qanastek/EMEA-V3 huggingface dataset:
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).
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. 11%; ħin għall- irkupru ta '5% tal- FEV1 tal- linja bażi 17. 76 min vs 27. 98 min).
The effect in both studies was demonstrated at the end of the once-daily dosing interval.
L- effett fiż- żewġ studji ġie muri fit- tmiem ta 'l - intervall ta' dożaġġ ta 'darba kuljum.
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).
F' pazjenti ażżmatiċi sensittivi għall- aspirina li rċevew kortikosterojdi meħuda man- nifs u/ jew orali fl - istess ħin, it- trattament b' montelukast, meta mqabbel mal- plaċebo, irriżulta f' titjib sinifikanti fil - kontroll ta 'l- ażżma (FEV1 8. 55% vs - 1. 74% bidla mil- linja bażi u tnaqqis fl- użu totali ta' β- agonist - 27. 78% vs 2. 09% bidla mil- linja bażi).
Absorption.
Assorbiment..
Montelukast is rapidly absorbed following oral administration.
Montelukast jiġi assorbit malajr wara għoti orali.
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.
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.
The mean oral bioavailability is 64%.
Il- bijodisponibilità medja orali hija ta '64%.
The oral bioavailability and Cmax are not influenced by a standard meal.
Il- bijodisponibilità orali u l- Cmax mhumiex affettwati minn ikla standard.
Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion.
Is- sigurtà u l- effikaċja ġew murija fi provi kliniċi fejn il- pillola miksija b' rita ta '10 mg ngħatat mingħajr ma tqies il- ħin ta' l- inġestjoni ta 'l- ikel.
For the 5 mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state.
Għall- pillola li tomgħodha ta '5 mg, il- Cmax tintlaħaq sagħtejn wara l- għoti f' persuni adulti sajma.
The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.
Il - bijodisponibilità orali medja hija ta '73% u tonqos għal 63% b' ikla standard.
After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in the fasted state, Cmax is achieved 2 hours after administration.
Wara l- għoti tal- pillola li tomgħodha ta '4 mg lil pazjenti pedjatriċi minn 2 sa 5 snin, sajma, il- Cmax jinkiseb sagħtejn wara l- għoti tal- pillola.
The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet.
Il- Cmax medja hija 66% ogħla filwaqt li l- Cmin medja hija aktar baxxa f' pazjenti adulti li jirċievu pillola ta '10 mg.
The 4 mg granule formulation is bioequivalent to the 4 mg chewable tablet when administered to adults in the fasted state.
24 Il- formulazzjoni tal- granuli ta '4 mg hija bijoekwivalenti għall- pillola li tomgħodha ta' 4 mg meta tingħata lil persuni adulti sajma.
In paediatric patients 6 months to 2 years of age, Cmax is achieved 2 hours after administration of the 4 mg granules formulation.
F' pazjenti pedjatriċi minn 6 xhur sa sentejn, Cmax tinkiseb sagħtejn wara l- għoti tal- formulazzjoni tal- granuli ta '4 mg.
Cmax is nearly 2-fold greater than in adults receiving a 10 mg tablet.
Il- Cmax hija kważi darbtejn akbar milli f' pazjenti adulti li jirċievu pillola ta '10 mg.
The co-administration of applesauce or a high-fat standard meal with the granule formulation did not have a clinically meaningful effect on the pharmacokinetics of montelukast as determined by AUC (1225.7 vs 1223.1 ng. hr/ mL with and without applesauce, respectively, and 1191.8 vs 1148.5 ng. hr/ mL with and without a high-fat standard meal, respectively).
L- għoti ta 'zalza tat- tuffieħ jew ikla standard b' kontenut għoli ta' xaħam mal- formulazzjoni tal- granuli ma kellux effett kliniku sinifikanti fuq il- farmakokinetiċi ta 'montelukast kif stabbilit mill- AUC (1225. 7 vs 1223. 1 ng. hr/ mL bi u mingħajr zalza tat- tuffieħ, rispettivament, u 1191. 8 vs 1148. 5 ng. hr/ mL bi u mingħajr ikla standard b' kontenut għoli ta' xaħam, rispettivament).
Distribution.
Distribuzzjoni.
Montelukast is more than 99% bound to plasma proteins.
Montelukast jeħel aktar minn 99% mal- proteini tal- plasma.
The steady-state volume of distribution of montelukast averages 8-11 liters.
Il- volum tad- distribuzzjoni fiss ta 'montelukast huwa bħala medja 8- 11 - il litru.
Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.
Studji fuq il- firien b' montelukast radjutikkettat jindikaw distribuzzjoni minima tul il- barriera bejn id- demm u l- moħħ.
24 Biotransformation.
Barra minn hekk, il - konċentrazzjonijiet ta 'materjal radjutikkettat 24 siegħa wara d- doża kienu minimi fit- tessuti l- oħrajn kollha.
Montelukast is extensively metabolized.
Montelukast jiġi metabolizzat b' mod estensiv.
In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.
Fi studji b' dożi terapewtiċi, il - konċentrazzjonijiet fil- plasma ta 'metaboliti ta' montelukast mhumiex rilevabbli fl- istat fiss f' persuni adulti u tfal.
In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
Studji in vitro li jużaw mikrosomi tal- fwied uman jindikaw li ċ- ċitokromi P459 3A4, 2A6 u 2C9 huma involuti fil- metaboliżmu ta 'montelukast.
Based on further in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6.
Fuq il- bażi ta 'aktar riżultati in vitro fuq mikrosomi tal- fwied uman, konċentrazzjonijiet terapewtiċi ta' montelukast fil- plasma ma jwaqqfux iċ- ċitokromi P450 3A4, 2C9, 1A2, 2A6, 2C19, jew 2D6.
The contribution of metabolites to the therapeutic effect of montelukast is minimal.
Il- kontribut tal- metaboliti għall- effett terapewtiku ta 'montelukast huwa minimu.
Elimination.
Eliminazzjoni.
The plasma clearance of montelukast averages 45 ml/ min in healthy adults.
Il- medja tat- tneħħija ta 'montelukast mill- plasma f' persuni adulti b' saħħithom hija 45 ml/ min.
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.
Wara doża orali ta 'montelukast radjutikkettat, 86% tar- radjuattività ġiet irkuprata fl - ippurgar ta' ħamest ijiem u < 0. 2% ġie rkuprat fl- awrina.
Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.
Flimkien ma 'stimi tal- bijodisponibilità orali ta' montelukast, dan jindika li montelukast u l- metaboliti tiegħu jitneħħew kważi esklussivament permezz tas- sistema biljari.
Characteristics in Patients.
Karatteristiċi fil- pazjenti.
No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency.
M' hemmx bżonn ta 'aġġustament fid- doża għall- anzjani jew f' każ ta' insuffiċjenza epatika ħafifa għal moderata.
Studies in patients with renal impairment have not been undertaken.
Ma sarux studji fuq pazjenti b' insuffiċjenza tal- kliewi.
Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment.
Peress li montelukast u l- metaboliti tiegħu jitneħħew mir- rotta biljari, mhux mistenni li jkun meħtieġ aġġustament fid- doża f' pazjenti b' indeboliment tal- kliewi.
There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score > 9).
M' hemmx informazzjoni dwar il - farmakokinetiċi ta 'montelukast f' pazjenti b' insuffiċjenza epatika severa (punteġġ Child- Pugh > 9).
With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed.
B' dożi għoljin ta 'montelukast (20 u 60 darba d- doża rakkomandata għall- adulti), kien osservat tnaqqis fil- konċentrazzjoni ta' theophylline fil- plasma.
This effect was not seen at the recommended dose of 10 mg once daily.
Dan l- effett ma deherx bid- doża rakkomandata ta '10 mg darba kuljum.
In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature.
Fi studji dwar l- effett tossiku fuq l- annimali, kienu osservati bidliet bijokimiċi żgħar fl- ALT, il - glukożju, il- fosfru u t- trigliċeridi fis- serum li kienu ta 'natura temporanja.
The signs of toxicity in animals were increased excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance.
Is- sinjali ta 'tossiċità fl - annimali kienu eskrezzjoni akbar ta' saliva, sintomi gastro- intestinali, purgar maħlul u żbilanċ tal- joni.
These occurred at dosages which provided > 17-fold the systemic exposure seen at the clinical dosage.
Dawn seħħew b' dożi li pprovdew > 17- il darba l- esponiment sistemiku muri bid- dożaġġ kliniku.
In monkeys, the adverse effects appeared at doses from 150 mg/ kg/ day (> 232-fold the systemic exposure seen at the clinical dose).
Fix - xadini, l- effetti avversi dehru b' dożi minn 150 mg/ kg/ ġurnata (> 232 darba l- esponiment sistemiku muri bid- doża klinika).
In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
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.
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).
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.
In studies in rabbits, a higher incidence of incomplete ossification, compared with concurrent control animals, was seen at systemic exposure > 24-fold the clinical systemic exposure seen at the clinical dose.
Fi studji fuq il- fniek, b' esponiment sistemiku ta '> 24 darba l- esponiment sistemiku kliniku muri bid- doża klinika, dehret inċidenza akbar ta' ossifikazzjoni mhux kompleta, meta mqabbel ma 'annimali ta' kontroll konkorrenti.
No abnormalities were seen in rats.
Ma dehrux anormalitajiet fil- firien.
Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.
Montelukast ġie muri li jgħaddi mill- barriera tal- plaċenta u joħroġ fil- ħalib tas- sider ta 'l- annimali.
No deaths occurred following a single oral administration of montelukast sodium at doses up to 5,000 mg/ kg in mice and rats (15,000 mg/ m2 and 30,000 mg/ m2 in mice and rats, respectively), the maximum dose tested.
25 Ma seħħew ebda mwiet wara għoti orali wieħed ta 'montelukast sodium f' dożi sa 5000 mg/ kg fil - ġrieden u l- firien (15, 000 mg/ m2 u 30, 000 mg/ m2 fil- ġrieden u l- firien, rispettivament), l- akbar doża ttestjata.
This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).
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).
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).
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).
Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
Montelukast la kien mutaġeniku f' testijiet in vitro u in vivo u lanqas tumoriġeniku fi speċijiet gerriema
Mannitol Hyprolose (E 463) Magnesium stearate
Mannitol Hyprolose (E 463) Magnesium stearate
Packaged in polyethylene/ aluminum/ polyester sachet in:
Ippakkjat f' qartas tal- polyethylene/ aluminju/ polyester f ':
Cartons of 7, 20, 28 and 30 sachets.
Pakketti ta '7, 20, 28 u 30 qartas.
MARKETING AUTHORIZATION HOLDER [To be completed nationally.]
ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ [Trid timtela mill- pajjiż konċernat.]
MARKETING AUTHORIZATION NUMBER
NUMRU TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
[TO BE COMPLETED NATIONALLY.]
[Trid timtela mill- pajjiż konċernat.]
DATE OF first AUTHORIZATION/ RENEWAL OF the AUTHORIZATION
DATA TA 'L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA' L- AWTORIZZAZZJONI
[To be completed nationally.]
[Trid timtela mill- pajjiż konċernat.]
SINGULAIR 4 MG CHEWABLE TABLETS
SINGULAIR 4 mg pilloli li tomgħodhom
ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS EQUIVALENT TO 4 MG MONTELUKAST.
Pillola waħda li tomgħodha fiha montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
EXCIPIENT:
Sustanza mhux attiva:
ASPARTAME (E 951) 1.2 MG PER TABLET.
Aspartame (E 951) 1. 2 mg kull pillola.
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
Għal- lista kompleta ta 'sustanzi mhux attivi, ara sezzjoni 6. 1.
CHEWABLE TABLET.
Pillola li tomgħodha.
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
Roża, ovali, ta 'għamla bikonvessa, SINGULAIR imnaqqax fuq naħa u MSD 711 fuq in- naħa l- oħra.
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 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.
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 ta ’ bejn sentejn u 5 snin b' ażżma ħafifa persistenti 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. 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 jkunu tidjiq tal- bronki kkawżat mill- eżerċizzju.
This medicinal product is to be given to a child under adult supervision.
Dan il- prodott mediċinali għandu jingħata lil tifel/ tifla taħt superviżjoni ta ’ adult.
For children who have problems consuming a chewable tablet, a granule formulation is available (see SINGULAIR 4 mg granule SPC).
Għal tfal li għandhom problemi jomogħdu pillola li tomgħodha, teżisti formulazzjoni ta ’ granuli (ara SPC tal - granuli ta ’ SINGULAIR 4 mg).
The dosage for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening.
Id- doża għal pazjenti pedjatriċi ta '2- 5 snin hija pillola waħda li tomgħodha ta' 4 mg kuljum li għandha tittieħed filgħaxija.
If taken in connection with food, SINGULAIR should be taken 1 hour before or 2 hours after food.
Jekk jittieħed ma 'l- ikel, SINGULAIR għandu jittieħed siegħa qabel jew sagħtejn wara l- ikel.
The SINGULAIR 4 mg chewable tablet formulation is not recommended below 2 years of age.
Il- formulazzjoni tal- pillola li tomgħodha SINGULAIR ta ’ 4 mg mhijiex rakkomandata għal tfal taħt is- sentejn.
General recommendations.
Rakkomandazzjonijiet ġenerali.
27 SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
28 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 persistenti moderata.
The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children 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 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).
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.
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 ħames snin, bronkokostrizzjoni mibdija minħabba eżerċizzju tista ’ tkun il- manifestazzjoni predominanti ta ’ ażżma persistenti, li teħtieġ trattament b’ kortikosterojdi li jittieħdu man- nifs.
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).
Terapija b' SINGULAIR fir- rigward ta 'trattament oħra għall- ażżma 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 miksijin b’ rita ta '10 mg huma disponibbli għal pazjenti adulti ta' 15- il sena jew aktar.
4 mg granules are available for paediatric patients 6 months to 5 years of age.
Granuli ta ’ 4 mg huma disponibbli għal pazjenti pedjatriċi ta 'bejn 6 xhur u 5 snin.
If an acute attack occurs, a short-acting inhaled β -agonist should be used.
F' każ ta 'attakk akut, għandu jintuża β- agonist li jaħdem malajr li jittieħed man - nifs.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
Ma hemm ebda informazzjoni li turi li l- kortikosterojdi orali jistgħu jitnaqqsu meta montelukast jingħata fl- istess ħin.
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.
Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
29 Pazjenti li jiżviluppaw dawn is- sintomi għandhom jiġu eżaminati mill- ġdid u r- reġimi tat- trattament tagħhom evalwati.
28 SINGULAIR contains aspartame, a source of phenylalanine.
SINGULAIR fih aspartame, li huwa sors ta 'phenylalanine.
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.
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.
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 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.
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.
4.8 Undesirable effects
30 4. 8 Effetti mhux mixtieqa
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, and 4 mg chewable tablets in 851 paediatric patients 2 to 5 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, u 4 mg pilloli li tomgħodhom fi 851 pazjent pedjatriku minn 2 sa 5 snin.
29 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:
Paediatric Patients
Pazjenti Pedjatriċi Pazjenti Pedjatriċi 2 sa 5 snin
Adult Patients
Pazjenti Adulti
6 to 14 years old
6 sa 14- il sena
2 to 5 years old
(studju wieħed ta '
Body System Class
Klassifika tas- Sistema tal -
15 years and older
15- il sena u aktar
(one 8-week study;
(studju wieħed ta '8
(one 12-week study;
12- il ġimgħa;
(two 12-week studies;
(żewġ studji ta '12- il ġimgħa;
n=201)
ġimgħat; n=201)
(two 56 week studies; n=615)
(żewġ studji ta '56
(one 48-week study; n=278)
ġimgħa; n=615)
Nervous system
(studju wieħed ta '48 ġimgħa; n=278)
disorders
uġigħ ta 'ras Disturbi fis- sistema nervuża
Gastrointestinal
uġigħ ta 'ras
disorders General disorders and
Disturbi gastro- intestinali
abdominal pain
uġigħ addominali
administration site conditions
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata
thirst
għatx
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.
The following adverse reactions have been reported in post-marketing use:
Ir- reazzjonijiet avversi li ġejjin kienu rrappurtati fl- użu ta 'wara t- tqegħid tal- prodott fis- suq:
Cardiac disorders: palpitations.
Disturbi tad- demm u tas- sistema limfatika: tendenza akbar ta 'fsada Disturbi fis- sistema immuni: reazzjonijiet ta' sensittività eċċessiva fosthom anafilassi, infiltrazzjoni esinofilika tal- fwied 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).
Skin and subcutaneous tissue disorders: angiooedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Disturbi fis- sistema nervuża: sturdament, ngħas, parasteżija/ ipoestesija, aċċessjonijiet Disturbi fil- qalb: palpitazzjonijiet Disturbi gastro- intestinali: dijarea, ħalq xott, dispepsja, dardir, rimettar Disturbi fil- fwied u fil- marrara: livelli għoljin ta 'transaminases fis- serum (ALT, AST), epatite kolestatika 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 Każi rari ħafna tas- Sindrome ta' Churg- Strauss (CSS) ġew irrappurtati waqt trattament b' montelukast f' pazjenti ażżmatiċi (ara sezzjoni 4. 4).
These include reports in adults and children with a dose as high as 1000 mg 30 (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 bronchodilation effect caused by a β -agonist was additive to that caused by montelukast.
L- effett ta 'twessigħ tal - bronki kkawżat minn β- agonist kien addittiv għal dak ikkawżat minn montelukast.
Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
It- trattament b' montelukast impedixxa tidjiq tal- bronki kemm f' fażi bikrija kif ukoll tard minħabba sfida ta 'l - antiġeni.
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%).
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 (200 µgramma darbtejn kuljum bi spacer device), montelukast wera rispons inizjali aktar rapidu, għalkemm fuq l- istudju ta' 12- il ġimgħa,
Montelukast also decreased "as-needed" β -agonist use and
Montelukast naqqas ukoll l- użu "skond il- ħtieġa" ta 'β- agonisti u salvataġġ ta' kortikosterojdi għal ażżma li tmur għall- agħar meta mqabbel mal- plaċebo.
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.
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.
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:
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.
33 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.
Absorption.
Assorbiment.
In addition, concentrations of radiolabeled material at 24 hours post-dose were minimal in all other tissues.
Barra minn hekk, il - konċentrazzjonijiet ta 'materjal radjutikkettat 24 siegħa wara d- doża kienu minimi fit- tessuti l- oħrajn kollha.
Biotransformation.
Bijotrasformazzjoni.
Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment.
34 Peress li montelukast u l- metaboliti tiegħu jitneħħew mir- rotta biljari, mhux mistenni li jkun meħtieġ aġġustament fid- doża f' pazjenti b' indeboliment tal- kliewi.
In studies in rabbits, a higher incidence of incomplete 33 ossification, compared with concurrent control animals, was seen at systemic exposure > 24-fold the clinical systemic exposure seen at the clinical dose.
Fi studji fuq il- fniek, b' esponiment sistemiku ta '> 24 darba l- esponiment sistemiku kliniku muri bid- doża klinika, dehret inċidenza akbar ta' ossifikazzjoni mhux kompleta, meta mqabbel ma 'annimali ta' kontroll konkorrenti.
No deaths occurred following a single oral administration of montelukast sodium at doses up to 5000 mg/ kg in mice and rats (15,000 mg/ m2 and 30,000 mg/ m2 in mice and rats, respectively), the maximum dose tested.
Ma seħħew ebda mwiet wara għoti orali wieħed ta 'montelukast sodium f' dożi sa 5000 mg/ kg fil - ġrieden u l- firien (15, 000 mg/ m2 u 30, 000 mg/ m2 fil- ġrieden u l- firien, rispettivament), l- akbar doża ttestjata.
Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
Montelukast la kien mutaġeniku f' testijiet in vitro u in vivo u lanqas tumoriġeniku fi speċijiet gerriema.
Mannitol Microcrystalline cellulose Hyprolose (E 463) Red ferric oxide (E 172) Croscarmellose sodium Cherry flavour Aspartame (E 951) Magnesium stearate
Mannitol Microcrystalline cellulose Hyprolose (E 463) Red ferric oxide (E 172) Croscarmellose sodium Cherry flavor Aspartame (E 951) Magnesium stearate
6.4 Special precautions for storage
35 6. 4 Prekawzjonijiet speċjali għall- ħażna
Packaged in polyamide/ PVC/ aluminum blister package in:.
Ippakkjat f' pakkett folji tal- polyamide/ PVC/ aluminju f ':
Blisters in packages of:
Folji f' pakketti ta ':
7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 u 200 pillola.
Blisters (unit doses), in packages of:
Folji (dożi singoli), f' pakketti ta ':
49, 50 and 56 tablets.
49, 50 u 56 pillola.
MARKETING AUTHORIZATION HOLDER
ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
34 [TO BE COMPLETED NATIONALLY]
[Trid timtela mill- pajjiż konċernat]
[TO BE COMPLETED NATIONALLY]
[Trid timtela mill- pajjiż konċernat]
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 TIKKETTA U FULJETT TA 'TAGĦRIF
SINGULAIR 4 mg Granules– Outer Carton
SINGULAIR 4 mg Granuli – Kartuna ta 'Barra
SINGULAIR 4 mg granules montelukast For children 6 months to 5 years of age
SINGULAIR 4 mg granuli montelukast Għal tfal ta ’ bejn sentejn u 5 snin
Granules 7 x 1 sachet 20 x 1 sachet 28 x 1 sachet 30 x 1 sachet
Granuli 7 x 1 qartas 20 x 1 qartas 28 x 1 qartas 30 x 1 qartas
[To be completed nationally]
[Trid timtela mill- pajjiż konċernat]
SINGULAIR 4 mg Granules - Sachet
SINGULAIR 4 mg Granuli - Qartas
SINGULAIR 4 mg granules montelukast
SINGULAIR 4 mg granuli montelukast
1 sachet
qartas 1
{Name of the Marketing Authorisation Holder} [To be completed nationally]
{L- Isem tad- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq} [Trid timtela mill- pajjiż konċernat]
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
SINGULAIR 4 mg Tablets – Outer Carton
SINGULAIR 4 mg Pilloli – Kartuna ta 'Barra
SINGULAIR 4 mg chewable tablets montelukast For children 2 to 5 years of age
SINGULAIR 4 mg pilloli li tomgħodhom montelukast Għal tfal ta ’ bejn sentejn u 5 snin
One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast.
Pillola waħda li tomgħodha fiha montelukast sodium, li huwa ekwivalenti għal 4 mg montelukast.
Contains aspartame (E 951).
Fih aspartame (E 951).
See the leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 pillola li tomgħodha
SINGULAIR 4 mg tablets - Blister
SINGULAIR 4 mg pilloli - Folja
SINGULAIR 4 mg chewable tablet
SINGULAIR 4 mg pillola li tomgħodha
42 PACKAGE LEAFLET
44 FULJETT TA 'TAGĦRIF
43 PACKAGE LEAFLET:
45 FULJETT TA 'TAGĦRIF:
SINGULAIR 4 mg Granules montelukast
SINGULAIR 4 mg Granuli montelukast
Read all of this leaflet carefully before your child starts taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel ma t- tifel/ tifla tiegħek jibdew jieħdu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for your child.
Jista 'jkollok bżonn terġa' taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lit- tifel/ tifla tiegħek.
It may harm them, even if their symptoms are the same as your child’ s. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista 'tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tat- tifel/ tifla tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What SINGULAIR is and what it is used for 2.
X' inhu SINGULAIR u għalxiex jintuża 2.
Before SINGULAIR is taken 3.
Qabel jittieħed SINGULAIR 3.
How to take SINGULAIR 4.
Kif għandek tieħu SINGULAIR 4.
How to store SINGULAIR 6.
Kif taħżen SINGULAIR 6.
WHAT SINGULAIR IS AND WHAT IT IS USED FOR
X' INHU SINGULAIR U GĦALXIEX JINTUŻA
SINGULAIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.
SINGULAIR huwa antagonist tar- riċetturi leukotriene li jimblokka sustanzi msejħa leukotrienes.
Leukotrienes cause narrowing and swelling of airways in the lungs.
Il - leukotrienes jikkawżaw tidjiq u nefħa tal- passaġġi ta 'l- arja fil- pulmuni tiegħek.
By blocking leukotrienes, SINGULAIR improves asthma symptoms and helps control asthma.
Billi jimblokka l - leukotrienes, SINGULAIR itejjeb is- sintomi ta 'l- ażżma u jgħin fil- kontroll ta' l- ażżma.
Your doctor has prescribed SINGULAIR to treat your child’ s asthma, preventing asthma symptoms during the day and night.
It- tabib tiegħek ordnalek SINGULAIR għat- trattament ta 'l- ażżma tat- tifel/ tifla tiegħek, biex jimpedixxi s- sintomi ta' l- ażżma matul il- ġurnata u bil- lejl.
• 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. • SINGULAIR may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. • SINGULAIR also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
• 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. • SINGULAIR jista' jintuża wkoll bħala trattament alternattiv għal kortikosterojdi meħuda man - nifs għal pazjenti minn 2 sa 5 snin li ma jkunux ħadu riċentement kortikosterojdi orali għall - ażżma tagħhom u wrew li mhumiex kapaċi jużaw kortikosterojdi meħuda man- nifs. • SINGULAIR jgħin ukoll biex jimpedixxi t- tidjiq tal- passaġġi ta 'l- arja kkawżat mill- eżerċizzju għal pazjenti li għandhom sentejn u aktar.
Your doctor will determine how SINGULAIR should be used depending on the symptoms and severity of your child's asthma.
It- tabib tiegħek jistabbilixxi kif għandu jintuża SINGULAIR skond is- sintomi u l- gravità ta 'l- ażżma tat- tifel/ tifla tiegħek.
What is asthma?
X' inhi l- ażżma?
Asthma is a long-term disease.
L- ażżma hija marda fuq perjodu fit- tul.
Asthma includes: • difficulty breathing because of narrowed airways.
L- ażżma tinkludi: • diffikultà biex tieħu nifs minħabba passaġġi ta 'l- arja dojoq.
This narrowing of airways worsens and improves in response to various conditions. • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise. • swelling (inflammation) in the lining of the airways.
Dan it- tidjiq tal - passaġġi ta 'l- arja jeħżien u jitjieb bi tweġiba għal diversi kundizzjonijiet. • passaġġi ta' l- arja sensittivi li jirreaġixxu għal ħafna affarijiet, bħal duħħan tas - sigarretti, polline, arja kiesħa, jew eżerċizzju
Symptoms of asthma include:
Is- sintomi ta 'l- ażżma jinkludu:
Coughing, wheezing, and chest tightness.
Sogħla, tħarħir, diqa fis- sider.
BEFORE SINGULAIR IS TAKEN
QABEL JITTIEĦED SINGULAIR
Tell your doctor about any medical problems or allergies your child has now or has had.
Għid lit- tabib tiegħek dwar kwalunkwe problemi mediċi jew allerġiji li t- tifel/ tifla tiegħek għandhom issa jew li kellhom.
Do not give SINGULAIR to your child if he/ she
Tagħtix SINGULAIR lit- tifel/ tifla tiegħek jekk huwa/ hija
• is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR (see 6.
• allerġiku/ a (ibatu minn sensittività eċċessiva) għal montelukast jew sustanzi oħra ta 'SINGULAIR (ara 6.
FURTHER INFORMATION).
AKTAR TAGĦRIF).
Take special care with SINGULAIR
Oqgħod attent ħafna b' SINGULAIR
• If your child’ s asthma or breathing gets worse, tell your doctor immediately.
• Jekk l- ażżma jew it- teħid tan- nifs tat- tifel/ tifla tiegħek jeħżien, għid lit- tabib tiegħek immedjatament.
• Oral SINGULAIR is not meant to treat acute asthma attacks.
• SINGULAIR orali mhuwiex maħsub biex jittratta attakki akuti ta 'l- ażżma.
If an attack occurs, follow the instructions your doctor has given you for your child.
F' każ ta 'attakk, segwi l- istruzzjonijiet li t- tabib tiegħek tak għat- tifel/ tifla tiegħek.
Always have your child’ s inhaled rescue medicine for asthma attacks with you.
Dejjem għandek iġġorr miegħek il- mediċina ta 'salvataġġ tat- tifel/ tifla tiegħek li tittieħed man- nifs għall- attakki ta' l - ażżma.
• It is important that your child take all asthma medications prescribed by your doctor.
• Importanti li t- tifel/ tifla tiegħek jieħdu l- medikazzjonijiet kollha kontra l- ażżma ordnati mit - tabib tiegħek.
SINGULAIR should not be used instead of other asthma medications your doctor has prescribed for your child.
SINGULAIR m' għandux jintuża minflok medikazzjonijiet oħra kontra l- ażżma li t- tabib tiegħek ordna għat- tifel/ tifla tiegħek.
• If your child is on anti-asthma medicines, be aware that if the he/ she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/ or rash, you should consult your doctor.
• Jekk it- tifel/ tifla tiegħek qegħdin jieħdu mediċini kontra l- ażżma, kun af li jekk jiżviluppa/ tiżviluppa taħlita ta 'sintomi bħal mard jixbah lill- influwenza, tingiż jew traqqid tad - dirgħajn jew tas- saqajn, taħżin tas- sintomi pulmonari, u/ jew raxx, inti għandek tikkonsulta lit - tabib tiegħek.
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/ her asthma worse.
• It- tifel/ tifla tiegħek m' għandhomx jieħdu aċidu aċetil- saliċikliku (aspirina) jew mediċini anti - infjammatorji (magħrufin ukoll bħala mediċini anti- infjammatorji mhux sterojdi jew NSAIDs) jekk dawn jagħmlu l- ażżma tiegħu/ tagħha agħar.
Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your child's other medicines work.
Ċerti mediċini jistgħu jaffettwaw il- mod kif jaħdem SINGULAIR, jew SINGULAIR jista 'jaffettwa l - mod kif jaħdmu l- mediċini l- oħra tat- tifel/ tifla tiegħek.
Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qegħdin jieħdu jew ħadu dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Tell your doctor if your child is taking the following medicines before starting SINGULAIR: • phenobarbital (used for treatment of epilepsy) • phenytoin (used for treatment of epilepsy) • rifampicin (used to treat tuberculosis and some other infections)
Għid lit- tabib tiegħek jekk it- tifel/ tifla tiegħek qegħdin jieħdu l- mediċini li ġejjin qabel ma jibdew SINGULAIR: • phenobarbital (użat għat- trattament ta 'l- epilessija) • phenytoin (użat għat- trattament ta' l- epilessija) • rifampicin (użat għat- trattament tat- tuberkulożi u xi infezzjonijiet oħra)
Taking SINGULAIR with food and drink
Meta tieħu SINGULAIR ma 'l- ikel u max- xorb
SINGULAIR granules can be taken without regard to the timing of food intake.
Il- granuli SINGULAIR jistgħu jittieħdu mingħajr każ tal- ħin ta 'l- inġestjoni ta' l- ikel.
Pregnancy and breast-feeding
47 Tqala u treddigħ
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.
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.
45 Use in pregnancy
Użu fit- tqala
Women who are pregnant or intend to become pregnant should consult their doctor before taking SINGULAIR.
Nisa tqal jew li beħsiebhom jinqabdu tqal għandhom jikkonsultaw lit- tabib tagħhom qabel jieħdu SINGULAIR.
Your doctor will assess whether you can take SINGULAIR during this time.
It- tabib tiegħek jevalwa jekk tistax tieħu SINGULAIR matul dan iż- żmien.
Use in breast-feeding
Użu fit- treddigħ
It is not known if SINGULAIR appears in breast milk.
Mhux magħruf jekk SINGULAIR jidhirx fil- ħalib tas- sider.
You should consult your doctor before taking SINGULAIR if you are breast-feeding or intend to breast-feed.
Inti għandek tikkonsulta lit- tabib tiegħek qabel tieħu SINGULAIR jekk qiegħda tredda 'jew jekk beħsiebek tredda'.
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.
Din is- subsezzjoni ma tapplikax għas- SINGULAIR 4 mg granuli billi huma intenzjonati għall- użu fi tfal minn 6 xhur sa 5 snin, madankollu l- informazzjoni li ġejja hija rilevanti għas- sustanza attiva, montelukast.
SINGULAIR is not expected to affect your ability to drive a car or operate machinery.
SINGULAIR mhux mistenni li jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
However, individual responses to medication may vary.
Madankollu, ir - reazzjonijiet individwali għall- medikazzjoni jistgħu jvarjaw.
Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with SINGULAIR may affect some patients’ ability to drive or operate machinery.
Ċerti effetti sekondarji (bħal sturdament u ngħas) li ġew irrappurtati rari ħafna b' SINGULAIR jistgħu jaffettwaw il- ħila ta 'xi pazjenti biex isuq jew iħaddmu magni.
HOW TO TAKE SINGULAIR
KIF GĦANDEK TIEĦU SINGULAIR
• This medicine is to be given to a child under adult supervision.
• Din il- mediċina għandha tingħata lil tifel/ tifla taħt is- superviżjoni ta ’ adult.
Your child should take SINGULAIR every evening. • It should be taken even when your child has no symptoms or if he/ she has an acute asthma attack. • Always have your child take SINGULAIR as your doctor has told you.
It- tifel/ tifla tiegħek għandhom jieħdu SINGULAIR kull filgħaxija. • Hija għandha tittieħed anki meta t- tifel/ tifla tiegħek ma jkollhom l- ebda sintomi jew jekk jagħtihom attakk akut ta 'l- ażżma. • Ara li t- tifel/ tifla tiegħek dejjem jieħdu SINGULAIR kif qallek it- tabib tiegħek.
You should check with your child’ s doctor or pharmacist if you are not sure. • To be taken by mouth
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l- ispiżjar tat- tifel/ tifla tiegħek jekk ikollok xi dubju. • Għandha tittieħed mill- ħalq
For children 6 months to 5 years of age:
Għal tfal minn 6 xhur sa 5 snin:
One sachet of SINGULAIR 4 mg granules to be taken by mouth each evening.
Qartas wieħed ta 'SINGULAIR 4 mg granuli li jrid jittieħed mill- ħalq kull filgħaxija.
If your child is taking SINGULAIR, be sure that your child does not take any other products that contain the same active ingredient, montelukast.
Jekk it- tifel/ tifla tiegħek qegħdin jieħdu SINGULAIR, kun żgur/ a li ma jeħdux prodotti oħra li fihom l- istess sustanza attiva, montelukast.
For children 6 months to 2 years old, SINGULAIR 4 mg granules are available.
Għal tfal ta ’ bejn 6 xhur u sentejn, hemm disponibbli granuli SINGULAIR 4 mg.
For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and SINGULAIR 4 mg granules are available.
Għal tfal ta ’ bejn sentejn u 5 snin, hemm disponibbli pilloli li tomgħodhom SINGULAIR 4 mg u granuli SINGULAIR 4 mg.
The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Il- formulazzjoni ta ’ granuli SINGULAIR 4 mg mhijiex rakkomandata għal trabi taħt is- 6 xhur.
How should I give SINGULAIR granules to my child?
Kif għandi nagħti l- granuli SINGULAIR lit- tifel/ tifla tiegħi?
• Do not open the sachet until ready to use.
• Tiftaħx il- qartas qabel tkun lest/ a biex tużah.
• SINGULAIR granules can be given either:
• Il- granuli SINGULAIR jistgħu jingħataw jew: