FrancophonIA/ELRC3.0 huggingface dataset:
English: the CVMP, concluded that the overall benefit/risk balance for these products remains positive subject to the recommended changes in the product information for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State.
Maltese: is-CVMP, ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskji globali għal dawn il-prodotti jibqa' pożittiv soġġett għall-bidliet rakkomandati fl-informazzjoni dwar il-prodott għal Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, u ismijiet assoċjati, awtorizzati permezz ta' MRP IE/V/02720275/001/MR fejn huma involuti l-Irlanda bħala Stat Membru ta' referenza u Franza bħala Stat Membru kkonċernat.
English: The main difference between the SPCs for the products relates to the claim regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis and use of the product in pups less than 9 weeks of age and dogs weighing less than 2.5 kg.
Maltese: Id-differenza ewlenija bejn is-Sommarji tal-Karatteristiċi talProdotti hija relatata mad-dikjarazzjoni rigward l-effikaċja kontra Echinococcus granulosus u Echinococcus multilocularis u l-użu tal-prodott fi ġriewi li għandhom inqas minn 9 ġimgħat u klieb li jiżnu inqas minn 2.5 kg.
English: Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.
Maltese: Kombinazzjonijiet ta' antelmintiċi u praziquantel.
English: Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus were authorised subsequently by MRP IE/V/0272-0275/001/MR as hybrid applications under Article 13(3) of Directive 2001/82/EC, as amended involving Ireland as reference Member State and France as concerned Member State.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott għal dawn it-tliet prodotti jinkludi indikazzjonijiet kontra Echinococcus granulosus u Echinococcus multilocularis. Milaxyn Plus, Strantel Plus, Prazical Plus u Voxical Plus ġew awtorizzati b'mod sussegwenti permezz ta' MRP IE/V/0272-0275/001/MR bħala applikazzjonijiet ibridi skont l-Artikolu 13(3) tad-Direttiva 2001/82/KE, kif emendata, fejn ġew involuti l-Irlanda bħala Stat Membru ta' referenza u Franza bħala Stat Membru kkonċernat.
English: User Precautions:
Maltese: Prekawzjonijiet għall-utent:
English: The marketing authorisations for Prazitel Plus, Exitel Plus, Cazitel Plus and associated names, authorised by MRP IE/V/0241-0243/001/MR (see Annex I) do not need to be amended.
Maltese: Ma hemmx bżonn ta' emenda għall-awtorizzazzjonijiet għat-tqegħid fis-suq għal Prazitel Plus, Exitel Plus, Cazitel Plus u ismijiet assoċjati, awtorizzati permezz ta' MRP IE/V/0241-0243/001/MR (ara Anness I).
English: Please refer to package leaflet for disposal advice.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Maltese: Il-prodotti kkonċernati huma seba' duplikati b'dossiers identiċi ta' applikazzjoni ibrida li l-prodott ta' referenza tagħhom huwa Drontal Plus.
English: The CVMP requested Chanelle Pharmaceuticals Manufacturing Ltd.to justify the claim for efficacy against Echinococcus species and to provide all relevant data in support of the Echinococcus claim, which were presented previously in the dossiers submitted for marketing authorisation, together with comments on the suitability of the documentation to support the extrapolation of efficacy from the reference product to the hybrid product.
Maltese: Is-CVMP talab lil Chanelle Pharmaceuticals Manufacturing Ltd. sabiex tiġġustifika d-dikjarazzjoni dwar l-effikaċja kontra l-ispeċi Echinococcus u sabiex tipprovdi d-dejta rilevanti kollha b'appoġġ għad-dikjarazzjoni dwar Echinococcus, li qabel kienet preżenti fid-dossiers sottomessi għal awtorizzazzjoni għat-tqegħid fis-suq, flimkien ma' kummenti dwar kemm hija xierqa ddokumentazzjoni sabiex issostni l-estrapolazzjoni tal-effikaċja mill-prodott ta' referenza għallprodott ibridu.
English: • the CVMP considered the in use of the products in puppies less than 9 weeks of age and dogs weighing less than 2.5 kg
Maltese: • is-CVMP ikkunsidra l-użu tal-prodotti fi ġriewi ta' inqas minn 9 ġimgħat u klieb li jiżnu inqas minn 2.5 kg
English: The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
Maltese: Is-Sommarji tal-Karatteristiċi tal-Prodotti għal dawn l-erba' prodotti ma jinkludux indikazzjonijiet kontra Echinococcus granulosus u Echinococcus multilocularis.
English: These data are adequate as a bridge between the documented efficacy of the reference product (Drontal Plus) and the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Maltese: Din id-dejta hija adegwata bħala pont bejn l-effikaċja dokumentata tal-prodott ta' referenza (Drontal Plus) u l-prodott ikkonċernat (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus u Prazitel Plus u ismijiet assoċjati).
English: Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Maltese: Il-mod ta' azzjoni tiegħu huwa li jistimula rriċetturi nikotinikċi kolinerġiċi tal-parassita, jinduċi paraliżi spastika tan-nematodi u b'hekk jippermetti t-tneħħija mis-sistema gastrointestinali permezz ta' peristalsi.
English: In conclusion, based on the totality of data presented, it is accepted that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog.
Maltese: Bħala konklużjoni, fuq il-bażi tat-totalità tad-dejta ppreżentata, huwa aċċettat li l-prodott ikkonċernat (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus u ismijiet assoċjati) sejjer ikun effettiv (sa 100%) fit-trattament ta' forom immaturi u maturi ta' E. granulosus u E. multilocularis fil-klieb.
English: Whereas
Maltese: OĦRA
English: Do not use simultaneously with piperazine compounds.
Maltese: Tużax fl-istess ħin ma' komposti ta' piperazine.
English: These in vitro data confirm that, under the conditions tested, the dissolution profiles are similar for both products.
Maltese: Din id-dejta in vitro tikkonferma li, fil-kundizzjonijiet tat-test, il-profili ta' taħlit huma simili għaż-żewġ prodotti.
English: Denmark Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Maltese: Danimarka Chanelle Pharmaceuticals Manufacturing Ltd.
English: 4.9 Amounts to be administered and administration route For oral administration only.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole.
Maltese: Fis-sistema tal-mammiferi, febantel jgħaddi minn għeluq tar-ring, u jifforma fenbendazole u oxfendazole.
English: The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary.
Maltese: Fir-rigward ta' dak li ntqal hawn fuq, is-CVMP iqis li huwa improbabbli li l-użu fi ġriewi ta' inqas minn 9 ġimgħat jew klieb ta' inqas minn 2.5 kg iwassal għal tħassib għas-sikurezza, għaldaqstant, mhemmx bżonn ta' restrizzjoni fuq l-użu f'dawn l-annimali.
English: Luxembourg Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Maltese: Lussemburgu Chanelle Pharmaceuticals Manufacturing Ltd.
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data;
Maltese: • is-CVMP analizza s-sommarju tal-karatteristiċi tal-prodotti, it-tikkettar u l-fuljett ta' tagħrif proposti mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq u kkunsidra d-dejta ġenerali kollha li ġiet sottomessa;
English: Section 3.
Maltese: A.
English: Amendments to relevant sections of the product information of methadone tablets containing low molecular weight povidone (K25 or K30)
Maltese: Emendi għas-sezzjonijiet rilevanti tal-informazzjoni dwar il-prodott tal pilloli tal-methadone li fihom povidon b'piż molekulari baxx (K25 jew K30)
English: Section 6.1 List of excipients [Information about the type of povidone, e.g. K25 or K30, should be included in this section.]
Maltese: Sezzjoni 6.1 Lista ta' eċċipjenti [F'din is-sezzjoni għandha tiġi inkluża informazzjoni dwar it-tip ta' povidon, eż.
English: Annex III Amendments to relevant sections of the product information
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tal-informazzjoni dwar il-prodott
English: B. Package Leaflet
Maltese: Sommarju tal-Karatteristiċi tal-Prodott
English: Section 4.2 Posology and method of administration [The following text should be included in this section] This product is for oral use only, and must not be injected.
Maltese: Sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata [It-test li ġej għandu jiġi inkluż f'din is-sezzjoni] Dan il-prodott huwa għall-użu orali biss, u m'għandux jiġi injettat.
English: May 2017
Maltese: 24 ta' Mejju 2017
English: 60 micrograms
Maltese: 60 mikrogramma
English: HAV/saline
Maltese: HAV/salina
English: Fever ≥ 38 °C (Pyrexia)
Maltese: Deni ≥ 38°C (Piressija)
English: Dose 3 1170
Maltese: Doża 3 1170
English: EU/1/17/1187/001 EU/1/17/1187/002 EU/1/17/1187/003 EU/1/17/1187/004 EU/1/17/1187/005 EU/1/17/1187/006
Maltese: EU/1/17/1187/001 EU/1/17/1187/002 EU/1/17/1187/003 EU/1/17/1187/004
English: Booster dose
Maltese: Doża booster
English: Saline
Maltese: Salina
English: Note: The lower limit of quantitation is an hSBA titre = 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Maltese: Nota: Il-limitu l-aktar baxx tal-kwantifikazzjoni huwa titru ta' hSBA = 1:16 għal PMB80 (A22) u 1:8 għal PMB2001 (A56), PMB2948 (B24), u PMB2707 (B44).
English: Sodium chloride, histidine, water for injections, aluminium phosphate and polysorbate 80 (E433).
Maltese: Sodium chloride, histidine, ilma għall-injezzjonijiet, aluminium phosphate and polysorbate 80 (E433).
English: total of 2,471 subjects received Trumenba and 822 received saline.
Maltese: Total ta' 2,471 individwu rċevew Trumenba u 822 rċevew salina.
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi friġġ (2° C-8° C).
English: Similar results were observed in Groups 2 and 3 as observed in Group 1.
Maltese: Ġew osservati riżultati simili fi Gruppi 2 u 3 kif osservati fi Grupp 1.
English: Polysorbate 80 (E433) Water for injections For adsorbent, see section 2.
Maltese: Polysorbate 80 (E433) Ilma għall-injezzjonijiet Għall-adsorbent, ara sezzjoni 2.
English: Limitations of clinical trials
Maltese: Limitazzjonijiet tal-provi kliniċi
English: Study B1971016 (18-25 years of age)
Maltese: Studju B1971016 (18-25 sena)
English: EU/1/17/1187/001 - pack of 1 with separate needle EU/1/17/1187/002 - pack of 1 without needle EU/1/17/1187/003 - pack of 5 with separate needles EU/1/17/1187/004 - pack of 5 without needles EU/1/17/1187/005 - pack of 10 with separate needles EU/1/17/1187/006 - pack of 10 without needles
Maltese: EU/1/17/1187/001 - pakkett ta' 1 b'labra separata EU/1/17/1187/002 - pakkett ta' 1 mingħajr labra EU/1/17/1187/003 - pakkett ta' 5 b'labar separati EU/1/17/1187/004 - pakkett ta' 5 mingħajr labar EU/1/17/1187/005 - pakkett ta' 10 b'labar separati EU/1/17/1187/006 - pakkett ta' 10 mingħajr labar
English: Boehringer Ingelheim RCV GmbH & Co KG (BI RCV) Dr. Boehringer Gasse 5-11
Maltese: KG (BI RCV) Dr. Boehringer Gasse 5-11
English: Meningococcal group B vaccine (recombinant, adsorbed)
Maltese: Vaċċin meningokokkali tal-grupp B (rikombinanti, adsorbita)
English: (Cyprus Branch) Tηλ: +357 22 817690
Maltese: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
English: Tel: + 420 283 004 111
Maltese: s r.o. Tel: + 420 283 004 111
English: Intramuscular use.
Maltese: Użu intramuskolari.
English: 1 dose (0.5 ml)
Maltese: doża waħda (0.5 ml)
English: Group 1 received Trumenba at months 0, 2, and 6.
Maltese: Grupp 1 irċieva Trumenba fix-xhur 0, 2 u 6.
English: White liquid suspension.
Maltese: Suspensjoni likwida bajda.
English: Pharmacotherapeutic group: vaccines; ATC code: J07AH09
Maltese: Kategorija farmakoterapewtika: vaċċini; Kodiċi ATC:
English: Group 1
Maltese: Grupp 1
English: Study B1971033 is an open-label, follow-up study of subjects previously enrolled in a primary study, including Study B1971012.
Maltese: L-istudju B1971033 huwa studju follow-up, open-label ta' individwi li qabel kienu rreġistrati fi studju primarju, inkluż fl-Istudju B1971012.
English: Table 3.
Maltese: Tabella 3.
English: The potential risk for pregnant women is unknown.
Maltese: Ir-riskju potenzjali għal nisa tqal mhuwiex magħruf.
English: Group 4
Maltese: Grupp 4
English: Group 2 received saline at months 0, 2, and 6.
Maltese: Grupp 2 irċieva salina fix-xhur 0, 2 u 6.
English: Neisseria meningitidis serogroup B fHbp subfamily A
Maltese: Neisseria meningitidis serogrupp B fHbp sottofamilja A
English: Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: Active substances:
Maltese: Sustanzi attivi:
English: Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5.
Maltese: Mill-1,713-il individwu li ntgħażlu b'mod każwali, 427 kienu fi Grupp 1, 430 kienu fi Grupp 2, 427 kienu fi Grupp 3, 286 kienu fi Grupp 4, u 143 kienu fi Grupp 5.
English: Manufacturer responsible for batch release: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Maltese: Manifattur responsabbli għall-ħruġ tal-lott: Pfizer Manufacturing Belgium N.V.
English: Gastrointestinal disorders Very Common: Diarrhoea; nausea Common:
Maltese: Disturbi gastro-intestinali Komuni Ħafna: Dijarea; dardir Komuni:
English: Neisseria meningitidis serogroup B fHbp subfamily B
Maltese: Neisseria meningitidis serogrupp B fHbp sottofamilja B
English: hSBA Strain (fHbp Variant)
Maltese: Razza ta' hSBA (Varjant ta' fHbp)
English: LOT:
Maltese: LOTT:
English: Sodium chloride, histidine, water for injections, and polysorbate 80 (E433).
Maltese: Ingredjenti oħrajn: Sodium chloride, histidine, ilma għall-injezzjonijiet u polysorbate 80 (E433).
English: Group 2
Maltese: Grupp 2
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Maltese: 1 fHbp (proteina tat-twaħħil tal-fattur H) lipidata rikombinanti Prodotta f'ċelluli Escherichia coli minn teknoloġija tad-DNA rikombinanti Adsorbita fuq aluminium phosphate (0.25 milligramma ta' aluminju għal kull doża)
English: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Maltese: Pfizer Manufacturing Belgium N.V.
English: The study assessed the safety, tolerability, immunogenicity, and demonstration of manufacturability of 3 lots of Trumenba administered on a 0-, 2-, and 6-month schedule.
Maltese: L-istudju evalwa s-sigurtà, it-tollerabilità, l-immunoġeniċità, u t-turija tal-manifatturabbiltà ta' 3 lottijiet ta' Trumenba mogħtija fuq skeda ta' 0, 2, u 6 xhur.
English: Trumenba can be given concomitantly with any of the following vaccines: Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis, and Inactivated Poliovirus Vaccine (TdaP-IPV), Quadrivalent Human Papillomavirus vaccine (HPV4), Meningococcal Serogroups A, C, Y, W conjugate vaccine (MenACWY) and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap).
Maltese: Trumenba għandu jingħata flimkien ma' kwalunkwe wieħed minn dawn il-vaċċini: Tossojde tatTetanu, Tossojde tad-Difterite Mnaqqas, Pertussis Aċellulari, u Vaċċin ta' Poljovirus Inattivat (TdaPIPV), vaċċin tal-Papillomavirus tal-Bniedem Kwadrivalenti (HPV4), vaċċin konjugat ta' Serogruppi A, C, Y, W Meningokokkali (MenACWY) u Vaċċin Adsorbit ta' Tossojde tat-Tetanu, ta' Tossojde tad-Difterite Mnaqqas u ta' Pertussi Aċellulari (Tdap).
English: See section 5.1 for information on the immune response against specific serogroup B strains.
Maltese: Ara sezzjoni 5.1 għal informazzjoni dwar ir-rispons immuni kontra razez speċifiċi ta' serogrupp B.
English: A survey of over 2,150 different invasive meningococcal serogroup B isolates collected from 2000-2014 in 7 European countries, the US and Canada demonstrated that over 91% of all meningococcal serogroup B isolates expressed sufficient levels of fHbp to be susceptible to bactericidal killing by vaccine-induced antibodies.
Maltese: Stħarriġ ta' 'l fuq minn 2150 iżolati ta' serogrupp B meningokokkali invażivi differenti miġbura mill-2000-2014 f'7 pajjiżi Ewropej, fl-Istati Uniti u l-Kanada wrew li 'l fuq minn 91% tal-iżolati ta' serogrupp B meningokokkali kollha esprimew livelli ta' fHbp li kienu biżżejjed biex ikunu suxxettibbli għall-qtil batteriċidali b'antikorpi li jistimula l-vaċċin.
English: (0, 2, and 6 Months)
Maltese: (0, 2, u 6 Xhur)
English: (0, 1, and 6 Months)
Maltese: (0, 1, u 6 Xhur)
English: Primary series 2 doses (0.5 ml each) administered at a 6 month interval (see section 5.1).
Maltese: Serje primarja 2 dożi (0.5 ml kull waħda) mogħtija f'intervall ta' 6 xhur (ara sezzjoni 5.1).
English: Group 3
Maltese: Grupp 3
English: Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.
Maltese: Individwi immunokompromessi, inkluż individwi li jirċievu terapija immunosoppressanti, jista' jkollhom rispons immuni mnaqqas għal Trumenba.
English: Time Point
Maltese: TIKKETTAR
English: fHbp variants segregate into 2 immunologically distinct subfamilies, A and B, and over 96% of meningococcal serogroup B isolates in Europe express fHbp variants from either subfamily on the bacterial surface.
Maltese: Il-varjanti tal-fHbp jinqasmu f'2 sottofamilji immunoloġikament distinti, A u B, u 'l fuq minn 96% tal-iżolati ta' serogrupp B meningokokkali flEwropa jesprimu l-varjanti tal-fHBP minn kwalunkwe sottofamilja fuq is-superfiċje batterjali.
English: 0.5 ml suspension in a pre-filled syringe (Type I glass) with plastic Luer Lok adapter, chlorobutyl rubber plunger stopper, and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap cover with or without needle.
Maltese: Suspensjoni ta' 0.5 ml f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'adapter Luer Lok tal-plastik, stopper tal-planġer tal-lastku chlorobutyl, u għatu tat-tarf tal-lastku isoprene bromobutyl sintetiku b'cover tal-għatu tat-tarf riġidu tal-plastik bil-labra jew mingħajrha.
English: Adverse reactions following booster vaccination in 268 subjects aged 15 to 23 years were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.
Maltese: Ir-reazzjonijiet avversi wara tilqima booster f'268 individwu ta' bejn il-15 u t-23 sena kienu simili għar-reazzjonijiet avversi matul is-serje ta' tilqim primarju bi Trumenba madwar 4 snin qabel.
English: Very common (≥ 1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: (0 and 6 Months)
Maltese: (0 u 6 Xhur)
English: A total of 2,693 subjects received at least 1 dose of Trumenba and 897 received at least 1 dose of HAV vaccine/saline.
Maltese: Total ta' 2,693 individwi rċevew mill-inqas doża waħda ta' Trumenba u 897 irċevew mill-inqas doża waħda ta' vaċċina/salina tal-HAV.
English: Group 3 (0, 1, and 6 Months) (0, 2, and 6 Months) (0 and 6 Months) N % (95% CI)
Maltese: Grupp 1 (0, 1, u 6 xhur); Grupp 2 (0, 2, u 6 xhur); Grupp 3 (0 u 6 xhur); Grupp 4 (0 u 2 xhur); Grupp 5 (0 u 4 xhur).
English: A 4-fold increase in hSBA titre for each of the 4 primary meningococcal serogroup B test strains was defined as follows: (1) For subjects with a baseline hSBA titre < 1:4, a 4-fold response was defined as an hSBA titre ≥ 1:16.
Maltese: Żieda ta' 4 darbiet fit-titru ta' hSBA għal kull wieħed mill-4 razez tal-ittestjar ta' serogrupp B meningokokkali primarji ġiet definita kif ġej: (1) Għal individwi b'titru ta' hSBA fil-linja bażi < 1:4, rispons ta' 4 darbiet ġie definit bħala titru ta' hSBA ≥ 1:16.
English: A
Maltese: N
English: Study B1971016 was a Phase 3, randomised, placebo-controlled, observer-blinded, multicentre trial in which subjects 18 to 25 years of age were assigned to 2 groups in a 3:1 ratio (Group 1:Group 2).
Maltese: L-istudju B1971016 kien prova ta' Fażi 3 multiċentrika, observer-blinded, ikkontrollata bi plaċebo, li fih il-parteċipanti ntgħażlu b'mod każwali, li fiha individwi ta' 18 sa 25 sena kienu assenjati għal 2 gruppi fi proporzjon ta' 3:1 (Grupp 1:Grupp 2).
English: 1 single-dose (0.5 ml) pre-filled syringe with needle 1 single-dose (0.5 ml) pre-filled syringe without needle 5 single-dose (0.5 ml) pre-filled syringes with needles 5 single-dose (0.5 ml) pre-filled syringes without needles 10 single-dose (0.5 ml) pre-filled syringes with needles 10 single-dose (0.5 ml) pre-filled syringes without needles
Maltese: Suspensjoni għall-injezzjoni siringa waħda mimlija għal-lest b'doża waħda (0.5 ml) bil-labra siringa waħda mimlija għal-lest b'doża waħda (0.5 ml) mingħajr labra 5 siringi mimlija għal-lest b'doża waħda (0.5 ml) bil-labar 5 siringi mimlija għal-lest b'doża waħda (0.5 ml) mingħajr labar 10 siringi mimlija għal-lest b'doża waħda (0.5 ml) bil-labra 10 siringi mimlija għal-lest b'doża waħda (0.5 ml) mingħajr labar
English: Other medicines and Trumenba
Maltese: Mediċini oħra u Trumenba
English: In the immunogenicity analysis for Trumenba, a response was defined as an hSBA titre of at least 1:8 or 1:16 depending on the hSBA strain.
Maltese: Fl-analiżi ta' immunoġeniċità għal Trumenba, ġie definit rispons bħala titru ta' hSBA ta' mill-inqas 1:8 jew 1:16 skont ir-razza ta' hSBA.
English: Trumenba can be given at the same time as any of the following vaccine components: tetanus, diphtheria, whooping cough (pertussis), poliovirus, papillomavirus, and meningococcal serogroups A, C, Y, W.
Maltese: Trumenba jista' jingħata fl-istess ħin ma' kwalunkwe wieħed minn dawn il-komponenti tal-vaċċin li ġejjin: tetnu difterite sogħla konvulżiva (pertussi), poliovirus papillomavirus, u serogruppi A, C, Y, W meningokokkali.
English: Musculoskeletal and connective tissue disorders Very Common: Muscle pain (myalgia); joint pain (arthralgia)
Maltese: Uġigħ fil-muskoli (mijalġja); uġigħ fil-ġogi (artralġja)
English: Persistence of immunity and response to booster vaccination
Maltese: Persistenza ta' immunità u rispons għat-tilqima booster
English: Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.
Maltese: Minħabba li din ir-reazzjoni ġiet derivata minn rapporti spontanji, il-frekwenza ma tistax tiġi ddeterminata u għalhekk hija meqjusa bħala mhux magħrufa.
English: The efficacy of Trumenba has not been evaluated through clinical trials.
Maltese: L-effikaċja ta' Trumenba ma ġietx evalwata permezz ta' provi kliniċi.
English: The hSBA responses for subjects enrolled from primary Study B1971012 Group 1 (0-, 1-, 6-Month Schedule), Group 2 (0-, 2-, 6-Month) and Group 3 (0-, 6-Month) are presented in Tables 6 and 7.
Maltese: Ir-risponsi tal-hSBA għal individwi rreġistrati minn Grupp 1 (Kors ta' 0, 1, 6 Xhur), Grupp 2 (0, 2, 6 Xhur) u Grupp 3 (0, 6
English: Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
Maltese: Trumenba jintuża għal immunizzazzjoni attiva ta' individwi li għandhom 10 snin jew aktar biex tiġi evitata l-marda meningokokkali invażiva kkawżata minn Neisseria meningitidis serogrupp B.