
Slovenian: Cepivo zmešate tako, da s sterilno injekcijsko brizgo in iglo izvlečete celotno vsebino viale z antigenom in jo dodate v vialo z adjuvansom.
English: A single administration of a human dose of HUMENZA elicited HI titers ≥ 80 and MN (Microneutralization) titers ≥ 160 specific to the vaccinal strain in 100% of vaccinated animals and a two-dose administration regimen markedly increased (at least a 5-fold increase) HI and MN antibody titers.
Slovenian: Enkratna aplikacija človeškega odmerka cepiva HUMENZA je izzvala titre HI ≥ 80 in titre MN (mikronevtralizacije) ≥ 160, specifične za sev cepiva pri 100 % cepljenih živali, shema apliciranja dveh odmerkov pa je znatno (vsaj 5-kratno povečanje) zvišala titre protiteles HI in MN.
English: Therefore, monitoring of temperature and measures to lower fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 8 years of age) after each vaccination.
Slovenian: Zato je mlajšim otrokom (npr. do približno 8. leta starosti) po vsakem cepljenju priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
English: The RMP will be updated accordingly to reflect this study within 15 calendar days of the receipt of the opinion.
Slovenian: Načrt za obvladovanje tveganja bo posodobljen potemtakem v 15 koledarskih dneh po prejemu presoje o izvedeni študiji.
English: Elderly above 60 years of age:
Slovenian: Starejši od 60 let:
English: Sanofi pasteur - Parc Industriel d'Incarville - F-27100 Val-de-Reuil - France Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'Etoile - France
Slovenian: Sanofi pasteur - Parc Industriel d'Incarville - F-27100 Val-de-Reuil - Francija Sanofi pasteur - Campus Mérieux - 1541, avenue Marcel Mérieux - F-69280 Marcy l'EtoileFrancija
English: For the most up-to-date information please consult the website of the European Medicines Agency : http://www.ema.europa.eu/.
Slovenian: Za najnovejše informacije glejte spletno stran Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/.
English: • Neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré Syndrome).
Slovenian: • nevrološke motnje lahko povzročijo otrdelost vratu, zmedenost, odrevenelost, bolečino in oslabelost okončin, izgubo ravnotežja, izgubo refleksov, paralizo dela ali vsega telesa
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: The rate of grade 3 (severe) reactions was overall low (from 2 to 14% in children from 3 to 8 years of age and from 2 to 8.2% in adolescents from 9 to 17 years of age).
Slovenian: Pojav reakcij 3. stopnje (hude) reakcije je bil v splošnem majhen (od 2 do 14 % pri otrocih od 3 do 8 let starosti in od 2 do 8,2 % pri odraščajočih od 9 do 17 let starosti.
English: You should discuss with your doctor whether you should receive HUMENZA.
Slovenian: Pogovorite se z zdravnikom, ali boste cepljeni s cepivom HUMENZA.
English: OTHER SPECIAL WARNING(S), IF NECESSARY MIX THE ANTIGEN INTO THE ADJUVANT VIAL BEFORE USE
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA PRED UPORABO VMEŠAJTE V VIALO Z ADJUVANSOM
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 54 elderly (29 elderly from 61 to 70 years of age, 18 elderly from 71 to 80 years of age and 7 elderly of 81 years of age and over).
Slovenian: V kliničnem preskušanju so imunogenost 21 dni po vsakem injiciranju cepiva HUMENZA , prejetim 21 dni narazen, ocenili pri 54 starejših osebah (29 starejših osebah, starih od 61 do 70 let, 18 starejših osebah, starih od 71 do 80 let, in 7 starejših osebah, starih 81 let ali več).
English: 4.5 ml After mixing with the antigen: 10 doses of 0.5 ml
Slovenian: 4,5 ml Po premešanju z antigenom: 10 odmerkov po 0,5 ml
English: Elderly 61 to 70 years of age
Slovenian: Starejše osebe, stare od 61 do 70 let
English: After mixing: 10 doses of 0.5 ml per vial.
Slovenian: Po premešanju: 10 odmerkov z 0,5 ml na vialo.
English: One dose of 0.5 ml at an elected date.
Slovenian: En 0,5-ml odmerek na izbrani datum.
English: No data have been generated in pregnant or lactating women with the vaccine HUMENZA or with any other vaccine containing adjuvant AF03.
Slovenian: Za nosečnice ali ženske, ki dojijo, trenutno ni na voljo nobenih podatkov o uporabi cepiva HUMENZA ali drugih cepiv, ki vsebujejo adjuvans AF03.
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2 ºC-8 ºC).
English: Do not use the antigen (suspension) and the adjuvant (emulsion) after the expiry date which is stated on the carton and the label after EXP.
Slovenian: Pred premešanjem cepiva: Antigena (suspenzije) in adjuvansa (emulzije) ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na ovojnini za oznako EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: After the addition of the antigen to the adjuvant, the mixture should be gently shaken by at least 5 rotating movements.
Slovenian: Potem, ko emulzijo dodate suspenziji, morate mešanico nežno pretresti z vsaj 5 krožnimi gibi.
English: During a clinical study conducted with HUMENZA in adults and elderly, the side effects listed below have been observed.
Slovenian: V klinični študiji z zdravilom HUMENZA, ki so jo opravili pri odraslih in starejših bolnikih, so opazili spodaj naštete neželene učinke.
English: During clinical studies conducted with HUMENZA in children and adolescents, the side effects listed below have been observed.
Slovenian: V kliničnih študijah z zdravilom HUMENZA, ki so jih opravili pri otrocih in mladostnikih, so opazili spodaj naštete neželene učinke:
English: Children from 3 to 8 years old:
Slovenian: Otroci od 3 do 8 leta starosti:
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Slovenian: Drugi odmerek cepiva je treba dati po presledku vsaj 3 tednov.
English: General disorders and administration site conditions - Very common: injection site pain - Common: malaise, shivering, fever, injection site reactions such as induration, erythema,
Slovenian: Splošne težave in spremembe na mestu aplikacije: - Zelo pogosti: bolečina na mestu injiciranja - Pogosti: slabost, tresavica, zvišana telesna temperatura, reakcije na mestu injiciranja kot so
English: Adults (from 18 to 60 years of age):
Slovenian: Odrasli (stari od 18 do 60 let):
English: Children (N=50)
Slovenian: N = 50
English: • Convulsions associated with fever,
Slovenian: • krči povezani z zvišano telesno temperaturo
English: One half-dose of 0.25 ml of the vaccine will be given.
Slovenian: Dobili boste en polovični 0,25-ml odmerek cepiva.
English: In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 99 adults.
Slovenian: V kliničnem preskušanju so ocenili imunogenost cepiva 21 dni po vsakem injiciranju cepiva HUMENZA cepiva pri 99 odraslih.
English: Instructions for the administration of the vaccine:
Slovenian: Navodila za dajanje cepiva:
English: • Post-marketing surveillance
Slovenian: • Opazovano obdobje po začetku trženja
English: 1st dose
Slovenian: 1. odmerek
English: Read all of this leaflet carefully before you receive this vaccine.
Slovenian: Preden prejmete to cepivo, natančno preberite navodilo.
English: 21 days after 2nd dose
Slovenian: 21 dni po 2. odmerku
English: Regarding unsolicited reactions after any vaccination, injection site warmth (4%) was reported in children from 3 to 8 years of age and oropharyngeal pain (6.1%) was reported in adolescents from 9 to 17 years of age.
Slovenian: Glede na spontane reakcije po vsakem cepljenju so poročali o vročem občutku na mestu injiciranja (4 %) pri otrocih starih od 3 do 8 let in orofaringealni bolečini (6,1 %) pri mladostnikih, starih od 9 do 17 let.
English: One dose of 0.5 ml of the vaccine will be given.
Slovenian: Dobili boste en 0,5-ml odmerek cepiva.
English: Children and adolescents (from 3 to 17 years of age):
Slovenian: Otroci in mladostniki (od 3 do 17 let starosti):