FrancophonIA/ELRC3.0 huggingface dataset:
English: • Oral SINGULAIR is not meant to treat acute asthma attacks.
Maltese: • SINGULAIR orali mhuwiex maħsub biex jittratta attakki akuti ta' l-ażżma.
English: Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Maltese: Id-data dwar l-effikaċja minn provi kliniċi f'pazjenti pedjatriċi minn 6 xhur sa sentejn b'ażżma persistenti hija limitata.
English: With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6 to 14 years of age, the safety profile did not change.
Maltese: Bi trattament prolungat fi provi kliniċi b'numru limitat ta' pazjenti għal perjodu sa sentejn għall-adulti, u sa 12 -il xahar għal pazjenti pedjatriċi minn 6 sa 14-il sena, il-profil tas-sigurtà ma nbidilx.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: SOMMARJU GLOBALI TA' L-EVALWAZZJONI
English: Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Maltese: L-aktar sintomi frekwenti rrappurtati b'doża eċċessiva fl-adulti u t-tfal kienu jinkludu wġigħ addominali, ngħas, għatx, uġigħ ta' ras, rimettar, u attività eċċessiva.
English: Reduction in EIB was also demonstrated in a short term study in paediatric patients 6 to 14 years of age (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min).
Maltese: Tnaqqis fl-EIB ġie muri wkoll fi studju qasir fuq pazjenti pedjatriċi minn 6 sa 14 -il sena (tnaqqis massimu fil-FEV1 18.27% vs 26.
English: 10 mg film-coated tablets are available for adults 15 years of age and older.
Maltese: Pilloli miksijin b'rita ta' 10 mg huma disponibbli għal pazjenti adulti ta' 15-il sena jew aktar.
English: In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences.
Maltese: Fi studji dwar ażżma kronika, montelukast ġie mogħti f'dożi sa 200 mg/kuljum lil pazjenti adulti għal 22 ġimgħa u fi studji fuq perjodu qasir, sa 900 mg/kuljum lil pazjenti għal madwar ġimgħa mingħajr esperjenzi avversi klinikament importanti.
English: The PDCO, basing its decision on the GINA paediatric handbook 2006 and expert intervention, concluded that, due to a shortage of clinical data in patients aged 6 months - 2 years with asthma, pharmacokinetic data from patients aged 2-5 years diagnosed with asthma cannot be extrapolated to younger patients aged 6 months- 2 years presenting with the same symptoms.
Maltese: Il-PDCO, ibbaża d-deċiżjoni tiegħu fuq il-gwida pedjatrika GINA ta' l-2006 u intervent espert, u kkonkluda li, minħabba nuqqas ta' dejta klinika f'pazjenti ta' bejn 6 xhur u sentejn bl-ażżma, dejta farmakokinetika minn pazjenti ta' bejn sentejn u 5 snin b'dijanjożi ta' l-ażżma ma tistax tiġi estrapolata għal pazjenti iżgħar ta' bejn 6 xhur u sentejn bl-istess sintomi.
English: The contribution of metabolites to the therapeutic effect of montelukast is minimal.
Maltese: Il-kontribut tal-metaboliti għall-effett terapewtiku ta' montelukast huwa minimu.
English: Red ferric oxide (E 172)
Maltese: Microcrystalline cellulose Hyprolose (E 463) Red ferric oxide (E 172) Croscarmellose sodium Cherry flavor Aspartame (E 951) Magnesium stearate
English: Nervous system disorders headache headache
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras uġigħ ta' ras
English: What SINGULAIR looks like and contents of the pack 4 mg SINGULAIR chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
Maltese: Il-pilloli li tomgħodhom ta' 4 mg SINGULAIR huma roża, ovali, bikonvessi b'SINGULAIR imnaqqax fuq naħa, MSD 711 fuq in-naħa l-oħra.
English: This medicinal product is to be given to a child under adult supervision.
Maltese: Din il-mediċina għandha tingħata lil tifel/tifla taħt superviżjoni ta' adult.
English: Montelukast sodium has been used for the add-on treatment (concomitantly with inhaled steroids) and to prevent exercise-induced bronchoconstriction.
Maltese: Montelukast sodium intuża għat-trattament addizzjonali (flimkien ma' l-isterojdi inalati) u biex jipprevjeni d-djuq tal-pajpijiet tan-nifs (bronkokostrizzjoni) imqanqla mill-eżerċizzju.
English: The safety profile in paediatric patients 6 months to 2 years of age did not change with treatment up to 3 months.
Maltese: Il-profil tas-sigurtà f'pazjenti pedjatriċi minn 6 xhur sa sentejn ma nbidilx bi trattament sa 3 xhur.
English: Montelukast has been evaluated in clinical studies as follows:
Maltese: Montelukast ġie evalwat fi studji kliniċi kif ġej:
English: Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets and 4mg oral granules:
Maltese: Għalhekk, is-CHMP qabel ma' l-indikazzjoni proposta li ġejja għall-pilloli li jintmagħdu ta' 4mg u granuli orali ta' 4mg:
English: In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -1.74% change from baseline and decrease in total β-agonist use -27.78% vs 2.09% change from baseline).
Maltese: F'pazjenti ażżmatiċi sensittivi għall-aspirina li rċevew kortikosterojdi meħuda man-nifs u/jew orali flistess ħin, it-trattament b'montelukast, meta mqabbel mal-plaċebo, irriżulta f'titjib sinifikanti filkontroll ta' l-ażżma (FEV1 8.55% vs -1.74% bidla mil-linja bażi u tnaqqis fl-użu totali ta' β-agonist27.
English: Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.
Maltese: Flimkien ma' stimi tal-bijodisponibilità orali ta' montelukast, dan jindika li montelukast u l-metaboliti tiegħu jitneħħew kważi esklussivament permezz tas-sistema biljari.
English: HOW TO STORE SINGULAIR
Maltese: X'fih SINGULAIR
English: For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and SINGULAIR 4 mg granules are available.
Maltese: Għal tfal ta' bejn sentejn u 5 snin, hemm disponibbli pilloli li tomgħodhom SINGULAIR 4 mg u granuli SINGULAIR 4 mg.
English: Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast.
Maltese: U KWANTITATTIVA Qartas wieħed ta' granuli fih montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
English: These important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment.
Maltese: Dawn il-medjaturi pro-ażżmatiċi importanti jeħlu ma' riċetturi cysteinyl leukotriene (CysLT) li jinsabu fil-passaġġ ta' l-arja uman u jikkawżaw azzjonijiet fil-passaġġ ta' l-arja, fosthom tidjiq tal-bronki, sekrezzjoni mukuża, permeabilità vaskulari, u rkupru ta' l-esinofili.
English: In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported.
Maltese: F'pazjenti ażżmatiċi ttrattati b'montelukast, ġew irrappurtati każijiet rari ħafna ta' kombinazzjoni ta' sintomi bħal mard jixbah lill-influwenza, tingiż jew traqqid tad-dirgħajn u tas-saqajn, taħżin tassintomi pulmonari u/jew raxx (sindrome ta' Churg-Strauss).
English: Batch
Maltese: Anki
English: In clinical studies with SINGULAIR 4 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were:
Maltese: Fi studji kliniċi b'SINGULAIR 4 mg granuli, l-aktar effetti sekondarji rrappurtati b'mod komuni (li jseħħu f'għallinqas pazjent 1 minn kull 100 u f'inqas minn pazjent pedjatriku 1 ikkurat minn kull 10) maħsuba li huma relatati ma' SINGULAIR kienu:
English: The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Maltese: Il-formulazzjoni ta' granuli SINGULAIR 4 mg mhijiex rakkomandata għal trabi taħt is-6 xhur.
English: • SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
Maltese: • SINGULAIR jista' jintuża wkoll bħala trattament alternattiv għal kortikosterojdi meħuda mannifs għal pazjenti minn 2 sa 5 snin li ma jkunux ħadu riċentement kortikosterojdi orali għallażżma tagħhom u wrew li mhumiex kapaċi jużaw kortikosterojdi meħuda man-nifs.
English: The Applicant/MAH also made reference to an original application concerning the 10 mg film-coated tablet and 5 mg CT, which presents the results of two placebo-controlled clinical studies in more than 1600 adult patients with mild-to-moderate asthma.
Maltese: L-Applikant/MAH għamel referenza wkoll għal applikazzjoni oriġinali dwar il-pilloli miksija b'rita tal10 mg u CT tal-5 mg, li tippreżenta r-riżultati ta' żewġ studji kliniċi kkontrollati bi plaċebo f'iktar minn 1600 pazjent adult b'ażżma ħafifa jew moderata.
English: There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score >9).
Maltese: M'hemmx informazzjoni dwar ilfarmakokinetiċi ta' montelukast f'pazjenti b'insuffiċjenza epatika severa (punteġġ Child-Pugh >9).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda li tomgħodha fiha montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
English: In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/day).
Maltese: Fi tliet studji bl-attività kkontrollata, fi kważi 1000 pazjent adult b'ażżma ħafifa jew moderata, intwera li l-effett ta' montelukast (10 mg darba kuljum) kien aħjar minn dak miksub mill-plaċebo, iżda inqas minn dak miksub minn beclometasone dipropionate li jittieħed man-nifs (400 µg kuljum).
English: The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
Maltese: L-aktar esperjenzi avversi li seħħew b'mod frekwenti kienu konsistenti mal-profil tas-sigurtà ta' montelukast u kienu jinkludu wġigħ addominali, ngħas, għatx, uġigħ ta' ras, rimettar u attività eċċessiva psikomotorili.
English: There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast.
Maltese: Ma hija disponibbli l-ebda informazzjoni speċifika dwar it-trattament ta' doża eċċessiva b'montelukast.
English: This subsection is not applicable for the SINGULAIR 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Maltese: Din is-subsezzjoni ma tapplikax għal SINGULAIR 4 mg pilloli li tomgħodhom billi huma intenzjonati għall-użu fi tfal minn 2 sa 5 snin, madankollu l-informazzjoni li ġejja hija rilevanti għas-sustanza attiva, montelukast.
English: These include reports in adults and children with a dose as high as 1000 mg (approximately 61 mg/kg in a 42 month old child).
Maltese: Dawn jinkludu rapporti f'persuni adulti u tfal b'doża għolja sa 1000 mg (madwar 61 mg/kg f'tifel/tifla ta' 42 xahar).
English: The wheezing observed in the younger age group could be attributed to a number of diagnoses (viral infection, RSV bronchiolitis, or early symptoms of classic asthma).
Maltese: It-tisfir osservat fil-grupp ta' età iżgħar jista' jiġi attribwit għal numru ta' dijanjożi (infezzjoni virali, bronkjolite RSV, jew sintomi bikrija ta' l-ażżma klassika).
English: This subsection is not applicable for the SINGULAIR 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Maltese: Din is-subsezzjoni ma tapplikax għal granuli SINGULAIR 4 mg billi huma intenzjonati għall-użu fi tfal minn 6 xhur sa 5 snin, madankollu l-informazzjoni li ġejja hija rilevanti għas-sustanza attiva, montelukast.
English: SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
Maltese: SINGULAIR huwa għażla ta' trattament alternattiv għal kortikosterojdi ta' doża baxxa li jittieħdu man-nifs għal ażżma ħafifa persistenti:
English: A slight decrease in pup body weight was noted in the female fertility study in rats at 200 mg/kg/day (>69-fold the clinical systemic exposure).
Maltese: Fi studju dwar il-fertilità tal-mara fil-firien b'doża ta' 200 mg/kg/ġurnata (>69 darba l-esponiment sistemiku kliniku) ġie nnotat tnaqqis żgħir fil-piż tal-ġisem tal-ferħ.
English: The plasma clearance of montelukast averages 45 ml/min in healthy adults.
Maltese: Il-medja tat-tneħħija ta' montelukast mill-plasma f'persuni adulti b'saħħithom hija 45 ml/min.
English: SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Maltese: Il-pilloli li tomgħodhom SINGULAIR fihom aspartame, li huwa sors ta' phenylalanine.
English: Singulair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma, in patients aged 6 months to 5 years.
Maltese: SINGULAIR huwa indikat fit-trattament ta' l-ażżma bħala terapija add-on f'dawk il-pazjenti ta' bejn sentejn u 5 snin b'ażżma persistenti ħafifa għal moderata li jkunu kkontrollati inadegwatament fuq kortikosterojdi li jittieħdu man-nifs u li fihom, β-agonisti ta' li jaħdmu malajr li jittieħdu "meta meħtieġa", jipprovdu kontroll kliniku inadegwat ta' l-ażżma.
English: SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Maltese: SINGULAIR huwa indikat fit-trattament ta' l-ażżma bħala terapija add-on f'dawk il-pazjenti ta' bejn 6 xhur u 5 snin b'ażżma persistenti ħafifa għal moderata li jkunu kkontrollati inadegwatament fuq kortikosterojdi li jittieħdu man-nifs u li fihom, β-agonisti li jaħdmu malajr li jittieħdu "meta meħtieġa", jipprovdu kontroll kliniku inadegwat ta' l-ażżma.
English: In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.
Maltese: F'pazjenti adulti u pedjatriċi minn 2 sa 14 -il sena, montelukast, meta mqabbel ma' plaċebo, naqqas l-esonifili tad-demm periferali filwaqt li tejjeb ilkontroll kliniku ta' l-ażżma.
English: • SINGULAIR is used for the treatment of 6 months to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Maltese: • SINGULAIR jintuża għat-trattament ta' pazjenti ta' bejn 6 xhur u 5 snin li ma jkunux ikkontrollati adegwatament bil-medikazzjoni tagħhom u jkollhom bżonn terapija addizzjonali.
English: • SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Maltese: • SINGULAIR huwa indikat fit-trattament ta' l-ażżma bħala terapija addizzjonali f'dawk ilpazjenti ta' bejn 6 xhur u 5 snin b'ażżma persistenti ħafifa jew moderata li ma jkunux ikkontrollati b'mod adegwat bil-kortikosterojdi li jittieħdu man-nifs u li fihom l-agonisti-β meħuda “skond il-bżonn” jipprovdu kontroll kliniku inadegwat ta' l-ażżma.
English: • scaly and itchy skin
Maltese: • għatx
English: Characteristics in Patients.
Maltese: Karatteristiċi fil-pazjenti.
English: In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
Maltese: Fl-istudji fuq l-annimali, montelukast ma affettwax il-fertilità jew l-attività riproduttiva b'esponiment sistemiku li qabeż l-esponiment sistemiku kliniku b'aktar minn 24 darba.
English: Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata: astenja/għeja, telqa, edema Każi rari ħafna tas-Sindrome ta' Churg-Strauss (CSS) ġew irrappurtati waqt trattament b'montelukast f'pazjenti ażżmatiċi (ara sezzjoni 4.4).
English: CHEWABLE TABLET.
Maltese: Użu orali.
English: Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
Maltese: Kull pillola fiha montelukast sodium li jikkorrespondi għal 4 mg ta' montelukast.
English: When treatment with SINGULAIR is used as add-on therapy to inhaled corticosteroids, SINGULAIR should not be abruptly substituted for inhaled corticosteroids (see section 4.4).
Maltese: Meta t-trattament b'SINGULAIR jintuża bħala terapija add-on ma' kortikosterojdi li jittieħdu mannifs, SINGULAIR m'għandux jiġu mibdul f'daqqa għal kortikosterojdi li jittieħdu man-nifs (ara sezzjoni 4.4).
English: Use in breast-feeding
Maltese: Użu fit-tqala
English: Additionally, the following side effect was reported in clinical studies with SINGULAIR 10 mg filmcoated tablets and 5 mg chewable tablets:
Maltese: Barra minn hekk, l-effett sekondarju segwenti ġie rrappurtat fi studji kliniċi b'SINGULAIR 10 mg pilloli miksijin b'rita u 5 mg pilloli li tomgħodhom:
English: • is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR (see
Maltese: • allerġiku/a (ibatu minn sensittività eċċessiva) għal montelukast jew sustanzi oħra ta' SINGULAIR (ara 6. AKTAR TAGĦRIF).
English: • SINGULAIR is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Maltese: • SINGULAIR jintuża għat-trattament ta' pazjenti ta' bejn sentejn u 5 snin li ma jkunux ikkontrollati adegwatament bil-medikazzjoni tagħhom u jkollhom bżonn terapija addizzjonali.
English: • SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Maltese: • SINGULAIR huwa indikat fit-trattament ta' l-ażżma bħala terapija addizzjonali f'dawk ilpazjenti ta' bejn sentejn u 5 snin b'ażżma persistenti ħafifa jew moderata li jkunu kkontrollati b'mod mhux adegwat bil-kortikosterojdi u li fihom l-agonisti-β li jaġixxu malajr meħudin “skond il-bżonn” jipprovdu kontroll adegwat ta' l-ażżma.
English: Microcrystalline cellulose
Maltese: RAĠUNIJIET GĦALL-EMENDI
English: The between group difference in LS means for the percentage of days with β-agonist use was significant: 2.7 with a 95% CI of 0.9, 4.5.
Maltese: 2.7 b'95% CI ta' 0.9, 4.5.
English: SINGULAIR This leaflet was last approved in {DD.MM.YYYY.}
Maltese: XJENTIFIKA TA' SINGULAIR U ISMIJIET ASSOĊJATI (ARA L-ANNESS I)
English: Additionally, while the medicine has been on the market, the following have been reported:
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati fl-użu ta' wara t-tqegħid tal-prodott fis-suq:
English: Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.
Maltese: Studji fuq il-firien b'montelukast radjutikkettat jindikaw distribuzzjoni minima tul il-barriera bejn id-demm u l-moħħ.
English: For children 6 to 14 years old, SINGULAIR 5 mg chewable tablets are available.
Maltese: Għal tfal ta' bejn is-6 snin u l-14-il sena, hemm disponibbli pilloli li tomgħodhom SINGULAIR 5 mg.
English: SINGULAIR 4 mg chewable tablets montelukast
Maltese: SINGULAIR 4 mg pillola li tomgħodha montelukast
English: The Applicant/MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (25 years old, 6-14 years old) according to ICH E11 guideline.
Maltese: L-applikant/MAH ipprovda dokumentazzjoni ta' appoġġ għal din l-indikazzjoni ta' OG ta' 4mg fi tfal ta' bejn 6 xhur u sentejn abbażi tad-dejta farmakokinetika PN 136/138, dejta tas-sigurtà ta' appoġġ
English: These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Maltese: Ġeneralment dawn kienu ħfief u seħħew fi frekwenza akbar f'pazjenti ttrattati b'SINGULAIR milli bi plaċebo (pillola li ma fihiex medikazzjoni).
English: Moreover the MAH submitted a proposal for harmonised chemical-pharmaceutical sections of the SPC and PL.
Maltese: Barra minn hekk, il-MAH issottometta proposta għal sezzjonijiet kimiċi-farmaċewtiċi ta' l-SPC u tal-PIL.
English: ** Antibody micro agglutination-lytic reaction.
Maltese: * Tissue culture infectious dose 50%. ** Antibody micro agglutination-lytic reaction.
English: Further information on Shingrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Shingrix tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Shingrix (herpes zoster vaccine, recombinant, adjuvanted)
Maltese: Shingrix (herpes zoster vaċċin, rikombinanti, aġġuvant)
English: Other information about Shingrix
Maltese: Informazzjoni oħra dwar Shingrix
English: Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo.
Maltese: Meta tingħata ħarsa lejn ir-riżultati għall-adulti f'dan il-grupp ta' età miż-żewġ studji flimkien, 25 adult minn 8,250 li rċievew Shingrix kellhom ħruq ta' Sant'Antnin fi żmien 4 snin wara t-tilqim meta mqabbel ma' 284 minn 8,346 li rċievew il-plaċebo.
English: The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Shingrix (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (bħal uġigħ, ħmura u nefħa), dehxiet ta' bard, deni, uġigħ filmuskoli, għeja, uġigħ ta' ras u effetti sekondarji tas-sistema diġestiva bħal nawżja, rimettar, dijarea u uġigħ fl-istonku.
English: Shingrix was assessed in two main studies in around 30,000 adults.
Maltese: Shingrix ġie vvalutat f'żewġ studji ewlenin f'madwar 30,000 adult.
English: This indicates that Shingrix prevented 91% of shingles cases and 89% of cases of post-herpetic neuralgia in adults aged 70 years and older.
Maltese: Dan jindika li Shingrix ipprevjena 91 % tal-każijiet ta' ħruq ta' Sant'Antnin u 89 % tal-każijiet ta' nevralġija ta' wara l-erpete f'adulti li kellhom 70 sena u aktar.
English: In the first study with adults aged 50 years and over, 7,695 received Shingrix and 7,710 received placebo.
Maltese: Fl-ewwel studju b'adulti li kellhom 50 sena u aktar, 7,695 irċievew Shingrix u 7,710 irċievew il-plaċebo.