FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names, and generic products thereof, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Maltese: • is-CVMP ikkunsidra li l-bilanċ ġenerali bejn il-benefiċċju u r-riskju huwa pożittiv għall-prodotti mediċinali veterinarji (ara anness I), soġġett għall-emendi fl-informazzjoni dwar il-prodott; is-CVMP irrakkomanda varjazzjonijiet fl-awtorizzazzjonijiet għat-tqegħid fis-suq għal Suanovil 20 u ismijiet assoċjati, Captalin u ismijiet assoċjati, u l-prodotti ġeneriċi tagħhom, sabiex jiġi emendat issommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljetti ta' tagħrif kif stabbilit fl-Anness
English: Spiramycin is weakly bound to plasma proteins.
Maltese: Spiramycin jintrabat b'mod dgħajjef malproteini fil-plażma.
English: Spiramicin proved to be more efficacious and with a lower relapse rate compared to the positive controls.
Maltese: Spiramicin intwera li huwa aktar effikaċi u b'rata ta' rikaduta aktar baxxa meta mqabbel mal-kontrolli pożittivi.
English: The indication was substantiated by in vitro susceptibility data for Staphylococcus aureus strains and by PK data of spiramycin in the target species, on the basis of which a detailed PK/PD assessment has been performed.
Maltese: L-indikazzjoni kienet issostanzjata minn dejta dwar is-suxxettibbiltà in vitro għal razez ta' Staphylococcus aureus u minn dejta PK ta' spiramycin fl-ispeċijiet li fuqhom ser jintuża l-prodott, abbażi ta' liema twettqet valutazzjoni PK/PD iddettaljata.
English: No residue depletion data in milk was provided following the admistration of Spirovet at the dose of 30 000 IU/per kg body weight, intramuscularly twice at 24 hours of interval.
Maltese: Ma ġiet ipprovduta ebda dejta dwar it-tnaqqis tar-residwi fil-ħalib wara l-għoti ta' Spirovet fid-doża ta' 30 000 IU/għal kull kg piż tal-ġisem, fil-muskolu darbtejn f'intervall ta' 24 siegħa.
English: La Ballastiere Libourne
Maltese: Kwistjonijiet ta' effikaċja
English: Origin Number of strains
Maltese: Numru ta' razez
English: Since the study has shortcomings (no data for tissues other than injection site and in some samples residues in the surrounding injection site were higher than in the core), it was considered necessary to use the alternative approach and add a 30% safety span which resulted in a withdrawal period of 68 days for cattle meat and offal.
Maltese: Peress li l-istudju għandu xi nuqqasijiet (l-ebda dejta għal tessuti minbarra s-sit tal-injezzjoni u f'xi kampjuni r-residwi fil-madwar tas-sit talinjezzjoni kienet ogħla milli fil-qalba), kien ikkunsidrat neċessarju li jintuża approċċ alternattiv u li tiżdied medda ta' sigurtà ta' 30 % li rriżultat f'perjodu ta' tiżmim ta' 68 jum għal-laħam tal-ifrat u lġewwieni.
English: Spirovet has been shown to be bioequivalent to Suanovil 20 and consequently the time taken for residue levels in non-injection site muscle, liver, fat, kidney and milk can be assumed to be the same as for the two products.
Maltese: Spirovet intwera li huwa bijoekwivalenti għal Suanovil 20 u għaldaqstant wieħed jista' jassumi li l-ħin meħud għal-livelli residwi f'muskolu mhux tas-sit tal-injezzjoni, il-fwied, ix-xaħam, il-kliewi u l-ħalib huwa l-istess għaż-żewġ prodotti.
English: 1/1 M
Maltese: 1/2 P
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem Qawwa Għamla farmaċewtika
English: l t o r
Maltese: Mnejn jingħata
English: Further information on Rixathon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rixathon.
Maltese: Aktar informazzjoni dwar Rixathon tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Rixathon.
English: Rixathon (rituximab)
Maltese: Rixathon (rituksimab)
English: The cancer improved in just over 87% of those given Rixathon (271 of 311 patients), and in similar numbers of those given MabThera (274 of 313 patients).
Maltese: Il-kanċer irrisponda għall-kura fi ftit aktar minn 87 % ta' dawk li ngħataw Rixathon (271 minn 311-il pazjent), u f'numri simili għal dawk li ngħataw MabThera (274 minn 313-il pazjent).
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Maltese: • granulomatożi b'polianġite (GPA jew granulomatożi ta' Wegener) u polianġite mikroskopika (MPA),
English: Other information about Rixathon
Maltese: Informazzjoni oħra dwar Rixathon
English: Rixathon is a ‘biosimilar medicine'.
Maltese: Rixathon huwa “mediċina bijosimili”.
English: The medicine is available for infusion (drip) into a vein.
Maltese: Il-mediċina tiġi bħala infużjoni (dripp) ġol-vina.
English: The reference medicine for Rixathon is MabThera.
Maltese: Il-mediċina ta' referenza għal Rixathon hija MabThera.
English: Rixathon contains the active substance rituximab.
Maltese: Rixathon fih is-sustanza attiva rituksimab.
English: Rixathon received a marketing authorisation valid throughout the EU on 15 June 2017.
Maltese: Rixathon ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Ġunju 2017.
English: • severe rheumatoid arthritis (an inflammatory condition of the joints);
Maltese: • artrite rewmatojde severa (kundizzjoni infjammatorja tal-ġogi);
English: Laboratory studies comparing Rixathon with the reference medicine MabThera have shown that the active substance in Rixathon is highly similar to that in MabThera in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Rixathon mal-mediċina ta' referenza MabThera wrew li s-sustanza attiva f'Rixathon hija simili ħafna għal dik f'MabThera f'termini ta' struttura, purità u attività bijoloġika.
English: It will also provide doctors and patients using the medicine for rheumatoid arthritis, GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Maltese: Il-kumpanija sejra tipprovdi wkoll lit-tobba u lill-pazjenti li jużaw ilmediċina għal artrite rewmatodje, GPA, MPA jew pemfigus materjal edukattiv dwar ir-riskju ta' infezzjoni inkluż dak dwar infezzjoni severa rari, lewkoenċefalopatija multifokali progressiva (PML, progressive multifocal leukoencephalopathy).
English: The active substance in Rixathon, rituximab, is a monoclonal antibody designed to attach to a protein called CD20, which is present on B cells.
Maltese: Is-sustanza attiva f'Rixathon, ir-rituksimab, hija antikorp monoklonali mfassal biex jeħel ma' proteina msejħa CD20, li hija preżentifuq iċ-ċelloli B.
English: What are the risks associated with Rixathon?
Maltese: X'inhuma r-riskji assoċjati ma' Rixathon?
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in rheumatoid arthritis and pemphigus (where B cells are involved in inflammation).
Maltese: Meta rituksimab jeħel ma' CD20, jikkawża l-mewt taċċelloli B, li jgħin fil-linfoma u fis-CLL (fejn iċ-ċelloli B ikunu saru kanċerużi) u fl-artrite rewmatojde u lpemfigus (fejn iċ-ċelloli B huma involuti fl-infjammazzjoni tal-ġogi).
English: In addition, Rixathon was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Rixathon or MabThera were added to other chemotherapy for part of the treatment.
Maltese: Barra minn hekk, Rixathon intwera wkoll li huwa effettiv daqs MabThera fi studju ewlieni wieħed li involva 629 pazjent b'linfoma follikulari avvanzata u mhux ikkurata, fejn Rixathon jew MabThera ġew miżjuda ma' kimoterapija oħra għal parti mill-kura.
English: A supportive study in patients with rheumatoid arthritis also indicated similar effectiveness between MabThera and Rixathon.
Maltese: Studju ta' appoġġ f'pazjenti b'artrite rewmatojde wkoll indika effikaċja simili bejn MabThera u Rixathon.
English: The most common side effects with Rixathon are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Maltese: L-effetti sekondarji l-aktar komuni b'Rixathon huma reazzjonijiet relatati mal-infużjoni (bħal deni, tertir u rogħda) filwaqt li l-effetti sekondarji serji l-aktar komuni huma reazzjonijiet għall-infużjoni, infezzjonijiet u problemi relatati mal-qalb.
English: For the full list of side effects and restrictions of Rixathon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Rixathon, ara l-fuljett ta' tagħrif.
English: This means that Rixathon is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Rixathon huwa simili ħafna għal mediċina bijoloġika oħra (il-“mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: As for all medicines, data on the use of Rixathon are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Rixathon hija ssorveljata kontinwament.
English: The safety of Rixathon has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Maltese: Is-sigurtà ta' Rixathon ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza MabThera.
English: All these data were considered sufficient to conclude that Rixathon will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Rixathon ser jaġixxi bl-istess mod bħal MabThera f'termini ta' effikaċja u sigurtà fl-użu approvat tiegħu.
English: Studies have also shown that giving Rixathon produces similar levels of the active substance in the body to giving MabThera.
Maltese: Listudji wrew wkoll li l-għoti ta' Rixathon jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' MabThera.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rixathon has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Rixathon għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit bl-istess mod fil-ġisem.
English: • pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.
Maltese: • pemfigus vulgaris, kundizzjoni serja li tinvolvi nfafet fuq firxa wiesgħa tal-ġilda u l-kisja tal-ħalq, l imnieħer, il-gerżuma u l-ġenitali.
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must also not receive Rixathon if they have severe heart problems.
Maltese: Il-pazjenti bl-artrite rewmatojde, b'GPA, b'MPA jew b'pemfigus vulgaris ma għandhomx jingħataw Rixathon jekk ikollhom problemi tal-qalb serji.
English: How does Rixathon work?
Maltese: X'inhu Rixathon u għal xiex jintuża?
English: Rixathon must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Maltese: Rixathon m'għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal rituksimab, proteini talġrieden jew għal kwalunkwe sustanza oħra tiegħu jew f'pazjenti b'infezzjoni severa jew b'sistema immunitarja mdgħajfa b'mod sever (id-difiżi tal-ġisem).
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
Maltese: • lewkimja linfoċitika kronika (CLL, kanċer ieħor tad-demm li jaffettwa ċ-ċelloli tad-demm bojod);
English: Rixathon is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Maltese: Rixathon huwa mediċina użata fl-adulti għall-kura tal-kanċers tad-demm u tal-kundizzjonijiet infjammatorji li ġejjin:
English: The full EPAR for Suliqua can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Suliqua insulin glargine / lixisenatide
Maltese: Suliqua insulina glargina / lixisenatide
English: Other information about Suliqua
Maltese: Informazzjoni oħra dwar Suliqua
English: This is a summary of the European public assessment report (EPAR) for Suliqua.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Suliqua.
English: Why is Suliqua approved?
Maltese: Għaliex ġie approvat Suliqua?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suliqua on 11 January 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Suliqua fil-11 ta' Jannar 2017.
English: The other active substance in Suliqua, lixisenatide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Maltese: Is-sustanza attiva l-oħra f'Suliqua, il-lixisenatide, tappartjeni għall-klassi ta' mediċini kontra d-dijabete magħrufa bħala agonisti GLP-1.
English: What are the risks associated with Suliqua?
Maltese: X'inhuma r-riskji assoċjati ma' Suliqua?
English: After 30 weeks of treatment average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.
Maltese: Wara 30 ġimgħa ta' kura, HbA1c medja niżlet għal 6.9 % fil-grupp li kien qed jieħu Suliqua u għal 7.5 % fil-pazjenti li kienu qed jirċievu insulina glargina.
English: The active substances in Suliqua are insulin glargine and lixisenatide.
Maltese: Is-sustanzi attivi f'Suliqua huma insulina glargina u lixisenatide.
English: Results showed that Suliqua is more effective at controlling blood glucose levels than either components: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.
Maltese: HbA1c medja fil-bidu tal-istudju kienet 8.1 %, li wara 30 ġimgħa ta' kura niżlet għal 6.5 % fil-grupp li kien qed juża Suliqua, meta mqabbel ma' 6.8 % fil-grupp li kien qed juża insulina glargina u 7.3 % fil-grupp li kien qed juża lixisenatide.
English: The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni b'Suliqua (li jista' jaffettwa aktar minn 1 minn kull 10) hu lipogliċemija (glukożju baxx fid-demm); problemi bis-sistema diġestiva huma komuni u jinkludu dijarea, remettar u nawsja (tħossok ma tiflaħx).
English: Suliqua has been shown to be effective at controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes.
Maltese: Suliqua ntwera li hu effettiv biex jikkontrolla l-glukożju fid-demm f'żewġ studji ewlenin li involvew 1,906 pazjent bid-dijabete tat-tip 2.
English: The CHMP concluded that combination treatments with a long-acting insulin and a GLP-1 agonist such as Suliqua are an important treatment option for patients who are eligible for insulin or who need intensive insulin therapy.
Maltese: Is-CHMP ikkonkluda li kuri kkombinati b'insulina li taħdem fit-tul u b'agonist GLP-1 bħal Suliqua huma għażla ta' kura importanti għall-pazjenti li huma eliġibbli għall-insulina jew li għandhom bżonn terapija intensiva bl-insulina.
English: Suliqua is a medicine that is used together with metformin (another diabetes medicine) for the treatment of adults with type 2 diabetes.
Maltese: Suliqua hu mediċina li tintuża flimkien ma' metformin (mediċina oħra kontra d-dijabete) għall-kura taladulti b'dijabete tat-tip 2.
English: Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine.
Maltese: Qabel il-pazjenti bdew jieħdu Suliqua jew insulina glargina, HbA1c medja kienet 8.1 %.
English: The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth.
Maltese: It-tieni studju involva 1,170 pazjent li l-glukożju fid-demm tagħhom ma kienx ikkontrollat b'mod xieraq b'metformin ma' mediċini kontra d-dijabete li jittieħdu mill-ħalq jew mingħajrhom.
English: The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Maltese: Il-kumpanija li tqiegħed Suliqua fis-suq se tipprovdi materjal edukattiv għall-professjonisti fil-qasam talkura tas-saħħa u għall-pazjenti, biex tispjega kif il-mediċina tintuża b'mod sigur, biex jonqos ir-riskju ta' żbalji tal-mediċina.
English: In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain.
Maltese: F'dawn il-pazjenti, Suliqua kien effettiv fil-kontroll tal-livelli tal-glukożju fid-demm u naqqas ir-riskju ta' problemi marbuta ma' terapija intensiva bl-insulina bħall-ipoglaċemija u żieda filpiż.
English: In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.
Maltese: F'termini ta' sigurtà ma kien hemm ebda tħassib ġdid dwar is-sigurtà bit-taħlita ta' insulina glargina u lixisenatide f'Suliqua meta mqabbel mal-komponenti meta jintużaw separatament.
English: It is used when blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or by a combination of metformin and another medicine (either another glucose-lowering medicine taken by mouth or a long-acting insulin).
Maltese: Din tintuża meta l-livelli tal-glukożju (zokkor) fid-demm ma jkunux ikkontrollati b'mod sodisfaċenti minn metformin waħdu jew minn taħlita ta' metformin u mediċina oħra (jew mediċina li tbaxxi l-livelli tal-glukożju li tittieħed mill-ħalq jew insulina li taħdem fit-tul).
English: One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood.
Maltese: Waħda mis-sustanzi attivi ta' Suliqua, l-insulina glargina, hija insulina ta' sostituzzjoni li taġixxi blistess mod bħall-insulina tal-ġisem stess u tgħin lill-glukożju jidħol fiċ-ċelloli mid-demm, u b'hekk, tikkontrolla l-livell tal-glukożju fid-demm.
English: The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth.
Maltese: It-tieni studju involva 736 pazjent li l-glukożju fid-demm tagħhom ma kienx ikkontrollat b'insulina li taħdem fit-tul bħal insulina glargina jew b'mediċini għad-dijabete li jittieħdu mill-ħalq jew mingħajrhom.
English: For the full list of all side effects and restrictions with Suliqua, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Suliqua, ara l-fuljett ta' tagħrif.
English: It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Maltese: Din taġixxi bl-istess mod bħal GLP-1 (ormon li tipproduċi l-musrana) billi żżid l-ammont ta' insulina rilaxxat mill-frixa bħala rispons għall-ikel.
English: EU (MA) Number
Maltese: Numru tal-UE
English: 6 bottles Not applicable
Maltese: 6 Fliexken Mhux applikabbli
English: 1 bottle Not applicable
Maltese: 1 Flixkun Mhux applikabbli
English: The full EPAR for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: ProQuad is a vaccine.
Maltese: ProQuad huwa vaċċin.
English: This is a summary of the European public assessment report (EPAR) for ProQuad.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal ProQuad.
English: The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox.
Maltese: Ir-rati ta' rispons fi tfal ta' ‘l fuq minn 12-il xahar (il-kejl ta' kif is-sistema immunitarja kienet irrispondiet għall-vajrusis) kienu: 98% għall-ħożba, 96% sa 99% għall-gattone, 96% għar-rubella u 91% għall-ġidri r-riħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal ProQuad fis-6 ta' April 2006.
English: A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later.
Maltese: Bi ProQuad sar studju ieħor f'1,620 tifel u tifla li ngħataw l-ewwel doża fl-età ta' 9, 11 u 12-il xahar u ttieni d-doża tliet xhur wara.
English: After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.
Maltese: Wara t-tieni doża, ir-rati kienu 99% għall-ħożba, 100% għall-gattone, 98% għarrubella, u 99% għall-ġidri r-riħ.
English: What is the risk associated with ProQuad?
Maltese: X'inhu r-riskju assoċjat ma' ProQuad?
English: Another study also looked at the responses one year after vaccination in 2,108 children.
Maltese: Studju ieħor stħarreġ ir-risponsi rreġistrati sena wara t-tilqim f'2,108 tifel u tifla.
English: ProQuad was compared with its ‘component vaccines', a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox.
Maltese: ProQuad tqabbel mal-‘vaċċini komponenti' tiegħu, vaċċin triplu kontra lħożba, il-gattone u r-rubella, u vaċċin kontra l-ġidri r-riħ.
English: Why has ProQuad been approved?
Maltese: Għaliex ġie approvat ProQuad?
English: The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months).
Maltese: L-istudji ewlenin saru biex tiġi studjata l-abbiltà ta' doża waħda jew tnejn tal-vaċċin li tqanqal rispons immunitarju f'5,446 tifel u tifla f'saħħithom (ta' bejn it-12 u t-23 xahar).
English: The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni bi ProQuad (li dehru f'aktar minn pazjent 1 minn 10) huma deni u wġigħ u eritema (ħmura) fis-sit tal-injezzjoni.
English: ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
Maltese: ProQuad huwa vaċċin kontra l-ħożba, il-gattone, ir-rubella u l-ġidri r-riħ.
English: What is ProQuad?
Maltese: X'inhu ProQuad?
English: The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age.
Maltese: L-istudju fuq tfal minn disa' sa tnax-il xahar wera li wara l-għoti ta' żewġ dożi ta' ProQuad, ir-rispons immunitarju kontra l-ħożba, il-gattone, ir-rubella u l-ġidri r-riħ fi tfal li ngħataw l-ewwel doża fl-età ta' disa' xhur kien kumparabbli mar-rispons ta' dawk li ngħataw l-ewwel doża fl-età ta' tnax-il xahar.
English: How has ProQuad been studied?
Maltese: Kif ġie studjat ProQuad?