FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with clinical study data on the timing of fever and measles-like rash, a post-marketing observational study in children 12 to 60 months of age revealed an approximate two-fold increase (0.70 per 1000 vs. 0.32 per 1000 children) in the risk of febrile seizures in the 5- to 12-day timeframe after a first dose of ProQuad (N=31,298) compared with concomitant administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck) (N=31,298).These data suggest one additional case of febrile seizure per 2600 children vaccinated with ProQuad compared with separate administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Maltese: Konsistenti ma' dejta miksuba minn studju kliniku dwar iż-żmien meta jitla' d-deni u l-preżenza ta' raxx jixbaħ lil dak tal-ħosba, studju ta' osservazzjoni wara t-tqegħid fis-suq fi tfal b'età minn 12 sa 60 xahar wera żjieda ta' madwar darbtejn aktar (0.70 għal kull 1000 vs. 0.32 għal kull 1000 tifel u tifla) fir-riskju ta' aċċessjonijiet tad-deni fil-perijodu bejn 5 ijem u 12-il jum wara l-għoti tal-ewwel doża ta' ProQuad (N=31,298) meta mqabbla mal-għoti f'daqqa tat-tilqima kontra l-ħosba, il-gattone u l-ħosba Ġemaniża mmanifatturata minn Merck & Co., Inc., u t-tilqima ħajja kontra l-ġidri r-riħ (Oka/Merck).
English: Only rarely have vaccine recipients developed chronic joint symptoms.
Maltese: Huwa rarament biss li r-riċevituri talvaċċin żviluppaw sintomi kroniċi tal-ġogi.
English: In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
Maltese: F'5 provi kliniċi, ProQuad ġie amministrat mingħajr l-ebda vaċċin ieħor lil 6038 tifel/tifla ta' bejn 12 u 23 xahar.
English: • An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
Maltese: • Infezzjoni bi Human Immunodeficiency Virus (HIV) mingħajr ma turi sintomi tal-marda talHIV.
English: Ear infection, Gastroenteritis, Nasopharyngitis, Otitis media, Pharyngitis, Roseola, Viral infection, Viral rash
Maltese: Infezzjoni fil-widnejn, Gastroenterite, Nasofarinġite, Otite tal-widna tannofs, Farinġite, Roseola, Infezzjoni virali, Raxx virali
English: b. Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella
English: 1 vial (powder) + 1 vial (solvent).
Maltese: Kunjett 1 (trab) + kunjett 1 (solvent).
English: Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Maltese: Wara tilqima fit-tfal, ir-reazzjonijiet fil-ġogi huma ġeneralment mhux komuni (0 sa 3%) u jdumu ftit.
English: • If the person to be vaccinated has a family history of congenital or hereditary immunodeficiency, unless the immune competence of this person is demonstrated.
Maltese: • Jekk il-persuna li se titlaqqam għandha storja familjari ta' immunodefiċjenza konġenitali jew ereditarja, sakemm ma tintweriex il-kompetenza tal-immunità ta' din il-persuna.
English: 10 vials (powder) + 10 vials (solvent).
Maltese: 10 kunjetti (trab) + 10 kunjetti (solvent).
English: In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
Maltese: Fi studju kbir ta' kontroll tal-każ, il-vaċċin kien stmat li kien 85 % effettiv kontra l-forom kollha ta' ġidri r-riħ u 97 % effettiv kontra mard moderatament sever u sever.
English: Immunogenicity was studied in children 12 through 23 months of age with a negative clinical history of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials.
Maltese: L-immunoġeniċità ġiet studjata fi tfal ta' 12 sa 23 xahar bi storja klinika negattiva ta' ħosba, gattone, rubella, u ġidri r-riħ li pparteċipaw f'5 provi kliniċi fuq bażi każwali.
English: SYRINGE OF SOLVENT
Maltese: Ż-ŻGĦAR EWLENIN SIRINGA TA' SOLVENT
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 gender, being greatest in adult females and least in prepubertal children.
Maltese: Artralġja u/jew artrite (normalment temporanji u rarament kroniċi) u polinewrite huma karatteristiċi ta' infezzjoni ma' rubella ta' tip selvaġġ u jvarjaw fil-frekwenza u fis-severità ma' l-età u s-sess, blaktar komuni jkunu fin-nisa adulti u l-anqas fi tfal prepubertali.
English: Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 96.3% to 98.8% for mumps, and 98.8% for rubella.
Maltese: Wara doża waħda ta' ProQuad, ir-rati ta' rispons tal-vaċċin kienu 97.7% għall-ħosba, 96.3% sa 98.8% għall-gattone, u 98.8% għar-rubella.
English: Tel.: +48.22.549.51.00 msdpolska@merck.com
Maltese: MSD Polska Sp. z o.o. Tel: +48.22.549.51.00 msdpolska@merck.com
English: Afebrile convulsions or seizures, Bell's palsy, Cerebrovascular accident, Dizziness, Dream abnormality, Encephalopathy*, Guillain-Barré syndrome, Measles inclusion body encephalitis (see section 4.3), Ocular palsies, Paraesthesia, Polyneuritis, Polyneuropathy, Subacute sclerosing panencephalitis*, Syncope, Transverse myelitis, Tremor
Maltese: Konvulżjonijiet jew aċċessjonijiet mingħajr deni, Paraliżi ta' Bell, Inċident ċerebrovaskulari, Sturdament, Ħolm mhux normali, Enċefalopatija* Sindrome ta' Guillain-Barré, Enċefalite tal-korp ta' inklużjoni tal-ħosba (ara sezzjoni 4.3), Paraliżi okulari, Parestesija, Polinevrite, Polinewropatija, Panenċefalite bi sklerożi bejn akuta u kronika*, Sinkope, Mijelite transversali, Rogħda
English: The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Maltese: Il-postijiet tal-injezzjoni ppreferuti huma l-parti anterolaterali tal-koxxa fi tfal żgħar u l-parti deltojd fi tfal akbar, adolexxenti, u adulti.
English: Lymphadenitis, Regional lymphadenopathy, Thrombocytopenia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.
Maltese: ProQuad huwa indikat għal tilqim simultanju kontra ħosba, gattone, rubella, u ġidri r-riħ f'individwu minn 12-il xahar 'il fuq.
English: Gastrointestinal disorders Diarrhoea, Vomiting
Maltese: Disturbi gastro-intestinali Dijarea, Rimettar
English: Vascular disorders Flushing, Pallor
Maltese: Disturbi vaskulari Fwawar, Pallidità
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BD54.
Maltese: Vaċċini, Vaċċin Virali; Kodiċi ATC:
English: Vaccination should be postponed during any illness with fever >38.5C.
Maltese: It-tilqim għandu jiġi pospost waqt mard b'deni li jitla' > 38.5°C.
English: • Very common (may affect more than 1 in 10 people): injection site complaints including pain/tenderness/soreness, redness; fever (38.9°C or higher);
Maltese: • Komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10): kundizzjonijiet fis-sit tal-injezzjoni inkluż uġigħ/tenerezza, ħmura, deni (38.9°C jew ogħla);
English: Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Maltese: Storja familjari ta' immunodefiċjenza konġenitali jew ereditarja, sakemm ma tintweriex il-kompetenza ta' l-immunità tar-riċevitur potenzjali tal-vaċċin.
English: The geometric mean titers (GMTs) following the second dose of ProQuad increased approximately 2 fold each for measles, mumps, and rubella, and approximately 41 fold for varicella (for safety information, see section 4.8).
Maltese: It-titres ġeometriċi medji (GMTs) wara ttieni doża ta' ProQuad żdiedu b'bejn wieħed u ieħor darbtejn kull wieħed għall-ħosba, gattone, u rubella, u bejn wieħed u ieħor 41 darba għall-ġidri r-riħ (għal informazzjoni dwar is-sigurtà, ara sezzjoni 4.8).
English: Clinical studies have shown that immunization with ProQuad elicits rates of antibody responses against varicella virus ≥5 gpELISA Units/ml similar to those observed after vaccination with Varicella Vaccine live (Oka/Merck).
Maltese: Studji kliniċi wrew li limmunizzazzjoni bi ProQuad tiġbed rati ta' risponsi ta' antikorpi kontra l-virus tal-ġidri r-riħ virus ≥ 5 gpELISA Units/ml simili għal dawk osservati wara t-tilqima b'Varicella Vaccine live (Oka/Merck).
English: Other medicines and ProQuad
Maltese: Mediċini oħra u ProQuad
English: Respiratory, thoracic, and mediastinal disorders Cough, Nasal congestion, Respiratory congestion, Rhinorrhoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla, Konġestjoni fl-imnieħer, Konġestjoni fis-sistema respiratorja, Rinoreja
English: Formal studies to evaluate the efficacy of ProQuad have not been performed.
Maltese: Ma sarux studji formali sabiex l-effikaċja ta' ProQuad tiġi evalwata.
English: Solvent Water for injections.
Maltese: f'postijiet ta' injezzjoni separati.
English: Bronchiolitis, Candida nappy rash, Candidiasis, Cellulitis, Infectious croup, Viral gastroenteritis, Hand-foot-mouth disease, Influenza, Pseudocroup, Respiratory infection, Skin infection, Tonsillitis, Varicella
Maltese: Bronkjolite, Raxx tal-ħrieqi mill-kandida,Kandidjasi , Ċellulite, Krupp infettiva, Gastroenterite virali, Marda tal-idejn, tas-saqajn u tal-ħalq, Influwenza, Pswedokrupp, Infezzjoni respiratorja, Infezzjoni tal-ġilda, Tonsillite, Ġidri r-riħ+ ‡, Konġuntivite virali
English: ProQuad has not been evaluated for potential to impair fertility.
Maltese: ProQuad ma ġiex stmat għall-possibbiltà ta' taħsir fil-fertilità.
English: The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella based on a post-vaccination antibody titer ≥5 gpELISA units/ml (an antibody titer that has been shown to be highly correlated with long-term protection).
Maltese: 8% sa 94.5%) għallġidri r-riħ fuq il-bażi ta' titer ta' antikorp ta' wara t-tilqima ≥ 5 gpELISA units/ml (titer ta' antikorp li ntwera li kien korrelatat ferm ma' protezzjoni fit-tul).
English: Clinical studies have demonstrated that ProQuad can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B antigen.
Maltese: Studji kliniċi urew li ProQuad jista' jingħata fl-istess ħin (iżda f'siti separati) ma' Prevenar u/jew vaċċin tal-epatite A, jew ma' tilqim monovalenti jew ikkombinat li jkun fih id-difterite, it-tetnu, ilpertussis aċellulari, il-Haemophilus influenzae tat-tip b, il-poljomelite inattivata, jew l-antiġen talepatite B.
English: Injection site complaints (Burning and/or Stinging of short duration, Eczema, Oedema/Swelling, Hive-like rash, Hematoma, Induration, Lump, Vesicles, Wheal and Flare), Inflammation, Lip abnormality, Papillitis, Roughness/Dryness, Stiffness, Trauma, Varicella-like rash, Venipuncture site haemorrhage, Warm sensation, Warm to touch
Maltese: Disturbi fis-sit tal-injezzjoni (Ħruq u/jewTingiż li ma jdumx biex jgħaddi, Ekżema, Edima/nefħa, Raxx jixbah il-ħorriqija, Ematoma, Ebusija, Boċċa, Bżieżaq bl-ilma, Ġerħa u Żbroff), Infjammazzjoni, Anormalità fix-xoffa, Papillite, Ħruxija/Nixfa, Ebusija, Trawma, Raxx jixbah lil tal-ġidri r-riħ, Emorraġija fis-sit tat-titqib tal-vina, Sensazzjoni ta' sħana, Ġilda tinħass sħuna
English: In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year.
Maltese: Fi prova klinika, 2 każijiet ta' herpes zoster ġew rappurtati f'2108 persuna f'saħħithom ta' età bejn 12 u 23 xahar li ġew imlaqqma b'doża waħda ta ProQuad u segwiti għal sena.
English: After reconstitution, one dose (0.5 ml) contains:
Maltese: Wara rikonstituzzjoni, doża waħda (0.5 ml) fiha:
English: Powder and solvent for suspension for injection.
Maltese: U KONTENUT Trab u solvent għal suspensjoni għall-injezzjoni.
English: • Common (may affect up to 1 in 10 people): injection site complaints including swelling or bruising; irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Maltese: • Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): kundizzjonijiet fis-sit tal-injezzjoni inkluż nefħa jew tbenġil; irritabilità; raxx (inkluż raxx simili għall-ħosba, raxx simili għall-ġidri r-riħ u raxx fis-sit tal-injezzjoni); infezzjoni fil-parti ta' fuq tal-apparat tan-nifs; rimettar u dijarea.
English: This vaccine contains 16 mg of sorbitol as an excipient.
Maltese: Dan il-vaċċin fih 16 mg ta' sorbitol bħala sustanza mhux attiva.
English: ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles; see sections 4.2, 4.4, and 5.1).
Maltese: ProQuad jista' jingħata lil individwi b'età minn 9 xhur 'l fuq f'ċirkustanzi speċjali (eż., b'konformità mal-iskedi nazzjonali ta' tilqim, sitwazzjonijiet fejn ikun hemm tifqigħa ta' mard, jew ivvjaġġar lejn reġjun bi prevalenza għolja ta' ħosba; ara sezzjonijiet 4.2, 4.4, u 5.1).
English: 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 sections 4.4 and 4.8).
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 sezzjonijiet 4.4 u
English: Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Maltese: Riżultati wrew tnaqqis gradwali fir-rati tal-ġidri r-riħ b'total ta' 90% sa 95% (madwar 10 sa 20 darba) mill-1995 sal-2009 fil-gruppi ta' età kollha, kemm fi tfal u adolexxenti mlaqqma kif ukoll f'dawk mhux imlaqqma.
English: ProQuad powder for suspension for injection IM/SC
Maltese: U MNEJN GĦANDU JINGĦATA ProQuad trab għal suspensjoni għall-injezzjoni IM/SC
English: 2 Wistar RA 27/3 strain (live, attenuated)...............not less than 3.00 log10 CCID Varicella virus
Maltese: Virus tar-rubella2 razza Wistar RA 27/3 (ħaj, attenwat) ........................mhux inqas minn 3.00 log10
English: The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/Merck)).
Maltese: It-tabib għandu lista ta' effetti sekondarji aktar kompleta għal ProQuad u għall-komponenti tat-tilqima għal ProQuad (it-tilqima tal-ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. u lVaċċin tal-Varicella live (Oka/Merck)).
English: Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Maltese: Konsegwentament, trasmissjoni b'kuntatt viċin personali, waqt li aċċettata bħala tejoretikament possibli, ma titqiesx bħala riskju sinifikanti; madankollu ġie ddokumentat li l-virus tar-rubella fil-vaċċin ġie trasmess lit-trabi mill-ħalib tas-sider mingħajr evidenza ta' mard kliniku (ara sezzjoni 4.6).
English: 1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 CCID Rubella virus
Maltese: Virus tal-gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, attenwat) ........... mhux inqas minn 4.30 log10
English: Musculoskeletal, connective tissue and bone disorders Arm pain, Musculoskeletal stiffness
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam Uġigħ fid-dirgħajn, Ebusija muskoluskelettrika
English: 1 vial (powder) + 1 pre-filled syringe (solvent)+ 2 needles.
Maltese: Kunjett 1 (trab) + siringa 1 mimlija għal-lest (solvent) + 2 labriet.
English: The immunogenicity and safety of ProQuad were evaluated in a clinical trial involving 799 subjects 4 through 6 years of age who had received Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at least 1 month prior to study entry.
Maltese: L-immunoġenicità u s-sigurtà ta' ProQuad ġew evalwati fi prova klinika li kienet tinvolvi 799 suġġett ta' 4 sa 6 snin t'età li kienu rċevew Varicella Vaccine live (Oka/Merck) u l-vaċċin tal-ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. għallinqas xahar qabel id-daħliet ta' l-istudju.
English: Arthritis and/or arthralgia (usually transient and rarely chronic)* , Musculoskeletal pain, Myalgia, Pain of the hip, leg, or neck, Swelling
Maltese: Artrite u/jew artralġja (normalment temporanja u kronika b'mod rari biss)*, Uġigħ muskoluskeletriku, Mijalġja, Uġigħ fil-ġenbejn, fis-saqajn jew fl-għonq, Nefħa
English: EU/1/05/323/005 - pack of 1 EU/1/05/323/006 - pack of 10 EU/1/05/323/007 - pack of 20
Maltese: EU/1/05/323/001 EU/1/05/323/002 EU/1/05/323/003 EU/1/05/323/004
English: The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention show that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
Maltese: Din id-dejta kienet ikkonfermata minn studju ta' osservazzjoni ta' wara t-tqegħid fissuq sponsorjat miċ-Ċentri għall-Kontroll u l-Prevenzjoni ta' Mard tal-Istati Uniti.
English: • Not known (frequency cannot be estimated from the available data): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/pneumonitis).
Maltese: • Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): fsada jew tbenġil taħt il-ġilda mhux tas-soltu, nefħa fit-testikoli; ħakk fil-ġilda, herpes zoster (ħruq ta' Sant'Antnin)*; infjammazzjoni tal-moħħ (enċefalite); infjammazzjoni tal-għata tal-moħħ u tan-nerv qawwi tas-sinsla mhux ikkawżata minn infezzjoni bil-batterji (meninġite asettika), mard sever talġilda; puplesija; aċċessjonijiet mingħajr deni; uġigħ u/jew nefħa fil-ġogi (li jistgħu jgħaddu jew jkunu kroniċi); u infjammazzjoni tal-pulmun (pnewmonja/pulmonite).
English: , Viral conjunctivitis
Maltese: Mhux komuni
English: ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Maltese: ProQuad jiġbed rati ta' risposti ta' antikorpi kontra l ħosba, gattone, u rubella simili għal dawk osservati wara t-tilqima bil-vaċċin tal-ħosba, gattone, u tarrubella mmanifatturat minn Merck & Co., Inc.
English: * See section c c. Description of selected adverse reactions
Maltese: *Ara sezzjoni ċ ċ. Deskrizzjoni ta' għażla ta' reazzjonijiet avversi
English: Post-Marketing Observational Safety Surveillance Study Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Maltese: Is-sigurtà ġiet stmata fi studju ta' osservazzjoni li kien jinkludi 69,237 tifel u tifla b'età minn 12-il xahar sa 12-il sena mlaqqma bi ProQuad u 69,237 tifel u tifla mqabbla fi grupp ta' tqabbil storiku li ngħataw it-tilqima kontra l-ħosba, l-gattone u l-ħosba Ġermaniża mmanifatturata minn Merck & Co., Inc. flimkien mat-tilqima ħajja kontra l-Ġidri r-Riħ (Oka/Merck).
English: • If the person to be vaccinated has any illness with fever higher than 38.5°C; however, low grade fever itself is not a reason to delay vaccination.
Maltese: • Jekk il-persuna li se titlaqqam għandha marda b'deni ogħla minn 38.5°C; madankollu, deni baxxa m'huwiex raġuni l-għala t-tilqima għandha ddum biex tingħata.
English: IM/SC
Maltese: CCID50*
English: The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.), currently used in routine vaccination in some countries.
Maltese: L-immunoġeniċità ta' doża waħda ta' formulazzjoni preċedenti ta' ProQuad kienet komparabbli għall-immunoġeniċità ta' vaċċini ta' komponent individwali ta' doża waħda (Varicella Vaccine live (Oka/Merck) u l-vaċċin talħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc.), użat fil-preżent f'tilqim ta' rutina f'xi pajjiżi.
English: High-risk individuals susceptible to varicella include:
Maltese: Individwi b'riskju għoli ta' suxxettibilità għall-virus jinkludu:
English: Post-exposure prophylaxis
Maltese: TAL-PRODOTT MEDIĊINALI
English: Acne, Clammy skin, Exfoliative dermatitis, Drug eruption, Exanthema, Henoch-Schönlein purpura, Livedo reticularis, Papular rash, Pruritus, Skin discolouration, Skin lesion, Zosteriform rash
Maltese: Akne, Ġilda umda, Dermatite li taqa' qxur qxur, Raxx fil-ġilda minħabba mediċina, Eksantema, Purpura ta' Henoch-Schönlein Livedo reticularis, Raxx bl-infafet, Ħakk, Telf ta' kulur tal-ġilda, Ferita fil-ġilda, Raxx bħal taż-zoster
English: 1 vial (powder) + 1 pre-filled syringe (solvent)+ 1 needle.
Maltese: Kunjett 1 (trab) + siringa 1 mimlija għal-lest (solvent) + labra 1.
English: The most common adverse events reported with the use of ProQuad were: injection-site reactions including pain/tenderness/soreness, redness, swelling or bruising; fever (≥39.4°C rectal equivalent); irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Maltese: L-aktar każijiet avversi rrappurtati b'mod komuni bl-użu ta' ProQuad kienu: reazzjonijiet fis-sit talinjezzjoni li jinkludu wġigħ/sensibilità, ħmura, nefħa jew tbenġil; deni (ekwivalenti għal ≥39.4°C firrektum); irritabiltà; raxx (li jinkludi raxx bħal tal-ħosba, raxx bħal tal-ġidri r-riħ, u raxx fis-sit talinjezzjoni); infezzjoni fin-naħa ta' fuq tal-apparat tan-nifs; rimettar u dijarea.
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Maltese: Artrite kronika ġiet assoċjata ma' infezzjoni tar-rubella tat-tip selvaġġ u kienet relatata ma' virus persistenti u/jew antiġen virali iżolat minn tessut tal-ġisem.
English: • Uncommon (may affect up to 1 in 100 people): cough.
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): aċċessjonijiet bid-deni.
English: 10 vials (powder) + 10 pre-filled syringes (solvent)+ 10 needles.
Maltese: 10 kunjetti (trab) + 10 siringi mimlijin għal-lest (solvent) + 10 labriet.
English: 20 vials (powder) + 20 pre-filled syringes (solvent)+ 40 needles.
Maltese: 20 kunjett (trab) + 20 siringa mimlijin għal-lest (solvent) + 40 labra.
English: ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe
Maltese: ProQuad trab u solvent għal suspensjoni għall-injezzjoni ProQuad trab u solvent għal suspensjoni għall-injezzjoni f'siringa mimlija għal-lest