FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the CHMP was of the view that PK and PD studies in healthy volunteers representing the broad range of phenotypes, or imaging studies in healthy volunteers to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device could be considered.
Maltese: Is-CHMP ikkonkluda wkoll dwar il-ħtieġa li jitwettaq studju PK/PD sabiex tinftiehem linfluwenza ta' fatturi differenti fuq id-distribuzzjoni, l-espożizzjoni u l-attività tal-adrenalina meta tingħata permezz ta' apparat b'injettur awtomatiku tal-adrenalina.
English: The CHMP noted that generally there is a large degree of consistency between the product information for the different auto-injectors in particular as regards main messages such as to seek emergency medical assistance immediately after a single administration, the use with caution in certain patient populations and that adrenaline should be administered intramuscularly in order to maximise the possibility of a positive outcome in the treatment of anaphylaxis.
Maltese: Is-CHMP innota li ġeneralment hemm grad kbir ta' inkonsistenza bejn l-informazzjoni dwar il-prodott għad-diversi injetturi awtomatiċi, b'mod partikolari fir-rigward tal-messaġġi ewlenin biex titfittex assistenza medika ta' emerġenza wara għoti ta' doża waħda, l-użu b'attenzjoni f'ċerti popolazzjonijiet ta' pazjenti u li l-adrenalina għandha tingħata ġol-muskolu sabiex tiġi mmassimizzata l-possibbiltà ta' eżitu pożittiv fil-kura ta' anafilassi.
English: The CHMP considered also the results of consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Is-CHMP ikkunsidra wkoll ir-riżultati tal-konsultazzjonijiet malprofessjonisti fil-kura tas-saħħa, l-esperti u l-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam talFarmakoviġilanza (PRAC).
English: The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) undertook a review of all authorised adrenaline auto-injectors to evaluate the most effective site for injection, the clarity of instructions for use as well as the most appropriate auto-injector needle length for ensuring intramuscular (IM) delivery of the adrenaline injection.
Maltese: L-Aġenzija Regolatorja tal-prodotti tal-Kura tas-Saħħa u l-Mediċini tar-Renju Unit (MHRA) wettqet reviżjoni tal-injetturi awtomatiċi tal-adrenalina awtorizzati kollha biex tevalwa s-sit l-aktar effikaċi għall-injezzjoni, iċ-ċarezza tal-istruzzjonijiet għall-użu kif ukoll it-tul tal-labra tal-injettur awtomatiku laktar xierqa biex jiġu żgurat għoti ġol-muskolu (IM) tal-injezzjoni tal-adrenalina.
English: • The CHMP considered that the efficacy of adrenaline in the treatment of anaphylaxis is wellsupported by anecdotal and retrospective evidence and that the safety of adrenaline is also well-established, and it has demonstrated a strong safety profile particularly with IM administration.
Maltese: • Is-CHMP ikkunsidra li l-effikaċja tal-adrenalina fil-kura ta' anafiliassi hija appoġġjata sew minn evidenza aneddotali u retrospettiva u li s-sigurtà tal-adrenalina hija wkoll stabbilita sew, u uriet profil tas-sigurtà b'saħħtu b'mod partikolari bl-għoti ġol-muskolu.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, applicant fl-Istati Membri
English: GlaxoSmithKline, S.A Severo Ochoa, 2 Tres Cantos, Madrid Spain
Maltese: GlaxoSmithKline, S.A Severo Ochoa, 2 Tres Cantos, Madrid Spanja
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA META JISKADI EXP {MM/YYYY}
English: • Irritability
Maltese: • Irritabilita'
English: 12.5 micrograms
Maltese: 12.5 mikrogrammi
English: Belgium GlaxoSmithkline Biologicals S.A., 89 rue de l'Institut, B-1330 Rixensart, Belgium
Maltese: Belġju GlaxoSmithkline Biologicals S.A., 89 rue de l'Institut, B1330 Rixensart, Belġju
English: Common (≥1/100, <1/10)
Maltese: Komuni (≥1/100, <1/10)
English: MenC PSC - Neisseria meningitidis serogroup C polysaccharide
Maltese: MenC PSC - Neisseria meningitidis serogrupp C polysaccharide
English: • Loss of appetite
Maltese: • Nuqqas t'aptit
English: • Fever (temperature of 38oC or above)
Maltese: • Deni (temperatura ta' 38oĊ jew aktar)
English: Subjects primed with 3 doses of Meningitec + Pediacel N= 115
Maltese: Persuni li jkunu ħadu 3 dożi ta' Meningitec + Pediacel N= 115
English: Trometamol Sucrose
Maltese: Trometamol Sukrosju
English: GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 Ireland
Maltese: Stonemasons Way, Rathfarnham, Dublin 16 Irlanda
English: • Diarrhoea
Maltese: • Dijareja
English: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom
Maltese: SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS
English: *GlaxoSmithKline combination vaccine
Maltese: *Vaċċin ikkombinat GlaxoSmithKline
English: * Hib PRP - Haemophilus influenzae type B polyribosylribitol phosphate TT - tetanus toxoid
Maltese: * Hib PRP - Haemophilus influenzae tip B fosfat tal-polyribosylribitol TT - toxoid tat-tetnu
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.
Maltese: 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.
English: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
Maltese: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS
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.
Maltese: Menitorix huwa preparazzjoni ta' vaċċin imnixxef bil-friża li jikkonsisti minn 5µg tal-polisakkarajd kapsulari H. influenzae tip b ippurifikat, polyribosylribitol phosphate (PRP) u 5µg tal-polisakkarajd kapsulari meningokokkali ta' grupp Ċ (PSC), it-tnejn direttament ikkonjugati mal-proteina ġarriera tetanus toxoid (TT).
English: SBA-MenC results are available for 177 subjects, anti-PRP results for 178 subjects.
Maltese: Riżultati għal SBA-MenC huma disponibbli għal 177 suġġett, riżultati anti-PRP għal 178 suġġett.
English: Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
Maltese: 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%).
English: GMC (micrograms/ml)
Maltese: GMC (mikrogrammi/ ml)
English: Neisseria meningitidis serogroup C (strain C11) polysaccharide
Maltese: Neisseria meningitidis serogrupp C (tip C11) polysaccharide
English: After three doses N=330†
Maltese: Wara tliet dożi N=330†
English: Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000)
Maltese: Rari (≥1/10,000, <1/1,000)
English: Hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients (see sections 2 and 6.1).
Maltese: Sensittività eċċessiva għas-sustanzi attivi, inkluż toxoid tat-tetnu, jew għal xi sustanzi mhux attivi (ara sezzjonijiet 2 u 6.1)
English: 10 x 1 dose (0.5 ml)
Maltese: 10 x doża waħda (0.5 ml)
English: In clinical trials, Menitorix was administered as a 3-dose primary series (N=1,171) or as a booster (N=991) dose.
Maltese: Fi studji kliniċi, Mentorix ingħata bħala serje primarja ta' 3 dożi (N=1,171) jew bħala booster (N=991).
English: 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
Maltese: 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
English: These issues were referred to the CHMP during the referral procedure under Article 29 of Directive 2001/83/EC, as amended, on 26 April
Maltese: Dawn l-argumenti kienu referuti lisCHMP waqt il-proċedura ta' referenza taħt l-Artikolu 29 tad-Direttiva 2001/83/KE, kif emendata, fis26 April 2007.
English: • Other possible side effects:
Maltese: • Effetti sekondarji oħra possibbli:
English: Take special care with Menitorix:
Maltese: Oqgħod attent ħafna meta tuża Menitorix:
English: Subjects primed with 2 doses of NeisVac-C** N=167
Maltese: Persuni li jkunu ħadu 2 dożi ta' NeisVac-C** N=167
English: See also section 4.4.
Maltese: Ara wkoll sezzjoni 4.4
English: GlaxoSmithkline Α.Ε.Β.Ε.
Maltese: GlaxoSmithkline Α.Ε.Β.Ε. 266 Leof.
English: Skin and subcutaneous tissue disorders: uncommon: dermatitis atopic rare: rash
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: mhux komuni: dermatite atopika rari: raxx
English: After two doses N=93
Maltese: Wara żewġ dożi N=93
English: STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (0.5 ml) contains: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Wara li tkun irrikostitwita, doża waħda (0.5 ml) ikun fiha: polisakkarid Haemophilus tip b (polyribosylribitol phosphate)
English: 10 vials: Powder 10 pre-filled syringes: Solvent 20 Needles
Maltese: 10 siringi mimlijin minn qabel: Solvent 20 Labar
English: Subjects primed with 3 doses of Menitorix* N= 349
Maltese: Persuni li jkunu ħadu 3 dożi ta' Menitorix N= 349
English: After two doses N=111
Maltese: Wara tliet dożi N=111
English: • Clinical trials
Maltese: • Studji kliniċi
English: 10 vials: Powder 10 pre-filled syringes: Solvent 10 x 1 dose (0.5 ml)
Maltese: 10 siringi mimlijin minn qabel: Solvent 10 x doża waħda (0.5 ml)
English: (see also sections 4.4 and 4.5)
Maltese: (ara wkoll sezzjonijiet 4.4 u
English: Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Maltese: Polisakkarid tal-Haemophilus tip b (polyribosylribitol phosphate)
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.
Maltese: Meta Mentorix ingħata bħala kors ta' tilqim bi tliet dożi, ingħata flimkien miegħu vaċċin DTPa-HBV-IPV* (N=796) jew vaċċin DTPa-IPV vaccine* (N=375).
English: N= number of subjects with available results
Maltese: N= Numru ta' persuni b'riżultati disponibbli
English: • Fever of 39.5°C or above
Maltese: • Deni ta' 39.5°Ċ jew aktar
English: 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.
Maltese: 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.
English: OTHER
Maltese: FJALA
English: In two clinical trials (N=578), Menitorix was administered concomitantly with Measles, Mumps, Rubella (MMR) vaccine.
Maltese: F'żewġ studji kliniċi (N=578), Menitorix ingħata flimkien ma' vaċċin tal-Measles, Mumps u Rubella (MMR).
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: An ongoing study will generate long-term SBA data while the Applicant/MAH also committed to monitor antibody persistence for five years in subsequent studies 023, 024, 025 and 026, in line with the “Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ICH/2711/99).
Maltese: Studju li bħalissa għadu għaddej se jiġġenera tagħrif SBA fuq tul ta' żmien waqt li l-Applikant/dDetentur ta' l-Awtorizzazzjoni għatTqegħid fis-Suq impenja ruħu wkoll li jissorvelja l-persistenza ta' l-antikorp għal ħames snin fi studji sussegwenti 023, 024, 025 u 026, b'mod konformi man-“Nota ta' gwida fuq stħarriġ kliniku ta' prodotti mediċinali fil-popolazzjoni pedjatrika” (CPMP/ICH/2711/99).
English: Antibody
Maltese: Antikorpi
English: Solvent: sodium chloride, water for injections.
Maltese: Trab: trometamol, sukrosju Solvent:klorur tas-sodju, ilma għall-injezzjonijiet.
English: (See sections 4.5 and 5.1)
Maltese: (Ara sezzjonijiet 4.5 u 5
English: Subjects primed with 3 doses of Menitorix* N=123
Maltese: Persuni li jkunu ħadu 3 dożi ta' Menitorix* N=123
English: 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.
Maltese: 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.
English: Hypersensitivity reaction after previous administration of Menitorix.
Maltese: Sensittivita' eċċessiva meta fl-imgħoddi ngħata Menitorix.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MENITORIX
Maltese: SOMMARJU TOTALI TA' L-EVALWAZZJONI XJENTIFIKA TA' MENITORIX
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Maltese: Rue de l'Institut 89
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).
Maltese: 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).
English: Booster vaccination:
Maltese: Tilqima booster:
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml)
Maltese: Anti-PRP mikrogrammi /ml mikrogrammi /ml
English: 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.
Maltese: 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.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali, ko-ordinati mill-Istat Membru ta' Referenza, jassiguraw li lkondizzjonijiet li ġejjin huma sodisfatti mid-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: 5 micrograms conjugated to tetanus toxoid as carrier protein
Maltese: 5 mikrogrammi konjugat ma' toxoid tat-tetnu bħala proteina ġarriera
English: ≥0.15 micrograms/ml ≥1 micrograms/ml
Maltese: mikrogrammi/ml ≥1 µg/ml
English: Subjects primed with 3 doses of Meningitec** or Menjugate** N=96
Maltese: Persuni li jkunu ħadu 3 dożi ta' Meningitec** Menjugate** liċenzjati N= 96
English: Anti-PRP antibodies micrograms/ml micrograms/ml GMC (micrograms/ml rSBA-MenC
Maltese: GMC (mikrogramm i/ml) rSBA-MenC
English: 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.
Maltese: Reazzjonijiet allerġiċi (li jinkludu urtikarja u reazzjonijiet anafilattiċi), limfadenopatija, sturdament, aċċessjonijiet minħabba d-deni, nuqqas ta' saħħa fil-muskoli, uġigħ ta' ras
English: ♦ Rare (in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine) • Rash
Maltese: Rari (inqas minn 1 minn kull 1,000 iżda aktar minn 1 minn kull 10,000 doża tal-vaċċin) • Raxx
English: Psychiatric disorders: very common: irritability uncommon: crying
Maltese: Disturbi psikjatriċi: komuni ħafna: irritabilita' mhux komuni: biki
English: PRP= polyribosylribitol phospohate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Maltese: PRP = polyribosylribitol phosphate rSBA-MenC= antikorpi batteriċidi fis-serum kontra l-polisakkarid Ċ tal-meninġokokku biż-żjieda ta' sustanza meħuda mill-fenek
English: However, following several reports of suspected ADRs, section 4.8 of the Menitorix SPC was updated.
Maltese: Madankollu, wara diversi rapporti ta' suspett ta' ADRs, sezzjoni 4.8 talSommarju tal-Karatteristiċi tal-Prodott ta' Menitorix ġiet aġġornata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, each 0.5 ml dose contains:
Maltese: U KWANTITATTIVA Wara li tiġi rrikostitwita, kull doża ta' 0.5 ml ikun fiha:
English: United Kingdo m
Maltese: Mnjen jingħata
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
Maltese: 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: - pakkett ta' fjala waħda bit-trab u siringa waħda mimlija minn qabel b'solvent b'żewġ labar separati jew mingħajr labar - pakkett ta' 10 fjali bit-trab u 10 siringi mimlijin minn qabel b'solvent u b'żewġ labar separati jew mingħajr labar
English: 1 dose (0.5 ml)
Maltese: Doża waħda (0.5 ml)
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.
Maltese: F'diversi studji b'vaċċini lliċenzjati monovalenti konjugati tal-grupp meninġokokku Ċ, l-għoti flistess ħin ta' kombinazzjonijiet b'komponenti bla ċelluli għas-sogħla konvulsiva (bi jew mingħajr ilvirus tal-polio mhux attiv, l-antiġen fil-wiċċ ta' l-epatite B jew konjugati ta' l-Hib [e.g. DTPa-HBVIPV-Hib*]), deher li rriżulta f'livelli medji ġeometriċi (GMT) ta' antikorpi batteriċidi (SBA) aktar baxxi fis-serum meta mqabbla ma' l-għoti separat jew l-għoti flimkien ma' vaċċini b'ċellula sħiħa għas-sogħla konvulsiva.
English: I.M.
Maltese: IV.
English: The total safety database derived from clinical studies now consists of 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 and therefore exceeds that suggested by the CHMP Guideline for truly new vaccines.
Maltese: Id-database ta' sigurtà totali mnissla minn studji kliniċi issa tikkonsisti minn 3293 tarbija mlaqqma b' Menitorix jew bħala kors primarju jew bħala booster u 578 tarbija mlaqqma b'1713-il doża ta' formulazzjonijiet relatati mill-qrib ma' Hib-MenC u għaldaqstant taqbeż dik issuġġerita mil-Linja
English: 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.
Maltese: 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.
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.
Maltese: Kollox ma' kollox, 92.7% mill-177 suġġett kellhom livelli ta' SBA-MenC ta' almenu 1:8 u 56/56 (100%) kellhom konċentrazzjonijiet ta' antikorpi anti-PRP ta' almenu 0.15µg/ml.
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).
Maltese: 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).
English: Also, Menitorix can only protect against meningitis and other infections caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Maltese: Menitorix iħarsek biss kontra Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp C.
English: In order to further justify the adequacy of the safety database in children primed and/or boosted with Menitorix, the Applicant/MAH provided additional data from two recently reported studies, augmenting the total database with an additional 1131 subjects who received a total of 2992 doses of Menitorix.
Maltese: Sabiex jiġġustifika aktar l-adegwatezza tad-database ta' sigurtà fi tfal li jkunu ġew mogħtija l-ewwel tilqima u/jew il-booster b'Menitorix, l-Applikant/Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif addizjonali minn żewġ studji irrapportati reċentement, li jżidu l-bażi ta' totali ta' dejta b'1131 suġġett addizjonali li rċievew total ta' 2992 doża ta' Menitorix.
English: 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.
Maltese: 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.
English: In individuals with impaired immune responsiveness (whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes) a protective immune response to Hib and MenC conjugate vaccines may not be obtained.
Maltese: F'individwi b'indeboliment tar-rispons immuni ( minħabba l-użu ta' terapija immunosoppressiva, difett ġenetiku, infezzjoni talvirus ta' l-immunodefiċjenza umana (HIV), u kawżi oħra) jista' ma jkunx hemm l-effett ta' immunita' protettiva għal tilqim b'konjugati għal Hib u 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.
Maltese: Hib u MenC, Menitorix ingħata flimkien (fil-koxox opposti) ma' l-ewwel doża ta' vaċċin ikkombinat għall-ħożba, gattone u rubella (MMR).
English: Sodium chloride Water for injections
Maltese: Klorur tas-sodju Ilma għall-injezzjoni
English: • Neisseria meningitidis group C (MenC): Like Hib bacteria, MenC bacteria most frequently cause meningitis.
Maltese: • Neisseria meningitidis grupp C (MenC):