FrancophonIA/ELRC3.0 huggingface dataset:
English: However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Maltese: Madankollu, l-istimi disponibbli jissuġġerixxu li fil-popolazzjoni ġenerali madwar 150 tifla u tfajla minn kull miljun li għandhom bejn 10 u 19-il sena jistgħu jiżviluppaw CRPS kull sena, u tal-inqas 150 tifla u tfajla minn kull miljun jistgħu jiżviluppaw POTS kull sena.
English: The Agency's review included published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States.
Maltese: Ir-reviżjoni tal-Aġenzija inkludiet riċerka ppubblikata, data minn provi kliniċi u rapporti ta' effetti sekondarji ssuspettati minn pazjenti u professjonisti fil-kura tas-saħħa, kif ukoll data fornita mill-Istati Membri.
English: • HPV (human papillomavirus) is a major cause of cancer of the cervix (neck of the womb) and some other cancers, as well as other conditions such as genital warts.
Maltese: • L-HPV (papillomavirus uman) huwa kawża ewlenija ta' kanċer taċ-ċerviċi (għonq tal-ġuf) u xi kanċers oħra, kif ukoll kundizzjonijiet oħra bħal felul ġenitali.
English: • Patients with POTS (postural orthostatic tachycardia syndrome) typically show abnormal increases in heart rate on standing, without orthostatic hypotension.
Maltese: • Il-pazjenti b'POTS (sindrome ta' takikardija ortostatika posturali) ġeneralment juru żidiet anormali fir-rata ta' taħbit tal-qalb meta jqumu bilwieqfa, mingħajr ipotensjoni ortostatika.
English: • Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of HPV vaccines and two syndromes, CRPS and POTS.
Maltese: • Is-sorveljanza ta' rutina ta' rapporti ta' reazzjonijiet avversi suspettati qajmet mistoqsijiet dwar lassoċjazzjoni potenzjali bejn l-użu tal-vaċċini tal-HPV u ż-żewġ sindromi, is-CRPS u l-POTS.
English: • There have been reports of two syndromes, CRPS and POTS, in girls who have been given HPV vaccines.
Maltese: • Kien hemm rapporti ta' żewġ sindromi, CRPS u POTS, fi bniet li ngħataw il-vaċċini tal-HPV.
English: In line with its initial recommendations, EMA confirmed that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil 9) and development of CRPS or POTS.
Maltese: F'konformità mar-rakkomandazzjonijiet inizjali tagħha, l-EMA kkonfermat li l-evidenza ma tappoġġjax rabta kawżali bejn il-vaċċini (Cervarix, Gardasil/Silgard u Gardasil 9) u l-iżvilupp ta' CRPS jew POTS.
English: The benefits of HPV vaccines therefore continue to outweigh the known side effects.
Maltese: Vaccine nazzjonali f'ħafna pajjiżi.
English: • CRPS and POTS are difficult to diagnose.
Maltese: • Is-CRPS u l-POTS huma diffiċli biex jiġu dijanjostikati.
English: The CHMP concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines.
Maltese: Is-CHMP qabel li l-evidenza disponibbli ma tappoġġjax li s-CRPS u l-POTS huma kkawżati minn vaċċini tal-HPV.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-mistoqsijiet dwar il-mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: • The review found no evidence that the overall occurrence of these syndromes in vaccinated girls was different from that expected in these age groups, even taking into account a variety of possible scenarios for underreporting and reports that did not fully meet diagnostic criteria for these syndromes.
Maltese: • Ir-reviżjoni ma sabet ebda evidenza li l-okkorrenza kumplessiva ta' dawn is-sindromi fi bniet imlaqqmin kienet differenti milli mistenni f'dawn il-gruppi ta' etajiet, anki meta titqies il-varjetà ta' xenarji possibbli għan-nuqqas ta' rapportar u r-rapporti li ma ssodisfawx b'mod sħiħ il-kriterji dijanjostiċi għal dawn is-sindromi.
English: Given that many reports have features of chronic fatigue syndrome, evidence including a large published study1 that showed no link between chronic fatigue syndrome and HPV vaccines was also considered relevant.
Maltese: Peress li ħafna rapporti għandhom karatteristiċi ta' sindrome ta' għeja kronika, evidenza li tinkludi studju kbir ippubblikat1 li ma wera l-ebda rabta bejn is-sindrome ta' għeja kronika u l-vaċċini tal-HPV kienet ikkunsidrata rilevanti wkoll.
English: CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
Maltese: Is-CRPS hija sindrome ta' uġigħ kroniku li taffettwa driegħ/riġel, filwaqt li l-POTS hija kundizzjoni fejn ir-rata ta' taħbit tal-qalb tiżdied b'mod anormali meta wieħed ipoġġi bilqiegħda jew meta jqum bilwieqfa, flimkien ma' sintomi bħal sturdament, ħass ħażin u dgħjufija, kif ukoll uġigħ ta' ras, uġigħ, dardir u għeja.
English: Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.
Maltese: L-użu ta' dawn il-vaċċini huwa mistenni li jipprevjeni ħafna każijiet ta' kanċer ċervikali (kanċer tal-għonq talġuf, li huwa responsabbli għal iktar minn 20,000 mewt fl-Ewropa kull sena) u diversi kanċers u kundizzjonijiet oħrajn ikkawżati mill-HPV.
English: The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.
Maltese: Is-sindromi huma magħrufa li jseħħu fil-popolazzjoni ġenerali, inkluż l-adolexxenti, irrispettivament mit-tilqim.
English: It is usually confined to a single limb.
Maltese: Ġeneralment ikun limitat għal driegħ/riġel wieħed.
English: CRPS produces long-lasting pain affecting a limb, and POTS is associated with an increase in heart rate on standing up, together with various symptoms including dizziness, weakness, pain, feeling sick, and fatigue.
Maltese: Is-CRPS tipproduċi uġigħ li jdum li jaffettwa driegħ/riġel, u l-POTS hija assoċjata ma' żieda fir-rata ta' taħbit tal-qalb meta tqum bilwieqfa, flimkien ma' diversi sintomi inkluż sturdament, dgħjufija, uġigħ, tħossok ma tiflaħx, u għeja.
English: Seroprotection rates [95% CI]
Maltese: Seroprotezzjoni [95% CI]
English: • Irritability.
Maltese: • Irritabilità.
English: produced in WI-38 human diploid lung fibroblasts.
Maltese: 2 prodott f'WI-38 human diploid lung fibroblasts.
English: Active untreated tuberculosis.
Maltese: Tuberkulożi attiva mhux trattata.
English: Interference with laboratory tests: see section 4.5.
Maltese: Tfixkil ma' testijiet tal-laboratorju: ara sezzjoni 4.5.
English: Medium 199 with Hanks' salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Maltese: Medium 199 b'Hanks' salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Maltese: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Franza
English: • Fever (38.5°C or higher).
Maltese: • Deni (38.5°C jew ogħla).
English: The vaccine contains 14.5 mg of sorbitol.
Maltese: It-tilqima fiha 14.5 mg ta' sorbitol.
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Maltese: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, L-Olanda
English: Current immunosuppressive therapy (including high doses of corticosteroids).
Maltese: Terapija immunosuppressiva kurrenti (inklużi dożi għoljin ta' corticosteroids).
English: M-M-RVAXPRO contains sorbitol.
Maltese: M-M-RVAXPRO fih sorbitol.
English: PostDose 1 PostDose 2
Maltese: INDIVIDWALI doża 1
English: Panniculitis, Pruritus, Purpura, Skin induration, Stevens-Johnson syndrome
Maltese: Pannikulite, Ħakk, Purpura, Ebusija fil-ġilda, Sindrome ta' Stevens-Johnson
English: Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Maltese: Anki f'nisa ta' età akbar (35-45 sena), dawn ir-reazzjonijiet ġeneralment huma ttollerati sewwa u rari jinterferixxu ma' l-attivitajiet normali.
English: Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11 ta' Mejju 2006
English: Sverige Merck Sharp & Dohme (Sweden) AB
Maltese: Merck Sharp & Dohme (Sweden) AB
English: Measles (titre ≥255 mIU/mL)
Maltese: Ħosba (titre ≥255 mUI/mL)
English: • Hives.
Maltese: • Biki.
English: 71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
Maltese: 71% tar-rapporti (212 minn 297) kienu jikkonċernaw biki bi żmien ta' aktar minn 24 siegħa għall-bidu tiegħu.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti ara sezzjoni 6.1.
English: Rubella virus Wistar RA 27/3 strain (live attenuated)
Maltese: Virus tar-rubella razza Wistar RA 27/3 (ħaj, attenwat)
English: Chronic arthritis
Maltese: Artrite kronika
English: Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Maltese: Wara tilqima fit-tfal, irreazzjonijiet fil-ġogi ġeneralment mhumiex komuni (0-3%) u ma tantx idumu.
English: EU/1/06/337/003 EU/1/06/337/004 EU/1/06/337/005 EU/1/06/337/006 EU/1/06/337/007 EU/1/06/337/008 EU/1/06/337/009 EU/1/06/337/010 EU/1/06/337/011 EU/1/06/337/012 EU/1/06/337/013
Maltese: EU/1/06/337/005 EU/1/06/337/006 EU/1/06/337/007 EU/1/06/337/008 EU/1/06/337/009 EU/1/06/337/010
English: Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
Maltese: Hydrochloric acid (biex jaġġusta l-pH) Sodium hydroxide (biex jaġġusta l-pH)
English: Rubella (titre ≥10 IU/mL)
Maltese: Ħosba Ġermaniża (titre ≥10 UI/mL)
English: Arthralgia and/or arthritis
Maltese: Artralġja u/jew artrite
English: Fertility M-M-RVAXPRO has not been evaluated in fertility studies.
Maltese: Fertilità M-M-RVAXPRO ma ġiex evalwat fi studji ta' fertilità.
English: Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25% ; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Maltese: Immunodefiċjenza tal-umuri jew ċellulari (primarja jew akkwistata) qawwija, eż., immunodefiċjenza kkombinata qawwija, agammaglobulinemija u AIDS jew infezzjoni bl-HIV bis-sintomi jew perċentwal ta' limfoċiti T CD4+ speċifiku għall-età fi tfal inqas minn 12-il xahar: CD4+ <25%; tfal bejn 12-il xahar u 35 xahar: CD4+ <20%; tfal bejn 36 u 59 xahar: CD4+ <15% (ara sezzjoni 4.4).
English: Such infants should be revaccinated at 12 to 15 months of age.
Maltese: Dawn it-trabi għandhom jiġu mlaqqma mill-ġdid meta jkollhom età minn 12 sa 15-il xahar.
English: M-M-RVAXPRO is available in packs of 1 and 10.
Maltese: M-M-RVAXPRO huwa disponibbli f'pakkett ta' 1 u f'pakkett ta' 10.
English: Common (may affect 1 to 10 in 100 vaccinees)
Maltese: Komuni (jista' jaffettwa minn persuna 1 sa 10 persuni minn kull 100 li jitlaqqmu)
English: Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]
Maltese: [Komuni ħafna (≥1/10); Komuni (≥1/100 sa <1/10); Mhux komuni (≥1/1,000 sa ≤1/100); Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)]
English: not less than 1x10
Maltese: mhux inqas minn 1x103
English: Under special circumstances, it can be given from 9 months of age.
Maltese: F'ċirkustanzi speċjali, huwa jista' jingħata mill-età ta' 9 xhur.
English: Published clinical data support concomitant administration of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella).
Maltese: Tagħrif kliniku ippubblikat jagħti appoġġ għal għoti tal-formolazzjoni preċedenti tal-vaċċin tal-ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc. ma' vaċċini oħra li jingħataw littfal, inkluż DTaP (jew DTwP), IPV (jew OPV), HIB (Haemophilus influenzae tip b), HIB-HBV (Haemophilus influenzae tip b ma' vaċċin ta' l-epatite B ), u VAR (variċella).
English: Respiratory, thoracic, and mediastinal disorders Rhinorrhoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rinorrea
English: The vaccine may contain traces of recombinant human albumin (rHA).
Maltese: It-tilqima jista' jkun fiha traċċi ta' albumina rikombinanti umana (rHA).
English: More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
Maltese: Iktar minn 400 miljun doża tal-formolazzjoni preċedenti tal-ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. tqassmu madwar id-dinja (1978-2003).
English: M-M-RVAXPRO can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1).
Maltese: M-M-RVAXPRO jista' jingħata lil trabi mill-età ta' 9 xhur f'ċirkustanzi speċjali (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Mumps (titre ≥10 ELISA Ab units/mL)
Maltese: (titre ≥10 unitajiet ta' Ak ELISA/mL)
English: not less than 1 x10
Maltese: mhux inqas minn 1 x103
English: M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles.
Maltese: M-M-RVAXPRO huwa disponibbli f'pakketti ta' 1, 10 u 20 bi jew mingħajr labar.
English: DO NOT INJECT INTRAVASCULARLY.
Maltese: Infezzjonijiet u infestazzjonijiet
English: In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Maltese: Fi prova klinika, M-M-RVAXPRO ingħata lil 1965 tifel u tifla (ara sezzjoni 5.1), u l-profil tas-sigurtà ġenerali kien komparabbli mal-formolazzjoni preċedenti tal-ħosba, gattone u ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc.
English: After reconstitution, one dose (0.5 ml) contains:
Maltese: Wara rikostituzzjoni, doża 1 (0.5 ml) fiha:
English: Uncommon (may affect 1 to 10 in 1000 vaccinees)
Maltese: Mhux komuni (jista' jaffettwa minn persuna 1 sa 10 persuni minn kull 1,000 li jitlaqqmu)
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu din it-tilqima.
English: †, Atypical measles, Epididymitis, Orchitis, Otitis media, Parotitis, Rhinitis, Subacute Sclerosing Panencephalitis
Maltese: Meninġite asettika†, Ħosba atipika, Epididimite, Orkite, Otite tal-widna tan-nofs, Parotite, Rinite, Panenċefalite sottoakuta bi sklerożi†
English: Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
Maltese: Spażmu tal-bronki, Sogħla, Pnewmonja, Pulmonite (ara sezzjoni 4.3), Uġigħ fil-griżmejn
English: This vaccine contains a trace amount of neomycin.
Maltese: Din it-tilqima fiha traċċi ta' neomycin.
English: • Deafness.
Maltese: • Ħorriqija.
English: M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals from 12 months of age (see section 4.2).
Maltese: M-M-RVAXPRO huwa indikat għat-tilqima simultanja kontra l-ħosba, il-gattone, u l-ħosba Ġermaniża f'individwi b'età minn 12-il xahar 'l fuq (ara sezzjoni 4.2).
English: Merck Sharp & Dohme Cyprus Limited.
Maltese: Malta Merck Sharp & Dohme Cyprus Limited., Tel:
English: 10 single dose vials (powder) + 10 vials (solvent).
Maltese: 10 kunjetti b'doża waħda (trab) + 10 kunjetti (solvent).
English: *50% cell culture infectious dose
Maltese: *50 % doża infettuża ta' kultura taċ-ċelloli
English: Non-pregnant adolescent and adult females
Maltese: Adoloxxenti u nisa adulti li m'humiex tqal
English: • Joint pain and/or swelling (usually transient and rarely chronic); muscle pain.
Maltese: • Uġigħ fil-ġogi u/jew nefħa (ġeneralment temporanja u li rari tkun kronika); uġigħ fil-muskoli.
English: • Diarrhoea, vomiting.
Maltese: • Dijarea, rimettar.
English: For storage conditions after the reconstitution of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3 6.5
English: †, Febrile convulsion (in children), Guillain-Barre syndrome, Headache, Measles inclusion body encephalitis (MIBE) (see section 4.3), Ocular palsies, Optic neuritis, Paraesthesia, Polyneuritis, Polyneuropathy, Retrobulbar neuritis, Syncope
Maltese: Konvulżjonijiet jew aċċessjonijiet bla deni, Atassja, Sturdament, Enċefalite†, Enċefalopatija†, Aċċessjoni tad-deni (fit-tfal), Sindrome ta' Guillain-Barre, Uġigħ ta' ras, Enċefalite b'korpi ta' inklużjoni tal-ħosba (MIBE) (ara sezzjoni 4.3), Paralisi fl-għajnejn, Nevrite ottika, Paresteżija, Polinevrite, Polinewropatija, Nevrite retrobulbari, Sinkope
English: • Headache; fainting; nerve disorders which can cause weakness, tingling, or numbness; eye nerve disturbances.
Maltese: • Uġigħ ta' ras; ħass ħażin; disturbi fin-nervituri li jistgħu jikkawżaw dgħufija, tingiż, jew tnemnim; disturbi fin-nerv tal-għajn.
English: This vaccine contains 14.5 mg of sorbitol as an excipient.
Maltese: Din it-tilqima fiha 14.5 mg ta' sorbitol bħala sustanza mhux attiva.
English: Immune globulin Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Maltese: Immune globulin Immune globulin (IG) m'għandux jingħata flimkien ma' M-M-RVAXPRO.
English: • Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff neck, and sensitivity to light); swollen testicles; infection of the middle ear; inflamed salivary glands; atypical measles (described in patients who received a killed measles virus vaccine, usually given before 1975).
Maltese: • Meninġite asettika (deni, tqalligħ, rimettar, uġigħ ta' ras, ebusija flgħonq, u sensittività għad-dawl); testikoli minfuħin; infezzjoni filwidna tan-nofs; glandoli tal-bżieq infjammati; ħosba mhux tipika (ġiet deskritta f'pazjenti li rċivew tilqima bil-virus tal-ħosba maqtul, is-soltu mogħtija qabel l-1975).
English: The MAH presented an analysis of reports with PT (preferred term) “Crying” From the data provided by the MAH “crying” was reported during clinical trials, post marketing source and literature report in paediatric population as an ADR.
Maltese: Mid-data pprovduta mill-MAH “biki” kien irrappurtat matul il-provi kliniċi, minn sors wara t-tqegħid fis-suq u f'rapport f'pubblikazzjoni medika fil-popolazzjoni pedjatrika bħala ADR.
English: Vaccination should be postponed during any illness with fever >38.5°C.
Maltese: It-tilqim għandu jiġi pospost waqt mard b'deni >38.5 °C.
English: History of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin (see sections 2, 4.4, and 6.1).
Maltese: Storja ta' sensitività eċċessiva għal xi vaċċin tal-ħosba, gattone, jew ħosba Ġermaniża, jew għal kwalunkwe wieħed mill-eċċipjenti, inkluż neomycin (ara sezzjonijiet 2, 4.4, u 6.1).
English: Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Maltese: Evalwazzjoni ta' i-immunoġeniċità u ta' l-effikaċja klinika Studju komparattiv f'1279 persuna li rċevew M-M-RVAXPRO jew il-formolazzjoni preċedenti (mmanifatturata minn albumina tas-serum uman) tal-ħosba, gattone jew ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. wera immunoġeniċità u sigurtà simili bejn iż-żewġ prodotti.
English: Pharmacotherapeutic group: Viral vaccine, ATC code J07BD52
Maltese: Vaċċin virali, Kodiċi ATC:
English: Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.
Maltese: Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 b'Hanks' salts, MEM, monosodium
English: Gastrointestinal disorders Diarrhoea or Vomiting
Maltese: Disturbi gastro-intestinali
English: M-M-RVAXPRO powder for suspension for injection
Maltese: M-M-RVAXPRO trab għal suspensjoni għall-injezzjoni.
English: Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Maltese: L-artralġja u/jew l-artrite (ġeneralment għaddiena u rarament kroniċi), u l-polinevrite huma karatteristiċi ta' infezzjoni b'rubella wild-type u jvarjaw fil-frekwenza u s-severità ma' l-età u s-sess talpersuna, l-akbar ikunu f'nisa adulti u l-anqas ikunu fi tfal ta' qabel il-pubertà.
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Maltese: F'individwi li huma immunokompromessi b'mod gravi li b'nuqqas ta' attenzjoni ġew imlaqqma b'vaċċin li fih il-ħosba, ġew rappurtati measles inclusion body encephalitis, pnewmonite u riżultati fatali bħala konsegwenza diretta ta' tixrid ta' l-infezzjoni tal-virus tal-vaċċin tal-ħosba.
English: Valence (seropro tection level)
Maltese: Valence (livell ta'
English: M-M-RVAXPRO is given as follows:
Maltese: Tużax M-M-RVAXPRO:
English: Detailed information on this vaccine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din it-tilqima tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2.of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Maltese: Studji kliniċi fuq 284 tifel u tifla li kienu negattivi fis-serum għal tlett darbiet, ta' età bejn 11-il xahar sa 7 snin, urew li l-formolazzjoni preċedenti tal-vaċċin tal-ħosba, gattone u ħosba Ġermaniża mmanifatturat minn Merck & Co., Inc. hija immunoġenika ħafna u ġeneralment tollerata sew.