FrancophonIA/ELRC3.0 huggingface dataset:
English: • In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.
Maltese: • F'pazjenti li qabel kienu ġew ikkurati b'methotrexate, 70 % tal-pazjenti (339 minn 487) fuq Olumiant kisbu tal-inqas titjib ta' 20 % fil-punteġġi tas-sintomi, meta mqabbel ma' 61 % talpazjenti (202 minn 330) fuq adalimumab (DMARD oħra) u 40 % (196 minn 488 pazjent) fuq ilplaċebo.
English: • In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.
Maltese: • F'pazjenti li qabel kienu ġew ikkurati bi klassi ta' DMARDs imsejħa inibituri-TNF, 55 % tal-pazjenti (98 minn 177) fuq Olumiant kisbu tal-inqas titjib ta' 20 %, meta mqabbla ma' 27 % tal-pazjenti (48 minn 176) fuq il-plaċebo.
English: Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.
Maltese: Olumiant ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Frar 2017.
English: The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control.
Maltese: Id-doża tas-soltu hi ta' 4 mg darba kuljum, iżda din tista' titnaqqas għal 2 mg darba kuljum meta l-marda tkun taħt kontroll.
English: Infections reported with Olumiant treatment also included herpes zoster (shingles).
Maltese: L-infezzjonijiet irrappurtati bil-kura b'Olumiant inkludew ukoll herpes zoster (ħruq ta' Sant'Antnin).
English: In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo.
Maltese: F'dawn l-istudji, Olumiant (waħdu jew mad-DMARD methotrexate) wassal biex aktar pazjenti kisbu titjib ta' 20 % jew aktar f'punteġġ tas-sintomi standard (ACR 20) milli mediċini komparaturi u l-plaċebo.
English: The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients.
Maltese: Il-kumpanija li tqiegħed Olumiant fis-suq ser tiżgura li t-tobba li mistennija jippreskrivu l-mediċina jirċievu pakkett ta' informazzjoni dwar ir-riskji ta' Olumiant, b'mod partikolari r-riskju ta' infezzjoni, u lmonitoraġġ li għandu jsir fuq il-pazjenti.
English: What are the risks associated with Olumiant?
Maltese: X'inhuma r-riskji assoċjati ma' Olumiant?
English: • In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
Maltese: • F'pazjenti li qabel kienu ġew ikkurati b'DMARDs konvenzjonali, 62 % tal-pazjenti (140 minn 227) fuq Olumiant kisbu tal-inqas titjib ta' 20 %, meta mqabbel ma' 40 % tal-pazjenti (90 minn 228) fuq il-plaċebo.
English: As for all medicines, data on the use of Olumiant is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Olumiant hija ssorveljata kontinwament.
English: The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Maltese: Jista' jkun ukoll li d-doża tkun teħtieġ titnaqqas f'pazjenti li jkollhom funzjoni tal-kliewi indebolita, li jkollhom riskju akbar ta' infezzjonijiet u f'dawk ta' ‘l fuq minn 75 sena jew li jkunu qed jieħdu ċerti mediċini oħra.
English: Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough.
Maltese: Tliet studji f'madwar 2,500 pazjent urew li Olumiant itejjeb is-sintomi, bħal tenerezza u nefħa fil-ġogi, f'pazjenti li d-DMARDs li jkunu ħadu qabel ma jkunux ħadmu tajjeb biżżejjed.
English: For the full list of side effects reported with Olumiant, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Olumiant, ara l-fuljett ta' tagħrif.
English: By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Maltese: Billi timblokka l-enzimi, il-baricitinib tnaqqas l-infjammazzjoni u sintomi oħrajn talmarda.
English: Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).
Maltese: Olumiant hu mediċina li tintuża għall-kura tal-artrite rewmatojde (marda li tikkawża infjammazzjoni filġogi).
English: Olumiant can be used either alone or in combination with the DMARD methotrexate.
Maltese: Olumiant jista' jintuża jew waħdu jew flimkien mad-DMARD methotrexate.
English: What measures are being taken to ensure the safe and effective use of Olumiant?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Olumiant?
English: In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given.
Maltese: B'mod ġenerali, l-effetti sekondarji tiegħu huma meqjusa maniġġabbli u ddaħħlu fis-seħħ diversi miżuri sabiex jiġu mminimizzati r-riskji b'din il-mediċina, b'mod partikolari, infezzjonijiet.
English: It is used in patients with moderate to severe arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs') has not worked well enough or if patients cannot tolerate them.
Maltese: Dan jintuża f'pazjenti b'artrite moderata sa severa meta kura standard b'mediċini antirewmatiċi li jimmodifikaw il-marda (magħrufa wkoll bħala “DMARDs”) ma jkunux ħadmu tajjeb biżżejjed jew jekk il-pazjenti ma jittollerawhomx.
English: Patients will be given a special alert card that summarises the safety information about the medicine.
Maltese: Il-pazjenti se jingħataw kard ta' twissija speċjali li tiġbor filqosor l-informazzjoni dwar is-sigurtà dwar il-mediċina.
English: How is Olumiant used?
Maltese: Kif jaħdem Olumiant?
English: The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).
Maltese: L-effetti sekondarji l-aktar komuni b'Olumiant użat waħdu jew flimkien ma' methotrexate kienu żidiet fil-livelli tal-kolesterol fid-demm, infezzjonijiet tal-imnieħer u tal-griżmejn u nawżja (li jistgħu jaffetwaw żewġ persuni jew aktar minn kull 100).
English: The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them.
Maltese: Olumiant ġie studjat ukoll f'pazjenti li ma kienu rċevew l-ebda kura preċedenti.
English: EMA/CHMP/138741/2015 EMEA/H/C/000563
Maltese: EMEA/H/C/000563
English: The full EPAR for Aloxi 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: The active substance in Aloxi, palonosetron, is a ‘5HT3 antagonist'.
Maltese: Is-sustanza attiva f'Aloxi, il-palonosetron, hija ‘5HT3 antagonist'.
English: Aloxi is a medicine that contains the active substance palonosetron.
Maltese: Aloxi huwa mediċina li fiha s-sustanza attiva palonosetron.
English: It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Maltese: Jiġi bħala soluzzjoni għall-injezzjoni (250 mikrogramma f'5ml) u bħala kapsuli (500 mikrogramma).
English: In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms.
Maltese: F'adulti, issoluzzjoni għandha tiġi injettata fil-vina tul 30 sekonda b'doża ta' 250 mikrogramma.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aloxi fit-22 ta' Marzu 2005.
English: This is a summary of the European public assessment report (EPAR) for Aloxi.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aloxi.
English: Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Maltese: Aloxi, mogħti f'żewġ dożaġġi differenti, tqabbel ma' ondansetron u dolasetron (mediċini oħra tal-istess tip).
English: A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.
Maltese: Studju ieħor qabbel tliet dożaġġi ta' kapsuli ta' Aloxi (250, 500 u 750 mikrogramma) mas-soluzzjoni għall-injezzjoni f'651 adult li kienu qed jirċievu l-kimoterapija bi tqanqil moderat ta' nawżja u remettar.
English: With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221).
Maltese: F'kimoterapija li kkawżat tqanqil qawwi ta' nawżja u remettar, 59% tal-adulti li ngħataw Aloxi ma rremettewx fl-24 siegħa ta' wara l-kimoterapija (132 minn 223), meta mqabbla ma' 57% tal-pazjenti li ngħataw ondansetron (126 minn 221).
English: When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of
Maltese: Meta tqabbel mad-dolasetron, dawn iċ-ċifri kienu 63% għal Aloxi (119-il pazjent minn 189) u 53% għad-dolasetron (101 pazjent minn 191).
English: With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Maltese: F'kimoterapija li kkawżat tqanqil moderat ta' nawżja u remettar, 81% tal-adulti li ngħataw Aloxi ma rremettewx fl-24 siegħa ta' wara l-kimoterapija (153 minn 189), meta mqabbla ma' 69% ta' dawk li ngħataw ondansetron (127 minn 185).
English: Why has Aloxi been approved?
Maltese: Għaliex ġie approvat Aloxi?
English: In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Maltese: Fit-tfal, is-soluzzjoni għandha tingħata b'infużjoni (dripp) fil-vina tul 15-il minuta b'doża ta' 20 mikrogramma għal kull kilogramm ta' piż tal-ġisem.
English: In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).
Maltese: Fl-istudju fit-tfal li ngħataw il-kimoterapija li kkawżat tqanqil qawwi jew moderat ta' nawżja u remettar, 59% tat-tfal li ngħataw is-soluzzjoni għall-injezzjoni ta' Aloxi b'doża ta' 20 mikrogramma/kull kilogramm ma rremettewx fl-24 siegħa ta' wara l-kimoterapija (98 minn 165), li kien l-istess perċentwal li ntwera f'pazjenti li ngħataw l-ondansetron (95 minn 162).
English: Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Maltese: Is-soluzzjoni għall-injezzjoni ta' Aloxi ġiet studjata fi tliet studji ewlenin li involvew 1,842 adult li kienu qed jingħataw kimoterapija li jikkawżaw tqanqil qawwi jew moderat ta' nawżja u remettar.
English: What is the risk associated with Aloxi?
Maltese: X'inhu r-riskju assoċjat ma' Aloxi?
English: Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Maltese: Aloxi jintuża sabiex jipprevjeni n-nawżja (tħoss id-dardir) u r-remettar li huma kkawżati millkimoterapija (mediċini użati fil-kura tal-kanċer).
English: How has Aloxi been studied?
Maltese: Kif ġie studjat Aloxi?
English: With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100.
Maltese: Bis-soluzzjoni għall-injezzjoni, dehru wkoll sturdament, stitikezza u dijarrea f'bejn pazjent 1 sa 10
English: The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.
Maltese: Il-kapsuli jintużaw biss għall-kimoterapija li tikkawża tqanqil moderat ta' nawżja u remettar f'adulti.
English: What is Aloxi?
Maltese: Kif jintuża Aloxi?
English: A risk management plan has been developed to ensure that Aloxi is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aloxi jintuża bl-aktar mod sigur possibbli.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Maltese: Dan ifisser li twaqqaf kimika fil-ġisem imsejħa 5-idrossitriptamina (5HT, magħrufa wkoll bħala serotonin) milli teħel mar-riċetturi 5HT3 flintestin.
English: Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.
Maltese: Is-soluzzjoni għall-injezzjoni ta' Aloxi kienet ukoll investigata fi studju wieħed li kien jinvolvi 502 tfal li kienu qed jirċievu l-kimoterapija bi tqanqil qawwi jew moderat ta' nawżja u remettar, fejn Aloxi tqabbel ma' ondansetron.
English: The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Maltese: Is-soluzzjoni għall-injezzjoni tintuża f'adulti u tfal fletà ta' xahar jew akbar għall-kimoterapija ma' mediċini li jew jikkawżaw tqanqil qawwi ta' nawżja u remettar (bħaċ-ċisplatinu) jew tqanqil moderat (bħaċ-ċiklofosfamide, id-doksorubiċin jew ilkarboplatinu).
English: However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Maltese: Madanakollu, id-doża tal500 mikrogramma biss baqgħet effettiva daqs is-soluzzjoni għall-injezzjoni tul l-ewwel ħamest ijiem wara l-kimoterapija: madwar 59% tal-pazjenti li ngħataw il-kapsula ta' 500 mikrogramma jew linjezzjoni ma' rremettewx matul dan il-perjodu.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Maltese: Meta 5HT teħel ma' dawn ir-riċetturi, normalment tikkawża nawżja u remettar.
English: It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Maltese: Dan jista' jkun iktar effettiv biż-żieda ta' kortikosterojde (tip ta' mediċina li tista' tintuża għall-prevenzjoni tan-nawżja u r-remettar).
English: The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache.
Maltese: L-effett sekondarju l-aktar komuni b'Aloxi (li deher f'bejn pazjent 1 sa 10 minn kull 100) kien uġigħ ta' ras.
English: Other information about Aloxi
Maltese: Informazzjoni oħra dwar Aloxi
English: Aloxi solution for injection was as effective as the comparator medicines.
Maltese: Is-soluzzjoni għall-injezzjoni ta' Aloxi kienet effettiva daqs il-mediċini ta' tqabbil.
English: For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Aloxi, ara lfuljett ta' tagħrif.
English: EMA/37738/2014 EMEA/H/C/001101
Maltese: EMEA/H/C/001101
English: The full EPAR for Fluenz can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Fluenz jinstab fs-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports..
English: It contains three live attenuated (weakened) influenza (flu) virus strains: A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 (H3N2)-like strain; and B/Massachusetts/2/2012-like strain.
Maltese: Fih tliet razez tal-virus tal-influwenza (flu) ħajjin attenwati (imdgħajfin): A/California/7/2009 tip simili għall-(H1N1)pdm09; A/Victoria/361/2011 tip simili għall-(H3N2); u tip simili għallB/Massachusetts/2/2012.
English: This is a summary of the European public assessment report (EPAR) for Fluenz.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Fluenz.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz on 27 January 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fluenz valida fl-Unjoni Ewropea kollha fis-27 ta' Jannar 2011.
English: Fluenz is a vaccine which is available as a nasal spray to protect against influenza A (sub-types H1N1 and H3N2) and influenza B.
Maltese: Fluenz huwa vaċċin li jiġi bħala sprej għall-imnieħer biex jipproteġi kontra l-influwenza A (subtipi H1N1 u H3N2) u kontra l-influwenza B.
English: In the studies in children and adolescents, Fluenz reduced the number of flu cases caused by the three flu strains by between 62% and 100% compared with placebo and by between 35% and 53% compared with the comparator inactivated vaccine.
Maltese: Fl-istudji fuq tfal u adoloxxenti, Fluenz naqqas in-numru ta' każijiet tal-influwenza kkawżati mit-tliet razez tal-influwenza b'bejn 62% u 100% meta mqabbel ma' plaċebo u b'bejn 35% u 53% meta mqabbel mal-vaċċin inattivat li tqabbel miegħu.
English: Fluenz is a vaccine.
Maltese: Fluenz huwa vaċċin.
English: Fluenz influenza vaccine (live attenuated, nasal)
Maltese: Fluenz vaċċin kontra l-influwenza (ħaj attenwat, nażali)
English: A risk management plan has been developed to ensure that Fluenz is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Fluenz jintuża bl-aktar mod sigur possibbli.
English: Fluenz is used to prevent flu in children and adolescents from 24 months to less than 18 years old.
Maltese: Fluenz jintuża għall-prevenzjoni tal-influwenza fi tfal u adolexxenti li jkollhom minn 24 xahar sa inqas minn 18-il sena.
English: Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with either placebo (a dummy vaccine) or another injectable flu vaccine containing inactivated (killed) viral material from the same three flu strains.
Maltese: Disa' studji prinċipali li fihom ħadu sehem madwar 24,000 tifel u tifla u adoloxxenti u erba' studji li fihom ħadu sehem madwar 11,000 adult qabblu Fluenz jew ma' plaċebo (vaċċin finta) jew ma' vaċċin ieħor tal-influwenza li jiġi injettat li fih materjal virali inattivat (maqtul) mill-istess tliet razez talinfluwenza.
English: This summary was last updated in 01-2014.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 01-2014.
English: What is Fluenz?
Maltese: X'inhu Fluenz?
English: Fluenz is given as a nasal spray using a single-use nasal applicator (0.1 ml sprayed into each nostril).
Maltese: Fluenz jingħata bħala sprej għall-imnieħer bl-użu ta' applikatur tal-imnieħer li jintuża darba biss (0.1 ml sprejjat f'kull minfes).
English: Fluenz will be updated with weakened virus strains type A-H1N1, type A-H3N2 and type B for each season, according to recommendations for the northern hemisphere from the WHO and from the European Union.
Maltese: Fluenz ser ikun aġġornat b'razez ta' virus imdgħajjef tat-tip A-H1N1, it-tip A-H3N2 u t-tip B għal kull staġun, skont ir-rakkomandazzjonijiet għall-emisferu tat-tramuntana mill-WHO u mill-Unjoni Ewropea.
English: What measures are being taken to ensure the safe and effective use of Fluenz?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Fluenz?
English: The CHMP therefore decided that Fluenz's benefits are greater than its risks in children and adolescents from 24 months to less than 18 years old and recommended that it be given marketing authorisation in this patient group.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Fluenz huma akbar mir-riskji tiegħu fit-tfal u l-adoloxxenti li jkollhom minn 24 xahar sa inqas minn 18-il sena u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq għal dan il-grupp ta' pazjenti.
English: Why has Fluenz been approved?
Maltese: Għaliex ġie approvat Fluenz?
English: Fluenz must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Maltese: Fluenz ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi jew għal xi waħda mis-sustanzi l-oħra, għal gentamicin (tip ta' antibijotiku), jew għal bajd jew proteini talbajd.
English: What is the risk associated with Fluenz?
Maltese: X'inhu r-riskju assoċjat ma' Fluenz?
English: How has Fluenz been studied?
Maltese: Kif ġie studjat Fluenz?
English: The studies in adults showed that Fluenz may have some benefits compared with placebo but the results were inconsistent.
Maltese: Xi studji ssuġġerew ukoll li fl-adulti, Fluenz ma kienx daqstant effikaċi daqs ilvaċċin inattivat li tqabbel miegħu.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes defences against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf lill-virus bħala “barrani” u tipproduċi difiżi kontrih.
English: The CHMP noted that the studies showed convincingly that Fluenz was more effective than placebo and the comparator inactivated vaccine in children and adolescents, but not in adults.
Maltese: Is-CHMP innota li l-istudji wrew b'mod konvinċenti li Fluenz kien iktar effikaċi minn plaċebo u millvaċċin inattivat li tqabbel miegħu fit-tfal u l-adoloxxenti, iżda mhux fl-adulti.
English: For the full list of all side effects reported with Fluenz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Fluenz ara l-fuljett ta' tagħrif.
English: Other information about Fluenz
Maltese: Kif jintuża Fluenz?
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 talġisem) kif tiddefendi ruħha kontra l-mard.
English: The most common side effects with Fluenz (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Maltese: L-effetti sekondarji l-aktar komuni bi Fluenz (li dehru f'aktar minn pazjent 1 minn 10) huma nuqqas ta' aptit, uġigħ ta' ras, imnieħer imblukkat jew riħ u ma tħossokx f'siktek.
English: Pack sizes: 30, 60, 120.
Maltese: Daqsijiet tal-pakkett: 30, 60, 120.
English: • Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
Maltese: • Preskrizzjoni ta' doża supraterapewtika (Terminu ta' MedDRA: tossiċità tal-mediċina)
English: PVC/PVDC-aluminium blister of 10 capsules.
Maltese: Folji tal-aluminju tal-PVC/PVDC ta' 10 kapsuli.
English: 30 hard capsules 60 hard capsules 120 hard capsules
Maltese: 30 kapsula iebsa 60 kapsula iebsa 120 kapsula iebsa
English: Familial hypertriglyceridemia
Maltese: Ipertrigliċeridemija familjali
English: MedDRA System Organ Class
Maltese: Klassi tal-Organi tas-Sistema MedDRA
English: Tel: +385 (1) 230 3446 info@medisadria.hr
Maltese: +385 (1) 230 3446 info@medisadria.hr