FrancophonIA/ELRC3.0 huggingface dataset:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za intramuskularno uporabo.
English: The first dose should be given no earlier than 2 months of age.
Slovenian: Prvega odmerka ne smete dati pred 2. mesecem starosti.
English: In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).
Slovenian: V podaljšani študiji so perzistenco imunskega odziva ocenjevali eno leto po poživitvenem odmerku (glejte preglednico 3).
English: Similar responses were also observed for adolescents administered two doses of Bexsero with an interval of six months.
Slovenian: Podobni odzivi so bili opaženi tudi pri mladostnikih, ki so prejeli dva odmerka cepiva Bexsero s šestmesečnim presledkom.
English: Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating.
Slovenian: Cepivo Bexsero je indicirano za aktivno imunizacijo oseb, starih 2 meseca in več, proti invazivni meningokokni bolezni, ki jo povzroča bakterija Neisseria meningitidis skupine B. Pred cepljenjem je treba upoštevati vpliv invazivne bolezni v različnih starostnih skupinah ter variabilnost epidemiologije antigenov za seve skupine B v različnih geografskih področjih.
English: 25 micrograms produced in E. coli cells by recombinant DNA technology adsorbed on aluminium hydroxide (0.5 mg Al³+) NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Slovenian: 25 mikrogramov izdelano v celicah E. coli s tehnologijo rekombinantne DNA adsorbirano na aluminijev hidroksid (0,5 mg Al³+) NHBA (Neisserial heparin vezavni antigen), NadA (Neisseria adhezin A), fHbp (faktor H vezavna beljakovina)
English: ** GMT = geometric mean titer.
Slovenian: ** GMT = geometrična sredina titrov.
English: - A booster will be given in the second year of life after an interval of at least 2 months from the second injection.
Slovenian: - Poživitveni odmerek se daje v drugem letu življenja s presledkom vsaj 2 mesecev po drugi injekciji.
English: Children 2 years to 10 years of age should receive two injections of the vaccine.
Slovenian: Otroci, stari od 2 let do 10 let, morajo prejeti dve injekciji cepiva.
English: Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after Bexsero has been given.
Slovenian: Zdravnik ali medicinska sestra vam bosta morda naročila, da svojemu otroku date zdravilo proti zvišani telesni temperaturi pred cepljenjem s cepivom Bexsero in po njem.
English: Name and address of the manufacturers of the biological active substances (NHBA, NadA, fHbp):
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalca bioloških zdravilnih učinkovin (NHBA, NadA, fHbp):
English: The vaccination schedules of two doses administered with an interval of one or two months showed similar immune responses in both adults and adolescents.
Slovenian: Shema cepljenja z dvema odmerkoma in eno- ali dvomesečnim presledkom je pokazala podobne imunske odzive v obeh študijah pri odraslih in mladostnikih.
English: Although the risk for developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex.
Slovenian: Čeprav je tveganje pojava alergijskih reakcij zelo majhno, mora zdravnik pred dajanjem cepiva osebam s preobčutljivostjo na lateks v anamnezi pretehtati razmerje med koristmi in tveganji.
English: In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
Slovenian: Pri dojenčkih in otrocih (starih do 2 let) so bili najpogostejši lokalni in sistemski neželeni učinki v kliničnih preskušanjih občutljivost in eritem na mestu injiciranja, zvišana telesna temperatura in razdražljivost.
English: In the initial study, whose results are summarised in Table 5, participants received two doses of Bexsero two months apart.
Slovenian: V uvodni študiji, katere rezultati so povzeti v preglednici 5, so preiskovanci prejeli dva odmerka cepiva Bexsero v presledku dveh mesecev.
English: After 24-36 months, the percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) declined, ranging across strains from 21% to 74% in children 4-7 years of age and from 47% to 86% in children 8-12 years of age.
Slovenian: Po 24 do 36 mesecih so se odstotki seropozitivnih preiskovancev (tj. tistih, ki so dosegli hSBA vsaj 1:4) zmanjšali in so segali za vse seve od 21 do 74 % pri otrocih v starosti od 4 do 7 let in od 47 do 86 % pri otrocih v starosti od 8 do 12 let.
English: There were no effects on female fertility in animal studies.
Slovenian: V študijah na živalih niso odkrili učinkov na plodnost samic.
English: However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Slovenian: Zaradi manjše okužbe kot je prehlad, pa cepljenja ni potrebno odložiti.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Slovenian: Pri cepljenju je, tako kot pri vseh cepivih za injiciranje, treba zagotoviti ustrezno obliko zdravljenja in zdravniški nadzor, ki morata biti v primeru anafilaktične reakcije po injiciranju nemudoma na voljo.
English: The need for, and timing of, further booster doses has not yet been determined.
Slovenian: Potreba po nadaljnjih poživitvenih odmerkih in ustrezni čas zanje še nista ugotovljena.
English: The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.
Slovenian: Cepivo se daje z globokim intramuskularnim injiciranjem, pri dojenčkih prednostno v anterolateralno področje stegna, pri starejših prejemnikih pa v področje deltoidne mišice nadlahti.
English: Previously unvaccinated children also received two doses in the second year of life, with antibody persistence being measured at one year after the second dose (see Table 4).
Slovenian: Prej necepljeni otroci so prejeli tudi dva odmerka v drugem letu življenja, perzistenco protiteles pa so izmerili eno leto po drugem odmerku (glejte preglednico 4).
English: In the extension study, in which two doses of Bexsero were administered one month apart in unvaccinated children, high percentages of subjects were seropositive one month after the second dose.
Slovenian: V podaljšani študiji, v kateri so dva odmerka cepiva Bexsero necepljenim otrokom dali v razmaku enega meseca, je bil visok delež preiskovancev seropozitiven en mesec po drugem odmerku.
English: - The first injection should be given no earlier than 3 months of age if two initial doses are given; the interval between injections should be at least 2 months.
Slovenian: - Prve injekcije ne smete dati pred 3 meseci starosti, če sta dana dva osnovna odmerka; presledek med odmerki mora biti vsaj 2 meseca.
English: Metabolism and nutrition disorders Very common: eating disorders
Slovenian: Presnovne in prehranske motnje Zelo pogosti: motnje prehranjevanja
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: Very common: rash (children aged 12 to 23 months) (uncommon after booster) Common: rash (infants and children 2 to 10 years of age) Uncommon: eczema
Slovenian: Zelo pogosti: izpuščaj (otroci, stari od 12 do 23 mesecev) (po poživitvenem odmerku občasen) Pogosti: izpuščaj (dojenčki in otroci, stari od 2 do 10 let) Občasni: ekcem
English: Following Bexsero vaccination, a high percentage of subjects were seropositive and achieved 4-fold increases in hSBA titers independent of pre-vaccination status.
Slovenian: Po cepljenju s cepivom Bexsero je bil velik delež preiskovancev seropozitiven in je dosegel 4-kratni porast titrov hSBA neodvisno od statusa pred cepljenjem.
English: Your child may receive an additional injection (booster).
Slovenian: Vaš otrok bo morda prejel dodatni odmerek (poživitveni odmerek).
English: The Meningococcal Antigen Typing System (MATS) was developed to relate antigen profiles of different strains of meningococcal group B bacteria to killing of the strains in the serum bactericidal assay with human complement (hSBA).
Slovenian: Sistem tipiziranja meningokoknih antigenov (MATS - Meningococcal Antigen Typing System) je bil razvit za določitev povezave med antigenskimi profili različnih sevov meningokokov skupine B in uničenjem sevov v testu baktericidnosti seruma s človeškim komplementom (hSBA).
English: The immunogenicity after two doses of Bexsero administered either one or two months apart in children 2 to 10 years of age has been evaluated in an initial phase 3 clinical study and its extension.
Slovenian: Imunogenost po dveh odmerkih cepiva Bexsero, uporabljenih v presledku enega ali dveh mesecev pri otrocih, starih od 2 do 10 let, so ocenjevali v uvodni klinični študiji faze 3 in njenem podaljšanju.
English: Your child should receive an initial course of two or three injections of the vaccine followed by an additional injection (booster).
Slovenian: Vaš otrok mora prejeti osnovno cepljenje dveh ali treh injekcij cepiva, katerim sledi še dodatna injekcija (poživitveni odmerek).
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: It is important to follow the instructions from the doctor or nurse so that you or your child completes the course of injections.
Slovenian: Pomembno je, da upoštevate navodila zdravnika ali medicinske sestre in da vi oz. vaš otrok prejmete vse odmerke.
English: In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone.
Slovenian: V kliničnih študijah pri dojenčkih, cepljenih v 2., 4. in 6. mesecu starosti, se je zvišana telesna temperatura (≥ 38 °C) pojavila pri 69 % do 79 % preiskovancev, če je bilo s cepivom Bexsero sočasno dano še rutinsko cepivo (ki je vsebovalo naslednje antigene: heptavalentni pnevmokokni konjugat, davica, tetanus, acelularni oslovski kašelj, hepatitis B, inaktivirani poliomielitis in Haemophilus influenzae tipa b) in pri 44 % do 59 % preiskovancev, če je bilo rutinsko cepivo dano samo.
English: You may receive an additional injection (booster).
Slovenian: Morda boste prejeli dodatni odmerek (poživitveni odmerek).
English: At 1 month following the 2-dose vaccination course, the percentages of subjects with hSBA ≥1:5 in individuals with complement deficiencies and asplenia or splenic dysfunction were 87% and 97% for antigen fHbp, 95% and 100% for antigen NadA, 68% and 86% for antigen PorA P1.4, 73% and 94% for antigen NHBA, respectively, indicating an immune response in these immunocompromised subjects.
Slovenian: En mesec po cepljenju z 2 odmerkoma je bil odstotek preiskovancev z rezultatom hSBA ≥ 1:5 pri posameznikih s pomanjkljivostmi komplementa 87 % za antigen fHbp, 95 % za antigen NadA, 68 % za antigen PorA P1.4 in 73 % za antigen NHBA; pri posameznikih z asplenijo ali nepravilnim delovanjem vranice pa 97 % za antigen fHbp, 100 % za antigen NadA, 86 % za antigen PorA P1.4 in 94 % za antigen NHBA, kar kaže na imunski odziv pri teh imunsko kompromitiranih osebah.
English: * There are no data in adults above 50 years of age.
Slovenian: * Za odrasle, starejše od 50 let, ni podatkov.
English: Data are not available from all vaccine schedules using the reference strain for NHBA.
Slovenian: Podatki referenčnega seva za NHBA niso na voljo za vse sheme cepljenja.
English: Via Fiorentina 1 53100 Siena Italy.
Slovenian: Via Fiorentina 1 53100 Siena Italija
English: Not known: allergic reactions (including anaphylactic reactions)
Slovenian: Neznana pogostnost: alergijske reakcije (vključno z anafilaktičnimi reakcijami)
English: 10 pre-filled syringes each containing 0.5 ml suspension with needles 10 pre-filled syringes each containing 0.5 ml suspension without needles
Slovenian: 10 napolnjenih injekcijskih brizg, vsaka vsebuje po 0,5 ml suspenzije, z iglami 10 napolnjenih injekcijskih brizg, vsaka vsebuje po 0,5 ml suspenzije, brez igel
English: Musculoskeletal and connective tissue disorders Very common: myalgia, arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: mialgija, artralgija
English: In the same study the response to an additional dose administered 2 to 3 years after the booster was indicative of immunological memory as shown by a robust antibody response against all Bexsero antigens, ranging from 81% to 100% and from 70% to 99%, respectively.
Slovenian: V isti študiji je odziv na dodaten odmerek, uporabljen 2 do 3 leta po poživitvenem odmerku, pokazal imunološki spomin, ki se je izrazil z močnim odzivom proti vsem antigenom cepiva Bexsero, in sicer od 81 % do 100 % med prvimi in od 70 % do 99 % med drugimi.
English: - A booster will be given between 12 months and 15 months of age after an interval of at least 6 months from the last injection of the initial course.
Slovenian: - Poživitveni odmerek se daje med 12. in 15. mesecem starosti, v presledku vsaj 6 mesecev od zadnje injekcije osnovnega cepljenja.
English: What Bexsero looks like and contents of the pack
Slovenian: Izgled cepiva Bexsero in vsebina pakiranja
English: At one month following a booster administered 6 months after the last dose, the percentages of seropositive subjects ranged from 87% to 100% for the two-dose schedule, and from 83% to 100% for the three-dose schedule.
Slovenian: En mesec po poživitvenem odmerku, ki je bil dan 6 mesecev po zadnjem odmerku, so bili deleži seropozitivnih preiskovancev od 87 % do 100 % za razpored z dvema odmerkoma in od 83 % do 100 % za razpored s tremi odmerki.
English: The response to a booster dose administered 24-36 months after the primary series was indicative of immunological memory as the percentages of seropositive subjects ranged across strains from 93% to 100% in children 4-7 years of age and from 96% to 100% in children 8-12 years of age.
Slovenian: Odziv na poživitveni odmerek, uporabljen od 24 do 36 mesecev po primarnem zaporedju, je pokazal imunološki spomin, saj so odstotki seropozitivnih preiskovancev za vse seve segali od 93 do 100 % pri otrocih v starosti od 4 do 7 let in od 96 do 100 % pri otrocih v starosti od 8 do 12 let.
English: Clinical studies demonstrated that the immune responses of the co-administered routine vaccines were unaffected by concomitant administration of Bexsero, based on non-inferior antibody response rates to the routine vaccines given alone.
Slovenian: V kliničnih študijah so dokazali, da pri sočasnem dajanju cepiva Bexsero imunski odzivi na sočasno uporabljena rutinska cepiva niso bili spremenjeni, saj stopnje odziva protiteles v primerjavi z uporabo samo rutinskih cepiv niso bile inferiorne.
English: - The interval between each injection should be at least 1 month.
Slovenian: - Presledek med injekcijama mora biti vsaj 1 mesec.
English: There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.
Slovenian: Ni podatkov o uporabi cepiva Bexsero pri osebah, starejših od 50 let; o uporabi pri bolnikih s kroničnimi boleznimi pa je na voljo malo podatkov.
English: No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation.
Slovenian: Pri cepljenih brejih kunčjih samicah in njihovih potomcih do 29. dneva laktacije niso opazili neželenih učinkov.
English: Bexsero has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Cepivo Bexsero nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Not known: hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.
Slovenian: Neznana: hipotonično-hiporesponzivne epizode, meningealno draženje (o znakih meningealnega draženja, kot so togost vratu ali fotofobija, so sporadično poročali kmalu po cepljenju.
English: 0, 2 months fHbp
Slovenian: Pri 0, 1 mesecu Pri 0, 2 mesecih fHbp
English: The immunogenicity after two doses has been also documented in another study in infants 6 months to 8 months of age at enrolment (see Table 4).
Slovenian: Imunogenost po dveh odmerkih so ugotavljali še v drugi študiji pri dojenčkih, ki so bili ob vključitvi stari od 6 do 8 mesecev (glejte preglednico 4).
English: As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients.
Slovenian: Kot pri drugih cepivih tudi cepivo Bexsero morda ne zaščiti vseh cepljenih oseb.
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4 (against reference strains for fHbp, NadA, PorA P1.4 antigens) and an hSBA ≥ 1:5 (against reference strain for NHBA antigen).
Slovenian: * % seropozitivnih = odstotek preiskovancev, ki so dosegli hSBA ≥ 1:4 (proti referenčnim sevom za antigene fHbp, NadA, PorA P1.4) in hSBA ≥ 1:5 (proti referenčnemu sevu za antigen NHBA).
English: Via Fiorentina, 1 IT-53100 Siena Italy
Slovenian: Via Fiorentina 1 IT-53100 Siena Italija
English: Bexsero can be given concomitantly with any of the following vaccine antigens, either as monovalent or as combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, measles, mumps, rubella, varicella, and meningococcal groups A, C, W, Y conjugate.
Slovenian: Cepivo Bexsero se lahko daje sočasno s katerim koli od naslednjih cepilnih antigenov v bodisi monovalentnih bodisi kombiniranih cepivih: davica, tetanus, acelularni oslovski kašelj, Haemophilus influenzae tipa b, inaktivirani poliomielitis, hepatitis B, heptavalentni pnevmokokni konjugat, ošpice, mumps, rdečke, norice in meningokokni konjugat skupin A, C, W, Y.
English: Musculoskeletal and connective tissue disorders Very common: arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: artralgija
English: The following side effects may also occur after receiving this vaccine.
Slovenian: Po cepljenju se lahko pojavijo tudi naslednji neželeni učinki.
English: Immunogenicity in children 2 to 10 years of age
Slovenian: Imunogenost pri otrocih, starih od 2 do 10 let
English: At approximately 4 years after the two-dose primary series, the percentages of subjects with hSBA ≥ 1:5 generally declined from a range across strains of 68% to 100% after the second dose to a range across strains of 9% to 84%.
Slovenian: Približno 4 leta po primarnem zaporedju z dvema odmerkoma so se odstotki preiskovancev s hSBA ≥ 1:5 na splošno zmanjšali od razpona od 68 do 100 % za vse seve po drugem odmerku do razpona od 9 do 84 % za vse seve.
English: Serum bactericidal response to NHBA antigen has not been evaluated.
Slovenian: Serumski baktericidni odziv na antigen NHBA ni bil ovrednoten.
English: - The interval between each injection should be at least 2 months.
Slovenian: - Presledek med injekcijama mora biti vsaj 2 meseca.
English: The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) ranged from 44% to 100% one month after the second dose and from 55% to 100% one month after the third dose.
Slovenian: dosežen hSBA vsaj 1:4) je bil v razponu od 44 % do 100 % en mesec po drugem odmerku in od 55 % do 100 % en mesec po tretjem odmerku.
English: Study V72P16 2, 3, 4 months fHbp
Slovenian: Študija V72P16 pri 2, 3, 4 meseci h fHbp
English: Injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).
Slovenian: Reakcije na mestu injiciranja, kot so obsežna oteklina cepljenega uda, mehurji na mestu injiciranja ali okoli njega in zatrdlina na mestu injiciranja (ki lahko vztraja več kot en mesec).
English: Comparable percentages of subjects were seropositive at 2 to 3 years after being previously vaccinated with either two doses followed by a booster of Bexsero (ranging from 35% to 91%) or three doses followed by a booster (ranging from 36% to 84%).
Slovenian: Delež seropozitivnih preiskovancev je bil po 2 do 3 letih primerljiv med preiskovanci, cepljenimi z dvema odmerkoma cepiva Bexsero in poživitvenim odmerkom (razpon: od 35 % do 91 %), in preiskovanci, cepljenimi s tremi odmerki cepiva Bexsero in poživitvenim odmerkom (razpon: od 36 % do 84 %).
English: In a phase 3 clinical study, children and adolescents 2 through 17 years of age with complement deficiencies (40), with asplenia or splenic dysfunction (107), and age-matched healthy subjects (85) received two doses of Bexsero two months apart.
Slovenian: V klinični študiji 3. faze so bili vključeni otroci in mladostniki, stari od 2 do 17 let, s pomanjkljivostmi komplementa (40), asplenijo ali nepravilnim delovanjem vranice (107) ter zdravi posamezniki iste starostne skupine (85).
English: Infants up to 5 months of age at the time of first dose
Slovenian: Dojenčki do 5 meseca starosti ob prvem odmerku
English: The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding.
Slovenian: Pred odločitvijo o cepljenju med dojenjem je treba pretehtati razmerje med koristmi in tveganji.
English: There are no data in adults above 50 years of age.
Slovenian: Za odrasle, starejše od 50 let, ni podatkov.
English: Study V72P12 2, 3, 4 months
Slovenian: Študija V72P12 pri 2, 3, 4 mesecih
English: 0.5 ml suspension in a pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (bromobutilna guma tipa I) in zaščitno zaporko konice (guma tipa I ali tipa II) z ali brez igle.
English: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8).
Slovenian: Pri cepljenju se lahko kot psihogeni odziv na vbod igle pojavijo s tesnobo povezane reakcije, vključno z vazovagalnimi reakcijami (sinkopa), hiperventilacija ali s stresom povezane reakcije (glejte poglavje 4.8).
English: Immunisation with Bexsero is intended to stimulate the production of bactericidal antibodies that recognize the vaccine antigens NHBA, NadA, fHbp, and PorA P1.4 (the immunodominant antigen present in the OMV component) and are expected to be protective against Invasive Meningococcal Disease (IMD).
Slovenian: Imunizacija s cepivom Bexsero je namenjena stimulaciji tvorbe baktericidnih protiteles, ki prepoznavajo cepilne antigene NHBA, NadA, fHbp in PorA P1.4 (imunsko prevladujoči antigen prisoten v OMV
English: - If you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Slovenian: - če ste vi ali vaš otrok alergični na zdravilne učinkovine ali katero koli sestavino tega cepiva