qanastek/EMEA-V3 huggingface dataset:
{Name of the Member State} {Name of the medicinal product} [See Annex I - To be completed nationally]
{Isem tal- Istat Membru} {Isem tal- prodott mediċinali} [Ara Anness I - Għandu jitlesta fil- pajjiż stess]
[To be completed nationally]
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} [Għandu jitlesta fil- pajjiż stess]
London, 14 November 2008 EMEA/ CHMP/ 633842/ 2008
Londra, 14 ta ’ Novembru 2008 EMEA/ CHMP/ 633332/ 2008
OPINION FOLLOWING AN ARTICLE 29(4) 1 REFERRAL FOR Lisonorm and associated names International Non-Proprietary Name (INN): lisinopril + amlodipine
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 29( 4) 1 GĦAL Lisonorm u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): lisinopril + amlodipina
Lisonorm tablet contains 5mg amlodipine/ 10mg lisinopril and is an anti-hypertensive indicated in patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Pillola ta ’ Lisonorm fiha 5mg amlodipina/ 10mg lisinopril u hija antipertensiv indikat f’ pazjenti bi pressjoni tad- demm ikkontrollata adegwatament b’ lisinopril u amlodipina mogħtija fl- istess ħin fl - istess livell tad- doża.
Gedeon Richter Plc obtained a national marketing authorisation for Lisonorm which was authorised in Bulgaria on 29 December 2006, before Bulgaria joined the European Union.
Gedeon Richter Plc kisbet awtorizzazzjoni nazzjonali għat- tqegħid fis- suq għal Lisonorm li kienet awtorizzata fil- Bulgarija fid- 29 ta ’ Diċembru 2006, qabel ma l- Bulgarija ssieħbet fl- Unjoni Ewropea.
Gedeon Richter Plc submitted a Marketing Authorisation Application (MAA) via mutual recognition procedure for Lisonorm on the basis of the marketing authorisation granted by Hungary on 30 April 2004.
Gedeon Richter Plc ippreżentat Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAA) permezz ta ’ proċedura ta ’ rikonoxximent reċiproku għal Lisonorm fuq il- bażi tal- awtorizzazzjoni għat - tqegħid fis- suq mogħtija mill- Ungerija fit- 30 ta ’ April 2004.
The Mutual Recognition Procedure started on 3 August 2007.
Il- Proċedura ta ’ Rikonoxximent Reċiproku bdiet fit- 3 ta ’ Awwissu 2007.
The Reference Member State was Hungary and the Concerned Member States were Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Romania and Slovak Republic.
L- Istat Membru ta ’ Referenza kien l- Ungerija u l- Istati Membri Kkonċernati kienu r- Repubblika Ċeka, l- Estonja, l- Ungerija, il- Litwanja, il- Latvja, il- Polonja, ir- Rumanija u r- Repubblika Slovakka.
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 setgħux jilħqu ftehim fir- rigward tar- Rikonoxximent Reċiproku tal- Awtorizzazzjoni għat- Tqegħid fis- Suq mogħtija mill- Istat Membru ta ’ Referenza.
The Czech Republic and Latvia referred the reasons for disagreement to the EMEA on 1 February 2008.
Ir- Repubblika Ċeka u l- Latvja irriferew ir- raġunijiet għan- nuqqas ta ’ qbil lill- EMEA fl- 1 ta ’ Frar 2008.
Concerns related to the formal proof of bioequivalence and the lack of a wide therapeutic experience which were considered a potential serious risk to public health.
It- tħassib kellu x’ jaqsam mal- prova formali ta ’ bioekwivalenza u n- nuqqas ta ’ esperjenza terapewtika wiesgħa tqies bħala riskju serju potenzjali għas- saħħa pubblika.
The arbitration procedure started on 21 February 2008 with the adoption of a list of questions.
Il- proċedura ta ’ arbitraġġ bdiet fil- 21 ta ’ Frar 2008 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The Rapporteur was Dr Ondř ej Slanař (CZ) and Co-Rapporteur(s) was Prof János Borvendég (HU).
Ir- Rapporteur kien Dott Ondřej Slanař (CZ) u l- Korapporteur( s) kien il- Profs János Borvendég (HU).
The Marketing Authorisation Holder provided written explanations on 2 June 2008.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta spjegazzjonijiet bil- miktub fit- 2 ta ’ Ġunju 2008.
During their July 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Lisonorm, that the objections raised by Czech Republic and Latvia should not prevent the granting of a Marketing Authorisation.
Matul il- laqgħa tiegħu ta ’ Lulju 2008, is- CHMP, fid- dawl tad- dejta ġenerali ppreżentata u tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proporzjon benefiċċju/ riskju kien wieħed favorevoli għal Lisonorm, li l- oġġezzjonijiet imqajma mir- Repubblika Ċeka u mil- Latvja ma għandhomx jimpedixxu l- għoti ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq.
The Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Is- Sommarju tal - Karatteristiċi tal- Prodott, it- Tikketta u l- Fuljett ta ’ Tagħrif tal- Istat Membru ta ’ Referenza għandhom jiġu emendati.
A positive opinion was adopted by consensus on 24 July 2008.
Fl- 24 ta ’ Lulju 2008 ġiet adottata opinjoni pożittiva b’ kunsens.
The list of the product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodotti kkonċernati hija mogħtija fl- Anness I.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 L- Artikolu 29( 4) tad- Direttiva 2001/ 83/ KE, kif emendata.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
LISTA TA` L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L- APPLIKANTI U D- DETENTURI TA` L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI Stat
Marketing Authorisation Holder
Id- Detentur ta ’ l -
(Invented) Name
(Isem
Strength *
Ivvintat)
Pharmaceutical form
Farmaċewtika
Route of administration
SmithKline Beecham PLC,
Content (concentration)
Menitorix
United Kingdo m
trab u solvent
SmithKline Beecham PLC, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom
980 Great West Road,
5 µg Hib PRP + 12.5 µg TT + 5 µg MenC PSC + 5 µg TT
12. 5 µg TT
powder and solvent for solution for injection
għal soluzzjoni
intramuscular injection
għal injezzjoni
GlaxoSmithkline Biologicals S. A., 89 rue de l'Institut, B-1330 Rixensart, Belgium
GlaxoSmithkline Biologicals S. A., 89 rue de l' Institut, B -
5 µg Hib PRP + 12.5 µg TT + 5 µg MenC PSC + 5 µg TT
5 µg Hib PRP + 12. 5 µg TT
powder and solvent for solution for injection
trab u solvent għal soluzzjoni
intramuscular injection
injezzjoni ġol - muskolu
Kifisias, 152 32 Halandri Greece
Kifisias, 152 32
Stonemasons Way, Rathfarnham, Dublin 16 Ireland
Stonemasons Way,
SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
SmithKline Beecham plc 980 Great West Road,
GlaxoSmithKline, S. A Severo Ochoa, 2 Tres Cantos, Madrid Spain
GlaxoSmithKline, S. A Severo Ochoa, 2 Tres
* Hib PRP - Haemophilus influenzae type B polyribosylribitol phosphate TT - tetanus toxoid MenC PSC - Neisseria meningitidis serogroup C polysaccharide
Hib PRP - Haemophilus influenzae tip B fosfat tal- polyribosylribitol TT – toxoid tat- tetnu MenC PSC - Neisseria meningitidis serogrupp C polysaccharide
2 ANNEX II
2 3 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻKONIJIET XJENTIFIĊI U ARGUMENTI GĦAL EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
3 SCIENTIFIC CONCLUSIONS
4 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MENITORIX
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ MENITORIX
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.
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).
The product is used for the active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) and is administered by intramuscular injection.
Il- prodott jintuża għat- tilqim attiv ta ’ trabi mill- età ta ’ xahrejn u trabi li telqu jimxu sa l- età ta ’ sentejn għall- prevenzjoni ta ’ mard invażiv ikkaġunat minn Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp Ċ (MenC) u jingħata permezz ta ’ injezzjoni ġol- muskoli.
The Applicant/ MAH submitted an application for a Marketing Authorisation through the mutual recognition procedure for Menitorix on the basis of the marketing authorisation granted by the UK.
L- Applikant/ id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq issottometta applikazzjoni għal Awtorizzazzjoni għat- Tqegħid fis- Suq mill- proċedura ta ’ għarfien reċiproku għal Menitorix fuq il- bażi ta ’ awtorizzazzjoni għat- tqegħid fis- suq ikkonċeduta mir- Renju Unit.
The referral procedure was initiated with UK as the reference member state (RMS), due to concerns raised by the concerned member states Greece, Poland and Spain regarding major safety and efficacy issues and the immunological protection correlates, they considered the submitted clinical documentation insufficient to establish the clinical efficacy and safety of Menitorix, considering the product to be an entirely new conjugated, bivalent vaccine.
Il- proċedura ta ’ referenza nbdiet mir- Renju Unit bħala l- Istat Membru ta ’ Referenza (RMS), minħabba tħassib imqajjem mill- Istati Membri ikkonċernati, il- Greċja, il- Polonja u Spanja rigward kwistjonijiet ta ’ sigurtà u effikaċja maġġuri u l- korrelati tal- protezzjoni immunoloġika, huma ikkunsidraw id- dokumentazzjoni klinika sottomessa bħala insuffiċjenti biex tkun stabbilita l- effikaċja klinika u s- sigurtà ta ’ Mentorix, peress li l- prodott huwa vaċċin bivalenti, ikkonjugat, totalment ġdid.
These issues were referred to the CHMP during the referral procedure under Article 29 of Directive 2001/ 83/ EC, as amended, on 26 April 2007.
Dawn l- argumenti kienu referuti lis - CHMP waqt il- proċedura ta ’ referenza taħt l- Artikolu 29 tad- Direttiva 2001/ 83/ KE, kif emendata, fis - 26 April 2007.
Following the initial assessment, the CHMP considered that under the conditions of study, the safety and immunogenicity data provided were adequate to assess the risk-benefit relationship for the use of Menitorix for priming and/ or boosting and could be used to assess the likely protection that will be afforded by the vaccine.
Wara l- valutazzjoni inizjali, is- CHMP ikkunsidra li taħt il- kondizzjonijiet ta ’ l- istudju, it- tagħrif dwar is- sigurtà u l- immunoġeniċità ipprovduti kienu adegwati biex jistmaw ir- relazzjoni ta ’ riskju - benefiċċju għall- użu ta ’ Menitorix għall- ewwel tilqima u/ jew l- għotja tal- booster u dawn jistgħu jintużaw biex jivvalutaw il- protezzjoni probabbli mogħtija mill- vaċċin.
The size of the safety database derived from clinical studies and the similarity of this new vaccine to already licensed products were both reasons to accept the database provided, which is supported by the fact that that the available safety data do not indicate any unusual problems.
Id- daqs tad- database tas - sigurtà misluta minn studji kliniċi u s- similarità ta ’ dan il- vaċċin il- ġdid ma ’ prodotti diġà liċenzjati kienu ż- żewġ raġunijiet l- għala ġiet aċċettata d- database ipprovduta, appoġġjata mill- fatt li t- tagħrif ta ’ sigurtà disponibbli ma jindikax xi problemi mhux tas- soltu.
However, the CHMP considered that there were concerns regarding the long-term antibody persistence, the adequacy of the safety data set in the light of the CHMP Guideline on Clinical Evaluation of New Vaccines, and the indication of Menitorix for both priming and boosting.
Madankollu, is- CHMP ikkunsidra li kien hemm tħassib rigward il- persistenza ta ’ l- antikorp għal tul ta ’ żmien, l- adegwatezza tat- tagħrif ta ’ sigurtà fid- dawl tal- Linja Gwida dwar l- Evalwazzjoni ta ’ Vaċċini Ġodda tas- CHMP, u l- indikazzjoni ta ’ Menitorix kemm għall- ewwel tilqima kif ukoll għall- booster.
The CHMP adopted a List of Outstanding Issues for the Applicant/ MAH to address and requested the Vaccine Working Party (VWP) to consider the same outstanding issues.
Is- CHMP adotta Lista ta ’ Argumenti Pendenti biex jiġu indirizzati mill- Applikant/ Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u talab lill- Grupp ta ’ Ħidma tal- Vaċċin (VWP) biex jikkunsidra l- istess argumenti pendenti.
The VWP considered the new submitted data along with the already submitted data and agreed that the safety and immunogenicity data are adequate and satisfactory to support the approval of Menitorix.
Dan il - Grupp ikkunsidra t- tagħrif il- ġdid sottomess flimkien mat- tagħrif diġà sottomess u qablet fuq it- tagħrif ta ’ sigurtà u immunoġeniċità li huma adegwati u sodisfaċenti għall- appoġġ ta ’ l- approvazzjoni ta ’ Mentorix.
The data support the use of Menitorix for priming in infancy and for boosting in the second year of life and for boosting toddlers who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
It- tagħrif jappoġġja l- użu ta ’ Menitorix għall- ewwel tilqima fl- infanzja u għall- booster fit - tieni sena tal- ħajja u sabiex jingħata bħala booster lit- trabi li jkunu telqu jimxu li jkunu ġew mogħtija l- ewwel tilqima b’ Menitorix jew b’ vaċċini konjugati Hib u MenC oħra.
In order to discuss the implication for long-term protection against MenC of the 18-month post booster data in study 022, in particular for those receiving primary vaccination with Menitorix, the Applicant/ MAH reviewed the available data relating to antibody titres and vaccine effectiveness after the administration of a single dose of mono-component vaccines in the second year of life.
Sabiex jiddiskuti l- implikazzjoni ta ’ protezzjoni fuq tul ta ’ żmien kontra MenC u d- dejta eżistenti għat- 18- il xahar wara li jkun ingħata il- booster fi studju 022, b’ mod partikolari għal dawk li qed jirċievu l- ewwel tilqima b’ Menitorix, l- Applikant/ id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq irreveda t- tagħrif disponibbli relatat mal- kwantità meħtieġa ta ’ antikorpi u l- effikaċja tal- vaċċin wara l- għoti fit- tieni sena tal- ħajja ta ’ doża waħda ta ’ vaċċini b’ komponent wieħed.
The data from SPCs, literature and generated during clinical development combined with recent surveillance data from the United Kingdom and Canada suggest that vaccine effectiveness remained high in unprimed subjects who had been vaccinated in their second year of life with a single dose.
It- tagħrif minn SPCs, letteratura u tagħrif iġġenerat waqt żvilupp kliniku ikkombinat ma ’ tagħrif ta ’ sorveljanza riċenti mir- Renju Unit u l- Kanada jissuġġerixxi li l- effikaċja tal- vaċċin baqgħet waħda għolja f’ suġġetti li kienu għadhom ma rċevewx l- ewwel tilqima u li kienu ġew imlaqqma fit- tieni sena tal - ħajja tagħhom b’ doża waħda.
Based on the SBA-MenC titres and SBA GMT obtained in studies and because of the effectiveness of single doses of mono-component MenC conjugate vaccines in unprimed toddlers, the Applicant/ MAH concluded that the long-term efficacy of Menitorix will be at least as good, if not better, as that observed in this age group in the UK and Canada.
Fuq il- bażi tat- titri SBA- MenC u l- GMT SBA miksuba fi studji u minħabba l- effikaċja ta ’ dożi singoli ta ’ vaċċini konjugati MenC ta ’ komponent wieħed fi trabi li telqu jimxu mhux imlaqqma, l- Applikant/ id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ikkonkluda li l- effikaċja ta ’ Menitorix fuq tul ta ’ żmien tkun ta ’ l- anqas tajba daqs, jekk mhux aħjar, minn dik osservata f’ dan il- grupp ta ’ età fir- Renju Unit u l- Kanada.
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).
Studju li bħalissa għadu għaddej se jiġġenera tagħrif SBA fuq tul ta ’ żmien waqt li l- Applikant/ dDetentur ta ’ l- Awtorizzazzjoni għat - Tqegħid 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).
The CHMP considered that the data suggests that the likely long term protection afforded by Menitorix should not be a cause for concern when used for priming and boosting or for boosting children primed with other MenC conjugate vaccines.
5 Is- CHMP ikkunsidra li d- dejta tissuġġerixxi li l- protezzjoni fuq tul ta ’ żmien li x’ aktarx tingħata minn Menitorix m’ għandhiex tkun il- kaġun għal tħassib meta użat għall- ewwel tilqima u għall- booster jew għall- għotja ta ’ booster lil tfal li jkunu ingħataw b’ vaċċini MenC ikkonġugati oħra.
Furthermore the CHMP considers that data on the persistence of SBA titres for up to 5 years after boosting with Menitorix alone cannot predict the
Barra minn hekk, is- CHMP ikkunsidra li d- dejta fuq il- persistenza ta ’ kwantitajiet SBA sa 5 snin wara l- għotja tal - booster b’ Menitorix waħdu ma jistax ibassar l- effett protettiv tat- tilqima fuq tul ta ’ żmien itwal, li jista ’ biss jiġi stmat minn sorveljanza dettaljata tal- mard u għaldaqstant jaqbel mal- proposta ta ’ reviżjoni tas- Sommarju tal- Karatteristiċi tal- Prodott li jirrifletti bir- reqqa u b’ mod komprensiv, l - ammont estensiv ta ’ dejta li diġà ġie akkumulatata fir- rigward ta ’ l- immunità mogħtija minn dan il - vaċċin.
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.
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.
The new totals are therefore 3293 infants vaccinated with Menitorix either as a primary course or as a booster and 578 infants vaccinated with 1713 doses of closely related Hib-MenC formulations.
Għaldaqstant, it- totali ġodda huma 3293 tarbija mlaqqma b’ Menitorix jew bħala kors primarju jew bħala booster u 578 tarbija imlaqqma b’ 1713- il doża ta ’ formulazzjonijiet Hib- MenC relatati mill- viċin.
The incidence of grade 3 unsolicited symptoms considered to be related to vaccination or booster vaccination in the previously submitted data was very low and similar between study groups.
L- inċidenza ta ’ sintomi mhux solleċitati ta ’ grad 3 ikkunsidrati li huma relatati ma ’ tilqim jew tilqim bħala booster fit- tagħrif sottomess qabel kienet baxxa ħafna u simili bejn iż- żewġ gruppi ta ’ l- istudju.
The two new studies provided similar data.
Iż- żewġ studji ġodda ipprovdew tagħrif simili.
Menitorix has been used in UK since September 2006 and three 6-monthly PSURs have been issued to date, with reassuringly low reporting rates and no new safety concerns allowing the Applicant/ MAH to conclude that the safety profile is adequately reflected in the Core Safety Information.
Menitorix ilu jintuża fir- Renju Unit minn Settembru 2006 u s’ issa inħarġu tliet PSURs (Rapporti Perjodiċi ta ’ Aġġornament dwar is- Sigurtà) ta ’ kull 6 xhur, b’ rati ta ’ rapportaġġ baxxi u mingħajr tħassib ta ’ sigurtà ġdid li jħallu lill- Applikant/ Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq) sabiex jikkonkludi li l- profil ta ’ sigurtà huwa rifless adegwatement fit- Tagħrif Ċentrali ta ’ Sigurtà.
However, following several reports of suspected ADRs, section 4.8 of the Menitorix SPC was updated.
Madankollu, wara diversi rapporti ta ’ suspett ta ’ ADRs, sezzjoni 4. 8 tal - Sommarju tal- Karatteristiċi tal- Prodott ta ’ Menitorix ġiet aġġornata.
The Applicant/ MAH considers that the extent of the total safety database is entirely consistent with the recommendations of the CHMP Guideline on Clinical Evaluation of New Vaccines and is sufficiently large to identify uncommon events.
L- Applikant/ Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq jikkunsidra li l- firxa tad- database ta ’ sigurtà totali hija konsistenti bis- sħiħ mar- rakkomandazzjonijiet tal- Linja Gwida ta ’ Evalwazzjoni Klinika fuq Vaċċini Ġodda tas- CHMP u hija kbira biżżejjed biex tidentifika episodji mhux komuni.
The CHMP considered that the safety data submitted indicates that the local and systemic AEs observed during clinical studies were as expected in terms of types and rates for a polysaccharide- protein conjugate vaccine and showed similar reactogenicity to other mono-component MenC and Hib vaccines in various clinical studies.
Is- CHMP ikkunsidra li t- tagħrif ta ’ sigurtà sottomess jindika li l- Każijiet Avversi lokali u sistemiċi osservati waqt studji kliniċi kienu kif mistennija f’ tipi u rati għall- vaċċin ikkonjugat ta ’ polisakkarajd - proteina u urew reazzjoniġeniċità għal vaċċini MenC u Hib ta ’ komponent wieħed f’ diversi studji kliniċi.
The post-marketing data raised no new concerns and the satisfactory safety profile of the vaccine was supported by the safety data reported in PSUR 3 from use of Menitorix in approximately 0.6 million toddlers as a booster dose for Hib and MenC in the UK.
It- tagħrif ta ’ wara t- tqegħid fis- suq ma qajjem l- ebda tħassib ġdid u l- profil ta ’ sigurtà sodisfaċenti tal- vaċċin kien appoġġjat mit- tagħrif ta ’ sigurtà irrapportat f’ PSUR 3 mill- użu ta ’ Menitorix f’ madwar 0. 6 miljuni tarbija li telqu jimxu u li ingħataw id- doża tal- booster għal Hib u MenC fir- Renju Unit.
Therefore, the CHMP considered that the size of the safety database was already satisfactory before provision of the additional clinical study data and that the new information submitted brings the total to well above the minimum suggested in the CHMP guideline.
Għaldaqstant, is- CHMP ikkunsidra li d- daqs tad- database ta ’ sigurtà diġà kien sodisfaċenti qabel l- għoti ta ’ tagħrif ta ’ studju kliniku addizjonali u li t- tagħrif ġdid sottomess ġab it - total ferm aktar mill- minimu issuġġerit fil- linja gwida tas- CHMP.
Overall, the CHMP considers the safety database to be of adequate size and satisfactory in content, supporting the use of Menitorix for priming in infancy and for boosting children in the second year of life who have been primed with Menitorix or with other Hib and MenC conjugate vaccines.
Kollox ma ’ kollox, is- CHMP jikkunsidra li d- database ta ’ sigurtà hija ta ’ daqs adegwat u sodisfaċenti fil- kontenut, u jappoġġja l- użu ta ’ Menitorix għall- ewwwel tilqima fl- infanzja u għall- booster ta ’ tfal fit- tieni sena ta ’ ħajja li kienu ġew l- ewwel imlaqqmin b’ Menitorix jew b’ vaċċini ikkonjugati Hib jew MenC oħra.
Efficacy and Safety conclusions The immunogenicity data indicates that Menitorix will be at least as effective as the licensed PRP-T and MenC conjugate vaccines when used for priming and/ or for boosting in accordance with the SPC.
Konklużjonijiet dwar l- Effikaċja u s- Sigurtà It- tagħrif ta ’ l- immunoġeniċità jindika li Menitorix se jkun effettiv daqs ta ’ l- inqas il- vaċċini ikkonjugati u liċenzjati PRP- T u MenC meta wżati għall- ewwel tilqima u/ jew għall- booster f’ konformità mas- Sommarju tal- Kartteristiċi tal- Prodott (SPC).
Menitorix can be used to boost toddlers primed with this vaccine or with other licensed Hib and MenC conjugate vaccines.
Menitorix jista ’ jintuża biex isaħħaħ trabi li telqu jimxu u li jkunu ngħataw l- ewwel tilqima b’ dan il- vaċċin jew b’ vaċċini konjugati Hib jew MenC oħra liċenzjati.
The CHMP considers that under the conditions of study, Menitorix elicits sufficient immune responses to both conjugate components to provide protection that is expected to be at least as good as that of licensed comparators.
Is- CHMP jikkunsidra li taħt il- kundizzjonijiet ta ’ l- istudju, Menitorix jiġbed reazzjonijiet immunitarji biżżejjed għaż- żewġ komponenti konjugattivi biex jipprovdi protezzjoni li hija mistennija li tkun tajba ta ’ l- inqas daqs tal- vaċċini ta ’ tqabbil liċenzjati.
The Company has already planned to assess long-term antibody persistence and, to complete this procedure, should formally commit to providing to the relevant national competent authorities for assessment the data from longer-term follow-up of studies 010/ 022 and 013 with anticipated timelines.
Il- Kumpanija diġà ippjanat li tistma l- persistenza ta ’ antikorpi fuq tul ta ’ żmien u, biex ittemm din il- proċedura, għandha timpennja ruħha formalment li tipprovdi lill- awtoritajiet kompetenti nazzjonali relevanti bit- tagħrif minn studji ta ’ follow- up fuq tul ta ’ żmien itwal 010/ 022 u 013 skond skedi ta ’ żmien ippjanati minn qabel.
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.
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
The similarity of Menitorix to already licensed products and the fact that the available safety data do not indicate any unusual problems are both reasons to accept the database provided.
Is- similarità ta ’ Menitorix għal prodotti diġà liċenzjati u l- fatt li tagħrif ta ’ sigurtà disponibbli ma jindika ebda problema mhux tas- soltu huma ż- żewġ raġunijiet biex tiġi aċċetta d- database ipprovduta.
Menitorix-containing regimens were not more reactogenic than the comparative regimens in which the same total range of antigens was administered.
Reġimen li fihom Menitorix ma kinux aktar reazzjoniġenetiċi minn reġimen ta ’ tqabbil fejn ingħatat l- istess firxa ta ’ antiġeni.
Finally, the post-marketing surveillance data from the UK are reassuring.
Fl- aħħarnett, it - tagħrif ta ’ sorveljanza ta ’ wara t- tqegħid fis- suq mir- Renju Unit huma inkoraġġanti.
The safety and immunogenicity data provided are adequate to establish that the risk-benefit relationship for the use of Menitorix for priming in infancy and/ or boosting in the second year of life is favourable.
It- tagħrif ta ’ sigurtà u immunoġeniċità ipprovduti huma adegwati biex jistabbilixxu li r- relazzjoni ta ’ riskju - benefiċċcju għall- użu ta ’ Mentorix għall- għoti ta ’ l- ewwel tilqima fl- infanzja u/ jew il- booster fit- tieni sena ta ’ ħajja hija favorevoli.
The most recent updates to the SPC serve to reflect the total data available thus far.
L- aktar aġġornamenti riċenti għall- SPC servew biex jirriflettu t- tagħrif totali disponibbli sa issa.
5 In line with these conclusions, the CHMP regarded Menitorix (GSK Bio) as acceptable for registration.
B’ mod konformi ma ’ dawn il- konklużjonijiet, is- CHMP stmat Menitorix (GSK Bio) bħala aċċettabbli għar- reġistrazzjoni.
Based on
Abbażi ta ’
- the Rapporteur’ s and Co-Rapporteur’ s assessment reports,
- Ir- rapporti ta ’ stima tar- Rapportatur u Ko- rapportatur,
- the Applicant/ MAH response to the CHMP questions,
- Ir- rispons ta ’ l- Applikant/ MAH għall- mistoqsijiet tas- CHMP,
- the Scientific discussion within the Committee,
- Id- diskussjoni Xjentifika fi ħdan il- Kumitat,
the CHMP has recommended granting the Marketing Authorisation for Menitorix, with amendments to the relevant sections of the PI and with commitments to be fulfilled.
is- CHMP irrakkomanda l- Awtorizzazzjoni għat- Tqegħid fis- Suq għal Menitorix, b’ emendi lis - sezzjonijiet relevanti tat- Tagħrif dwar il- Prodott (PI) u b’ obbligi li jeħtieġu jiġu sodisfatti.
The revised Product Information (Summary of Product Characteristics, Labelling and Package Leaflet) is set out in Annex II of the Opinion.
It- Tagħrif rivedut dwar il- Prodott (Sommarju tal- Karatteristiċi tal- Prodott, Tikketta u Fuljett ta ’ Tagħrif) jidher fl- Anness II ta ’ l- Opinjoni.
The conditions of the Marketing Authorisation are set out in Annex IV.
Il- kondizzjonijiet ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jidhru fl - Anness IV.
7 SUMMARY OF PRODUCT CHARACTERISTICS
7 ANNESS III
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 għal soluzzjoni għal injezzjoni Vaċċin konjugat tal- Haemophilus tip b u tal- Meninġokokku grupp Ċ [Ara Anness I - BIEX TIMTELA MILL- PAJJIŻ PARTIKOLARI]
After reconstitution, each 0.5 ml dose contains:
Wara li tiġi rrikostitwita, kull doża ta ’ 0. 5 ml ikun fiha:
Haemophilus type b polysaccharide (polyribosylribitol phosphate)
Polisakkarid tal- Haemophilus tip b (fosfat tal- polyribosylribitol)
conjugated to tetanus toxoid as carrier protein Neisseria meningitidis serogroup C (strain C11) polysaccharide conjugated to tetanus toxoid as carrier protein
konjugat ma ’ toxoid tat- tetnu bħala proteina ġarriera Neisseria meningitidis serogrupp C (tip C11) polysaccharide konjugat ma ’ toxoid tat- tetnu bħala proteina ġarriera
12.5 micrograms 5 micrograms 5 micrograms
12. 5 mikrogrammi 5 mikrogrammi 5 mikrogrammi
Powder and solvent for solution for injection White powder and a clear colourless solvent.
Trab u solvent għal soluzzjoni għal injezzjoni Trab abjad u solvent ċar u bla kulur.
Active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC).
Tilqim attiv ta ’ trabi bejn xahrejn u sentejn għall- prevenzjoni ta ’ mard invasiv ikkawżat mill - Haemophilus influenzae tip b (Hib) u Neisseria meningitidis serogrupp C (MenC).
See also section 4.4.
Ara wkoll sezzjoni 4. 4
Primary vaccination in infants from 2 months up to 12 months of age:
Tilqim primarju fi trabi minn xahrejn sa 12- il xahar:
Three doses, each of 0.5 ml, should be given with an interval of at least 1 month between doses.
Tliet dożi, kull waħda ta ’ 0. 5 ml, għandhom jingħataw b’ intervall ta ’ mill- inqas xahar bejn doża u oħra.
There are no data on the use of Menitorix for one or two doses of the primary vaccination course and other Hib and/ or MenC conjugate vaccines for other dose(s).
M’ hemmx informazzjoni dwar l- użu ta ’ Menitorix għal doża jew tnejn mill- kors ta ’ tilqim primarju u l- użu ta’ vaċċini oħra konjugati għal Hib u/ jew MenC għal doża( i) oħra.
It is recommended that infants who receive Menitorix for the first dose should also receive this vaccine for the second and third doses of the primary vaccination course.
Hu rrakkomandat li trabi li jieħdu Menitorix bħala l- ewwel doża għandhom jieħdu din it- tilqima għat- tieni u t- tielet doża tal- kors ta ’ tilqim primarju.
Booster vaccination:
Tilqima booster:
After primary vaccination in infancy, booster doses of Hib and MenC must be administered.
Wara tilqim primarju fi trabi, għandhom jingħataw dożi booster ta ’ Hib u MenC.
In children who received an acellular pertussis combination vaccine containing Hib in the primary infant immunisation series the Hib booster dose should be given before the age of 2 years.
Tfal li jkunu ħadu tilqima kkombinata għal sogħla konvulsiva bla ċelluli li kien fiha Hib fis- serje ta ’ tilqim primarju għat- trabi, id- doża booster Hib għandha tingħata qabel l- eta ’ ta ’ sentejn.
9 A single (0.5 ml) dose of Menitorix may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series with Menitorix or with other Hib or MenC conjugate vaccines.
L- eta ’ ta ’ meta tingħata din it -
The timing of the booster dose should be in accordance with available official recommendations and should usually be from the age of 12 months onwards and before the age of 2 years.
10 tilqima booster għandha tkun skond ir- rakkomandazzjonijiet uffiċjali disponibbli u li normalment tkun ’ il fuq minn tnax- il xahar u qabel is- sentejn.
Menitorix is not recommended for use in children above 2 years of age due to a lack of data on safety and efficacy.
Menitorix m’ huwiex irrakkomandat biex jintuża fi tfal wara l- eta 'ta' sentejn minħabba li ma jeżisti ebda tagħrif dwar sigurta ’ u effikaċja.
Long-term immunogenicity data following the use of Menitorix as a primary and booster vaccination are not yet available (see section 5.1).
Għadu m’ hux disponibbli tagħrif dwar immunoġeniċita fit- tul wara l- użu ta ’ Menitorix bħala vaċċin primarju jew booster
Menitorix should be given by intramuscular injection only, preferably in the anterolateral thigh region.
Menitorix għandu jiġi njettat ġol- muskoli biss, preferibbilment fi- naħa anterolaterali tal- koxxa.
In children 12 to 24 months of age, the vaccine may be administered in the deltoid region.
Fi tfal ta ’ bejn it- 12 u l- 24 xahar, il- vaċċin jista ’ jingħata fl- inħawi tad- deltojde.
(see also sections 4.4 and 4.5)
(ara wkoll sezzjonijiet 4. 4 u 4. 5)
Menitorix should under no circumstances be administered intravascularly, intradermally or subcutaneously.
Menitorix m’ għandu qatt jingħata ġol- vini, ġol- ġilda jew taħt il- ġilda.
Hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients (see sections 2 and 6.1).
Sensittività eċċessiva għas- sustanzi attivi, inkluż toxoid tat- tetnu, jew għal xi sustanzi mhux attivi (ara sezzjonijiet 2 u 6. 1)
Hypersensitivity reaction after previous administration of Menitorix.
Sensittivita ’ eċċessiva meta fl- imgħoddi ngħata Menitorix.
Acute severe febrile illness.
Mard akut b’ deni għoli.
The presence of a minor infection is not a contraindication for vaccination.
Il- preżenza ta ’ x’ infezzjoni ħafifa mhix kontra- indikazzjoni għat- tilqima.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil- każ tal- vaċċini kollha li jingħataw bl- injezzjoni, dejjem għandu jkun hemm disponibbli xi trattament mediku kif għandu jkun għall- possibbilta ’ rari ta ’ xi anafilassi wara li jingħata l- vaċċin.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Qabel tingħata t- tilqima għandha tiġi rriveduta l- istorja medika (speċjalment f’ dak li hu tilqim ta ’ qabel u l- possibbilta ’ ta ’ xi effetti mhux mixtieqa) u jsir eżami kliniku.
The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
It- tilqim għandu jingħata b’ ħafna attenzjoni lil individwi bi tromboċitepenja jew b’ xi problema ta ’ xi koagulazzjoni tad- demm.
No data are available on subcutaneous administration of Menitorix, therefore the possibility of any toxicity or reduced efficacy that might occur with this route of administration is unknown.
Ma jeżistix tagħrif dwar l- għoti ta ’ Menitorix taħt il- ġilda, għalhekk mhuwiex magħruf jekk hemmx il- possibbilta ’ ta ’ xi tossiċita ’ jew ta ’ tnaqqis ta ’ effikaċja li jista ’ jkun hemm b’ dan il- metodu.
Menitorix will only confer protection against Haemophilus influenzae type b and Neisseria meningitidis group C.
Menitorix iħarsek biss kontra Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp C.
As for any vaccine, Menitorix may not completely protect against the infections it is intended to prevent in every vaccinated individual There are no data available on administration of Menitorix in toddlers not already primed with Hib and MenC conjugates.
Ma jeżistix tagħrif dwar l- għoti ta ’ Menitorix lil trabi li jkunu għadhom ma ħadux il- konjugati għal Hib u MenC.
No data are available on the use of Menitorix in immunodeficient subjects.
Ma jeżistix tagħrif dwar l- użu ta ’ Menitorix f’ persuni immunodefiċjenti.
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.
F’ individwi b’ indeboliment tar- rispons immuni (minħabba l- użu ta ’ terapija immunosoppressiva, difett ġenetiku, infezzjoni tal - virus 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.
Individuals with complement deficiencies and individuals with functional or anatomical asplenia may mount an immune response to Hib and MenC conjugate vaccines; however the degree of protection that would be afforded is unknown.
Individwi b’ defiċjenzi tal- komplement u individwi b’ asplenja funzjonali jew anatomika jistgħu jiżviluppaw immunita ’ effettiva bil- vaċċini b’ konjugati għal Hib u MenC; madankollu mhuwiex magħruf x’ livell ta ’ protezzjoni jista ’ jkun hemm.
10 There are no data available on the use of Menitorix in infants who were born prematurely.
Ma jeżistix tagħrif dwar l- użu ta ’ Menitorix fi trabi mwielda qabel iż- żmien.
Therefore the degree of protection that would be afforded is unknown.
Għalhekk mhux magħruf il- livell ta ’ protezzjoni li jista ’ jinħoloq.
Although symptoms of meningism such as neck pain/ stiffness or photophobia have been reported following administration of other MenC conjugate vaccines, there is no evidence that MenC conjugate vaccines cause meningitis.
Għalkemm kienu ġew irrappurtati sintomi ta ’ meninġiżmu bħal uġigħ/ ebusija ta ’ l- għonq jew fotofobja wara l- għoti ta ’ vaċċini oħra b’ konjugati għal MenC, m’ hemm xejn li juri li l- vaċċini bil - konjugati għal MenC jikkawżaw meninġite.
Clinical alertness to the possibility of co-incidental meningitis should be maintained.
Għandha dejjem tingħata attenzjoni klinika xierqa għall - possibbilta ’ ta ’ meminġite ko- inċidentali.
Immunisation with this vaccine does not substitute for routine tetanus immunisation.
11 Tilqim b’ dan il- vaċċin mhijiex sostitut għall- tilqim ta ’ rutina għat- tetnu.
Since Hib capsular polysaccharide antigen is excreted in the urine, a positive urine antigen test can be observed within 1-2 weeks following vaccination.
Billi l- antiġen polisakkarid kapsulari tal- Hib jitneħħa fl- awrina, test għal antiġeni fl- awrina jista ’ jimmarka pożittiv fi żmien ġimgħa jew tnejn wara t- tilqima.
Other diagnostic tests, not based on the detection of the capsular antigen in urine, should be used to confirm Hib disease during this period.
Testijiet dijanjostiċi oħra, mhux ibbażati fuq is- sejba ta ’ antiġeni kapsulari fl- awrina, għandhom jintużaw biex tkun ikkonfermata l- marda Hib waqt dan il- perijodu.
Menitorix must not be mixed with any other vaccine in the same syringe.
Menitorix m’ għandux jitħallat ma ’ xi vaċċini oħra fl- istess siringa.
Different injectable vaccines should always be given at different injection sites.
Meta jintużaw aktar minn vaċċin wieħed dawn għandhom jingħataw dejjem f’ postijiet differenti tal - ġisem
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.
F’ diversi studji b’ vaċċini lliċenzjati monovalenti konjugati tal- grupp meninġokokku Ċ, l- għoti fl - istess ħin ta ’ kombinazzjonijiet b’ komponenti bla ċelluli għas- sogħla konvulsiva (bi jew mingħajr il - virus tal- polio mhux attiv, l- antiġen fil- wiċċ ta ’ l- epatite B jew konjugati ta ’ l- Hib [e. g.
DTPa- HBV-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.
DTPa- HBV - IPV- 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.
The proportions reaching SBA titres of at least 1:8 are not affected.
Il- proporzjon ta ’ livelli SBA li jilħqu 1: 8 ma jiġix affettwat.
At present, the potential implications of these observations for the duration of protection are not known.
Għalissa, l - implikazzjonijiet potenzjali ta ’ dawn l- osservazzjonijiet tul il- perijodu ta ’ protezzjoni mhumiex magħrufa.
In clinical trials of primary vaccination series, Menitorix was administered concomitantly (into opposite thighs) with a DTPa-HBV-IPV vaccine.
Fi provi kliniċi ta’ serje ta ’ tilqim primarju, Menitorix ingħata flimkien (mhux fl- istess koxxa) ma ’ vaċċin DTPa- HBV- IPV.
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.
Ir- reazzjoni għall- antiġeni kollha li ngħataw flimkien kienet tajba u kienet l - istess bħal dik li rriżultat fi gruppi ta ’ kontroll li ħadu DTPa- HBV- IPV- Hib * flimkien mal- vaċċin b’ konjugati ta ’ Hib u mingħajr MenC.
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.
Ir- reazzjoni ta ’ immunita ’ għall - komponenti ta ’ Hib u MenC ta ’ Menitorix ġiet assessjata biss fi studji kliniċi ta ’ tilqim primarju li kienu jinkludu l- għoti flimkien tal- vaċċini DTPa- IPV * jewDTPa- 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.
Fi prova ta ’ tilqim primarju, l- għoti flimkien ta ’ tilqima investigattiva bl- istess ammont ta ’ sakkaridi konjugati ta ’ l - Hib u MenC bħal f’ Menitorix b ’ DTPa- HBV- IPV * u vaċċin liċenzjat ta ’ sakkarid ta ’ pnewmokokku konjugat (it- tliet injezzjonijiet f’ postijiet anatomikament bogħod minn xulxin) kellu l - istess reazzjonijiet ta ’ immunita ’ għas- seba ’ serotipi ta ’ pnewmokokku bħal ma rriżultaw fi grupp li ngħataw DTPa- HBV- IPV * flimkien ma ’ Hib (konjugat għal toxoid tat- tetnu) u vaċċin illiċenzjat ta 'sakkarid ta' pnewmokokku kkonjugat.
There are no data on concomitant use of Menitorix with whole cell pertussis and oral poliomyelitis vaccines, however, no interference is expected.
M’ hawnx tagħrif dwar l- użu flimkien ta ’ Menitorix ma ’ vaċċini b’ ċellula sħiħa għas- sogħla konvulsiva u dawk tal- polio li jittieħdu mill- ħalq għalkemm mhumiex mistennija xi effetti mhux mixtieqa f’ dan il- każ.
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.
Fi prova ta ’ vaċċinazzjoni booster kontra Hib u MenC, Menitorix ingħata flimkien (fil- koxox opposti) ma ’ l- ewwel doża ta ’ vaċċin ikkombinat għall- ħożba, gattone u rubella (MMR).
Compared to the two control groups that received either Menitorix or MMR alone the immune responses to the antigens in both vaccines were not affected by concomitant administration.
Meta mqabbla maż - żewġ gruppi ta ’ kontroll li ħadu Menitorix jew MMR waħdu ir- reazzjonijiet ta ’ immunita ’ għall - antiġeni fiż- żewġ vaċċini ma ġewx affettwati meta ngħataw flimkien.
See sections 4.8 and 5.1.
Ara sezzjonijiet 4. 8 u 5. 1.
*GlaxoSmithKline combination vaccine
* Vaċċin ikkombinat ta ’ GlaxoSmithKline
11 4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
Menitorix is not intended for use in adults.
Mentorix mhuwiex maħsub biex jintuża f’ adulti.
Information on the safety of the vaccine when used during pregnancy or lactation is not available.
M’ hawnx tagħrif dwar is- sigurta ’ tal- vaċċin waqt tqala jew fuq il- ħalib tas- sider.
Not relevant.
12 Mhux rilevanti.
• Clinical trials
• Studji kliniċi
In clinical trials, Menitorix was administered as a 3-dose primary series (N=1,171) or as a booster (N=991) dose.
Fi studji kliniċi, Mentorix ingħata bħala serje primarja ta ’ 3 dożi (N=1, 171) jew bħala booster (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.
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).
Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination.
Waqt dawn l- istudji l- aktar li ġew irrappurtati effetti ħżiena kien fl- ewwel 48 siegħa wara t- tilqima.
In two clinical trials (N=578), Menitorix was administered concomitantly with Measles, Mumps, Rubella (MMR) vaccine.
F’ żewġ studji kliniċi (N=578), Menitorix ingħata flimkien ma ’ vaċċin tal- Measles, Mumps u Rubella (MMR).
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).
F’ wieħed minn dawn l- istudji, l- inċidenza ta ’ effetti mhux mixtieqa li ġiet osservata f’ persuni (N=102) li ħadu Menitorix flimkien ma ’ MMR * kienet l- istess bħal dik fil- grupp li kienu ħadu MMR waħdu (N=91) jew Menitorix waħdu (N+104).
(See sections 4.5 and 5.1)
(Ara sezzjonijiet 4. 5 u 5. 1)
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.
Effetti mhux mixtieqa kkunsidrati possibilment relatati mat- tilqima ġew ikklassifikati kif ġej skond il - frekwenza tagħhom.
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)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100, < 1/ 10) Mhux komuni (≥1/ 1, 000, < 1/ 100) Rari (≥1/ 10, 000, < 1/ 1, 000) Rari ħafna (< 1/ 10, 000) mhix magħrufa (ma tistax tiġi stmata mill- informazzjoni disponibbli)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta 'frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni ta ’ l- anqas serji fil- bidu
Psychiatric disorders: very common: irritability uncommon: crying
Disturbi psikjatriċi: komuni ħafna: irritabilita ’ mhux komuni: biki
Nervous system disorders: very common: drowsiness
Disturbi tas- sistema nervuża: komuni ħafna: ħedla
Gastrointestinal disorders: very common: appetite lost uncommon: diarrhoea, vomiting
Disturbi gastro- intestinali: komuni ħafna: nuqqas t’ aptit mhux komuni: dijareja, remettar
Skin and subcutaneous tissue disorders: uncommon: dermatitis atopic rare: rash
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: mhux komuni: dermatite atopika rari: raxx