FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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 listess 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.
English: 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.
Maltese: 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.
English: • Haemophilus influenzae type b (Hib): Hib bacteria most frequently cause meningitis (inflammation of the coverings of the brain and spinal cord).
Maltese: • Haemophilus influenzae tip b (Hib): Batterji Hib ta' sikwit jikkawżaw meninġite (infjammazzjoni tat-tessuti li jiksu l-moħħ u x-xewka tad-dahar).
English: All subjects responded immunologically to a challenge dose of 10 µg of unconjugated group C meningococcal polysaccharide with a thirty-three-fold increase in SBA titres demonstrating the immune memory induced by the primary vaccination course.
Maltese: Il-persuni kollha rrispondew immunoloġikament għal doża challenge ta' 10 µg ta' polisakkarid mhux ikkonjugat tal-grupp Ċ tal-meninġokokku bi żjieda ta' tlieta u tletin darba aktar f' livelli ta' SBA li turi lmemorja immuni li rriżultat mill-kors primarju ta' tilqim.
English: N= number of subjects with available results %= percentage of subjects with titres equal to or above the cut-off PRP= polyribosylribitol phosphate rSBA-MenC= serum bactericidal antibodies against meningococcal polysaccharide C using rabbit complement
Maltese: N= Numru ta' persuni b'riżultati disponibbli % = perċentwal ta' persuni b'livelli daqs jew aktar mill-cut-off PRP = polyribosylribitol phosphate rSBA-MenC= antikorpi batteriċidi fis-serum kontra l-polisakkarid Ċ meninġokokku biż-żjieda ta' sustanza meħuda mill-fenek
English: Menitorix should be given by intramuscular injection only, preferably in the anterolateral thigh region.
Maltese: Menitorix għandu jiġi njettat ġol-muskoli biss, preferibbilment fi-naħa anterolaterali tal-koxxa.
English: 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).
Maltese: 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).
English: Menitorix should not be given:
Maltese: X'fih Menitorix:
English: Nervous system disorders: very common: drowsiness
Maltese: Disturbi tas-sistema nervuża: komuni ħafna: ħedla
English: Strength *
Maltese: EFFETTI
English: GMC or GMT= geometric mean antibody concentration or titre
Maltese: GMC jew GMT= konċentrazzjoni jew livell medju ġeometriku ta' antikorpi
English: Even after recovery from Hib meningitis there can be complications such as mental retardation, spastic paralysis, deafness or epilepsy.
Maltese: Anke wara l-fejqan minn meninġite Hib jista' jkun hemm komplikazzjonijiet bħal moħħ irritardjat, paraliżi spastika, turxien jew epilessija.
English: It cannot protect against meningitis caused by other bacteria or viruses, including other types and groups of Haemophilus or Neisseria bacteria.
Maltese: Ma jistax jagħti protezzjoni kontra l-meninġite kkawżata minn batterji jew viruses oħra, inklużi tipi u gruppi oħra ta' batterji Haemophilus jew Neisseria.
English: United Kingdom
Maltese: • Ngħas
English: Clinical trials have evaluated the antibody responses at one month after two doses and after completion of a 3-dose primary vaccination course of Menitorix (co-administered with DTPa-HBVIPV or DTPa-IPV vaccines) given at approximately 2, 3, 4 months or 2, 4, 6 months to 814 infants.
Maltese: Studji kliniċi vvalutaw ir-reazzjonijiet ta' antikorpi fi żmien xahar wara żewġ dożi u wara li jintemm kors ta' tilqim primarju bi tliet dożi ta' Menitorix (mogħti flimkien ma' vaċċini DTPa-HBV-IPV jew DTPa-IPV) li ġew mogħtija fl-etajiet ta' 2, 3 u 4 xhur jew 2, 4 u 6 xhur lil 814 tarbija.
English: 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.
Maltese: 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.
English: Menitorix is not intended for use in adults.
Maltese: Mentorix mhuwiex maħsub biex jintuża f'adulti.
English: The vaccine cannot cause Hib and MenC.
Maltese: Il-vaċċin ma jistax jikkawża infezzjoni tal-batterji Hib u MenC.
English: Booster vaccination
Maltese: Tilqim booster
English: Gastrointestinal disorders: very common: appetite lost uncommon: diarrhoea, vomiting
Maltese: Disturbi gastro-intestinali: komuni ħafna: nuqqas t'aptit mhux komuni: dijareja, remettar
English: BATCH NUMBER
Maltese: TIKKETTA
English: 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.
Maltese: 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.
English: Severe skin reactions, collapse or shock-like state (hypotonic-hyporesponsiveness episode), faints, seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia, relapse of nephrotic syndrome, arthralgia, petechiae and/or purpura.
Maltese: Dawn li ġejjin ma ġewx irrappurtati b'xi konnessjoni ma' l-għoti ta' Menitorix iżda seħħew rarament ħafna waqt l-użu ta' rutina ta' vaċċini konjugati lliċenzjati tal-meninġokokku tas-serogrupp Ċ : Reazzjonijiet qawwija fil-ġilda, kollass jew stat qisu ta' xokk (episodju hypotonichyporesponsiveness), ħass ħażin, aċċessjonijiet f'persuni li kienu minn qabel suġġetti għalihom, hypoaesthesia, paraesthesia, rikaduta tas-sindrome nefrotika, artralġja, petechiae u/jew purpura.
English: Pharmacotherapeutic group: bacterial vaccines ATC code: J07AG53
Maltese: Vaċċini batterjali Kodiċi ATC:
English: Menitorix and associated names (See Annex I) powder for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally] I.M.
Maltese: Menitorix u ismijiet assoċjati (ara Anness I) trab għal soluzzjoni għall-injezzjoni Haemophilus tip b u Meningococcal grupp C vaċċin ikkonjugat [Ara Anness I - Biex timtela mill-pajjiz partikolari ] I.M.
English: 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.
Maltese: 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*
English: 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 polysaccharideprotein conjugate vaccine and showed similar reactogenicity to other mono-component MenC and Hib vaccines in various clinical studies.
Maltese: 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' polisakkarajdproteina u urew reazzjoniġeniċità għal vaċċini MenC u Hib ta' komponent wieħed f'diversi studji kliniċi.
English: 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).
Maltese: Tilqim attiv ta' trabi bejn xahrejn u sentejn għall-prevenzjoni ta' mard invasiv ikkawżat millHaemophilus influenzae tip b (Hib) u Neisseria meningitidis serogrupp C (MenC).
English: Haemophilus type b and Meningococcal group C conjugate vaccine
Maltese: Vaċċin konjugat tal-Haemophilus tip b u tal-meninġokokku grupp Ċ
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI U D-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and single and repeated dose toxicity studies.
Maltese: Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika u effetti tossiċi minn dożi rripetuti, ma turi l-ebda periklu speċjali għall-bnedmin
English: Estimates of vaccine effectiveness from the UK's routine immunisation programme (using various quantities of three meningococcal group C conjugate vaccines) covering the period from introduction at the end of 1999 to March 2004 have demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3 and 4 months).
Maltese: Kalkoli ta' l-effettivita' tal-vaċċin mill-programm ta' rutina dwar tilqim fir-Renju Unit (li juru kwantitajiet diversi ta' tliet vaċċini kkonjugati tal-grupp Ċ tal-meningokokku), li jkopru l-perijodu mindu bdew fl-aħħar ta' l-1999 sa Marzu 2004, urew il-bżonn ta' doża booster wara t-tkomplija talkors primarju (tliet dożi mogħtija fl-etajiet ta' 2, 3 u 4 xhur).
English: (Invented) Name
Maltese: (Isem Ivvintat) Isem
English: In this leaflet:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq :
English: 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.
Maltese: 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.
English: Although Menitorix contains tetanus toxoid (inactivated bacterial toxin), which is used to immunise people against tetanus (lockjaw), it is still necessary that your child should receive the recommended childhood vaccinations against tetanus.
Maltese: Għalkemm Menitorix fih toxoid tat-tetnu (tossina batterjali mhux attivata) , li tintuża biex timmunizza n-nies kontra t-tetnu (lockjaw), xorta jibqa' l-bżonn li t-tarbija tiegħek titlaqqam kif rrakkomandat kontra t-tetnu.
English: Menitorix is a vaccine that can be given to children after the age of 2 months up to 2 years to prevent infectious diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria.
Maltese: Barra dan, Menitorix jista' biss jagħti protezzjoni kontra l-meninġite u infezzjonijiet oħra kkawżati mill- Haemophilus influenzae tip b (Hib) u Neisseria meningitidis grupp C (MenC).
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Maltese: M'hemmx għalfejn evalwazzjoni tal-kwalitajiet farmakokinetiċi għal vaċċini.
English: 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.
Maltese: 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.
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:
Maltese: Perċentwali ta' persuni b'livelli ta' antikorpi ≥ assay cut-off xahar wara tilqima booster b'Menitorix mogħtija flimkien ma' vaċċin għal ħożba-gattone-rubella (MMR)* kienu kif ġej:
English: Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows:
Maltese: Perċentwali ta' persuni b'livelli ta' antikorpi ≥ assay cut-off xahar wara tilqim primarju b'Menitorix mogħti b'vaċċini DTPa-IPV* jew DTPa-HBV-IPV* kienu kif ġej:
English: 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]
Maltese: 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]
English: If Menitorix is used to boost protection against Hib and MenC:
Maltese: Meta Menitorix jintuża bħala booster għall-protezzjoni kontra Hib u MenC:
English: 2-3-4 month schedule
Maltese: Skeda ta' 2-4-6 xhur
English: Other side effects which have occurred very rarely (in less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with Menitorix include:
Maltese: Effetti sekondarji oħra li ġraw rarament (f'anqas minn 1 kull 10,000 doża ta' vaċċin) fil-ġranet jew ġimgħat wara tilqim b'Menitorix jinkludu:
English: Experimental data show that the reconstituted vaccine could also be kept to 24 hours at ambient temperature (25°C).
Maltese: Tagħrif sperimentali juri li l-vaċċin irrikostitwit jista' wkoll jinżamm għal 24 siegħa f'temperatura ambjentali (25°Ċ).
English: 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.
Maltese: 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.
English: [ For the status on marketing authorisation under exceptional circumstances and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]
Maltese: [ For the status on marketing authorisation under exceptional circumstances and, where appropriate, for similarity and derogation, please select the statement(s) as provided below.]
English: <ANNEX IV
Maltese: <ANNESS IV
English: <one-year <marketing protection> <data exclusivity>>
Maltese: <sena waħda ta' <protezzjoni tal-kummerċjalizzazzjoni > <esklussività tad-data> >
English: [For Art 14(11)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Maltese: [For Art 14(11)] <Is-CHMP irreveda d-data sottomessa mid-Detentur ta' Awtorizzazzjoni għat-Tqegħid fis-Suq, filwaqt li kkunsidra d-dispożizzjonijiet tal-Artikolu 14(11) tar-Regolament (KE) Nru 726/2004, u jqis li l-indikazzjonijiet terapewtiċi jġibu magħhom benefiċċju kliniku sinifikanti meta mqabbla ma' terapiji eżistenti, kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: <The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report :
Maltese: <Is-CHMP huwa tal-fehma li skont l-Artikolu 8 tar-Regolament (KE) Nru 141/2000 u <l-Artikolu 3 tar-Regolament tal-Kummissjoni (KE) Nru 847/2000> [only for the superiority derogation] id-deroga/i li ġejja/ġejjin stabbilita/i fl-Artikolu 8.3 tal-istess Regolament tapplika/japplikaw kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni:
English: [Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report.
Maltese: [For Art 10(5)] <Is-CHMP irreveda d-data sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, filwaqt li kkunsidra d-dispożizzjonijiet tal-Artikolu 10(5) tad-Direttiva 2001/83/KE, u jqis li <t-testijiet pre-kliniċi> <u> <l-istudji kliniċi> mwettqa b'rabta mal-indikazzjoni l-ġdida kienu sinifikanti, kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
Maltese: <l-applikant jista' jistabbilixxi fl-applikazzjoni li l-prodott mediċinali, minkejja li huwa simili għall-<prodott mediċinali orfni awtorizzat>, huwa aktar sigur, aktar effettiv jew inkella klinikament superjuri (kif definit fl-Artikolu 3 tar-Regolament tal-Kummissjoni (KE) Nru 847/200) għall-istess indikazzjoni terapewtika> <u>
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Maltese: <Is-CHMP huwa tal-fehma li <isem il-prodott mediċinali> hu simili għal prodotti mediċinali orfni fis-sens tal-Artikolu 3 tar-Regolament tal-Kummissjoni (KE) Nru 847/2000 kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.>
English: Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
English: ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2.
Maltese: ReproCyc ParvoFLEX fih ir-razza 27a tal-proteina 2 virali tal-parvovirus inattivat (maqtul) tal-ħnieżer.
English: ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019.
Maltese: ReproCyc ParvoFLEX irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 26/04/2019.
English: An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
Maltese: Wara t-tilqim jista' jkun hemm żieda fit-temperatura tal-ġisem (li tista' taffettwa sa annimal 1 minn 10) iżda din tgħaddi fi żmien 24 sa 48 siegħa.
English: Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus.
Maltese: Tliet studji fil-laboratorju wrew li ReproCyc ParvoFLEX jipproteġi kontra infezzjoni transplaċentali talparvovirus tal-ħnieżer, peress li aktar minn 95 % tal-qżieqeż minn ħnieżer nisa mlaqqmin kienu protetti minn infezzjoni, kif muri min-nuqqas tal-parvovirus.
English: Other information about ReproCyc ParvoFLEX
Maltese: Informazzjoni oħra dwar ReproCyc ParvoFLEX
English: ReproCyc ParvoFLEX is a vaccine.
Maltese: ReproCyc ParvoFLEX huwa vaċċin.
English: ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer.
Maltese: ReproCyc ParvoFLEX fih ukoll l-adjuvant (ingredjent li jsaħħaħ ir-rispons immunitarju) karbomer.
English: A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters.
Maltese: Studju fuq il-post fi Spanja wera li ReproCyc ParvoFLEX, meta jingħata lill-ħnieżer nisa, kien effettiv daqs vaċċin tal-parvovirus tal-ħnieżer awtorizzat, Parvoseng, kif imkejjel mill-fertilità ta' annimali mlaqqmin, in-numru ta' qżieqeż imwielda mejtin u d-daqs tal-boton.
English: What are the risks associated with ReproCyc ParvoFLEX?
Maltese: X'inhuma r-riskji assoċjati ma' ReproCyc ParvoFLEX?
English: Porcine parvovirus causes infertility, still births and small litters in female pigs.
Maltese: Ilparvovirus tal-ħnieżer jikkawża infertilità, qżieqeż imwielda mejtin u boton żgħar fi ħnieżer nisa.
English: The vaccine contains a porcine parvovirus protein that does not cause disease.
Maltese: Il-vaċċin fih proteina tal-parvovirus tal-ħnieżer li ma tikkawżax mard.
English: Why is ReproCyc ParvoFLEX authorised in the EU?
Maltese: Għalfejn ReproCyc ParvoFLEX huwa awtorizzat fl-UE?
English: ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta.
Maltese: ReproCyc ParvoFLEX huwa vaċċin veterinarju li jingħata lil ħnieżer nisa għall-protezzjoni tal-qżieqeż tagħhom li għadhom ma twieldux minn infezzjoni tal-parvovirus tal-ħnieżer permezz tal-plaċenta.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi “jgħallmu” lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: How is ReproCyc ParvoFLEX used?
Maltese: Kif jaħdem ReproCyc ParvoFLEX?