natgillin/translations-raw huggingface dataset:
Responses to all the co-administered antigens were satisfactory and were similar to those achieved in control groups that received DTPa-HBV-IPV-Hib* concomitantly with a MenC conjugate vaccine (MenCC) or DTPa-HBV-IPV* concomitantly with a Hib conjugate vaccine and no MenCC.
V kontrolni skupini so osebe prejele cepivo DTPa- HBV- IPV - Hib * skupaj s konjugiranim cepivom proti MenC (MenCC) ali cepivo DTPa- HBV- IPV * skupaj s konjugiranim cepivom proti Hib, brez MenCC.
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.
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 *.
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.
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.
See sections 4.8 and 5.1.
Glejte poglavji 4. 8 in 5. 1.
*GlaxoSmithKline combination vaccine
* Kombinirano cepivo podjetja GlaxoSmithKline
In clinical trials, Menitorix was administered as a 3-dose primary series (N=1,171) or as a booster (N=991) dose.
V kliničnih preskušanjih so osebe cepivo Menitorix prejele med osnovnim cepljenjem s tremi odmerki (N = 1. 171) ali kot obnovitveni odmerek (N = 991).
When Menitorix was administered as a 3-dose primary vaccination course, a DTPa- HBV-IPV* vaccine (N=796) or a DTPa-IPV vaccine* (N=375) was administered concomitantly.
Med osnovnim cepljenjem s 3 odmerki cepiva so osebe sočasno prejele cepivo DTPa- HBV- IPV * (N = 796) ali cepivo DTPa- IPV * (N = 375).
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).
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).
(See sections 4.5 and 5.1)
(Glejte poglavji 4. 5 in 5. 1).
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.
Pogostnost je navedena kot:
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)
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).
Nervous system disorders: very common: drowsiness
Zelo pogosti: zaspanost
Skin and subcutaneous tissue disorders: uncommon: dermatitis atopic rare: rash
Občasni: atopični dermatitis Redki: izpuščaj
General disorders and administration site conditions: very common: fever (rectal ≥ 38°C), swelling, pain, rednesscommon: injection site reaction uncommon: fever (rectal > 39.5°C), malaise 12 • Post-marketing experience
Zelo pogosti: zvišana telesna temperatura (rektalna ≥ 38 °C), oteklina, bolečina, rdečina Pogosti: reakcija na mestu injiciranja Občasni: zvišana telesna temperatura (rektalna > 39, 5 °C), splošno slabo počutje
The following adverse events have been reported after administration of Menitorix:
Po cepljenju s cepivom Menitorix so poročali o naslednjih neželenih učinkih:
Allergic reactions (including urticaria and anaphylactoid reactions), lymphadenopathy, dizziness, febrile seizures, hypotonia, headache.
Alergijske reakcije (vključno z urtikarijo in anafilaktoidnimi reakcijami), limfadenopatija, omotica, vročinski krči, hipotonija in glavobol.
• Other possible side effects:
12 • Drugi možni neželeni učinki:
Severe skin reactions, collapse or shock-like state (hypotonic-hyporesponsiveness episode), faints, seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia, relapse of nephrotic syndrome, arthralgia, petechiae and/ or purpura.
Hude kožne reakcije, kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda), omedlevica, epileptični napadi, pri bolnikih z epilepsijo, hipestezija, parestezija, ponovitev nefrotskega sindroma, artralgija, petehije in/ ali purpura.
Pharmacotherapeutic group: bacterial vaccines ATC code:
Bakterijska cepiva, oznaka ATC:
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-HBV- IPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
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.
Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po osnovnem cepljenju s cepivom Menitorix sočasno s cepivom DTPa- IPV * ali cepivom DTPa- HBV- IPV * je naslednji:
2-3-4 month schedule
Shema 2- 3- 4 mesec
After two doses N=93
Po dveh odmerkih N = 93 96, 8% 76, 3%
After three doses N=330†
Po treh odmerkih N = 330 † 100, 0% 97, 3%
Anti-PRP rSBA-MenC ≥ 1:8
Po dveh odmerkih N = 111 96, 4% 74, 8%
≥ 0.15 micrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
Po treh odmerkih N = 111 100, 0% 97, 3%
96.8% 76.3% 3.40 100.0% 98.9% 98.9% 679.6
100, 0%
100.0% 97.3% 11.18 98.8% 97.9% 92.4% 685.5
100, 0%
Antibody
≥ 1: 128
After three doses N=111
GMT
≥ 0.15 lmicrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
2. 467, 1
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 GMC or GMT= geometric mean antibody concentration or titre
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 GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer
Antibody persistence has been demonstrated for Hib in three clinical trials (N=217) with 98.2% of subjects having an anti-PRP concentration of ≥ 0.15 microgramsml at 11-18 months of age i. e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
V starosti od 11 do 18 mesecev, to je od 7 do 14 mesecev po dokončanem osnovnem cepljenju s tremi odmerki cepiva Menitorix, je 98, 2% oseb imelo koncentracije anti- PRP ≥ 0, 15 mikrogramov/ ml.
In three clinical trials (N=209), 92.3% of subjects had an SBA-MenC titre ≥ 1/ 8 at 11– 18 months of age, i. e. at 7-14 months following completion of a 3-dose primary series with Menitorix.
V treh kliničnih preskušanjih (N = 209) je v starosti od 11 do 18 mesecev, to je od 7 do 14 mesecev po dokončanem osnovnem cepljenju s tremi odmerki cepiva Menitorix, 92, 3% oseb imelo titre SBA - MenC ≥ 1/ 8.
All subjects responded immunologically to a challenge dose of 10 µg of unconjugated group C meningococcal polysaccharide with a thirty-three-fold increase in SBA titres demonstrating the immune memory induced by the primary vaccination course.
Vse osebe so se imunološko odzvale na cepljenje z 10 µg nekonjugiranega polisaharida meningokokov skupine C s 33- kratnim povečanjem titrov SBA, kar kaže na prisotnost imunskega spomina po osnovnem cepljenju.
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix, samim ali v kombinaciji s cepivom DTPa- HBV- IPV *, je naslednji:
Primary vaccination history
Osnovno cepljenje
Subjects primed with 3
Osebe, ki so bile osnovno
Subjects primed with 2 doses
Osebe, ki so bile osnovno
Subjects primed with 3
cepljene s 3 odmerki
Anti-PRP antibodies
Anti- PRP protitelesa
of Menitorix* N=123
3 odmerki cepiva Menitorix * N = 123
NeisVac-C** N=167
cepiva NeisVac- C ** N = 167
of Meningitec** or Menjugate** N=96
cepiva Meningitec ** ali Menjugate ** N = 96
≥ 0.15 micrograms/ ml
≥ 0, 15 mikrogramov/ ml
≥ 1 micrograms/ ml
≥ 1 mikrogram/ ml
GMC (micrograms/ ml) rSBA-MenC
GMC (mikrogrami/ ml) rSBA- MenC
≥ 1:8 ≥ 1:32 ≥ 1:128 GMT
100, 0%
100.0% 100.0% 99.2% 4172.5
100, 0%
99.4% 99.4% 99.4% 11710.5
99, 4%
98.9% 97.9% 92.6% 685.0
92, 6%
N= number of subjects with available results PRP= polyribosylribitol phospohate
N = število oseb z razpoložljivimi rezultati PRP= poliribozilribitol fosfat rSBA- MenC= serumska baktericidna protitelesa proti meningokoknemu polisaharidu C pri uporabi kunčjega komplementa GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer
14 rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines
14% = odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa * = sočasno cepljenje s cepivom DTPa- HBV- IPV ** = sočasno cepljenje s cepivi s komponentami DTPa- Hib- TT
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix v kombinaciji s cepivom proti ošpicam, mumpsu in rdečkam (MMR) *, je naslednji:
Primary vaccination history
cepljene s 3 odmerki
Subjects primed with 3 doses of Menitorix* N= 349
3 odmerki cepiva Menitorix * N = 349
Subjects primed with 3 doses of Meningitec + Pediacel N= 115
cepiva Meningitec + Pediacel N = 115
Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
uradno potrjenega cepiva Meningitec ** ali cepiva Menjugate ** N = 96
Anti-PRP antibodies ≥ 0.15 micrograms/ ml
Anti- PRP protitelesa ≥ 0, 15 mikrogramov/ ml
GMC (micrograms/ ml)
GMC (mikrogrami/ ml)
37.17
94, 7%
≥ 1:8 ≥ 1:32 ≥ 1:128 GMT
96, 8%
99.1% 98.8% 97.7% 2193.7
97, 7%
95.6% 94.7% 86.0% 477.9
86, 0%
98.9% 96.8% 89.5% 670.2
89, 5%
N= number of subjects with available results PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-IPV vaccines **= co-administered with DTPa-Hib-TT containing vaccines
N = število oseb z razpoložljivimi rezultati PRP= poliribozilribitol fosfat rSBA- MenC= serumska baktericidna protitelesa proti meningokoknemu polisaharidu C pri uporabi kunčjega komplementa GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer% = odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa * = sočasno cepljenje s cepivom DTPa- HBV- IPV ** = sočasno cepljenje s cepivi s komponentami DTPa- Hib- TT
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).
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).
SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
Rezultati SBA- MenC so na voljo za 177 oseb, rezultati anti - PRP pa za 178 oseb.
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.
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.
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.
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%).
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.
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%).
There were no significant differences between the two groups in the proportions with SBA-MenC titers of at least 1:8 or anti-PRP antibody concentrations of at least 0.15 µg/ ml.
Med obema skupinama ni bilo pomembne razlike v deležih oseb s titri SBA- MenC vsaj 1: 8 ali koncentracijo protiteles anti- PRP vsaj 0, 15 µg/ ml.
Within one year of completion of
Ocene učinkovitosti cepiva iz programa rutinskega cepljenja v Veliki Britaniji (z uporabo različne količine treh konjugiranih cepiv proti meningokokom skupine C, ki pokrivajo obdobje od uvedbe konec leta 1999 do meseca marca 2004 kažejo na potrebnost obnovitvenega odmerka po dokončanju osnovnega cepljenja (cepljenje s tremi odmerki v starosti 2, 3 in 4 mesece).
15 the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
V enem letu po dokončanju osnovnega cepljenja, je bila učinkovitost cepiva v kohorti dojenčkov ocenjena na 93% (95% interval zaupanja; 67 – 99%).
Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.
Učinkovitost pri osebah v vseh ostalih starostnih skupinah (do 18 leta starosti), ki so
*GlaxoSmithKline combination vaccine
15 prejele enkratni odmerek, trenutno ostaja približno 90- odstotna ali večja v času enega leta po cepljenju ali kasneje.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C – 8°C).
Cepivo morate aplicirati takoj po rekonstituciji ali pa ga shraniti v hladilniku (2 °C – 8 °C).
Do not freeze Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
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:
6. 5 Vrsta ovojnine in vsebina
- pack size of 1 vial of powder plus 1 pre-filled syringe of solvent with 2 separate needles or
- 1 viala s praškom in 1 napolnjena injekcijska brizga z vehiklom, skupaj z 2 priloženima
without needles
injekcijskima iglama ali brez.
- pack size of 10 vials of powder plus 10 pre-filled syringes of solvent with 2 separate needles or
- 10 vial s praškom in 10 napolnjenih injekcijskih brizg z vehiklom, skupaj z 2 priloženima
Not all pack sizes may be marketed.
16 Na trgu ni vseh navedenih pakiranj.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Pred cepljenjem morate rekonstituirano cepivo vizualno pregledati glede morebitne prisotnosti kakršnihkoli tujih delcev in/ ali neobičajnega fizikalnega videza.
The reconstituted vaccine is a clear and colourless solution. Inject the entire contents of the vial.
Injicirajte celotno vsebino viale.
Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I – To be completed nationally]
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica]
After reconstitution, 1 dose (0.5 ml) contains:
Po rekonstituciji en odmerek (0, 5 ml) cepiva vsebuje:
Solvent 1 dose (0.5 ml)
Prašek in vehikel za raztopino za injiciranje 1 viala: prašek 1 napolnjena injekcijska brizga: vehikel 1 odmerek (0, 5 ml)
Solvent 2 needles 1 dose (0.5 ml)
1 viala: prašek 1 napolnjena injekcijska brizga: vehikel 2 injekcijski igli 1 odmerek (0, 5 ml)
Solvent 10 x 1 dose (0.5 ml)
10 vial: prašek 10 napolnjenih injekcijskih brizg: vehikel 10 x 1 odmerek (0, 5 ml)
Powder 10 pre-filled syringes:
10 vial: prašek 10 napolnjenih injekcijskih brizg: vehikel 20 injekcijskih igel 10 x 1 odmerek (0, 5 ml)
Solvent 20 Needles 10 x 1 dose (0.5 ml)
POSTOPEK IN POT( I) UPORABE ZDRAVILA
19 5.
19 Intramuskularna uporaba.
Intramuscular use Read the package leaflet before use Shake well before use
Pred uporabo dobro pretresite.
Do not inject intravenously.
Cepivo ne smete injicirati v žilo.
GENERAL CLASSIFICATION FOR SUPPLY
20 [Izpolni država članica]
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA
Menitorix and associated names (see Annex I) solvent for solution for injection [See Annex I – To be completed nationally] I. M.
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica] i. m.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA
Menitorix and associated names (See Annex I) powder for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I – To be completed nationally] I. M.
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica] i. m.
24 PACKAGE LEAFLET:
24 NAVODILO ZA UPORABO:
Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I – To be completed nationally]
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica]
What Menitorix is and what it is used for 2.
Kaj je cepivo Menitorix in za kaj ga uporabljamo 2.
Before your child receives Menitorix 3.
Kaj morate vedeti, preden bo otrok cepljen s cepivom Menitorix 3.
How Menitorix is given 4.
Kako se cepivo Menitorix uporablja 4.
How to store Menitorix 6.
Shranjevanje cepiva Menitorix 6.
• Haemophilus influenzae type b (Hib):
• Haemophilus influenzae tipa b (Hib):
Even after recovery from Hib meningitis there can be complications such as mental retardation, spastic paralysis, deafness or epilepsy.
Hib je bakterija, ki najpogosteje povzroči meningitis (vnetje možganskih ovojnic in ovojnic hrbtnega mozga), ki je kljub ozdravitvi lahko povezan z zapleti, kot so duševna zaostalost, spastična paraliza, gluhost ali epilepsija.
Less commonly, the bacteria can infect other parts of the body, particularly the lungs (causing pneumonia) and the bones and joints. • Neisseria meningitidis group C (MenC):
Bakterija lahko redkeje prizadene druge dele telesa, predvsem pljuča (povzroči pljučnico) in kosti ter sklepe. • Neisseria meningitidis skupine C (MenC):
Like Hib bacteria, MenC bacteria most frequently cause meningitis.
Podobno kot bakterija Hib tudi bakterija MenC najpogosteje povzroči meningitis.
• 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).
• 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
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
25 preobčutljiv za katerokoli sestavino cepiva (glejte poglavje 6).
25 • if your child has a high temperature (38oC or above) or a severe infection.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težko dihanje in otekanje obraza ali jezika. • če ima zvišano telesno temperaturo (38 ºC ali višjo) ali hudo okužbo.
Also, if your child has HIV infection or any other illness that can reduce his or her immunity to infections.
• če ima otrok težave s krvavitvami ali hitrim pojavom modric. • 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.
Your child can still be given Menitorix if your doctor or nurse advises it but your child may not develop as good protection against Hib and MenC infections as other children. • if your child was born prematurely (before 37 weeks).
Če otrokov zdravnik ali medicinska sestra cepljenje svetuje, lahko otrok cepivo Menitorix kljub temu prejme, vendar pa je zaščita proti Hib in MenC lahko slabša kot pri drugih otrocih. • če je bil otrok rojen prezgodaj (pred 37 tednom nosečnosti).
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Zdravnika obvestite tudi, če je bil otrok pred kratkim cepljen s katerimkoli cepivom.
Each dose of Menitorix is a single injection of half a millilitre (0.5 ml).
En odmerek cepiva Menitorix je enkratna injekcija pol mililitra (0, 5 ml) cepiva.
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.
Oseba, ki bo otroka cepila, bo poskrbela, da cepiva ne bo vbrizgala v žilo ali v zgornjo plast kože.
If Menitorix is used in infants for the first vaccinations against Hib and MenC:
Osnovno cepljenje proti Hib in MenC s cepivom Menitorix: