FrancophonIA/ELRC3.0 huggingface dataset:
English: In individuals with chronic renal failure, an impaired hepatitis B response is observed and administration of additional doses of hepatitis B vaccine should be considered according to the antibody level against hepatitis B virus surface antigen (anti-HBsAg).
Slovenian: Pri posameznikih s kronično ledvično odpovedjo opažajo slabši odziv pri hepatitisu B, zato je treba glede na količino protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBsAg) razmisliti o dajanju dodatnih odmerkov cepiva proti hepatitisu B.
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Slovenian: Pri aplikaciji osnovne serije imunizacije zelo prezgodaj rojenim nedonošenčkom (rojenim v 28. tednu gestacije ali prej), še zlasti tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati morebitno tveganje za apnejo in je potrebo spremljanje pljučnega delovanja od 48 do 72 ur po cepljenju.
English: • Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (GuillainBarré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
Slovenian: • začasno vnetje živcev, ki povzroča bolečino, paralizo in motnje občutljivosti (Guillain-Barré sindrom) ter hudo bolečino in omejeno mobilnost roke in rame (brahialni nevritis) po injiciranju cepiva, ki vsebuje komponento tetanusa
English: Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination.
Slovenian: 9 let pri 93 % cepljenih, s pojavom geometrične srednje koncentracije 3692 (95 % IZ: 1886-7225) mi.e./ml po cepljenju.
English: No data are available for premature infants.
Slovenian: Podatkov o nedonošenčkih ni na voljo.
English: When given at the same time with other vaccines, Hexacima will be given at different injection sites.
Slovenian: Če se cepljenje opravlja sočasno z drugim cepivom, bo cepivo Hexacima injicirano na različno mesto.
English: • Haemophilus influenzae type b polysaccharide
Slovenian: • polisaharid hemofilusa influence tipa b
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexacima in children over 24 months of age has not been studied in clinical trials.
Slovenian: Farmakoterapevtska skupina: Cepiva, kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA09
English: Hexacima will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Slovenian: Kako uporabljati cepivo Hexacima Cepivo Hexacima bo vašemu otroku injiciral zdravnik ali medicinska sestra, saj sta usposobljen za uporabo cepiv in za obravnavo vseh občasnih hudih alergijskih reakcij na injekcijo.
English: Hexacima in vials EU/1/13/828/001
Slovenian: Cepivo Hexacima v vialah EU/1/13/828/001
English: • previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Slovenian: • v preteklosti imel Guillain-Barréjev sindrom (prehodno vnetje živcev, ki povzroča bolečino, paralizo in nenormalno občutljivost) ali brahialni nevritis (hude bolečine in zmanjšanje mobilnosti roke in ramena) po prejemu predhodnega cepiva, ki je vsebovalo tetanusni toksoid
English: The administration of Hexacima must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components.
Slovenian: Pri posameznikih z anamnezo resnih oziroma hudih reakcij v 48 urah po predhodni injekciji cepiva, ki je vsebovalo podobne komponente, je treba skrbno premisliti o cepljenju s cepivom Hexacima.
English: How to store Hexacima
Slovenian: Shranjevanje cepiva Hexacima
English: • Very rare side effects (may affect up to 1 in 10,000 people) are: - episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).
Slovenian: - epizode, pri katerih je vaš otrok v šoku podobnem stanju oziroma je določen čas bled, mlahav in neodziven (hipotonične reakcije ali hipotonično-hiporesponzivne epizode
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja redki izpuščaj
English: 8 D antigen units5
Slovenian: 8 D-antigenskih enot5
English: (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU2
Slovenian: Zdravilne učinkovine na odmerek (0,5 ml)1 so: davični toksoid ne manj kot 20 i.e.2
English: Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexacima:
Slovenian: Možni neželeni učinki O drugih neželenih učinkih, ki niso navedeni zgoraj, poročajo občasno pri drugih cepivih, ki vsebujejo cepiva proti davici, tetanusu, oslovskemu kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b vendar ne neposredno pri uporabi cepiva Hexacima:
English: Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Slovenian: Cepivo Hexacima (DTaP-IPV-HB-Hib) je indicirano za osnovno in obnovitveno cepljenje dojenčkov in malčkov, starejših od šest tednov, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B,
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexacima.
Slovenian: Anamneza vročinskih krčev in družinska anamneza krčev ali sindroma nenadne smrti dojenčka (SIDS
English: 32 D antigen units5
Slovenian: 32 D-antigenskih enot5
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes without attached needle.
Slovenian: Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg brez pritrjene igle.
English: Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti-PT (Seroconversion ‡‡) (Vaccine response§) Anti-FHA (Seroconversion ‡‡) (Vaccine response§)
Slovenian: Protitelesa proti davici (≥ 0,01 i.e./ml) Protitelesa proti tetanusu (≥ 0,01 i.e./ml) Protitelesa proti PT (Serokonverzija ‡‡) (odziv na cepljenje§) Protitelesa proti FHA (Serokonverzija ‡‡) (odziv na cepljenje§)
English: • suffers from an acute or chronic illness including chronic renal insufficiency or failure (inability of the kidneys to work properly).
Slovenian: • trpi za akutno ali kronično boleznijo vključno s kronično oslabljenim ledvičnim delovanjem
English: ELISA).
Slovenian: HHE).
English: General disorders and administration site conditions Oedematous reaction affecting one or both lower limbs may occur following vaccination with Haemophilus influenzae type b containing vaccines.
Slovenian: Splošne težave in spremembe na mestu injiciranja Po cepljenju s cepivi, ki vsebujejo komponento proti hemofilusu influence tipa b, lahko pride do edematoznih reakcij, ki prizadenejo eno ali obe spodnji okončini.
English: Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Slovenian: Podatki o sočasni uporabi rotavirusnih cepiv niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
English: - persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
Slovenian: v 48 urah po cepljenju; - stalen, neutolažljiv jok, ki traja 3 ure ali več in se pojavi v 48 urah po cepljenju;
English: Abnormal crying (prolonged crying)
Slovenian: Bolezni živčevja zelo pogosti jok, zaspanost pogosti nenormalen jok (dolgotrajen jok)
English: 40 D antigen units5
Slovenian: 40 D-antigenskih enot5
English: Anti-diphtheria (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.1 IU/ml) Anti-PT (Seroconversion‡‡) (Vaccine response§) Anti-FHA (Seroconversion‡‡) (Vaccine response§)
Slovenian: Protitelesa proti davici (≥ 0,1 i.e./ml) Protitelesa proti tetanusu (≥ 0,1 i.e./ml) Protitelesa proti PT (Serokonverzija ‡‡) (odziv na cepljenje§) Protitelesa proti FHA (Serokonverzija ‡‡) (odziv na cepljenje§)
English: c- Description of selected adverse reactions
Slovenian: † Poglejte poglavje c c- Opis označenega neželenega učinka
English: • Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Slovenian: • Zaradi dolge dobe do pojava simptomov hepatitisa B je mogoče, da v času cepljenja že obstaja neprepoznana okužba s hepatitisom B. V takih primerih cepivo morda ne bo preprečilo okužbe s hepatitisom B.
English: • Common side effects (may affect up to 1 in 10 people) are: - abnormal crying (prolonged crying) - diarrhoea - injection site hardness (induration)
Slovenian: • Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 cepljenih) so: - nenormalen jok (dolgotrajen jok) - diareja - otrdelost na mestu injiciranja (induracija).
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexacima or a vaccine containing the same components or constituents.
Slovenian: Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1, na sledove zaostankov (gluteraldehida, formaldehida, neomicina, streptomicina in polimiksina B), na katero koli cepivo proti oslovskemu kašlju ali preobčutljivost po predhodnem cepljenju s cepivom
English: • has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process - after previous administration of Hexacima or any other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines.
Slovenian: - na katero koli pomožno snov, navedeno v poglavju 6; - na gluteraldehid, formaldehid, neomicin, streptomicin ali polimiksin B, saj se te snovi uporabljajo pri procesu izdelave cepiva; - po predhodni aplikaciji cepiva Hexacima ali na katero koli cepivo, ki vsebuje cepiva proti davici, tetanusu, oslovskem kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Slovenian: Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z dvema ločenima iglama.
English: Otherwise, post-booster antibody concentration should be ≥ pre immunisation level (pre-dose 1)
Slovenian: Sicer pa naj bi bila koncentracija protiteles po obnovitvenem cepljenju ≥ kakor je bila pred cepljenjem (pred 1. odmerkom).
English: Extensive limb swelling: Large injection-site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints, have been reported in children.
Slovenian: - izpuščaj - večje reakcije na mestu injiciranja (večje od 5 cm), vključno z obširnim otekanjem udov od mesta injiciranja prek enega ali obeh sklepov.
English: Hexacima in vials 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Slovenian: 0,5 ml suspenzije v viali (steklo tipa I) z zamaškom (halobutil).
English: After a 2-dose primary vaccination with Hexacima, a booster dose must be given.
Slovenian: Po osnovnem cepljenju z 2-odmerkoma cepiva Hexcima mora otrok prejeti obnovitveni odmerek.
English: If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Slovenian: Če česa ne razumete, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
English: History of an anaphylactic reaction after a previous administration of Hexacima.
Slovenian: Pojav anafilaktične reakcije po predhodnem cepljenju s cepivom Hexacima.
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Slovenian: Zaradi dolge inkubacijske dobe hepatitisa B je mogoče, da v času cepljenja že obstaja neprepoznana okužba s hepatitisom B. V takih primerih cepivo morda ne bo preprečilo okužbe s hepatitisom B.
English: - fits (convulsions) with or without fever.
Slovenian: - krči (konvulzije) z zvišano telesno temperaturo ali brez nje.
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Slovenian: Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 1 ali 10 napolnjenih injekcijskih brizg z eno ločeno iglo.
English: 10 vials (0.5 ml)
Slovenian: suspenzija za injiciranje 10 vial (0,5 ml)
English: Contents of the pack and other information
Slovenian: Shranjevanje cepiva Hexacima Vsebina pakiranja in dodatne informacije
English: - fits (convulsions) with or without fever, occurring within 3 days of vaccination.
Slovenian: - krče z zvišano telesno temperaturo ali brez nje, ki so se pojavili v treh dneh po cepljenju.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intramuskularna uporaba
English: • If your child gets any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate injections sites.
Slovenian: V primeru sočasne aplikacije z drugimi cepivi je treba uporabiti ločena mesta injiciranja.
English: Convulsions with or without fever*
Slovenian: redki krči z zvišano telesno temperaturo ali brez nje*
English: After a 3-dose WHO EPI schedule with Hexacima (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given.
Slovenian: Po 3-odmerkih cepiva Hexacima po EPI shemi SZO (6, 10 in 14 tednov) in če cepljeni ni prejel cepiva proti hepatitisu B ob rojstvu, ga je treba cepiti z obnovitvenim odmerkom cepiva proti hepatitisu B. Potrebno je dati najmanj obnovitveni odmerek cepiva proti otroški paralizi.
English: Pyrexia (body temperature ≥39.6°C)
Slovenian: - zvišana telesna temperatura (39,6°C ali več).
English: After a 3-dose primary vaccination with Hexacima, a booster dose should be given.
Slovenian: Po osnovnem cepljenju s 3-odmerki cepiva Hexacima mora otrok prejeti obnovitveni odmerek.
English: Data on concomitant administration of Hexacima with a pneumococcal polysaccharide conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Slovenian: Podatki o sočasni uporabi cepiva Hexacima in polisaharidnega konjugiranega cepiva proti pnevmokokom niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
English: Haemophilus influenzae type b polysaccharide
Slovenian: 10 mikrogramov polisaharid hemofilusa influence tipa b
English: - fits (convulsions) with or without fever
Slovenian: - krči (konvulzije) z zvišano telesno temperaturo ali brez nje
English: OTHER Sanofi Pasteur
Slovenian: DRUGI PODATKI Sanofi Pasteur
English: - collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
Slovenian: - kolaps ali šoku podobno stanje s hipotonično-hiporesponzivno epizodo (upad energije)
English: In the absence of hepatitis B vaccination at birth, it is necessary to give a hepatitis B vaccine booster dose.
Slovenian: Če cepljeni ni bil cepljen proti hepatitisu B ob rojstvu, je nujno obnovitveno cepljenje s cepivom proti hepatitisu B. Cepivo Hexacima se lahko uporabi za obnovitveno cepljenje.
English: Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Slovenian: - periferna nevropatija (poliradikulonevritis, obrazna paraliza), optični nevritis in demielinizacija centralnega živčevja (multipla skleroza) je bila poročana po aplikaciji cepiva, ki vsebuje antigen hepatitisa B - encefalopatija/encefalitis
English: The need for a toddler booster dose was seen in this study.
Slovenian: V tej študiji so opazili, da je pri malčkih potreben obnovitveni odmerek.
English: In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3%
Slovenian: Poleg tega je dokazano, da imunost proti komponenti hepatitisa B v cepivu traja do 9. leta starosti po primarnem cepljenju, ki obsega en odmerek cepiva proti hepatitisu B, uporabljen ob rojstvu, ter zaporedje 3 odmerkov pri dojenčku v starosti 2, 4 in 6 mesecev, brez obnovitvenega odmerka pri malih otrocih; pri tem je imelo 49,3 % cepljenih protitelesa ≥ 10 mi.e./ml, geometrična sredina koncentracije pa je bila 13,3 (95 % IZ: 8,82-20,0) mi.e./ml.
English: † See section c.
Slovenian: 2 i.e. internacionalna enota.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 2 separate needles.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), z dvema ločenima iglama.
English: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.
Slovenian: Druge sestavine cepiva so: dinatrijev hidrogenfosfat, kalijev dihidrogenfosfat, trometamol, saharoza, esencialne aminokisline, vključno z L-fenilalaninom, natrijev hidroksid in/ali ocetna kislina in/ali klorovodikova kislina (za uravnavanje pH) in voda za injiciranje.
English: • Swelling of one or both feet and lower limbs which may occur along with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and severe crying following vaccination with Haemophilus influenzae type b containing vaccines.
Slovenian: To se lahko pojavi skupaj z modrikastim obarvanjem kože (cianoza), pordelostjo, majhnimi območji krvavitev pod kožo (prehodna purpura) in hudim jokom, ki lahko sledijo cepljenju s cepivom proti Haemophilusu Influenzae tipa b. Če se pojavi taka reakcija, se običajno pojavi po prvih cepljenjih in jo opažajo v prvih nekaj urah po cepljenju.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label - Vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexacima or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster.
Slovenian: Če je cepljeni prejel cepivo proti hepatitisu B ob rojstvu in nato 3-odmerke osnovnega cepljenja, je priporočljivo obnovitveno cepljenje s cepivom Hexacima ali s petvalentnim cepivom DTaP-IPV/Hib.
English: With hepatitis B at birth
Slovenian: S cepljenjem proti hepatitisu B ob rojstvu
English: Hexacima can be considered for the booster.
Slovenian: Cepivo Hexacima se lahko uporabi za obnovitveno cepljenje.
English: titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
Slovenian: Imunski odziv na (PRP) in antigene PT in FHA en mesec po prejemu 2 odmerka, ki sta bila dana pri 2 in 4 mesecu starosti je bil sličen, kot pri podskupini, ki je prejela 2 odmerka pri 3 in 5 mesecih starosti: proti-PRP titer ≥ 0,15µg/ml je imelo 73,0% posameznikov, proti-PT odziv je imelo 97,9% posameznikov in proti-FHA odziv je imelo 98,6% posameznikov.
English: Very common Vomiting Common
Slovenian: Bolezni prebavil zelo pogosti bruhanje pogosti driska
English: Pyrexia (body temperature ≥ 38.0°C)
Slovenian: - zvišana telesna temperatura (38°C ali več).
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (halobutyl) and tip cap (halobutyl), with 1 separate needle.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (iz halobutila) in zaščiteni z zaporko (iz halobutila), z eno ločeno iglo.
English: Prior to administration, the pre-filled syringe should be shaken in order to obtain a homogeneous, whitish, cloudy suspension.
Slovenian: Cepivo Hexacima v vialah Pred uporabo cepivo v viali pretresite, da dobite homogeno, belkasto, motno suspenzijo.
English: Essential amino acids including L-phenylalanine Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment) Water for injections.
Slovenian: dinatrijev hidrogenfosfat kalijev dihidrogenfosfat trometamol saharoza esencialne aminokisline, vključno z L-fenilalaninom natrijev hidroksid, ocetna kislina ali klorovodikova kislina (za uravnavanje pH) voda za injiciranje.
English: Other side effects
Slovenian: Neželeni učinek
English: Injection-site induration
Slovenian: - vozlič na mestu injiciranja
English: 5 Or equivalent antigenic quantity determined by a suitable immunochemical method 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Slovenian: 5 Ali enakovredna količina antigenov, določena z ustrezno imunokemijsko metodo.
English: IM
Slovenian: SERIJ
English: Data on concomitant administration of a booster dose of Hexacima with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
Slovenian: Podatki o sočasni uporabi obnovitvenega odmerka cepiva Hexacima in cepiva proti ošpicam, mumpsu in rdečkam niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
English: Package leaflet: Information for the user Hexacima suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Slovenian: Hexacima suspenzija za injiciranje v napolnjeni injekcijski brizgi Mešano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu influence tipa b (konjugirano), adsorbirano.
English: Talk to your doctor, pharmacist or nurse before vaccination if your child:
Slovenian: Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če (je) vaš otrok: • ima zmerno do zelo povišano telesno temperaturo ali akutno bolezen (npr. vročino, vnetje grla,
English: Without hepatitis B at birth
Slovenian: Brez cepljenja proti hepatitisu B ob rojstvu
English: Anti-Polio type 1 (≥ 8 (1/dilution))
Slovenian: (≥ 8 (1/razredčenje))