FrancophonIA/ELRC3.0 huggingface dataset:
English: • if your child has previously had any allergic reaction to Menitorix, to any Hib or MenC vaccine, to tetanus toxoid or to any other ingredient present in the vaccine (see section 6).
Slovenian: • če se je po predhodnem cepljenju s cepivom Menitorix, katerimkoli drugim cepivom proti Hib ali proti MenC ali tetanusnim toksoidom pri otroku pojavila alergijska reakcija ali če je otrok preobčutljiv za katerokoli sestavino cepiva (glejte poglavje 6).
English: However, following several reports of suspected ADRs, section 4.8 of the Menitorix SPC was updated.
Slovenian: Vendar pa je predlagatelj po nekaj poročilih o sumu na neželene reakcije posodobil poglavje 4.8 Povzetka glavnih značilnosti zdravila za zdravilo Menitorix.
English: Clinical alertness to the possibility of co-incidental meningitis should be maintained.
Slovenian: Upoštevati je treba možnost sočasnega pojava meningitisa.
English: Menitorix is a freeze-dried vaccine preparation consisting of 5µg of the purified H. influenzae type b capsular polysaccharide, polyribosylribitol phosphate (PRP) and 5µg of the meningococcal capsular polysaccharide of group C (PSC) both directly conjugated to tetanus toxoid (TT) carrier protein.
Slovenian: Zdravilo Menitorix je sušeno in zamrznjeno cepivo, ki vsebuje 5 µg prečiščenega polisaharida kapsule virusa H. influenzae tipa b, poliribozilribitol fosfata (PRP) in 5 µg polisaharida kapsule meningokoka iz skupine C (PSC), ki sta oba neposredno konjugirana s prenašalno beljakovino tetanusnega toksoida (TT).
English: In one of these trials, the incidences of adverse reactions observed in subjects (N=102) who received Menitorix concomitantly with MMR* were similar to those observed in the group who received MMR alone (N=91) or Menitorix alone (N=104).
Slovenian: V enem od teh preskušanj je bila pojavnost neželenih učinkov pri osebah, ki so cepivo Menitorix prejele skupaj s cepivom proti MMR* (N = 102), podobna kot pri osebah, ki so prejele samo cepivo proti MMR (N = 91) ali samo cepivo Menitorix (N = 104).
English: If your child experiences neck pain, neck stiffness or a dislike of light (photophobia), drowsiness or confusion, or red or purple bruise-like spots that do not fade under pressure you should contact your doctor or local accident and emergency department immediately to rule out other causes.
Slovenian: Če se pri otroku pojavi bolečina v vratu, otrdelost vratu ali odpor pred svetlobo (fotofobija), zaspanost ali zmedenost, rdeči ali škrlatni madeži, podobni modricam, ki pri pritisku nanje ne zbledijo, se morate zaradi izključitve drugih možnih vzrokov nemudoma posvetovati z otrokovim zdravnikom ali poiskati zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Velika Britanija
English: In clinical trials, Menitorix was administered as a 3-dose primary series (N=1,171) or as a booster (N=991) dose.
Slovenian: V kliničnih preskušanjih so osebe cepivo Menitorix prejele med osnovnim cepljenjem s tremi odmerki (N = 1.171) ali kot obnovitveni odmerek (N = 991).
English: Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000)
Slovenian: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Subjects primed with 3 doses of Meningitec + Pediacel N= 115
Slovenian: Osebe, ki so bile osnovno cepljene s 3 odmerki cepiva Meningitec + Pediacel N = 115
English: GMC or GMT= geometric mean antibody concentration or titre
Slovenian: GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer
English: The following adverse events have been reported after administration of Menitorix: Allergic reactions (including urticaria and anaphylactoid reactions), lymphadenopathy, dizziness, febrile seizures, hypotonia, headache.
Slovenian: Po cepljenju s cepivom Menitorix so poročali o naslednjih neželenih učinkih: Alergijske reakcije (vključno z urtikarijo in anafilaktoidnimi reakcijami), limfadenopatija, omotica, vročinski krči, hipotonija in glavobol.
English: The CHMP considered that the safety data submitted indicates that the local and systemic AEs observed during clinical studies were as expected in terms of types and rates for a polysaccharideprotein conjugate vaccine and showed similar reactogenicity to other mono-component MenC and Hib vaccines in various clinical studies.
Slovenian: CHMP je menil, da predloženi podatki o varnosti kažejo, da so bili lokalni in sistemski neželeni učinki, ki so jih opazili med kliničnimi študijami, pričakovani glede na tipe in razmerja za cepivo konjugiranega polisaharida-proteina in da je cepivo pokazalo podobne sposobnosti sproženja imunske reakcije kot druga enokomponentna cepiva proti MenC in Hib v različnih kliničnih študijah.
English: ♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
Slovenian: ♦ Redki (pri manj kot 1 od 1.000, vendar več kot 1 od 10.000 odmerkov cepiva) • Izpuščaj.
English: Menitorix can be given at the same time as vaccines intended to protect against one or more of diphtheria, tetanus, whooping cough, polio, hepatitis B, pneumococcal conjugate vaccine and combined vaccines against measles, mumps and rubella (MMR).
Slovenian: Cepivo Menitorix se lahko uporablja sočasno z enim ali več konjugiranimi cepivi proti davici, tetanusu, oslovskemu kašlju, otroški ohromelosti, hepatitisu B ali pneumokokom in kombiniranimi cepivi proti ošpicam, mumpsu in rdečkam (MMR).
English: Subjects primed with 2 doses of NeisVac-C** N=167
Slovenian: Osebe, ki so bile osnovno cepljene z dvema odmerkoma cepiva NeisVac-C** N = 167
English: Menitorix can be used to boost protection in children who received Menitorix previously or in children who previously received other vaccines against these diseases (including children who received two doses of a MenC vaccine in early life).
Slovenian: Cepivo Menitorix se lahko uporabi za obnovitev odziva pri otrocih, ki so bili osnovno cepljeni s cepivom Menitorix, in otrocih, ki so bili osnovno cepljeni z drugim cepivom proti tem boleznim (vključno z otroci, ki so prejeli dva odmerka cepiva proti MenC v zgodnjem otroštvu).
English: Nervous system disorders: very common: drowsiness
Slovenian: Bolezni živčevja: Zelo pogosti: zaspanost
English: Booster vaccination:
Slovenian: Obnovitveno cepljenje:
English: The CHMP considered that the data suggests that the likely long term protection afforded by Menitorix should not be a cause for concern when used for priming and boosting or for boosting children primed with other MenC conjugate vaccines.
Slovenian: CHMP je menil, da podatki kažejo, da verjetna dolgotrajna zaščita, ki jo nudi zdravilo Mentorix, ne bi smela biti razlog za skrb pri uporabi za osnovno in poživitveno cepljenje ali samo za poživitveno cepljenje pri otrocih, ki so prejeli osnovni odmerek drugega konjugiranega cepiva proti MenC.
English: Clinical trials have evaluated the antibody responses at one month after two doses and after completion of a 3-dose primary vaccination course of Menitorix (co-administered with DTPa-HBVIPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
Slovenian: V kliničnih preskušanjih so protitelesni odziv en mesec po prejemu dveh odmerkov cepiva in po dokončanju osnovnega cepljenja s tremi odmerki cepiva Menitorix (sočasno cepljenje s cepivom DTPa-HBV-IPV ali DTPa-IPV) približno v 2., 3., 4. mesecu ali 2., 4., 6 mesecu ovrednotili pri 814 otrocih.
English: The nurse or doctor will give Menitorix as an injection into the muscle (usually into the thigh muscle but in toddlers the arm muscle can be used) and will make sure that the vaccine is not given into a blood vessel or into the upper layer of the skin.
Slovenian: Medicinska sestra ali zdravnik bo cepivo vbrizgal v mišico (običajno v mišico stegna, pri starejših otrocih pa lahko tudi v mišico nadlahti).
English: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
Slovenian: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, Velika Britanija
English: After the first course of vaccinations against Hib and MenC has been completed a booster dose of Hib and MenC should be given, usually at some time in the second year of life.
Slovenian: Po dokončanem osnovnem cepljenju proti Hib in MenC mora otrok prejeti obnovitveni odmerek cepiva proti Hib in MenC, običajno sočasno v drugem letu življenja.
English: The new totals are therefore 3293 infants vaccinated with Menitorix either as a primary course or as a booster and 578 infants vaccinated with 1713 doses of closely related Hib-MenC formulations.
Slovenian: Novi seštevki bolnikov so torej 3.293 dojenčkov, ki so jih cepili z zdravilom Menitorix v obliki osnovnega ali poživitvenega cepljenja, in 578 dojenčkov, ki so jih cepili s 1.713 odmerki zdravil z zelo podobnimi formulacijami Hib-MenC.
English: Each dose of Menitorix is a single injection of half a millilitre (0.5 ml).
Slovenian: En odmerek cepiva Menitorix je enkratna injekcija pol mililitra (0,5 ml) cepiva.
English: Antibody levels have been measured at 18 months after the administration of a booster dose of Menitorix at age 14 Months to subjects who had been primed in infancy with either Menitorix at 2, 4 and 6 months of age or with NeisVac-C at 2, 4 months of age (and a DTPa/Hib containing vaccine at 2, 4, 6 months of age).
Slovenian: Koncentracija protiteles je bila določena 18 mesecev po cepljenju z obnovitvenim odmerkom cepiva Menitorix pri starosti 14 mesecev pri osebah, ki so bile osnovno cepljene v otroštvu bodisi s cepivom Menitorix v starosti 2, 4 in 6 mesecev ali cepivom NeisVac-C v starosti 2, 4 mesece (in cepivom DTPa/Hib pri starosti 2, 4, 6 mesece).
English: Menitorix should be given by intramuscular injection only, preferably in the anterolateral thigh region.
Slovenian: Cepivo Menitorix je treba injicirati intramuskularno, po možnosti v anterolateralni predel stegna.
English: The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
Slovenian: Cepivo rekonstituirajte tako, da celotno količino vehikla v napolnjeni injekcijski brizgi dodate viali s praškom.
English: In a trial of primary vaccination, concomitant administration of an investigational vaccine containing the same amount of conjugated Hib and MenC saccharides as in Menitorix with DTPa-HBV-IPV* and a licensed pneumococcal saccharide conjugated vaccine (the three injections were made into anatomically distant sites) gave similar immune responses to the seven pneumococcal serotypes as achieved in a group that received DTPa-HBV-IPV* concomitantly with Hib (conjugated to tetanus toxoid) and a licensed pneumococcal saccharide conjugated vaccine.
Slovenian: V preskušanju osnovnega cepljenja je bil pri sočasnem cepljenju s preiskovanim cepivom, ki je vsebovalo enako količino konjugiranih Hib in MenC saharidov, kot cepivo Menitorix, in cepivom DTPa-HBV-IPV* ter uradno potrjenim cepivom s konjugiranim pnevmokoknim saharidom (tri injekcije na anatomsko različna mesta) imunski odziv na sedem serotipov pnevmokokov enak kot v skupini, ki je prejela cepivo DTPa-HBV-IPV* skupaj s cepivom proti Hib (konjugirano na tetanusni toksoid) in uradno potrjeno konjugirano cepivo s pnevmokoknim saharidom.
English: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom
Slovenian: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS
English: In two clinical trials (N=578), Menitorix was administered concomitantly with Measles, Mumps, Rubella (MMR) vaccine.
Slovenian: V dveh kliničnih preskušanjih so osebe (N = 578) cepivo Menitorix prejele skupaj s cepivom proti ošpicam, mumpsu in rdečkam (MMR).
English: Remember that the first dose of Menitorix should not be given before your child is 2 months of age.
Slovenian: Otrok prvega odmerka cepiva Menitorix ne sme prejeti, dokler ne dopolni dveh mesecev starosti.
English: Powder in a vial (type I glass) with a stopper (butyl rubber), 0.5 ml of solvent in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) with or without separate needles in the following pack sizes: - pack size of 1 vial of powder plus 1 pre-filled syringe of solvent with 2 separate needles or without needles - pack size of 10 vials of powder plus 10 pre-filled syringes of solvent with 2 separate needles or without needles
Slovenian: 0,5 ml vehikla v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) in s priloženimi injekcijskimi iglami ali brez v naslednjih velikostih pakiranja: - 1 viala s praškom in 1 napolnjena injekcijska brizga z vehiklom, skupaj z 2 priloženima injekcijskima iglama ali brez.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravenously.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Cepivo ne smete injicirati v žilo.
English: ≥0.15 micrograms/ml ≥1 micrograms/ml
Slovenian: ≥ 0,15 mikrogramov/ml ≥ 1 mikrogram/ml
English: Like all medicines, Menitorix can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi cepivo Menitorix neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
English: • if your child takes medicines or has any treatment which may affect the immune system.
Slovenian: • če se otrok zdravi ali se je zdravil s katerimkoli zdravilom, ki lahko vpliva na delovanje imunskega sistema, ali ima okužbo z virusom HIV ali katero drugo bolezen, ki lahko zmanjša njegovo odpornost proti okužbam.
English: Overall, the CHMP considers the safety database to be of adequate size and satisfactory in content, supporting the use of Menitorix for priming in infancy and for boosting children in the second year of life who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
Slovenian: V splošnem CHMP meni, da je baza podatkov o varnosti primerne velikosti in zadovoljiva po vsebini ter da podpira uporabo zdravila Menitorix za osnovno cepljenje dojenčkov in poživitveno cepljenje otrok v drugem letu starosti, ki so že prejeli osnovno cepljenje z zdravilom Menitorix ali drugimi konjugiranimi cepivi proti virusu Hib in MenC.
English: Overall, 92.7% of 177 subjects had SBA-MenC titres of at least 1:8 and 99.4% of the 178 subjects had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Slovenian: V celoti je titre SBA-MenC vsaj 1:8 imelo 92,7 % od 177 oseb, koncentracijo protiteles anti-PRP vsaj 0,15 µg/ml pa 99,4 % od 178 oseb.
English: In the group primed with NeisVac-C 115/121 (95%) had SBA-MenC titers of at least 1:8 and 121/122 (99.2%) had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Slovenian: V skupini, ki je bila osnovno cepljena s cepivom NeisVac-C je titre SBA-MenC vsaj 1:8 imelo 115/121 (95 %) oseb, koncentracijo protiteles anti-PRP vsaj 0,15 µg/ml pa 121/122 (99,2 %).
English: Acute severe febrile illness.
Slovenian: Hujše akutno obolenje z zvišano telesno temperaturo.
English: The vaccine cannot cause Hib and MenC.
Slovenian: Cepivo ne more povzročiti okužbe s Hib ali MenC.
English: Although symptoms of meningism such as neck pain/stiffness or photophobia have been reported following administration of other MenC conjugate vaccines, there is no evidence that MenC conjugate vaccines cause meningitis.
Slovenian: Po dajanju drugih konjugiranih cepiv proti MenC so poročali simptomih meningizma, kot so bolečina v vratu/otrdelost vratu ali fotofobija, vendar pa ni dokazov, da bi konjugirana cepiva proti MenC povzročila meningitis.
English: When Menitorix was administered as a 3-dose primary vaccination course, a DTPaHBV-IPV* vaccine (N=796) or a DTPa-IPV vaccine* (N=375) was administered concomitantly.
Slovenian: Med osnovnim cepljenjem s 3 odmerki cepiva so osebe sočasno prejele cepivo DTPa-HBV-IPV* (N = 796) ali cepivo DTPa-IPV* (N = 375).
English: Powder and solvent for solution for injection White powder and a clear colourless solvent.
Slovenian: FARMACEVTSKA OBLIKA Prašek in vehikel za raztopino za injiciranje Bel prašek in bister ter brezbarven vehikel.
English: Psychiatric disorders: very common: irritability uncommon: crying
Slovenian: Zelo pogosti: razdražljivost Občasni: jok
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration.
Slovenian: Pred cepljenjem morate rekonstituirano cepivo vizualno pregledati glede morebitne prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza.
English: The immune response to the Hib and MenC components of Menitorix was only assessed in primary vaccination clinical studies that employed co-administration with DTPa-IPV* or DTPa-HBV-IPV* vaccines.
Slovenian: Imunski odziv na komponenti proti Hib in MenC cepiva Menitorix je bil ovrednoten le v kliničnih študijah osnovnega cepljenja, v katerih so osebe sočasno prejele tudi cepivo DTPa-IPV* ali DTPa-HBV-IPV*.
English: There are no data on concomitant use of Menitorix with whole cell pertussis and oral poliomyelitis vaccines, however, no interference is expected.
Slovenian: O sočasni uporabi cepiva Menitorix in cepiva proti oslovskemu kašlju s celotno celico ter peroralnega cepiva proti otroški ohromelosti ni podatkov, vendar pa medsebojnega delovanja ne pričakujemo.
English: 10 x 1 dose (0.5 ml)
Slovenian: 10 x 1 odmerek (0,5 ml)
English: Read the package leaflet before use Shake well before use
Slovenian: Pred uporabo preberite priloženo navodilo.
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml rSBA-MenC
Slovenian: Anti-PRP protitelesa mikrogramov/ml ≥ 1 mikrogram/ml GMC (mikrogrami/ml) rSBA-MenC
English: In a trial of booster vaccination against Hib and MenC, Menitorix was administered concomitantly (into opposite thighs) with a first dose of combined measles, mumps and rubella (MMR) vaccine.
Slovenian: V preskušanju obnovitvenega cepljenja proti Hib in MenC, so osebe cepivo Menitorix prejele sočasno (v drugo stegno) s prvim odmerkom kombiniranega cepiva proti ošpicam, mumpsu in rdečkam (MMR).
English: Hypersensitivity reaction after previous administration of Menitorix.
Slovenian: Preobčutljivostna reakcija po predhodnem cepljenju s cepivom Menitorix.
English: No data are available on the use of Menitorix in immunodeficient subjects.
Slovenian: Podatki o uporabi cepiva Menitorix pri nedonošenčkih niso na voljo.
English: In various studies with licensed monovalent meningococcal group C conjugate vaccines, concomitant administration with combinations containing diphtheria, tetanus and acellular pertussis components (with or without inactivated polio viruses, hepatitis B surface antigen or Hib conjugate [e.g. DTPaHBV-IPV-Hib*]), has been shown to result in lower serum bactericidal antibody (SBA) geometric mean titres (GMT) compared to separate administrations or to co-administration with whole cell pertussis vaccines.
Slovenian: V različnih študijah so bili pri cepljenju z uradno potrjenimi monovalentnimi konjugiranimi cepivi proti meningokokom skupine C v kombinaciji s cepivi proti davici, tetanusu in oslovskemu kašlju (acelularno) (z inaktiviranimi poliovirusi, površinskim antigenom virusa hepatitisa B ali Hib konjugatom ali brez [npr. DTPa-HBV-IPV-Hib*]) geometrijski srednji titri (GMT; “geometric mean titres”) baktericidnih protiteles v serumu nižji kot pri ločenem ali sočasnem cepljenju s cepivi proti oslovskemu kašlju s celotno celico, delež oseb s titri SBA vsaj 1:8 pa ni bil manjši.
English: powder and solvent for solution for injection intramuscular injection
Slovenian: Prašek in vehikel za raztopino za injiciranje
English: If you miss an appointment, it is very important that you contact the surgery or clinic and make a new appointment for your child to have the missed dose or doses as soon as possible.
Slovenian: Če ste na dogovorjeni termin pozabili je zelo pomembno, da se čimprej dogovorite za naslednji termin, da bo otrok čimprej prejel preostale odmerke cepiva.
English: Based on - the Rapporteur's and Co-Rapporteur's assessment reports, - the Applicant/MAH response to the CHMP questions, - the Scientific discussion within the Committee,
Slovenian: - ocenjevalnih poročil poročevalca in soporočevalca, - odziva predlagatelja/imetnika dovoljenja za promet z zdravilom na vprašanja odbora CHMP, - znanstvene razprave v Odboru je CHMP priporočil odobritev dovoljenja za promet z zdravilom Menitorix, s popravki v ustreznih delih informacij o zdravilu in z obvezami, ki jih je treba izpolniti.
English: N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Slovenian: N = število oseb z razpoložljivimi rezultati %= odstotek oseb s titri, enakimi ali večjimi od mejne vrednosti testa PRP= poliribozilribitol fosfat rSBA-MenC= serumska baktericidna protitelesa proti meningokoknemu polisaharidu C pri uporabi kunčjega komplementa
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] Medicinal product subject to medical prescription.
Slovenian: [Izpolni država članica] Izdaja zdravila je le na recept.
English: In the Menitorix primed and boosted group 49/56 (87.5%) of the subjects had SBA-MenC titers of at least 1:8 and 56/56 (100%) had anti-PRP antibody concentrations of at least 0.15 µg/ml.
Slovenian: V skupini, ki je prejela osnovne in obnovitveni odmerek cepiva Menitorix, je titre SBA-MenC vsaj 1:8 imelo 49/56 (87,5 %) oseb, koncentracijo protiteles anti-PRP vsaj 0,15 µg/ml pa 56/56 (100%).
English: The reconstituted vaccine is a clear and colourless solution.Inject the entire contents of the vial.
Slovenian: Rekonstituirano cepivo je bistra in brezbarvna raztopina.
English: MenC PSC - Neisseria meningitidis serogroup C polysaccharide
Slovenian: MenC PSC - polisaharid Neisseria meningitidis serološke skupine C
English: After two doses N=111
Slovenian: Po dveh odmerkih N = 111
English: In children who received an acellular pertussis combination vaccine containing Hib in the primary infant immunisation series the Hib booster dose should be given before the age of 2 years.
Slovenian: Otrok, ki je med osnovnim cepljenjem prejel kombinirano cepivo z acelularno komponento proti oslovskemu kašlju in komponento proti Hib, mora obnovitveni odmerek cepiva proti Hib prejeti pred dopolnjenim drugim letom starosti.
English: There are no data on the use of Menitorix for one or two doses of the primary vaccination course and other Hib and/or MenC conjugate vaccines for other dose(s).
Slovenian: Podatki o osnovnem cepljenju z enim ali dvema odmerkoma cepiva Menitorix in odmerkom (odmerki) drugega konjugiranega cepiva proti Hib in/ali MenC niso na voljo.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and single and repeated dose toxicity studies.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri enkratnem odmerku ter ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: The data support the use of Menitorix for priming in infancy and for boosting in the second year of life and for boosting toddlers who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
Slovenian: Podatki podpirajo uporabo zdravila Menitorix za osnovno cepljenje pri dojenčkih in poživitveno cepljenje v drugem letu starosti ter za poživitveno cepljenje majhnih otrok, ki so prejeli osnovni odmerek zdravila Menitorix ali drugih konjugiranih cepiv proti Hib in MenC.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki morata biti v takšnem primeru nemudoma na voljo.