qanastek/EMEA-V3 huggingface dataset:
SINGULAIR as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction.
SINGULAIR bħala prevenzjoni ta ’ l- ażżma għal pazjenti ta ’ bejn sentejn u 5 snin li fihom il - komponent prinċipali huwa t- tidjiq fil- pajpijiet tan- nifs imqanqal mill- eżerċizzju.
In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
F’ pazjenti ta ’ bejn sentejn u 5 snin, it- tidjiq fil- pajpijiet tan- nifs imqanqal mill- eżerċizzju jista ’ jkun il- manifestazzjoni predominanti ta ’ ażżma persistenti li tkun teħieġ trattament b’ kortikosterojdi li jittieħdu man- nifs.
Patients should be evaluated after 2 to 4 weeks of treatment with montelukast.
Il- pazjenti għandhom jiġu vvalutati wara bejn ġimagħtejn u 4 ġimħat trattament b’ montelukast.
If satisfactory response is not achieved, an additional or different therapy should be considered .”
Jekk ma jinkisibx rispons sodisfaċenti, għandha tiġi kkunsidrata terapija addizzjonali jew differenti. ”
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, L- ITTIKKETTAR U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop ta ’ din ir- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, it -
labelling, package leaflet and Module 3.
tikketta, il- fuljett ta ’ tagħrif u l- Modulu 3.
- the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta, il- fuljett ta ’ tagħrif u l- Modulu 3 proposti mid -
Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ġew ivvalutati abbażi tad- dokumenti sottomessi u d- diskussjoni xjentifika fi ħdan il- Kumitat,
- the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg
- is- CHMP ikkonkluda li l- Awtorizzazzjoni għat- Tqegħid fis- Suq tista ’ tiġi armonizzata għall- Granuli
Granules (previously known as Oral Granules) for patients aged 6 months to 5 years on the following indications:
ta ’ 4mg ta ’ Singulair (qabel magħrufin bħala Granuli Orali) għal pazjenti ta ’ bejn 6 xhur u 5 snin għall- indikazzjonijiet li ġejjin:
• 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.
• SINGULAIR huwa indikat fit- trattament ta ’ l- ażżma bħala terapija addizzjonali f’ dawk il - pazjenti 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.
• 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).
• SINGULAIR jista ’ wkoll ikun opzjoni ta ’ trattament alternattiv għal kortikosterodji b’ doża baxxa li jittieħdu man- nifs għal pazjenti ta ’ bejn sentejn u 5 snin b’ ażżma persistenti li ma jkollhomx storja riċenti ta ’ attakki serji ta ’ l- ażżma li jirrikjedu użu orali ta ’ kortikosterojdi, u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs (ara s- sezzjoni 4. 2).
• SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
• SINGULAIR huwa indikat ukoll fil- prevenzjoni ta ’ l- ażżma minn sentejn ’ il fuq li fihom il - komponent predominanti jkun it- tidjiq fil- pajpijiet tan- nifs imqanqal mill- eżerċizzju.
- the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg
- is- CHMP ikkonkluda li l- Awtorizzazzjoni għat- Tqegħid fis- Suq tista ’ tiġi armonizzata biss għal
Chewable Tablets for patients aged 2 to 5 years on the following indications:
Pilloli Jintmagħdu ta ’ Singulair ta ’ 4 mg għal pazjenti ta ’ bejn sentejn u 5 snin fuq l- indikazzjonijiet li ġejjin:
• 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.
• SINGULAIR huwa indikat fit- trattament ta ’ l- ażżma bħala terapija addizzjonali f’ dawk il - pazjenti 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.
• 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
• SINGULAIR jista ’ wkoll ikun opzjoni ta ’ trattament alternattiv għal kortikosterojdi li jittieħdu man- nifs f’ doża baxxa għal pazjenti ta ’ bejn sentejn u 5 snin b’ ażżma persistenti ħafifa li ma għandhomx storja riċenti ta ’ attakki ta ’ l- ażżma serji li għalihom kellhom bżonn l - użu ta ’ kortikosterojdi orali, u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs (ara s- sezzjoni 4. 2).
• SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
• SINGULAIR huwa indikat ukoll fil- prevenzjoni ta ’ l- ażżma għal persuni minn sentejn ’ il fuq li fihom il- komponent predominanti jkun it- tidjiq fil- pajpijiet tan- nifs imqanqal mill - eżerċizzju.
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Singulair and associated names (see Annex I).
Is- CHMP irrakkomanda l- emenda ta ’ l- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, Tikketta u Fuljett ta ’ tagħrif għalihom huma stabbiliti fl- Anness III għal Singulair u ismijiet assoċjati (ara l- Anness I).
16 SUMMARY OF PRODUCT CHARACTERISTICS
16 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
SINGULAIR 4 mg granules
SINGULAIR 4 mg granuli
One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
Qartas wieħed ta 'granuli fih montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
Granules.
Granuli
White granules
Granuli bojod
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.
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.
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).
SINGULAIR jista 'jkun ukoll għażla ta' trattament alternattiv għal kortikosterojdi ta 'doża baxxa li jittieħdu man- nifs għal pazjenti minn 2 sa 5 snin b' ażżma ħafifa persistenti li ma jkollhomx storja riċenti ta' attakki serji ta 'l- ażżma li kienu jeħtieġu l- użu ta' kortikosterojdi orali, u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs (ara sezzjoni 4. 2).
SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
SINGULAIR huwa indikat ukoll fil- profilassi ta 'ażżma minn sentejn ’ il fuq li fiha l- komponent prinċipali jkun it- tidjiq tal- bronki kkawżat mill- eżerċizzju.
This medicinal product is to be given to a child under adult supervision.
Din il- mediċina għandha tingħata lil tifel/ tifla taħt superviżjoni ta ’ adult.
The dosage for paediatric patients 6 months to 5 years of age is one sachet of 4 mg granules daily to be taken in the evening.
Id- doża għal pazjenti pedjatriċi minn 6 xhur sa 5 snin hija qartas wieħed ta '4 mg granuli li għandu jittieħed filgħaxija.
No dosage adjustment within this age group is necessary.
M' hemmx bżonn ta 'aġġustament fid- doża f' dan il- grupp ta' etajiet.
Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Id- data dwar l- effikaċja minn provi kliniċi f' pazjenti pedjatriċi minn 6 xhur sa sentejn b’ ażżma persistenti hija limitata.
Patients should be evaluated after 2 to 4 weeks for response to montelukast treatment.
Il- pazjenti għandhom jiġu evalwati wara ġimagħtejn sa 4 ġimgħat għar- rispons tagħhom għal kura b’ montelukast.
Treatment should be discontinued if a lack of response is observed.
It- trattament għandu jitwaqqaf jekk ikun osservat nuqqas ta ’ rispons.
The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Il- granuli SINGULAIR ta ’ 4 mg mhumiex rakkomandati għal trabi taħt l- età ta ’ 6 xhur.
Administration of SINGULAIR granules:
Għoti tal- granuli SINGULAIR:
SINGULAIR granules can be administered either directly in the mouth, or mixed with a spoonful of cold or room temperature soft food (e. g., applesauce, ice cream, carrots and rice).
Il- granuli SINGULAIR jistgħu jingħataw jew direttament fil- ħalq, jew imħallta ma 'mgħarfa ta' ikel artab kiesaħ jew fit- temperatura tal- kamra (eż. zalza tat- tuffieħ, ġelat, karrotti u ross).
The sachet should not be opened until ready to use.
Il- qartas m' għandux jinfetaħ sakemm ikun lest biex jintuża.
After opening the sachet, the full dose of SINGULAIR granules must be administered immediately (within 15 minutes).
Wara li jinfetaħ il- qartas, id- doża sħiħa ta 'granuli SINGULAIR trid tingħata immedjatament (fi żmien 15 - il minuta).
If mixed with food, SINGULAIR granules must not be stored for future use.
Jekk jitħalltu ma 'l- ikel, il- granuli SINGULAIR ma għandhomx jinħażnu għal użu futur.
SINGULAIR granules are not intended to be dissolved in liquid for administration.
Il- granuli SINGULAIR mhumiex intenzjonati sabiex jinħallu fil- likwidu biex jingħataw.
However, liquids may be taken subsequent to administration.
Madankollu, jistgħu jittieħdu likwidi wara l- għoti.
SINGULAIR granules can be administered without regard to the timing of food ingestion.
Il - granuli SINGULAIR jistgħu jingħataw mingħajr każ tal- ħin ta 'l- inġestjoni ta' l- ikel.
18 General recommendations.
18 Rakkomandazzjonijiet ġenerali.
The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one day.
L- effett terapewtiku ta 'SINGULAIR fuq il- parametri tal- kontroll ta' l - ażżma jseħħ fi żmien ġurnata.
Patients should be advised to continue taking SINGULAIR even if their asthma is under control, as well as during periods of worsening asthma.
Il- pazjenti għandhom jingħataw parir biex ikomplu jieħdu SINGULAIR anki jekk l- ażżma tagħhom tkun taħt kontroll, kif ukoll matul perjodi meta l- ażżma tmur għall- agħar.
No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment.
M' hemmx bżonn ta 'aġġustament fid- doża għal pazjenti b' insuffiċjenza tal- kliewi, jew indeboliment ħafif għal moderat tal- fwied.
There are no data on patients with severe hepatic impairment.
M' hemmx tagħrif dwar pazjenti b' indeboliment sever tal- fwied.
The dosage is the same for both male and female patients.
Id- doża hija l- istess kemm għal pazjenti rġiel kif ukoll għal pazjenti nisa.
SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
SINGULAIR huwa għażla ta 'trattament alternattiv għal kortikosterojdi ta' doża baxxa li jittieħdu man- nifs għal ażżma ħafifa persistenti:
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.
Montelukast mhux rakkomandat bħala monoterapija f' pazjenti b' ażżma moderata persistenti.
The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children 2 to 5 years old with mild persistent asthma should only be considered for patients 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 4.1).
L- użu ta 'montelukast bħala għażla ta' trattament alternattiv għal kortikosterojdi ta 'doża baxxa li jittieħdu man - nifs għal tfal minn 2 sa 5 snin b' ażżma ħafifa persistenti għandu jiġi kkunsidrat biss għal pazjenti li ma jkollhomx storja riċenti ta' attakki serji ta 'l- ażżma li kienu jeħtieġu l- użu ta' kortikosterojd orali u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs (ara sezzjoni 4. 1).
Mild persistent asthma is defined as asthma symptoms more than once a week but less that once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes.
Ażżma ħafifa persistenti hija definita bħala sintomi ta 'l- ażżma aktar minn darba fil- ġimgħa iżda anqas minn darba kuljum, sintomi bil- lejl aktar minn darbtejn fix- xahar iżda anqas minn darba fil- ġimgħa, b' funzjoni normali tal- pulmuni bejn episodju u ieħor.
If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated.
Jekk ma jinkisibx kontroll sodisfaċenti ta 'l - ażżma fil- follow- up (normalment fi żmien xahar), għandha tiġi evalwata l- ħtieġa għal terapija anti - infjammatorja addizzjonali jew differenti bbażata fuq is- sistema mtarrġa għal terapija ta' l- ażżma.
Patients should be periodically evaluated for their asthma control.
Il - pazjenti għandhom jiġu evalwati perjodikament għall- kontroll tagħhom ta 'l- ażżma.
SINGULAIR as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction.
SINGULAIR bħala profilassi ta ’ l- ażżma għal pazjenti ta ’ bejn is- sentejn u l- ħames snin li l - komponent predominanti fihom huwa bronkokostrizzjoni mibdija minħabba eżerċizzju:
In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
F’ pazjenti ta ’ bejn sentejn u l- ħames snin, bronkokostrizzjoni mibdija minħabba eżerċizzju tista ’ tkun il- manifestazzjoni predominanti ta ’ ażżma persistenti.
Patients should be evaluated after 2 to 4 weeks of treatment with montelukast.
Il- pazjenti għandhom jiġu evalwati wara ġimagħtejn sa 4 ġimgħat ta ’ trattament b’ montelukast.
If satisfactory response is not achieved, an additional or different therapy should be considered.
Jekk ma jinkisibx rispons sodisfaċjenti, għandha tiġi kkunsidrata terapija addizzjonali jew differenti.
Therapy with SINGULAIR in relation to other treatments for asthma.
Terapija b' SINGULAIR fir- rigward ta 'trattament oħra għall- ażżma.
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).
Meta t- trattament b' SINGULAIR jintuża bħala terapija add- on ma 'kortikosterojdi li jittieħdu man - nifs, SINGULAIR m' għandux jiġu mibdul f' daqqa għal kortikosterojdi li jittieħdu man- nifs (ara sezzjoni 4. 4).
10 mg film-coated tablets are available for adults 15 years of age and older.
Pilloli ta '10 mg miksijin b’ rita huma disponibbli għal pazjenti adulti ta' 15- il sena jew aktar.
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
Pilloli li tomgħodhom ta '5 mg huma disponibbli għal pazjenti pedjatriċi ta' 6 sa 14- il sena.
4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age.
Pilloli li tomgħodhom ta '4 mg huma disponibbli bħala formulazzjoni alternattiva għal pazjenti pedjatriċi minn 2 sa 5 snin.
The diagnosis of persistent asthma in very young children (6 months – 2 years) should be established by a paediatrician or pulmonologist.
Id- dijanjożi ta ’ ażżma persistenti fi tfal żgħar ħafna (6 xhur sa sentejn) għandha tiġi stabbilita minn tabib tat- tfal jew pulmunoloġista.
Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available.
Il- pazjenti għandhom jiġu avżati biex qatt ma jużaw montelukast orali biex jittrattaw attakki akuti ta 'l- ażżma u biex iżommu l- medikazzjoni ta' salvataġġ xierqa tagħhom tas- soltu għal dan il- għan faċilment disponibbli.
If an acute attack occurs, a short-acting inhaled β -agonist should be used.
F' każ ta 'attakk akut, għandu jintuża β- agonist jaħdem malajr li jittieħed man - nifs.
Patients should seek their doctors’ advice as soon as possible if they need more inhalations of short-acting β -agonists than usual.
Il- pazjenti għandhom ifittxu l- parir tat- tabib tagħhom malajr kemm jista 'jkun jekk ikollhom bżonn aktar inalazzjonijiet mis- soltu ta' β- agonisti li jaħdmu malajr.
Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Montelukast m' għandux jiġi mibdul f' daqqa għal kortikosterojdi li jittieħdu man- nifs jew orali.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
19 Ma hemm ebda informazzjoni li turi li l- kortikosterojdi orali jistgħu jitnaqqsu meta montelukast jingħata fl- istess ħin.
19 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 Churg- Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
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 bil - kortikosterojdi.
These cases usually, but not always, have been associated with the reduction or withdrawal of oral corticosteroid therapy.
Dawn il- każijiet normalment, iżda mhux dejjem, ġew assoċjati mat- tnaqqis jew twaqqif tat- terapija b' kortikosterojdi orali.
The possibility that leukotriene receptor antagonists may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established.
Il- possibbiltà li antagonisti għar- riċetturi leukotriene jistgħu jkunu assoċjati mat- tfaċċar tas- sindrome ta 'Churg- Strauss la tista' tiġi eskluża u lanqas stabbilita.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/ or neuropathy presenting in their patients.
It- tobba għandhom joqogħdu attenti għal esinofilja, raxx vaskulari, sintomi pulmonari li jmorru għall- agħar, kumplikazzjonijiet tal- qalb, u/ jew newropatija li jidhru fil- pazjenti tagħhom.
Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
Pazjenti li jiżviluppaw dawn is- sintomi għandhom jiġu eżaminati mill- ġdid u r- reġimi tat- trattament tagħhom evalwati.
4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma.
Montelukast jista 'jingħata ma' terapiji oħra komunement użati fil- profilassi u t- trattament kroniku ta 'l- ażżma.
In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ norethindrone 35/ 1), terfenadine, digoxin and warfarin.
Fi studji dwar l- interazzjonijiet tal- mediċina, id- doża klinika rakkomandata ta 'montelukast ma kellhiex effetti kliniċi importanti fuq il- farmakokinetiċi tal- prodotti mediċinali li ġejjin: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ norethindrone 35/ 1), terfenadine, digoxin u warfarin.
The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital.
L- erja taħt il- kurva tal- konċentrazzjoni fil- plasma (AUC) għal montelukast tnaqqset b' madwar 40% f' pazjenti li ngħataw ukoll phenobarbital.
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.
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.
In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8.
Studji in vitro wrew li montelukast huwa inibitur qawwi ta 'CYP 2C8.
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.
Madankollu, informazzjoni minn studju kliniku dwar l- interazzjoni bejn mediċina u oħra 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.
Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolized by this enzyme (e. g., paclitaxel, rosiglitazone, and repaglinide.)
Għalhekk, montelukast mhux mistenni li jibdel b' mod evidenti l- metaboliżmu ta 'prodotti mediċinali metabolizzati minn dan l- enzim (eż. paclitaxel, rosiglitazone, u repaglinide).
Use during pregnancy
Użu fit- tqala
Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/ foetal development.
Studji fuq il- bhejjem ma jurux effetti ħżiena fuq it- tqala jew fuq l- iżvilupp ta 'l- embriju/ fetu.
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.
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.
SINGULAIR may be used during pregnancy only if it is considered to be clearly essential.
SINGULAIR jista 'biss jintuża waqt it- tqala jekk ikun ikkunsidrat li hemm bżonn ċar.
Studies in rats have shown that montelukast is excreted in milk (see section 5.3).
Studji fuq il- firien urew li montelukast jitneħħa fil- ħalib (ara sezzjoni 5. 3).
It is not known if montelukast is excreted in human milk.
Mhux magħruf jekk montelukast jitneħħiex fil- ħalib uman.
SINGULAIR may be used in breast-feeding mothers only if it is considered to be clearly essential.
SINGULAIR jista 'biss jintuża f' nisa li jkunu qegħdin ireddgħu jekk ikun ikkunsidrat li hemm bżonn ċar.
20 Montelukast is not expected to affect a patient’ s ability to drive a car or operate machinery.
Montelukast mhux mistenni li jaffettwa l- ħila ta 'pazjent biex isuq karrozza jew iħaddem magni.
However, in very rare cases, individuals have reported drowsiness or dizziness.
Madankollu, f' każijiet rari ħafna, individwi rrappurtaw ngħas jew sturdament.
Montelukast has been evaluated in clinical studies as follows:
Montelukast ġie evalwat fi studji kliniċi kif ġej:
10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age, and 4 mg granules in 175 paediatric patients 6 months to 2 years of age.
10 mg pilloli miksijin b' rita f' madwar 4000 pazjent adult ta '15 - il sena jew aktar 5 mg pilloli li tomgħodhom f' madwar 1750 pazjent pedjatriku minn 6 sa 14 - il sena 4 mg pilloli li tomgħodhom fi 851 pazjent pedjatriku minn 2 sa 5 snin, u 4 mg granuli f' 175 pazjent pedjatriku minn 6 xhur sa sentejn.
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:
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:
Adult Patients
Pazjenti
Patients
Pedjatriċi
15 years and
Pazjenti Adulti
6 to 14 years
6 sa 14- il sena
2 to 5 years old
2 sa 5 snin
old
Klassifika tas -
6 months up to
15- il sena u aktar
Body System
Pedjatriċi
older
Sistema tal -
(one
(żewġ studji ta '
8-week
ta '8 ġimgħat;
(one 12-week
ta '12- il ġimgħa;
2 years old
6 xhur sa sentejn
Class
Ġisem
(two 12-week
12- il ġimgħa;
study; n=461)
n=461)
studies; n=795)
(studju wieħed ta '
(one 48-week study; n=278)
Disturbi fis - sistema
study; n=175)
n=795)
studies; n=615)
(żewġ studji ta '56 ġimgħa; n=615)
headache headache
(studju wieħed ta '48 ġimgħa; n=278)
hyperkinesia
6 ġimgħat; n=175)
Respiratory, thoracic, and mediastinal disorders
nervuża Disturbi respiratorji, toraċiċi u medjastinali Disturbi gastro -
asthma
uġigħ ta 'ras uġigħ ta' ras
Gastrointestina l disorders
iperkinesja ażżma
abdominal pain
intestinali Disturbi fil - ġilda u fit -
abdominal pain
uġigħ addominali uġigħ addominali
Skin and subcutaneous tissue disorders General disorders and administration site conditions
dermatite bl - tessuti ta 'taħt ekżema, raxx il- ġilda Disturbi ġenerali u kundizzjonijiet għatx ta' mnejn jingħata
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.
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.
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.
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.
With prolonged treatment, the safety profile did not change in these patients either.
Bi trattament prolungat, il- profil tas- sigurtà ma nbidilx f' dawn il- pazjenti lanqas.
The safety profile in paediatric patients 6 months to 2 years of age did not change with treatment up to 3 months.
Il- profil tas- sigurtà f' pazjenti pedjatriċi minn 6 xhur sa sentejn ma nbidilx bi trattament sa 3 xhur.
The following adverse reactions have been reported in post-marketing use:
21 Ir- reazzjonijiet avversi li ġejjin kienu rrappurtati fl- użu ta 'wara t- tqegħid tal- prodott fis- suq:
Blood and lymphatic system disorders: increased bleeding tendency.
Disturbi tad- demm u tas- sistema limfatika: tendenza akbar ta 'fsada.
21 Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Disturbi fis- sistema immuni: reazzjonijiet ta 'sensittività eċċessiva fosthom anafilassi, infiltrazzjoni esinofilika tal- fwied.
Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behaviour, and tremor), depression, suicidal thinking and behaviour (suicidality) in very rare cases.
Disturbi psikjatriċi: anormalitajiet tal- ħolm fosthom inkubi, alluċinazzjonijiet, nuqqas ta ’ rqad, attività psikomotorili eċċessiva (inkluż irritabilità, irrekwitezza, aġitazzjoni li tinkludi mġiba aggressiva, u rogħda), depressjoni, ħsibijiet u mġiba suwiċidjali (suwiċidjalità f’ każijiet rari ħafna).
Nervous system disorders: dizziness drowsiness, paraesthesia/ hypoesthesia, seizure.
Disturbi fis- sistema nervuża: sturdament, ngħas, parasteżija/ ipoestesija, aċċessjonijiet Disturbi fil- qalb: palpitazzjonijiet.
Gastrointestinal disorders: diarrhoea, dry mouth, dyspepsia, nausea, vomiting.
Disturbi gastro- intestinali: dijarea, ħalq xott, dispepsja, dardir, rimettar.
Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Disturbi fil- fwied u fil- marrara: livelli għoljin ta 'transaminases fis- serum (ALT, AST), epatite kolestatika.
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda: anġjoedema, tbenġil, urtikarja, ħakk, raxx, erythema nodosum.
Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
Disturbi muskolu- skeltrali u tal- connective tissue: artralġja, uġigħ fil- muskoli fosthom bugħawwiġijiet Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata: astenja/ għeja, telqa, edema, Każijiet rari ħafna tas- Sindrome ta' Churg- Strauss (CSS) ġew irrappurtati waqt trattament b' montelukast f' pazjenti ażżmatiċi (ara sezzjoni 4. 4).
No specific information is available on the treatment of overdose with montelukast.
Ma hija disponibbli l- ebda informazzjoni speċifika dwar it- trattament ta 'doża eċċessiva b' montelukast.
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.
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.
There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast.
Kien hemm rapporti ta 'doża eċċessiva akuta fl- esperjenza ta' wara t- tqegħid fis- suq u fi studji kliniċi b' montelukast.
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).
Dawn jinkludu rapporti f' persuni adulti u tfal b' doża għolja sa 1000 mg (madwar 61 mg/ kg f' tifel/ tifla ta '42 xahar).
The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.
Is- sejbiet kliniċi u osservati fil- laboratorju kienu konsistenti mal - profil tas- sigurtà f' pazjenti adulti u pedjatriċi.
There were no adverse experiences in the majority of overdose reports.
Ma kien hemm ebda esperjenzi avversi fil- maġġoranza tar- rapporti ta 'doża eċċessiva.
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.
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.
It is not known whether montelukast is dialyzable by peritoneal- or hemo-dialysis.
Mhux magħruf jekk montelukast jiġix dijalizzat b' ħemodijalisi jew b' dijalisi peritoneali.
Leukotriene receptor antagonist ATC-code:
Antagonista tar- riċetturi leukotriene Kodiċi ATC:
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils.
Is- cysteinyl leukotrienes (LTC4, LTD4, LTE4) huma eicosanoids infjammatorji qawwija merħija minn diversi ċelloli fosthom il- mast cells u l- esinofili.
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.
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.
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.
Montelukast huwa kompost attiv oralment li jeħel b' affinità u selettività kbira mar- riċettur CysLT1.
In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg.
Fi studji kliniċi, montelukast jimpedixxi t- tidjiq tal- bronki minħabba LTD4 meħud man- nifs f' dożi baxxi sa 5 mg.
Bronchodilation was observed within 2 hours of oral administration.
Twessigħ tal- bronki kien osservat fi żmien sagħtejn minn għoti orali.
The bronchodilation effect caused by a β -agonist was additive to that caused by montelukast.
It- trattament
Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
22 b' montelukast impedixxa tidjiq tal- bronki kemm f' fażi bikrija kif ukoll tardiva minħabba sfida ta 'l - antiġeni.
Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients.
Meta mqabbel mal- plaċebo, montelukast naqqas l- esinofili tad- demm periferali f' pazjenti adulti u pedjatriċi.
In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum).
Fi studju separat, it- trattament b' montelukast naqqas l- esonifili fil- passaġġi ta 'l - arja b' mod sinifikanti (kif imkejjel fi sputum).
In adult and paediatric patients 2 to 14 years of age, montelukast, compared with placebo, decreased peripheral blood eosinophils while improving clinical asthma control.
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 il - kontroll kliniku ta' l- ażżma.
22 In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 (10.4% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/ min vs 3.3 L/ min change from baseline), and significant decrease in total β -agonist use (-26.1% vs -4.6% change from baseline).
Fi studji fuq l- adulti, montelukast, 10 mg darba kuljum, meta mqabbel ma 'plaċebo, wera titjib sinifikanti fil- FEV1 ta' filgħodu (bidla mil- linja bażi ta '10. 4% vs 2. 7%), fir- rata massima ta' fluss ta 'nifs' il barra filgħodu (PEFR) (bidla mil- linja bażi ta '24. 5 L/ min vs 3. 3 L/ min), u tnaqqis sinifikanti fl- użu totali ta' β- agonist (bidla mil- linja bażi ta '- 26. 1% vs - 4. 6%).
Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo.
It- titjib fil- punteġġi tas- sintomi ta 'l- ażżma rrappurtati mill- pazjenti stess matul il- ġurnata u bil- lejl kienu konsiderevolment aħjar mill - plaċebo.
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:
Studji fuq l- adulti wrew il- ħila ta 'montelukast li jżid ma' l- effett kliniku ta 'korikosterojd meħud man - nifs (bidla perċentwali mil- linja bażi għal beclomethasone meħud man- nifs u montelukast vs beclomethasone, rispettivament għal FEV1:
5.43% vs 1.04%; β -agonist use: -8.70% vs 2.64%).
5. 43% vs 1. 04%; użu ta 'β- agonist: - 8. 70% vs 2. 64%).
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:
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%; β -agonist use: -28.28% vs -43.89%).
7. 49% vs 13. 3%; użu ta 'β- agonist: - 28. 28% vs - 43. 89%).
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).
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).
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).
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 PEFR 27. 9 L/ min vs 17. 8 L/ min bidla mil- linja bażi) u naqqas l- użu "skond il- ħtieġa" ta 'β- agonisti (bidla mil- linja bażi ta' - 11. 7% vs +8. 2%).
In a 12-month study comparing the efficacy of montelukast to inhaled fluticasone on asthma control in paediatric patients 6 to 14 years of age with mild persistent asthma, montelukast was non-inferior to fluticasone in increasing the percentage of asthma rescue-free days (RFDs), the primary endpoint.
Fi studju ta '12- il xahar li qabbel l- effikaċja ta' montelukast ma 'fluticasone meħud man- nifs, fuq il - kontroll ta' l- ażżma f' pazjenti pedjatriċi minn 6 sa 14- il sena b' ażżma ħafifa persistenti, montelukast ma kienx inferjuri għal fluticasone fiż- żieda tal- ġranet mingħajr salvataġġ kontra l- ażżma (RFDs), il - punt finali prinċipali.
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.
Bħala medja fuq il- perjodu ta 'trattament ta' 12- il xahar, il- perċentwali ta 'RFDs mill- ażżma żdied minn 61. 6 għal 84. 0 fil- grupp ta' montelukast u minn 60. 9 għal 86. 7 fil- grupp ta 'fluticasone.
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.
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.
Both montelukast and fluticasone also improved asthma control on secondary variables assessed over the 12 month treatment period:
Kemm montelukast u anki fluticasone tejbu wkoll il- kontroll ta 'l- ażżma fuq varjabbli sekondarji evalwati fuq il- perjodu ta' trattament ta '12- il xahar:
FEV1 increased from 1.83 L to 2.09 L in the montelukast group and from 1.85 L to 2.14 L in the fluticasone group.
FEV1 żdied minn 1. 83 L għal 2. 09 L fil- grupp ta 'montelukast u minn 1. 85 L għal 2. 14 L fil- grupp ta' fluticasone.
The between-group difference in LS mean increase in FEV1 was -0.02 L with a 95% CI of -0.06, 0.02.
Id- differenza bejn grupp u ieħor fiż- żieda medja LS fil- FEV1 kienet ta '- 0. 02 L b' 95% CI ta' - 0. 06, 0. 02.
The mean increase from baseline in% predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Iż- żieda medja mil- linja bażi f' perċentwali mbassra ta 'FEV1 kienet ta' 0. 6% fil- grupp ta 'trattament b' montelukast, u 2. 7% fil- grupp ta' trattament bi fluticasone.
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.
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, - 0. 7.
The percentage of days with β -agonist use decreased from 38.0 to 15.4 in the montelukast group, and from 38.5 to 12.8 in the fluticasone group.
Il- perċentwali ta 'ġranet b' użu ta' β- agonist naqsu minn 38. 0 għal 15. 4 fil- grupp ta 'montelukast, u minn 38. 5 għal 12. 8 fil- grupp ta' fluticasone.
The between group difference in LS means for the percentage of days with β -agonist use was significant:
Id- differenza bejn grupp u ieħor fil- medji LS għall - perċentwali ta 'ġranet b' użu ta' β- agonist kienet sinifikanti:
2.7 with a 95% CI of 0.9, 4.5.
2. 7 b' 95% CI ta '0. 9, 4. 5.
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).
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).
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.
23 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. 5% fil- grupp ta' fluticasone.
The between group difference in LS means was significant:
Id- differenza bejn grupp u ieħor fil- medji LS kienet sinifikanti:
7.3% with a 95%CI of 2.9; 11.7.
7. 3% b' 95% CI ta '2. 9; 11. 7.
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).
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).
Sixty percent of patients were not on any other controller therapy.
Sittin fil- mija tal- pazjenti ma kienu fuq ebda terapija oħra ta 'kontroll.
Montelukast improved daytime symptoms (including coughing, wheezing, trouble breathing and activity limitation) and nighttime symptoms compared with placebo.
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.
Montelukast also decreased "as-needed" β -agonist use and 23 corticosteroid rescue for worsening asthma compared with placebo.
Montelukast naqqas ukoll l- użu "skond il- ħtieġa" ta 'β- agonisti u s- salvataġġ ta' kortikosterojdi għal ażżma li tmur għall- agħar meta mqabbel mal- plaċebo.
Patients receiving montelukast had more days without asthma than those receiving placebo.
Il- pazjenti li rċevew montelukast kellhom aktar ġranet mingħajr ażżma minn dawk li rċevew plaċebo.
A treatment effect was achieved after the first dose.
Effett tat- trattament ġie miksub wara l- ewwel doża.
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.
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.
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].
2. 34 EE, rispettivament), [EE definita bħala ≥3 ijiem konsekuttivi b' sintomi ta 'matul il - jum li kienu jeħtieġu l- użu ta' β- agonisti, jew kortikosterojdi (orali jew meħuda man- nifs), jew dħul l - isptar minħabba l- ażżma].
The percentage reduction in yearly EE rate was 31.9%, with a 95% CI of 16.9, 44.1.
It- tnaqqis perċentwali fir- rata annwali ta 'EE kien ta' 31, 9%, b' 95% CI ta '16, 9, 44. 1.
Efficacy of montelukast is supported in paediatric patients 6 months to 2 years of age by extrapolation from the demonstrated efficacy in patients 2 years of age and older with asthma, and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the medicinal products’ s effect are substantially similar among these populations.
L- effikaċja ta 'montelukast hija appoġġjata f' pazjenti pedjatriċi minn 6 xhur sa sentejn b' estrapolazzjoni mill- effikaċja murija f' pazjenti ta' sentejn jew akbar li kellhom l- ażżma, u hija bbażata fuq tagħrif farmakokinetiku simili, kif ukoll l- ipotesi li l- kors tal- marda, il- patofiżjoloġija u l - effett tal- prodott mediċinali huma sostanzjalment simili fost dawn il- popolazzjonijiet.
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).
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. 22 min vs 60. 64 min).
This effect was consistent throughout the 12- week study period.
Dan l- effett kien konsistenti tul il- perjodu kollu ta 'l- istudju ta' 12- il ġimgħa.