qanastek/EMEA-V3 huggingface dataset:
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
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata: komuni ħafna: deni (fir- rectum ≥ 38°Ċ) nefħa, uġigħ, ħmura, komuni: reazzjoni fis- sit ta ’ l- injezzjoni mhux komuni: deni (fir- rectum > 39. 5°Ċ), telqa
The following adverse events have been reported after administration of Menitorix:
Ġew innotati dawn l- effetti sekondarji li ġejjin wara li ngħatat Menitorix:
Allergic reactions (including urticaria and anaphylactoid reactions), lymphadenopathy, dizziness, febrile seizures, hypotonia, headache.
Reazzjonijiet allerġiċi (li jinkludu urtikarja u reazzjonijiet anafilattiċi), limfadenopatija, sturdament, aċċessjonijiet minħabba d- deni, nuqqas ta ’ saħħa fil- muskoli, uġigħ ta ’ ras
• Other possible side effects:
• Effetti sekondarji oħra possibbli:
The following have not been reported in association with administration of Menitorix but have occurred very rarely during routine use of licensed meningococcal group C conjugate vaccines:
13 Dawn li ġejjin ma ġewx irrappurtati b’ xi konnessjoni ma ’ l- għoti ta ’ Menitorix iżda seħħew rarament ħafna waqt l- użu ta ’ rutina ta ’ vaċċini konjugati lliċenzjati tal- meninġokokku tas- serogrupp Ċ:
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.
Reazzjonijiet qawwija fil- ġilda, kollass jew stat qisu ta ’ xokk (episodju hypotonic - hyporesponsiveness), ħass ħażin, aċċessjonijiet f’ persuni li kienu minn qabel suġġetti għalihom, hypoaesthesia, paraesthesia, rikaduta tas- sindrome nefrotika, artralġja, petechiae u/ jew purpura.
*GlaxoSmithKline combination vaccine
* Vaċċin ikkombinat GlaxoSmithKline
Pharmacotherapeutic group: bacterial vaccines ATC code:
Vaċċini batterjali Kodiċi ATC:
Primary vaccination course
Kors ta ’ tilqim primarju
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.
Studji kliniċi vvalutaw ir- reazzjonijiet ta ’ antikorpi fi żmien xahar wara żewġ dożi u wara li jintemm kors ta ’ tilqim primarju bi tliet dożi ta ’ Menitorix (mogħti flimkien ma ’ vaċċini DTPa- HBV- IPV jew DTPa- IPV) li ġew mogħtija fl- etajiet ta ’ 2, 3 u 4 xhur jew 2, 4 u 6 xhur lil 814 tarbija.
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:
Perċentwali ta ’ persuni b’ livelli ta ’ antikorpi ≥ assay cut- off xahar wara tilqim primarju b’ Menitorix mogħti b’ vaċċini DTPa- IPV * jew DTPa- HBV- IPV * kienu kif ġej:
Antibody
Antikorp Anti- PRP
2-3-4 month schedule
≥0. 15 mikrogrammi / ml
After two doses N=93
Wara żewġ N=93 96. 8%
After three doses N=330†
Skeda ta ’ 2- 3- 4 xhur dożi Wara tliet dożi N=330 † 100. 0%
≥ 0.15 micrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
685. 5
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%
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
100. 0%
13 † = subjects ≤ 18 weeks of age at time of third Menitorix dose
≥1: 32
Antibody
100. 0%
2-4-6 month schedule
100. 0%
After two doses N=111
≥1: 128
After three doses N=111
96. 4%
Anti-PRP rSBA-MenC ≥ 1:8
99. 1%
≥ 0.15 lmicrograms/ ml ≥ 1 micrograms/ ml GMC (micrograms/ ml) ≥ 1:32 ≥ 1:128 GMT
GMT
96.4% 74.8% 3.26 100.0% 100.0% 96.4% 847.2
847. 2
100.0% 97.3% 12.84 100.0% 100.0% 99.1% 2467.1
2467. 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= numru ta ’ persuni b’ riżultati disponibbli% = perċentwal ta ’ persuni b’ livelli ugwali daqs jew aktar mill- cut- off PRP = polyribosylribitol phosphate rSBA- MenC= antikorpi batteriċidi fis- serum kontra l- polisakkarid Ċ tal- meninġokokku biż- żjieda ta ’ sustanza meħuda mill- fenek GMC jew GMT= konċentrazzjoni jew livell medju ġeometriku ta ’ antikorpi
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.
Irriżultat persistenza ta ’ antikorpi għal Hib fi tliet provi kliniċi (N=217) f’ 98. 2% tal- persuni b’ konċentrazzjoni ta ’ ≥ 0. 15 mikrogrammi/ ml fl- eta ’ ta ’ 11 - sa 18- il xahar, jiġifieri 7 - sa 14- il xahar wara li jkun tlesta l- kors primarju ta ’ 3 dożi Menitorix.
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.
Fi tliet provi kliniċi (N=209), 92. 3% tal- persuni kellhom liveli SBA- MenC ≥ 1/ 8 fl- eta ’ ta ’ 11 - sa 18- il xahar, jiġifieri 7 - sa 14- il xahar wara li jkun tlesta l- kors primarju ta ’ tliet dożi b’ Menitorix.
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.
Il- persuni kollha rrispondew immunoloġikament għal doża challenge ta ’ 10 µg ta ’ polisakkarid mhux ikkonjugat tal- grupp Ċ tal- meninġokokku bi żjieda ta ’ tlieta u tletin darba aktar f ’ livelli ta ’ SBA li turi l - memorja immuni li rriżultat mill- kors primarju ta ’ tilqim.
Booster vaccination
Tilqim booster
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:
Perċentwali ta ’ persuni b’ livelli ta ’ antikorpi ≥ assay cut- off xahar wara t- tilqima booster b’ Menitorix mogħtija waħedha jew flimkien ma ’ vaċċin DTPa- HBV- IPV * kienu kif ġej:
Primary vaccination history
Storja ta ’ tilqim primarju
Subjects primed with 3
Persuni li jkunu ħadu 3 dożi ta ’ Menitorix * N=123
Subjects primed with 2 doses
Persuni li jkunu ħadu 2 dożi ta ’ NeisVac- C ** N=167
Subjects primed with 3
Persuni li jkunu ħadu 3 dożi ta ’ Meningitec ** jew Menjugate ** N=96
Anti-PRP antibodies
Antikorpi Anti- PRP ≥0. 15 mikrogrammi / ml
of Menitorix* N=123
100. 0% 100. 0%
of
100. 0%
NeisVac-C** N=167
15 ≥1 mikrogrammi / ml
doses
100. 0%
≥ 0.15 micrograms/ ml
98. 8%
100.0%
99. 0%
100.0%
100. 0%
≥ 1 micrograms/ ml
11710. 5
100.0%
685. 0
98.8%
N= Numru ta ’ persuni b’ riżultati disponibbli PRP = polyribosylribitol phosphate rSBA- MenC= antikorpi batteriċidi fis- serum kontra l- polisakkarid Ċ tal- meninġokokku biż- żjieda ta ’ sustanza meħuda mill- fenek GMC jew GMT = konċentrazzjoni jew livell ġeometriku ta ’ medja ta ’ antikorpi% = perċentwal ta ’ persuni b’ livelli daqs jew aktar mill- cut- off * = mogħti flimkien ma ’ DTPa- HBV- IPV ** = mogħti flimkien ma ’ vaċċini b ’ DTPa- Hib- TT
99.0%
Perċentwali ta ’ persuni b’ livelli ta ’ antikorpi ≥ assay cut- off xahar wara tilqima booster b’ Menitorix mogħtija flimkien ma ’ vaċċin għal ħożba- gattone- rubella (MMR) * kienu kif ġej:
GMC (micrograms/ ml) rSBA-MenC
Storja ta ’ tilqim primarju
56.72
Persuni li jkunu ħadu 3 Persuni li jkunu ħadu 3 dożi ta ’ Menitorix dożi ta ’ Meningitec +
30.27
Persuni
100.0% 100.0% 99.2% 4172.5
li jkunu ħadu 3 dożi ta ’
99.4% 99.4% 99.4% 11710.5
N= 349
98.9% 97.9% 92.6% 685.0
Pediacel
Subjects primed with 3 doses of Menitorix* N= 349
Meningitec **
Subjects primed with 3 doses of Meningitec + Pediacel N= 115
N= 115
Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96
Menjugate ** liċenzjati N= 96
Anti-PRP antibodies ≥ 0.15 micrograms/ ml
Antikorpi Anti- PRP ≥0. 15 mikrogrammi/ ml
≥ 1 micrograms/ ml
GMC (mikrogrammi/ ml)
100%
rSBA- MenC
100%
95. 6%
97.9%
98. 9%
GMC (micrograms/ ml)
≥1: 32
93.19
96. 8%
44.27 rSBA-MenC
≥1: 128
37.17
89. 5%
99.1% 98.8% 97.7% 2193.7
2193. 7
95.6% 94.7% 86.0% 477.9
477. 9
98.9% 96.8% 89.5% 670.2
670. 2
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 = numru ta ’ persuni b’ riżultati disponibbli PRP= polyribosylribitol phosphate rSBA- MenC= antikorpi batteriċidi fis- serum kontra l- polisakkarid Ċ tal- meninġokokku biż- żjieda ta’ sustanza meħuda mill- fenek GMC jew GMT= konċentrazzjoni jew livell ġeometriku medju ta ’ antikorpi% = perċentwal ta ’ persuni b’ livelli daqs jew aktar mill- cut- off * = mogħtija flimkien ma ’ vaċċini DTPa- IPV ** = mogħtija flimkien ma ’ vaċċini li fihom 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).
Il- livelli ta ’ antikorpi tkejlu 18- il xahar wara li ngħatat booster ta ’ Menitorix fl- età ta ’ 14- il xahar f’ suġġetti li diġa kienu mlaqqmin fit- tfulija b’ Menitorix f’ età ta ’ xahrejn, 4, 6 xhur jew b’ NeisVac- C fl- età ta ’ xahrejn, 4 xhur (u vaċċin DTPa/ Hib fl- eta ’ ta 'xahrejn, 4, 6 xhur).
SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
Riżultati għal SBA- MenC huma disponibbli għal 177 suġġett, riżultati anti- PRP għal 178 suġġett.
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.
Kollox ma ’ kollox, 92. 7% mill- 177 suġġett kellhom livelli ta ’ SBA- MenC ta ’ almenu 1: 8 u 56/ 56 (100%) kellhom
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.
16 konċentrazzjonijiet ta ’ antikorpi anti- PRP ta ’ almenu 0. 15µg/ ml.
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.
Fil- grupp li ngħata NeisVac- C minn qabel, 115/ 121 (95%) kellhom livelli ta ’ SBA- MenC ta ’ almenu 1: 8, u 121/ 122 (99. 2%) kellhom konċentrazzjonijiet ta ’ antikorpi anti- PRP ta ’ almenu 0. 15µg/ ml.
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.
Ma kien hemm l- ebda differenza sinifikanti bejn iż- żewġ gruppi fil- proporzjonijiet b’ livelli ta ’ SBC- MenC ta ’ almenu 1: 8 u konċentrazzjonijiet ta ’ antikorpi anti- PRP ta ’ almenu 0. 15µg/ ml.
Within one year of completion of
Kalkoli ta ’ l- effettivita ’ tal- vaċċin mill- programm ta ’ rutina dwar tilqim fir- Renju Unit (li juru kwantitajiet diversi ta ’ tliet vaċċini kkonjugati tal- grupp Ċ tal- meningokokku), li jkopru l- perijodu mindu bdew fl- aħħar ta ’ l- 1999 sa Marzu 2004, urew il- bżonn ta ’ doża booster wara t- tkomplija tal - kors primarju (tliet dożi mogħtija fl- etajiet ta ’ 2, 3 u 4 xhur).
15 the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
Fi żmien sena mit- tmiem tal- kors primarju, l- effettivita ’ tal- vaċċin fil- kategorija tat- trabi kienet ġiet stmata 93% (95% confidence intervals 67- 99%).
However, more than one year after completion of the primary series, there was clear evidence of waning protection.
Madankollu, wara aktar minn sena wara t- tmiem tal- ewwel kors ta ’ tilqim, kien hemm sinjali ċari li l- protezzjoni kienet qed tiddgħajjef.
Estimates of effectiveness based on a small number of cases to date indicate that there may also be waning protection in children who received a single priming dose as toddlers.
Kalkoli ta ’ l- effettivita ’ bbażati fuq numru żgħir ta ’ każi jindikaw li l- protezzjoni kienet qed tiddgħajjef ukoll fi tfal li jkunu ħadu doża waħda mill- ewwel kors ta ’ tilqim meta kienu għadhom kemm telqu jimxu.
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.
L- effettivita ’ fil- gruppi ta ’ etajiet oħra (sa 18- il sena) b’ doża waħda sallum baqgħet madwar 90% jew aktar fi żmien sena jew aktar mill - vaċċinazzjoni.
Evaluation of pharmacokinetic properties is not required for vaccines.
M’ hemmx għalfejn evalwazzjoni tal- kwalitajiet farmakokinetiċi għal vaċċini.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and single and repeated dose toxicity studies.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika u effetti tossiċi minn dożi rripetuti, ma turi l- ebda periklu speċjali għall- bnedmin
Trometamol Sucrose
Trometamol Sukrosju
Sodium chloride Water for injections
Kloridu tas- sodju Ilma għall- injezzjonijiet
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C – 8°C).
Wara li jkun irrikostitwit, il- vaċċin għandu jingħata mill- ewwel jew jinżamm fi friġġ (2°Ċ – 8°Ċ).
If it is not used within 24 hours, it should be discarded.
Jekk ma jintużax fi żmien 24 siegħa, għandu jintrema.
Experimental data show that the reconstituted vaccine could also be kept to 24 hours at ambient temperature (25°C).
Tagħrif sperimental juri li l- vaċċin irrikostitwit jista ’ wkoll jinżamm għal 24 siegħa f’ temperatura ambjentali (25°Ċ).
If it is not used within 24 hours, it should be discarded.
Jekk ma jintużax fi żmien 24 siegħa għandu jintrema.
6.4 Special precautions for storage
17 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not freeze Store in the original package in order to protect from light.
Aħżen fi friġġ (2°Ċ – 8°Ċ) Tagħmlux fil- friża Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
16 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
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:
Trab fi fjala (ħġieġ tip 1) b’ tapp (lastiku butyl), 0. 5 ml solvent f’ siringa mimlija minn qabel b’ tapp plunger (lastiku butyl) b’ labar separati jew mingħajrhom f’ daqsijiet ta ’ pakketti kif ġej:
- pack size of 1 vial of powder plus 1 pre-filled syringe of solvent with 2 separate needles or
- pakkett ta ’ fjala waħda bit- trab u siringa waħda mimlija minn qabel b’ solvent b’ żewġ labar
without needles
separati jew mingħajr labar
- pack size of 10 vials of powder plus 10 pre-filled syringes of solvent with 2 separate needles or
- pakkett ta ’ 10 fjali bit- trab u 10 siringi mimlijin minn qabel b’ solvent u b’ żewġ labar separati
without needles
jew mingħajr labar
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin irrikostitwit għandu jiġi eżaminat viżwalment għal xi sustanza barranija partikolari u/ jew xi varjazzjoni ta ’ l- aspett fiżiku qabel ma jingħata.
In the event of either being observed, discard the vaccine.
Fil- każ li taħseb li hemm xi ħaġa mhix flokha, armi l - vaċċin.
The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
Il- vaċċin għandu jiġi rrikostitwit billi l- kontenut sħiħ tas- siringa mimlija minn qabel bis- solvent jiżdied fil- fjala li jkun fiha it- trab.
After the addition of the solvent, the mixture should be well shaken until the powder is completely dissolved in the solvent.
Wara ż- żjieda tas- solvent, it- taħlita għandha titħawwad sew sakemm it- trab jinħall kollu kemm hu fis- solvent.
The reconstituted vaccine is a clear and colourless solution. Inject the entire contents of the vial.
Injetta l- kontenut kollu tal- fjala.
[See Annex I – To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiz partikolari]
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 TIKKETTA
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 u ismijiet assoċjati (ara Anness I) trab u solvent li jsiru soluzzjoni għal injezzjoni Vaċċin ikkonjugat tal- Haemophilus tip b u tal- grupp Ċ tal- meninġokokku [Ara Anness I - Biex timtela mill- pajjiz partikolari]
After reconstitution, 1 dose (0.5 ml) contains:
Wara li tkun irrikostitwita, doża waħda (0. 5 ml) ikun fiha:
Haemophilus type b polysaccharide (polyribosylribitol phosphate)
polisakkarid Haemophilus tip b (polyribosylribitol phosphate)
conjugated to tetanus toxoid as carrier protein Neisseria meningitidis serogroup C (strain C11) polysaccharide conjugated to tetanus toxoid as carrier protein
konjugat tat- toxoid tat- tetnu bħala proteina ġarriera Polisakkarid tas- serogrupp Ċ( strain C 11) tan- Neisseria meningitidis konjugat tat- toxoid tat- tetnu bħala proteina ġarriera
Sodium chloride Water for injections
Klorur tas- sodju Ilma għall- injezzjoni
Powder and solvent for solution for injection 1 vial:
Trab u solvent li jsiru solvent għal injezzjoni fjala waħda:
Solvent 1 dose (0.5 ml)
Trab siringa waħda mimlija minn qabel:
1 vial:
Solvent doża waħda (0. 5 ml)
Powder 1 pre-filled syringe:
fjala waħda: trab siringa waħda mimlija minn qabel:
Solvent 2 needles 1 dose (0.5 ml)
Solvent 2 labar doża waħda (0. 5 ml)
10 vials:
10 fjali:
Powder 10 pre-filled syringes:
Trab 10 siringi mimlijin minn qabel:
Solvent 10 x 1 dose (0.5 ml)
Solvent 10 x doża waħda (0. 5 ml)
Solvent 20 Needles 10 x 1 dose (0.5 ml)
Solvent 20 Labar 10 x doża waħda (0. 5 ml)
Intramuscular use Read the package leaflet before use Shake well before use
Għal użu fil- muskolu Aqra l- fuljett ta ’ tagħrif qabel l- użu Ħawwad tajjeb qabel tużah
Do not inject intravenously.
Tinjettax fil- vina.
SPECIAL STORAGE CONDITIONS
Żommu fi friġġ
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Tiffriżahx Aħżen fil- pakkett oriġinali biex tilqa ’ mid- dawl
Dispose of in accordance with local regulations.
Armi skond ir- regolamenti tal- lokal
[To be completed nationally]
[Biex timtela mill- pajjiz partikolari]
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA MINN QABEL
Menitorix and associated names (see Annex I) solvent for solution for injection [See Annex I – To be completed nationally] I. M.
Menitorix u ismijiet assoċjati (ara Anness I) solvent għall- injezzjoni [Ara Anness I - Biex timtela mill- pajjiz partikolari] I. M.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
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 u ismijiet assoċjati (ara Anness I) trab għal soluzzjoni għall- injezzjoni Haemophilus tip b u Meningococcal grupp C vaċċin ikkonjugat [Ara Anness I - Biex timtela mill- pajjiz partikolari] I. M.
24 PACKAGE LEAFLET:
24 FULJETT TA ’ TAGĦRIF
Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I – To be completed nationally]
Menitorix u ismijiet assoċjati (ara Anness I), trab u solvent biex isiru soluzzjoni għal injezzjoni [Ara Anness I - Biex timtela mill- pajjiz partikolari]
Haemophilus type b and Meningococcal group C conjugate vaccine
Vaċċin konjugat tal- Haemophilus tip b u tal- meninġokokku grupp Ċ
Read all of this leaflet carefully before your child starts receiving this vaccine.
Aqra sew dan il- fuljett kollu qabel ma t- tarbija tiegħek tibda tieħu dan il- vaċċin.
- This vaccine has been prescribed for your child.
- Din il- mediċina ġiet miktuba għat- tarbija tiegħek.
What Menitorix is and what it is used for 2.
X’ inhu Menitorix u għalxiex jintuża 2.
Before your child receives Menitorix 3.
Qabel ma t- tarbija tiegħek tingħata Menitorix 3.
How Menitorix is given 4.
Kif għandek tuża Menitorix 4.
How to store Menitorix 6.
Kif taħżen Menitorix 6.
WHAT MENITORIX IS AND WHAT IT IS USED FOR
X’ INHU MENITORIX U GĦALXIEX JINTUŻA
Menitorix is a vaccine that can be given to children after the age of 2 months up to 2 years to prevent infectious diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria.
Menitorix huwa vaċċin li jista ’ jingħata lil tfal ta ’ bejn ix- xahrejn u s- sentejn biex iħares kontra mard infettiv ikkawżat minn batterji Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp C (MenC).
The vaccine works by causing the body to produce its own protection (antibodies) against these bacteria.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem jipproduċi antikorpi għall- protezzjoni kontra dawn il- batterji.
The vaccine cannot cause Hib and MenC.
Il- vaċċin ma jistax jikkawża infezzjoni tal- batterji Hib u MenC.
• Haemophilus influenzae type b (Hib):
Haemophilus influenzae tip b (Hib):
Hib bacteria most frequently cause meningitis (inflammation of the coverings of the brain and spinal cord).
Batterji Hib ta ’ sikwit jikkawżaw meninġite (infjammazzjoni tat- tessuti li jiksu l- moħħ u x- xewka tad- dahar).
Even after recovery from Hib meningitis there can be complications such as mental retardation, spastic paralysis, deafness or epilepsy.
Anke wara l- fejqan minn meninġite Hib jista ’ jkun hemm komplikazzjonijiet bħal moħħ irritardjat, paraliżi spastika, turxien jew epilessija.
Hib infection can also cause a life-threatening inflammation of the throat with severe swelling that can cause suffocation.
L- infezzjoni Hib tista ’ wkoll tikkawża infjammazzjoni tal- gerżuma li tista ’ tipperikola l- ħajja b’ nefħa qawwija li tista ’ tagħlaq il- pajp ewlieni tan- nifs.
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):
Neisseria meningitidis grupp C (MenC):
Like Hib bacteria, MenC bacteria most frequently cause meningitis.
Bħall- batterji Hib, il- batterji MenC ta ’ sikwit jikkawżaw meninġite.
They may also cause severe blood infections and spread throughout the body.
Jistgħu wkoll jikkawżaw infezzjonijiet qawwija fid- demm u jixterdu mal- ġisem kollu.
Vaccination is the best way to protect against diseases caused by these bacteria.
It- tilqim l- aħjar l- aħjar mezz ta ’ protezzjoni kontra mard ikkawżat minn dawn il- batterji.
Remember, however, that no vaccine can provide complete, life-long protection in all people vaccinated.
Madankollu, għandek iżżomm f’ moħħok li ebda vaċċin ma jista ’ jagħti protezzjoni sħiħa tul il- ħajja kollha f’ dawk kollha li jitlaqqmu.
Also, Menitorix can only protect against meningitis and other infections caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Barra dan, Menitorix jista ’ biss jagħti protezzjoni kontra l- meninġite u infezzjonijiet oħra kkawżati mill - Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp C (MenC).
It cannot protect against meningitis caused by other bacteria or viruses, including other types and groups of Haemophilus or Neisseria bacteria.
Ma jistax jagħti protezzjoni kontra l- meninġite kkawżata minn batterji jew viruses oħra, inklużi tipi u gruppi oħra ta ’ batterji Haemophilus jew Neisseria.
BEFORE YOUR CHILD RECEIVES MENITORIX
QABEL MA T- TARBIJA TIEGĦEK TINGĦATA MENITORIX
Menitorix should not be given:
Menitorix m’ għandux jingħata:
• 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).
jekk fl- imgħoddi t- tarbija tiegħek kellha xi reazzjoni allerġika għal Menitorix jew għal xi vaċċin ieħor kontra l- Hib u MenC, għat- toxoid tat- tetnu jew għal xi sustanza oħra li jkun
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
26 hemm fil- vaċċin (ara sezzjoni 6).
25 • if your child has a high temperature (38oC or above) or a severe infection.
Sinjali ta ’ reazzjoni allerġika jistgħu jkunu raxx fil- ġilda bil- ħakk, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien. jekk it- tarbija tiegħek ikollha deni għoli (38oC jew aktar) jew xi nfezzjoni qawwija.
It is usual to wait until the child is better before giving the vaccine.
Normalment wieħed għandu jistenna sakemm it- tarbija tkun aħjar qabel ma jingħata l- vaċċin.
A minor infection such as a cold should not be a problem but talk to your doctor or nurse first.
Infezzjoni ħafifa bħal riħ m’ għandhiex tkun problema, biss dejjem kellem lit- tabib jew lin - nurse tiegħek qabel.
Remember that the first dose of Menitorix should not be given before your child is 2 months of age.
Tinsiex li l- ewwel doża ta ’ Menitorix m’ għandhiex tingħata qabel it- tarbija jkollha xahrejn.
Take special care with Menitorix:
Oqgħod attent ħafna meta tuża Menitorix:
• if your child has a bleeding problem or bruises easily. • if your child takes medicines or has any treatment which may affect the immune system.
jekk id- demm tat- tarbija tiegħek idum ma jagħqad jew jekk titbenġel mix- xejn. jekk it- tarbija tkun qed tieħu xi mediċini oħra jew xi kura oħra li tista ’ jkollha xi effett fuq is - sistema immuni.
Also, if your child has HIV infection or any other illness that can reduce his or her immunity to infections.
U wkoll jekk it- tarbija għandha xi infezzjoni ta ’ l- HIV jew xi mard ieħor li jista ’ jnaqqas l- immunita ’ tagħha f’ każ ta ’ xi infezzjonijiet.
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).
jekk it- tarbija tkun twieldet qabel iż- żmien (qabel 37 ġimgħa).
Menitorix can be given from the age of 2 months after birth onwards but it is not known if protection against Hib and MenC will be as good as in children born at term.
Menitorix jista ’ jingħata mill - eta ’ ta ’ xahrejn wara t- twelid biss mhuwiex magħruf jekk il- protezzjoni kontra l- Hib u MenC tkunx tajba daqs fil- każ ta ’ trabi mwielda fi żmienhom.
In the first 1-2 weeks after a dose of Menitorix it is possible that urine tests to detect Hib infection could give the wrong (false positive) results.
Fl- ewwel ġimgħa jew tnejn wara doża ta ’ Menitorix jista ’ jiġri li t- testijiet ta ’ l- awrina li jikkonfermaw l- infezzjoni Hib jagħtu riżultati ħżiena (pożittivi foloz).
Using other medicines or vaccines
Użu ta ’ mediċini jew vaċċini oħra
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.
Jekk jogħġbok għid lit- tabib tiegħek jekk it- tarbija hijiex qed tieħu jew dan l- aħħar kenitx qed tieħu xi mediċini oħra, inklużi mediċini mingħajr riċetta tat- tabib jew jekk dan l- aħħar ingħatatx xi tilqim ieħor.
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).
Menitorix jista ’ jingħata fl- istess ħin ma ’ vaċċini oħra maħsuba biex jagħtu protezzjoni kontra wieħed jew aktar fost difterite, tetnu, sogħla konvulżiva, poljo, epatite B, vaċċin konjugat tal- pnewmokokku u vaċċini kkombinati kontra l- ħożba, gattone u rubella (MMR).
Any other vaccines that are given at the same time as Menitorix will be injected separately at different parts of the body.
Vaċċini oħra li jingħataw fl- istess ħin ma ’ Menitorix għandhom jiġu njettati separatament f’ partijiet differenti tal- ġisem.
Although Menitorix contains tetanus toxoid (inactivated bacterial toxin), which is used to immunise people against tetanus (lockjaw), it is still necessary that your child should receive the recommended childhood vaccinations against tetanus.
Għalkemm Menitorix fih toxoid tat- tetnu (tossina batterjali mhux attivata), li tintuża biex timmunizza n- nies kontra t- tetnu (lockjaw), xorta jibqa ’ l- bżonn li t- tarbija tiegħek titlaqqam kif rrakkomandat kontra t- tetnu.
HOW MENITORIX IS GIVEN
KIF GĦANDEK TAGĦTI MENITORIX
Each dose of Menitorix is a single injection of half a millilitre (0.5 ml).
Kull doża ta ’ Menitorix hi injezzjoni waħda ta ’ nofs millilitru (0. 5 ml).
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.
In- nurse jew it- tabib jagħtu Menitorix bħala injezzjoni fil- muskolu (normalment fil- muskolu tal- koxxa għalkemm fi trabi li għadhom kemm telqu jimxu jista ’ jingħata fid- driegħ) u jiżgura ruħu li l- vaċċin ma jingħatax f’ xi vina jew arterja jew fis- saff ta ’ fuq tal- ġilda.
If Menitorix is used in infants for the first vaccinations against Hib and MenC:
Meta Menitorix jintuża fuq trabi għall- ewwel tilqim kontra l- Hib u MenC:
Your child will receive three doses of Menitorix.
It- tarbija tingħata tliet dożi Menitorix.
The first dose should not be given before the age of 2 months and there should be a gap of at least four weeks between injections.
L- ewwel doża m’ għandhiex tingħata qabel ma t- tarbija jkollha xahrejn u għandu jkun hemm spazju ta ’ mill- inqas erba ’ ġimgħat bejn injezzjoni u oħra.
If Menitorix is used to boost protection against Hib and MenC:
Meta Menitorix jintuża bħala booster għall- protezzjoni kontra Hib u MenC:
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.
Wara li tintemm l- ewwel serje ta ’ tilqim kontra Hib u MenC għandha tingħata doża booster kontra Hib u MenC, normalment fit- tieni sena tal- ħajja tat- tarbija.
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).
27 Menitorix jista ’ jintuża biex isaħħah il- protezzjoni fi tfal li jkunu ħadu Menitorix qabel jew fi tfal li qabel ikunu ħadu vaċċini oħra kontra dan il- mard (inklużi tfal li jkunu ħadu żewġ dożi tal- vaċċin kontra MenC fl- ewwel xhur).
26 If your child receives more Menitorix than he/ she should It is very unlikely that your child will receive too much or too little vaccine because each dose is provided in a separate vial and the vaccine is given by a doctor or nurse.
Jekk it- tarbija tiegħek tirċievi aktar Menitorix milli suppost Mhux probabbli li t- tarbija tiegħek tingħata vaċċin żejjed jew nieqes għax kull doża tingħata fi fjala separata u l- vaċċin jingħata min- nurse jew mit- tabib.
If you are concerned about the dose or doses that have been given, please talk to your doctor or nurse.
Jekk tinkwieta dwar xi doża jew dożi li ngħataw, jekk jogħġbok kellem lit- tabib jew lin- nurse.
If you forget to take your child for vaccination with Menitorix Your doctor or nurse will advise when your child should attend for these injections.
Jekk tinsa tieħu lit- tarbija tiegħek għal xi tilqima b’ Menitorix It- tabib jew nurse tiegħek jgħidulek meta t- tarbija tiegħek għandhek teħodha għal dawn l - injezzjonijiet.
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.
Jekk tfalli xi appuntament, hu importanti ħafna li tagħmel kuntatt mal- klinika biex tagħmel appuntament ġdid malajr kemm jista ’ jkun ħalli t- tarbija tiegħek tingħata d- doża jew dożi li tkun qabżet.
Like all medicines, Menitorix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Menitorix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated.
Reazzjonijiet allerġiċi qawwija jistgħu jirriżultaw minn kull vaċċin iżda dan jiġri rarament ħafna u normalment iseħħ f’ inqas minn 1 f’ kull 10, 000 persuna li jitlaqqmu.
Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction.
It- tarbija tiegħek tkun trid tibqa ’ fil- klinika jew fiż- żona tal- vaċċinazzjoni għal żmien qasir wara t- tilqim biex ikun żgurat li ma kien hemm ebda reazzjoni allerġika.
Tell the doctor or nurse immediately if your child develops a rash (which may be raised or lumpy), tightness of the throat, swelling of the face or neck or shortness of breath.
Għid lit- tabib jew lin- nurse minnufih jekk it- tarbija tiżviluppa xi raxx (li jista ’ jkun b’ nefħa jew ħobż ħobż), tingħalaq il- gerżuma, nefħa fil- wiċċ jew fl- għonq jew qtugħ ta ’ nifs.
Other possible symptoms of a severe allergic reaction include a drop in blood pressure and unconsciousness.
Sintomi oħra possibbli ta ’ reazzjoni allerġika qawwija huma li taqa ’ l- pressjoni tad- demm jew meta wieħed jintilef minn sensih.
It is very important that your child has immediate medical treatment for any severe allergic reaction.
Huwa mportanti ħafna li t- tarbija tiegħek tiġi kkurata mill - ewwel fil- każ ta ’ reazzjoni allerġika qawwija.
If the symptoms start after you have left the clinic, you should get medical help as soon as possible (for example, go to the nearest accident and emergency department).
Jekk is- sintomi jibdew jidhru wara li tkun ħallejt il - klinika, għandek tfittex għajnuna medika kemm jista ’ jkun malajr (per eżempju, mur fl- eqreb sptar jew post ieħor ta ’ emerġenza).
In clinical trials that involved giving Menitorix for the first vaccinations against Hib and MenC or to boost protection against these diseases the side effects that occurred after vaccination were:
Fi studji kliniċi li fihom ingħata Menitorix bħala l- ewwel tilqim kontra l- Hib u MenC jew biex isaħħaħ il- protezzjoni kontra dan il- mard l- effetti sekondarji li seħħew wara t- tilqima kienu:
♦ Very common (in more than 1 per 10 doses of vaccine) • Pain, redness or swelling at the site of the injection • Fever (temperature of 38oC or above) • Irritability • Loss of appetite • Sleepiness
Komuni ħafna (f’ aktar minn 1 minn kull 10 dożi tal- vaċċin) • Uġigħ, ħmura jew nefħa fil- post ta ’ l- injezzjoni • Deni (temperatura ta ’ 38oĊ jew aktar) • Irritabilita ’ • Nuqqas t’ aptit • Ngħas
♦ Uncommon (in less than 1 per 100 but more than 1 per 1,000 doses of vaccine) • Crying • Diarrhoea • Being sick • Generally feeling unwell • Fever of 39.5°C or above
Mhux komuni (inqas minn 1 minn kull 100 iżda aktar minn 1 minn kull 1, 000 doża tal- vaċċin) • Biki • Dijareja • Tħossok marid • Ma tkunx f’ sikktek • Deni ta ’ 39. 5°Ċ jew aktar
♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
Rari (inqas minn 1 minn kull 1, 000 iżda aktar minn 1 minn kull 10, 000 doża tal- vaċċin) • Raxx
Other side effects which have occurred very rarely (in less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with Menitorix include:
Effetti sekondarji oħra li ġraw rarament (f’ anqas minn 1 kull 10, 000 doża ta ’ vaċċin) fil- ġranet jew ġimgħat wara tilqim b’ Menitorix jinkludu:
Allergic reactions (these can be recognised by itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing), swelling of the glands, dizziness, convulsions (fits) with high temperature, unusual muscle slackness, headache.
Reazzjonijiet allerġiċi (dawn jistgħu jintagħrfu b’ raxx bil- ħakk ta ’ l- idejn u s- saqajn, nefħa ta ’ l - għajnejn u l- wiċċ, diffikulta 'biex tieħu n- nifs jew tibla ’), nefħa fil- glandoli, sturdament,
They include:
28 konvulżjonijiet (aċċessjonijiet) minħabba deni għoli, nuqqas ta ’ saħħa mhux tas- soltu fil- muskoli, uġigħ ta ’ ras.
27 children who have had them before, lack of sensation or an increased sensation (for example pain, pins and needles or itching at the injection site), joint pain, or purple spots or patches under the skin.
Xi effetti sekondarji oħra ġew irrapportati rarament ħafna (f’ anqas minn 1 kull 10, 000 doża ta ’ vaċċin) fi trabi li jkunu ħadu vaċċini oħra kontra MenC, li jinkludu: kollass jew xokk, it- tarbija ma turi l- ebda reazzjoni għal xi kliem jew ħsejjes tal- ġenituri wara t- tilqima, nefħa fil- glandoli, ħass ħażin, konvulżjonijiet fi tfal li kienu jbatu bihom qabel, nuqqas ta ’ sensazzjoni jew sensazzjoni mhux tas - soltu (per eżempju uġigħ, eċċitament żejjed jew ħakk fil- post ta ’ l- injezzjoni), uġigħ fil- ġogi, uġigħat fil- muskoli, jew tikek vjola jew tbajja taħt il- ġilda.
This vaccine cannot cause MenC or Hib infections.
Il- vaċċin ma jistax jikkawża l- infezzjonijiet MenC jew Hib.
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.
Jekk it- tarbija turi li għandha uġigħat fl - għonq, ebusija fl- għonq jew jekk id- dawl jinkwetaha (fotofobija), ħedla jew konfużjoni, jew tikek ħomor jew vjola bħal tbenġil li ma jmorrux meta jingħafsu għandek minnufih tikkuntattja lit- tabib jew lil xi sptar ta ’ emerġenza biex teskludi xi mard ieħor.
You should tell your doctor if you notice similar symptoms in your child after vaccination.
Jekk it- tabib kien qallek minn qabel li t- tarbija tiegħek kienet tbati mis- sindrome nefrotika (marda tal - kliewi li tista ’ tikkawża nefħa, partikolarment fil- wiċċ jew madwar l- għajnejn, u li l- proteina tagħmel l- awrina qiesha bir- ragħwa u/ jew żjieda fil- piż) hemm possibbilta ’ akbar li din il- kundizzjoni terġa ’ titfaċċa fit- tarbija tiegħek ftit xhur wara l- vaċċinazzjoni.
HOW TO STORE MENITORIX
KIF TAĦŻEN MENITORIX
Do not use Menitorix after the expiry date which is stated on the carton.
Tużax Menitorix wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in the original package in order to protect from light.
Tiffriżahx Żommu fil- pakkett oriġinali biex tipproteġieh mid- dawl
What Menitorix contains
X’ fih Menitorix:
- The active substances are:
- Is- sustanzi attivi huma:.....
Haemophilus type b polysaccharide
Polisakkarid tal- Haemophilus tip b
(polyribosylribitol phosphate)
(polyribosylribitol phosphate)
conjugated to tetanus toxoid as carrier protein Neisseria meningitidis serogroup C (strain C11) polysaccharide conjugated to tetanus toxoid as carrier protein
Konjugat tat- toxoid tat- tetnu bħala proteina ġarriera Polisakkarid tas- serogrupp Ċ (tip C 11) tan- Neisseria meningitidis Konjugat tat- toxoid tat- tetnu bħala proteina ġarriera
Powder: trometamol, sucrose Solvent: sodium chloride, water for injections.
Trab: trometamol, sukrosju Solvent: klorur tas- sodju, ilma għall- injezzjonijiet.
What Menitorix looks like and contents of the pack
29 Id- dehra ta ’ Menitorix u l- kontenuti tal- pakkett:
Menitorix is supplied as a white powder of Hib-MenC vaccine in a glass vial, together with half a millilitre (0.5 ml) of clear colourless sodium chloride solvent in a pre-filled syringe for a 1 dose vaccine.
Menitorix jinbiegħ bħal trab abjad tal- vaċċin Hib- MenC fi fjala tal- ħġieġ, flimkien ma ’ nofs millilitru (0. 5 ml) solvent ta ’ klorur tas- sodju bla kulur f’ siringa mimlija minn qabel għal doża waħda tal- vaċċin.
This powder is dissolved in the solvent provided, just before injection.
Dan it- trab jinħall fis- solvent immedjatament qabel l- injezzjoni.
Menitorix is available in packs of 1 or 10 with 2 separate needles or without needles.
Menitorix jinbiegħ f’ pakketti ta ’ 1 jew 10 b’ żewġ labar separati jew mingħajr labar.
28 Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha jistgħu jkunu għal skop kummerċjali.
Manufacturer GlaxoSmithKline Biologicals s. a.
Manifattur GlaxoSmithKline Biologicals s. a.
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri ta 'l- EEA b' dawn l- ismijiet:
Detailed information on this medicine is available on the web site of:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’:
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/ or variation of physical aspect prior to administration.
Il- vaċċin irrikostitwit għandu jiġi eżaminat viżwalment għal xi materjal mhux floku u/ jew xi varjazzjoni fl- aspett fiżiku qabel ma jingħata.
In the event of either being observed, discard the vaccine.
Jekk taħseb li hemm xi ħaġa mhix flokha, armi l- vaċċin.
The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.
Il- vaċċin għandu jiġi irrikostitwit biż- żjieda tal- kontenut kollu tas- siringa mimlija minn qabel mas - solvent fil- fjala li jkun fih it- trab.
After the addition of the solvent, the mixture should be well shaken until the powder is completely dissolved in the solvent.
Wara li jiżdied is- solvent, it- taħlita għandha titħawwad tajjeb sakemm it- trab jinħall kompletament fis- solvent.
Inject the entire contents of the vial.
Injetta l- kontenut kollu tal- fjala.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C – 8°C).
Wara li jiġi irrikostitwit, għandu jingħata mill- ewwel jew jinżamm fi friġġ (2°Ċ – 8°Ċ).
Experimental data show that the reconstituted vaccine could also be kept to 24 hours at ambient temperature (25°C).
Tagħrif sperimentali juri li l- vaċċin irrikostitwit jista ’ wkoll jinżamm għal 24 siegħa f’ temperatura ambjentali (25°Ċ).
If it is not used within 24 hours, it should be discarded.
Madankollu, dan it- tagħrif mhuwiex xi rakkomandazzjoni dwar il- ħażna.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- mediċina jew fdal ieħor għandu jintrema skond il- ħtiġijiet tal- lokal.
29 ANNEX IV
30 ANNESS IV
30 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
L- Awtoritajiet Kompetenti Nazzjonali, ko- ordinati mill- Istat Membru ta ’ Referenza, jassiguraw li l - kondizzjonijiet li ġejjin huma sodisfatti mid- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
The Applicant/ MAH is requested to commit to submitting for assessment, to the relevant national competent authorities, the results from the long-term antibody persistence data from the ongoing studies with Menitorix i. e. subjects from booster studies 013 and 022 are being followed up for antibody persistence as follows: o Over 4 years of follow up of subjects from study 013 in studies 027, 028 and 029. o Five years follow-up from 010/ 022 in subsequent studies 023, 024, 025 and 026.
31 L- Applikant/ Deetentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa mitlub li jwiegħed li jissottometti għal valutazzjoni, lill- awtoritajiet kompetenti nazzjonali relevanti, ir- riżultati mit- tagħrif ta ’ persistenza ta ’ l- antikorp fuq tul ta ’ żmien minn studji li għadhom għaddejja bħalissa b’ Menitorix jiġifieri suġġetti minn studji booster 013 u 022 qed jiġu segwiti għall- persistenza ta ’ antikorpi kif ġej: o Fuq 4 snin ta ’ follow- up ta ’ suġġetti minn studju 013 fi studji 027, 028 u 029. o Ħames snin ta ’ follow- up minn 010/ 022 fi studji sussegwenti 023, 024, 025 u 026.
London, 01 April 2008 EMEA/ CHMP/ 180097/ 2008
Londra, 01 ta 'April 2008 EMEA/ 180089/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Menitorix
OPINJONI DWAR RIFERIMENT SKOND L- ARTIKOLU 29( 4) 1 GĦAL Menitorix
Common Name:
Isem komuni:
Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate) conjugated to tetanus toxoid and Neisseria meningitidis serogroup C (MenC) polysaccharide conjugated to tetanus toxoid
Polisakkaride tal- Haemophilus influenzae tat- tip b (polyribosyl ribitol phosphate) konjugat ma 'tossojde tat- tetnu u polisakkaride tan- Neisseria meningitidis tas - serogrupp C (MenC) konjugat ma' tossojde tat- tetnu
Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of Powder and Solvent for Solution for Injection is a vaccine, indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) in infants from the age of 2 months and children up to the age of 2 years.
Menitorix, 5 mikrogrammi PRP bi 12. 5 mikrogrammi TT, 5 mikrogrammi PSC b' 5 mikrogrammi TT fil - forma ta 'trab u solvent għal soluzzjoni injettabbli huwa vaċċin, indikat għall- prevenzjoni ta' mard invażiv ikkawżat minn Haemophilus influenzae tat- tip b (Hib) u Neisseria meningitidis tal- grupp C (MenC) fit- trabi mill- età ta 'xahrejn u tfal żgħar sa l- età ta' sentejn.
GlaxoSmithKline Biologicals submitted applications for mutual recognition of Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of powder and solvent for solution for injection, on the basis of the marketing authorisation granted by the United Kingdom on 19 December 2005.
GlaxoSmithKline Biologicals ippreżentat applikazzjonijiet għar- rikonoxximent reċiproku ta 'Menitorix, 5 mikrogrammi PRP bi 12. 5 mikrogrammi TT, 5 mikrogrammi PSC b' 5 mikrogrammi TT fil- forma ta' trab u solvent għal soluzzjoni injettabbli, fuq il- bażi ta 'l- awtorizzazzjoni għat- tqegħid fis- suq mir- Renju Unit fid - 19 ta' Diċembru 2005.
The Mutual Recognition Procedure started on 17 October 2006.
Il- Proċedura ta 'Rikonoxximent Reċiproku bdiet fis- 17 ta' Ottubru 2006.
The Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Greece, Ireland, Poland and Spain.
L- Istat Membru ta 'Referenza kien ir- Renju Unit u l- Istati Membri Konċernati kienu l- Belġju, il- Greċja, l- Irlanda, il - Polonja u Spanja.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma kinux kapaċi jilħqu ftehim rigward ir- Rikonoxximent Reċiproku ta ’ l- Awtorizzazzjoni tat- Tqegħid fis- Suq mogħtija mill- Istat Membru ta 'Referenza.
The United Kingdom referred the reasons for disagreement to the EMEA on 29 March 2007.
Ir- Renju Unit rrefera r - raġunijiet għan- nuqqas ta 'qbil lill- EMEA fid- 29 ta' Marzu 2007.
Public health objections were raised because no immunological correlates of protection were established for MenC conjugates and because the submission of data on pre-licensure effectiveness were required to cover infant and toddler use.
Tqajmu objezzjonijiet marbuta mas- saħħa pubblika minħabba li l- ebda korrelat ta 'protezzjoni immunoloġika ma kien stabbilit għall- MenC konjugati u minħabba li kienet meħtieġa l- preżentazzjoni tad- dejta dwar l - effikaċja ta' l- istudji ta 'qabel il- liċenzja għall- awtorizzazzjoni ta' l- użu minn tfal żgħar u trabi li għadhom kif telqu jimxu.