FrancophonIA/ELRC3.0 huggingface dataset:
English: Packaged in polyamide/PVC/aluminum blister package in:
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ippakkjat f'pakkett folji tal-polyamide/PVC/aluminju f':
English: Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%).
Maltese: Studji fuq l-adulti wrew il-ħila ta' montelukast li jżid ma' l-effett kliniku ta' korikosterojd meħud mannifs (bidla perċentwali mil-linja bażi għal beclomethasone meħud man-nifs u montelukast vs beclomethasone, rispettivament għal FEV1: 5.43% vs 1.04%; użu ta' β-agonist: -8.70% vs 2.64%).
English: Route of administration
Maltese: Road,
English: Quality
Maltese: Il-kwalità
English: However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolized by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo.
Maltese: Madankollu, informazzjoni minn studju kliniku dwar l-interazzjoni bejn il-mediċini li kien jinvolvi montelukast u rosiglitazone (sottostrat sonda rappreżentattiv ta' prodotti mediċinali metabolizzati prinċipalment minn CYP 2C8) wriet li montelukast ma jinibixxix CYP 2C8 in vivo.
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Maltese: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU Ir-Renju Unit
English: The present referral procedure sought harmonisation of the product information for Singulair 4 mg chewable tablets and 4 mg oral granules with the indications already approved for children 2-5 years old and 6 months to 2 years old in Mutual Recognition Procedures, with Finland acting as the reference member state.
Maltese: Il-proċedura ta' referenza attwali ppruvat tikseb armonizzazzjoni tat-tagħrif tal-prodott għal Singulair 4 mg pilloli li jintmagħdu u 4 mg granuli orali bl-indikazzjonijiet diġà approvati għal tfal ta' bejn sentejn u ħames snin u bejn 6 xhur u sentejn fil-Proċeduri ta' Rikonoxximent Reċiproku, bil-Finlandja tagħmilha ta' Stat Membru ta' referenza.
English: It is a leukotriene-1 receptor antagonist.
Maltese: Dan huwa antagonist tar-riċettur ta' leukotriene-1.
English: INFORMATION IN BRAILLE SINGULAIR 4 mg granules
Maltese: INFORMAZZJONI BIL-BRAILLE SINGULAIR 4 mg granuli
English: Following an oral dose of radiolabeled montelukast, 86% of the radioactivity was recovered in 5-day fecal collections and <0.2% was recovered in urine.
Maltese: Wara doża orali ta' montelukast radjutikkettat, 86% tar-radjuattività ġiet irkuprata flippurgar ta' ħamest ijiem u <0.2% ġie rkuprat fl-awrina.
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Maltese: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, Ir-Renju Unit
English: • This medicine is to be given to a child under adult supervision.
Maltese: • Din il-mediċina għandha tingħata lil tifel/tifla taħt is-superviżjoni ta' adult.
English: 4 mg granules are available for paediatric patients 6 months to 5 years of age.
Maltese: Granuli ta' 4 mg huma disponibbli għal pazjenti pedjatriċi ta' bejn 6 xhur u 5 snin.
English: Treatment should be discontinued if a lack of response is observed.
Maltese: It-trattament għandu jitwaqqaf jekk ikun osservat nuqqas ta' rispons.
English: Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Maltese: Intwera li Montelukast (10 mg darba kuljum f'ħin lirqad) itejjeb il-funzjonijiet respiratorji, inaqqas is-sintomi ta' l-ażżma u l-użu ta' l-agonisti-beta, u jtejjeb il-kwalità tal-ħajja meta mqabbel mal-plaċebo.
English: Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide.)
Maltese: Għalhekk, montelukast mhux mistenni li jibdel b'mod evidenti l-metaboliżmu ta' prodotti mediċinali metabolizzati minn dan l-enzim (eż. paclitaxel, rosiglitazone, u repaglinide).
English: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.
Maltese: Montelukast huwa kompost attiv oralment li jeħel b'affinità u selettività kbira mar-riċettur CysLT1.
English: • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/numbness, seizure;
Maltese: • għeja, irrekwitezza, aġitazzjoni li tinkludi mġiba aggressiva, irritabilità, rogħda, depressjoni, ħsibijiet u azzjonijiet relatati ma' suwiċidju (f'każijiet rari ħafna), sturdament, ngħas, alluċinazzjonijiet, abnormalitajiet tal-ħolm, fosthom inkubi u diffikultà biex torqod, tingiż/tnemnim, aċċessjonijiet
English: The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant (2.8 with a 95% CI of -4.7, -0.9), but within the limit pre-defined to be clinically not inferior.
Maltese: Id-differenza bejn grupp u ieħor fiż-żieda medja LS fil-perċentwali ta' RFDs mill-ażżma statistikament sinifikanti (-2.8 b'95% CI ta' -4.7, -0.9), iżda fil-limitu stabbilit minn qabel li kien mhux inferjuri.
English: The oral bioavailability and Cmax are not influenced by a standard meal.
Maltese: Il-bijodisponibilità orali u l-Cmax mhumiex affettwati minn ikla standard.
English: Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma.
Maltese: Montelukast jista' jingħata ma' terapiji oħra komunement użati fil-profilassi u t-trattament kroniku ta' l-ażżma.
English: The CHMP agreed with the following proposed indication for 4mg oral granules:
Maltese: Is-CHMP qabel ma' l-indikazzjoni proposta li ġejja għall-granuli orali ta' l-4mg:
English: This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).
Maltese: Din id-doża hija ekwivalenti għal 25,000 darba d-doża ta' kuljum rakkomandata għall-adulti (ibbażata fuq piż ta' pazjent adult ta' 50 kg).
English: Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Maltese: Merck Sherp & Dohme Chaussée de Waterloo 1135
English: Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is coadministered with inducers of CYP 3A4, such as phenytoin, phenobarbital and rifampicin.
Maltese: Billi montelukast jiġi metabolizzat minn CYP 3A4, għandha tintuża kawtela, b'mod partikolari fit-tfal, meta montelukast jingħata fl-istess ħin ma' indutturi ta' CYP 3A4, bħal phenytoin, phenobarbital u rifampicin.
English: Respiratory, thoracic, and mediastinal disorders asthma
Maltese: Disturbi respiratorji, toraċiċi u medjastinali ażżma
English: Singulair 4 mg granulado 4 mg Granules
Maltese: Singulair 4 mg granulado 4 mg Granuli
English: However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses (e.g., 50% of patients treated with beclomethasone achieved an improvement in FEV1 of approximately 11% or more over baseline while approximately 42% of patients treated with montelukast achieved the same response).
Maltese: Madankollu, meta mqabbel ma' beclomethasone, perċentwali għoli ta' pazjenti ttrattati b'montelukast kisbu rispons kliniku simili (eż., 50% tal-pazjenti ttrattati b'beclomethasone kisbu titjib fil-FEV1 ta' madwar 11% jew aktar fuq il-linja bażi filwaqt li madwar 42% tal-pazjenti ttrattati b'montelukast kisbu l-istess rispons).
English: Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Maltese: Disturbi fis-sistema immuni: reazzjonijiet ta' sensittività eċċessiva fosthom anafilassi, infiltrazzjoni esinofilika tal-fwied.
English: The percentage reduction in yearly EE rate was 31.9%, with a 95% CI of 16.9, 44.1.
Maltese: It-tnaqqis perċentwali fir-rata annwali ta' EE kien ta' 31.9%, b'95% CI ta'
English: Patients with phenylketonuria should take into account that each 4 mg chewable tablet contains phenylalanine in an amount equivalent to 0.674 mg phenylalanine per dose.
Maltese: Pazjenti b'phenylketonuria għandhom iqisu li kull pillola li tomgħodha ta' 4 mg fiha phenylalanine f'ammont ekwivalenti għal 0.674 mg phenylalanine għal kull doża.
English: Singulair mini 4 mg Granulat4 mg Granules
Maltese: Singulair mini 4 mg Granulat4 mg Granuli
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, The Netherlands
Maltese: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, L-Olanda
English: SINGULAIR 4 mg granules montelukast
Maltese: SINGULAIR 4 mg granuli montelukast
English: SINGULAIR 4 mg Granules montelukast
Maltese: SINGULAIR 4 mg Granuli montelukast
English: The percentage of patients with systemic (mainly oral) corticosteroid use during the study period was 17.8% in the montelukast group and 10.5% in the fluticasone group.
Maltese: Il-perċentwali ta' pazjenti b'użu sistemiku ta' kortikosterojdi (l-aktar orali) matul il-perjodu ta' studju kien ta' 17.8% fil-grupp ta' montelukast u 10.
English: The Applicant/MAH also made reference to an original application concerning 5 mg CT, which presented the results of a study in 336 paediatric patients (age 6 to 14 years).
Maltese: L-Applikant/MAH għamel referenza wkoll għal applikazzjoni oriġinali dwar CT tal-5 mg CT, li ppreżentat ir-riżultati ta' studju fi 336 pazjent pedjatriku (ta' bejn 6 u 14-il sena).
English: Montelukast is rapidly absorbed following oral administration.
Maltese: Montelukast jiġi assorbit malajr wara għoti orali.
English: Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer.
Maltese: B'mod kumulattiv, 502 pazjenti pedjatriċi minn 2 sa 5 snin ġew ittrattati b'montelukast għal mill-anqas 3 xhur, 338 għal 6 xhur jew aktar, u 534 pazjent għal 12 -il xahar jew aktar.
English: The difference in LS means for the change from baseline in the % predicted FEV1 was significant: -2.2% with a 95% CI of -3.6, -0.7.
Maltese: Id-differenza fil-medji LS għall-bidla mil-linja bażi fil-perċentwali mbassra ta' FEV1 kienet sinifikanti: -2.2% b'95% CI ta' -3.6,
English: In a 12-week, placebo-controlled study in paediatric patients 2 to 5 years of age, montelukast 4 mg once daily improved parameters of asthma control compared with placebo irrespective of concomitant controller therapy (inhaled/nebulized corticosteroids or inhaled/nebulized sodium cromoglycate).
Maltese: Fi studju ta' 12-il ġimgħa kkontrollat bil-plaċebo fuq pazjenti pedjatriċi minn 2 sa 5 snin, montelukast 4 mg darba kuljum tejjeb il-parametri tal-kontroll ta' l-ażżma meta mqabbel mal-plaċebo, irrispettivament mit-terapija ta' kontroll konkomitanti (kortikosterojdi meħuda man-nifs/nebulizzati jew sodium cromoglycate meħud man-nifs/nebulizzat).
English: Subsequently, Section 4.4 of Singulair 4mg OG SPC was revised to include the following wording:
Maltese: Sussegwentament, is-Sezzjoni 4.4 ta' l-SPC ta' Singulair OG ta' 4mg ġiet riveduta biex tinkludi dan il-kliem:
English: If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
Maltese: Jekk ittifel/tifla tiegħek għandu/għandha fenilketonurja (disturb rari, ereditarju tal-metaboliżmu), inti għandek tikkunsidra li kull pillola li tomgħodha ta' 4 mg fiha phenylalanine (ekwivalenti għal 0.674 mg phenylalanine għal kull pillola li tomgħodha ta' 4 mg).
English: In a 12-month, placebo-controlled study in paediatric patients 2 to 5 years of age with mild asthma and episodic exacerbations, montelukast 4 mg once daily significantly (p≤0.001) reduced the yearly rate of asthma exacerbation episodes (EE) compared with placebo (1.60 EE vs. 2.34 EE, respectively), [EE defined as ≥3 consecutive days with daytime symptoms requiring β-agonist use, or corticosteroids (oral or inhaled), or hospitalization for asthma].
Maltese: Fi studju ta' 12-il xahar ikkontrollat bil-plaċebo fuq pazjenti pedjatriċi minn 2 sa 5 snin li kellhom ażżma ħafifa u aggravazzjonijiet episodiċi, montelukast 4 mg darba kuljum naqqas b'mod sinifikanti (p≤0.001) r-rata annwali ta' l-episodji ta' aggravazzjoni ta' l-ażżma (EE) meta mqabbel mal-plaċebo (1.60 EE vs.
English: ul.
Maltese: • nefħa.
English: Gastrointestinal disorders: diarrhoea, dry mouth, dyspepsia, nausea, vomiting.
Maltese: Disturbi gastro-intestinali: dijarea, ħalq xott, dispepsja, dardir, rimettar.
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Maltese: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem L-Olanda
English: Skin and subcutaneous tissue disorders eczematous dermatitis, rash
Maltese: Disturbi filġilda u fittessuti ta' taħt il-ġilda dermatite blekżema, raxx
English: The signs of toxicity in animals were increased excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance.
Maltese: Is-sinjali ta' tossiċità flannimali kienu eskrezzjoni akbar ta' saliva, sintomi gastro-intestinali, purgar maħlul u żbilanċ tal-joni.
English: PHARMACEUTICAL FORM Granules.
Maltese: GĦAMLA FARMAĊEWTIKA Granuli
English: - the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg Granules ( previously known as Oral Granules) for patients aged 6 months to 5 years on the following indications:
Maltese: - is-CHMP ikkonkluda li l-Awtorizzazzjoni għat-Tqegħid fis-Suq tista' tiġi armonizzata għall-Granuli ta' 4mg ta' Singulair (qabel magħrufin bħala Granuli Orali) għal pazjenti ta' bejn 6 xhur u 5 snin għall-indikazzjonijiet li ġejjin:
English: Administration of SINGULAIR granules:
Maltese: Għoti tal-granuli SINGULAIR:
English: Gastrointestinal disorders abdominal pain abdominal pain
Maltese: Disturbi gastro-intestinali uġigħ addominali uġigħ addominali
English: Cherry flavour
Maltese: TAGĦRIF
English: Results of P907 showed efficacy over placebo.
Maltese: Ir-riżultati ta' P907 wrew effikaċja meta mqabbla mal-plaċebo.
English: Asthma includes:
Maltese: Sustanza mhux attiva:
English: STATEMENT OF ACTIVE SUBSTANCE(S) One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Qartas wieħed ta' granuli fih montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
English: Limited data from available pregnancy databases do not suggest a causal relationship between SINGULAIR and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Maltese: Tagħrif limitat minn databases disponibbli dwar it-tqala ma jissuġġerixxix relazzjoni kawżali bejn SINGULAIR u l-malformazzjonijiet (i.e. difetti fid-dirgħajn u r-riġlejn) li ġew irrappurtati rarament fl-esperjenza ta' wara t-tqegħid tal-prodott fis-suq madwar id-dinja.
English: Paediatric Patients 6 months up to 2 years old (one 6-week study; n=175)
Maltese: Pazjenti Pedjatriċi 6 xhur sa sentejn (studju wieħed ta' 6 ġimgħat; n=175)
English: 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
Maltese: Pilloli li tomgħodhom ta' 5 mg huma disponibbli għal pazjenti pedjatriċi ta' 6 sa 14-il sena.
English: For the 10 mg film-coated tablet, the mean peak plasma concentration (Cmax) is achieved 3 hours (Tmax) after administration in adults in the fasted state.
Maltese: Għall-pillola miksija b'rita ta' 10 mg, il-konċentrazzjoni massima medja fil-plasma (Cmax) tinkiseb 3 sigħat (Tmax) wara l-għoti f'persuni adulti sajma.
English: SINGULAIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Maltese: SINGULAIR huwa antagonist tar-riċetturi leukotriene li jimblokka sustanzi msejħa leukotrienes.
English: Montelukast was determined not to be phototoxic in mice for UVA, UVB or visible light spectra at doses up to 500 mg/kg/day (approximately >200-fold based on systemic exposure).
Maltese: Montelukast ġie stabbilit li mhux fototossiku fil-ġrieden għall-UVA, UVB jew spettri ta' dawl viżibbli f'dożi sa 500 mg/kg/ġurnata (madwar >200 darba bbażat fuq esponiment sistemiku).
English: In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
Maltese: F'każijiet rari, pazjenti li jkunu fuq terapija b'sustanzi kontra l-ażżma fosthom montelukast jistgħu jippreżentaw esinofilja sistemika, kultant ippreżentata b'karatteristiċi kliniċi ta' vaskulite konsistenti mas-sindrome ta' Churg-Strauss, kundizzjoni li ħafna drabi tiġi ttrattata b'terapija sistemika bilkortikosterojdi.
English: • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis;
Maltese: • sensazzjoni ta' mard, uġigħ fil-ġogi jew fil-muskoli, bugħawwiġijiet, ħalq xott, dardir, rimettar, indiġestjoni, dijarea, epatite
English: After careful deliberations, the CHMP considered that the clinical data to support the add-on therapy in very young children are sufficient for approval, taking into account that this formulation was approved for use in children aged 6 months to 2 years in approximately 52 countries, including 17 of 27 European Union (EU) Member States (first approval in 2002) plus Iceland and Norway.
Maltese: Wara deliberazzjonijiet bir-reqqa, is-CHMP ikkunsidra li d-dejta klinika b'appoġġ għat-terapija miżjuda fi tfal żgħar ħafna hija suffiċjenti għall-approvazzjoni, meta wieħed iqis li din ilformulazzjoni ġiet approvata għall-użu fi tfal ta' bejn 6 xhur u sentejn f'madwar 52 pajjiż, inklużi 17 mis-27 Stat Membru ta' l-Unjoni Ewropea (UE) (l-ewwel approvazzjoni fl-2002) kif ukoll fl-Iżlanda u fin-Norveġja.
English: Packaged in polyethylene/aluminum/polyester sachet in:
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ippakkjat f'qartas tal-polyethylene/aluminju/polyester f':
English: For children who have problems consuming a chewable tablet, a granule formulation is available (see SINGULAIR 4 mg granule SPC).
Maltese: Għal tfal li għandhom problemi jomogħdu pillola li tomgħodha, teżisti formulazzjoni ta' granuli (ara SPC talgranuli ta' SINGULAIR 4 mg).
English: The percentage of patients with an asthma attack (an asthma attack being defined as a period of worsening asthma that required treatment with oral steroids, an unscheduled visit to the doctor's office, an emergency room visit, or hospitalization) was 32.2 in the montelukast group and 25.6 in the fluticasone group; the odds ratio (95% CI) being significant: equal to 1.38 (1.04, 1.84).
Maltese: Il-perċentwali ta' pazjenti b'attakk ta' l-ażżma (attakk ta' l-ażżma jkun definit bħala perjodu ta' ażżma li marret għall-agħar li kellu bżonn trattament bi sterojdi orali, żjara mhux skedata fl-uffiċċju tat-tabib, vista f'kamra ta' l-emerġenza, jew dħul fl-isptar) kien ta' 32.2 fil-grupp ta' montelukast u 25.6 fil-grupp ta' fluticasone; l-odds ratio (95% CI) ikun sinifikanti: ugwali għal 1.38 (1.04, 1.84).
English: The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo:
Maltese: Ir-reazzjonijiet avversi segwenti relatati mal-mediċina fi studji kliniċi ġew irrappurtati b'mod komuni (>1/100 sa <1/10) f'pazjenti ttrattati b'montelukast u b'inċidenza akbar f'pazjenti ttrattati bi plaċebo:
English: For children 6 months to 2 years old, SINGULAIR 4 mg granules are available.
Maltese: Għal tfal ta' bejn 6 xhur u sentejn, hemm disponibbli granuli SINGULAIR 4 mg.
English: Nervous system disorders: dizziness drowsiness, paraesthesia/hypoesthesia, seizure.
Maltese: Disturbi fis-sistema nervuża: sturdament, ngħas, parasteżija/ipoestesija, aċċessjonijiet Disturbi fil-qalb: palpitazzjonijiet.
English: Nervous system disorders headache headache hyperkinesia
Maltese: Disturbi fissistema nervuża uġigħ ta' ras uġigħ ta' ras iperkinesja
English: Averaged over the 12-month treatment period, the percentage of asthma RFDs increased from 61.6 to 84.0 in the montelukast group and from 60.9 to 86.7 in the fluticasone group.
Maltese: 0 fil-grupp ta' montelukast u minn 60.9 għal 86.7 fil-grupp ta' fluticasone.
English: The following wording was therefore accepted for Section 4.2, 4 mg CT and 4 mg OG:
Maltese: Il-kliem li ġej għalhekk ġie aċċettat għas-Sezzjoni 4.2, CT ta' 4mg u OG ta' 4 mg:
English: Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
Maltese: Roża, ovali, ta' għamla bikonvessa, SINGULAIR imnaqqax fuq naħa u MSD 711 fuq in-naħa l-oħra.
English: In this leaflet:
Maltese: IMPORTANTI:
English: • SINGULAIR granules are not intended to be dissolved in liquid.
Maltese: • Il-granuli SINGULAIR mhumiex intenzjonati biex jinħallu fil-likwidu.
English: Montelukast improved daytime symptoms (including coughing, wheezing, trouble breathing and activity limitation) and nighttime symptoms compared with placebo.
Maltese: Montelukast tejjeb is-sintomi ta' bi nhar (fosthom sogħla, tħarħir, problemi bin-nifs u limitazzjoni ta' l-attività) u s-sintomi ta' bil-lejl meta mqabbel mal-plaċebo.
English: Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min).
Maltese: Fi studju ta' 12-il ġimgħa fuq pazjenti adulti ġie muri tnaqqis sinifikanti fit-tidjiq tal-bronki kkawżat mill-eżerċizzju (tnaqqis massimu fil-FEV1 22.33% għal montelukast vs 32.40% għall-plaċebo; ħin għall-irkupru sa 5% tal-FEV1 tal-linja bażi 44.
English: In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function (FEV1 8.71% vs 4.16% change from baseline; AM PEFR 27.9 L/min vs 17.8 L/min change from baseline) and decreased "as-needed" β-agonist use (-11.7% vs +8.2% change from baseline).
Maltese: Fi studju ta' 8 ġimgħat fuq pazjenti pedjatriċi minn 6 sa 14-il sena, montelukast 5 mg darba kuljum, meta mqabbel mal-plaċebo, tejjeb b'mod sinifikanti l-funzjoni respiratorja (FEV1 bidla mil-linja bażi ta' 8.71% vs 4.16%; AM
English: The following sections of the SPCs were presented for harmonisation: 4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.3 Contraindications, 4.4 Special Warnings and Precautions for Use, 4.8 Undesirable effects, and 6.5 Shelf life.
Maltese: Dawn is-sezzjonijiet ta' l-SPCs kienu ppreżentati għall-armonizzazzjoni: 4.1 Inkidazzjonjiet Terapewtiċi, 4.2 Pożoloġija u metodu ta' kif jingħata, 4.3 Kontra-indikazzjonijiet, 4.4
English: Compared with inhaled beclomethasone (200 µg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; β-agonist use: -28.28% vs -43.89%).
Maltese: Meta mqabbel ma' beclomethasone meħud man-nifs (200µgramma darbtejn kuljum bi spacer device), montelukast wera rispons inizjali aktar rapidu, għalkemm fuq l-istudju ta' 12-il ġimgħa, beclomethasone pprovda effett medju akbar ta' trattament (bidla perċentwali mil-linja bażi għal montelukast vs beclomethasone, rispettivament għal FEV1: 7.49% vs 13.3%; użu ta' β-agonist:
English: Therefore the final revised indication for 4mg CT and 4mg OG is as follows:
Maltese: Għalhekk l-indikazzjoni finali riveduta għal CT ta' 4mg u OG ta' 4mg hija kif ġej: