natgillin/translations-raw huggingface dataset:
Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment.
Ker se montelukast in njegovi presnovki izločajo z žolčem, odmerkov pri bolnikih z ledvično okvaro ni treba prilagajati.
Treatment with montelukast inhibited both early- and late-phase bronchoconstriction due to antigen challenge.
Zdravljenje z montelukastom je zaviralo obe - zgodnjo in pozno fazo bronhokonstrikcije zaradi zaviranja reakcije na antigen.
Ask your doctor or pharmacist for more information about side effects.
Za več informacij o neželenih učinkih prosite zdravnika ali farmacevta.
The oral bioavailability and Cmax are not influenced by a standard meal.
Standardni obrok ne vpliva na peroralno biološko uporabnost in cmax.
The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
Najbolj pogosti simptomi, o katerih so poročali pri prekomernem odmerjanju pri odraslih in otrocih, pa so bili bolečine v trebuhu, zaspanost, žeja, glavobol, bruhanje in hiperaktivnost.
Montelukast is rapidly absorbed following oral administration.
Montelukast se po peroralni uporabi hitro absorbira.
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).
Odstotek bolnikov z napadi astme (napad astme definiran kot obdobje poslabšanja astme, ki zahteva zdravljenje s peroralnimi steroidi, nenačrtovan obisk zdravnika, obisk nujne zdravniške pomoči ali zdravljenje v bolnišnici) je bil 32,2 v skupini, ki je prejemala montelukast, in 25,6 v skupini, ki je prejemala flutikazon; razmerje obetov (odds ratio) (95-odstotni IZ) je bilo pomembno: enako 1,38
It is not known if montelukast is excreted in human milk.
Ni znano, če se montelukast izloča v materino mleko pri človeku.
Try to give SINGULAIR as prescribed.
Zdravilo SINGULAIR poskušajte otroku dajati tako, kot mu je bilo predpisano.
Montelukast is extensively metabolized.
Montelukast se v veliki meri presnavlja.
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.
Bolniki s fenilketonurijo morajo upoštevati, da vsaka 4 mg žvečljiva tableta vsebuje fenilalanin v količini, ki ustreza 0,674 mg fenilalanina na odmerek.
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.
Nadaljnji rezultati in vitro raziskav kažejo, da terapevtske koncentracije montelukasta v plazmi ne zavirajo citokromov P450 3A4, 2C9, 1A2, 2A6, 2C19 ali 2D6.
SINGULAIR as an alternative treatment option to low-dose inhaled corticosteroids for mild, persistent asthma:
Zdravilo Singulair kot alternativa majhnim odmerkom inhalacijskih kortikosteroidov za blago persistentno astmo:
However, the Applicant/MAH only seeks to maintain the indication for montelukast as monotherapy in mild to moderate persistent asthma in children aged 2 years to 5 years.
Vendar želi predlagatelj/imetnik dovoljenja za promet za montelukast le ohranitev indikacije kot samostojnega zdravljenja za blago do zmerno perzistentno astmo pri otrocih, starih od 2 do 5 let.
The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Imetnik dovoljenja za promet je predložil usklajena modula 3 v formatu CTD za zdravili Singulair 4 mg zrnca in 4 mg žvečljive tablete.
The results of P910 suggest that with montelukast, as good benefit-risk ratio can be achieved in the treatment of paediatric mild, persistent asthma as with inhaled fluticasone.
Rezultati študije P910 kažejo, da lahko pri zdravljenju blage, perzistentne astme z montelukastom dosežemo dobro razmerje med koristmi in tveganji kakor z flutikazonom za vdihavanje.
Nervous system disorders headache headache hyperkinesia
Bolezni živčevja glavobol glavobol hiperkinezija
If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
Če ima otrok fenilketonurijo (redko dedno motnjo presnove), morate vedeti, da vsaka 4 mg žvečljiva tableta vsebuje fenilalanin (0,674 mg fenilalanina na eno 4 mg žvečljivo tableto).
The mean Cmax is 66% higher while mean Cmin is lower than in adults receiving a 10 mg tablet.
Povprečna cmax je 66 % višja , medtem ko je povprečna cmin nižja kot pri odraslih po zaužitju 10 mg tablete.
• tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/numbness, seizure;
• utrujenost, vznemirjenost, razburjenje z nasilnim vedenjem, razdražljivost, tresenje, depresija, samomorilne misli in samomorilno vedenje (v zelo redkih primerih), omotica, dremavost, halucinacije, nenormalne sanje vključno z nočnimi morami in težavami s spanjem, mravljinčenje/odrevenelost, epileptični napad;
Formulations for paediatric use, 4 mg chewable tablets and 4 mg oral granules, have been available since 2000 and 2002, respectively.
Obliki za uporabo pri otrocih, 4 mg žvečljive tablete oziroma 4 mg peroralna zrnca, sta dostopni od leta 2000 oziroma 2002.
It is important for your child to continue taking SINGULAIR for as long as your doctor prescribes.
Pomembno je, da otrok zdravilo SINGULAIR jemlje tako dolgo, kot mu to predpiše zdravnik.
INSTRUCTIONS ON USE [To be completed nationally]
NAVODILA ZA UPORABO [Izpolniti nacionalno.]
• Be sure the child is given the entire spoonful of the granule/food mixture immediately (within
• Bodite pozorni, da otrok takoj (v 15 minutah) zaužije celo žlico mešanico zrnc in hrane.
In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/day).
V treh aktivno kontroliranih študijah pri skoraj 1000 odraslih bolnikih z blago do zmerno astmo so dokazali, da je učinek montelukasta (10 mg enkrat dnevno) večji od placeba, vendar manjši od vdihanega beklometazona dipropionata (400 µg/dan).
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.
Odstotek dni z uporabo agonistov beta se je zmanjšal z 38,0 na 15,4 v skupini, ki je prejemala montelukast, in z 38,5 na 12,8 v skupini, ki je prejemala flutikazon.
SINGULAIR should not be used instead of other asthma medications your doctor has prescribed for your child.
Zdravila SINGULAIR ne sme jemati namesto drugih zdravil, ki mu jih je predpisal zdravnik.
Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Zdravniki morajo biti pozorni na eozinofilijo, vaskulitični izpuščaj, poslabšanje pljučnih simptomov, srčne zaplete in/ali nevropatijo.
Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Dokazali so, da montelukast (10 mg enkrat dnevno pred spanjem) v primerjavi s placebom izboljša dihalne funkcije, zmanjša simptome astme in rabo beta-agonista ter izboljša kakovost življenja.
In a small study on 27 paediatric patients it was also shown that montelukast seems to protect paediatric patients against exercise-induced bronchoconstriction.
V majhni študiji pri 27 otrocih so ugotovili, da montelukast verjetno ščiti otroke pred bronhokonstrikcijo, ki jo povzroči telesna vadba.
PHARMACEUTICAL FORM Granules.
FARMACEVTSKA OBLIKA Zrnca.
Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
• Pomožne snovi so: manitol, mikrokristalna celuloza, hiproloza (E 463), rdeči železov oksid (E 172), premrežen natrijev karmelozat, aroma češnje, aspartam (E 951) in magnezijev stearat.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
- predmet napotitvenega postopka je bilo usklajevanje povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo ter modula 3,
The signs of toxicity in animals were increased excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance.
Znaki toksičnosti pri živalih so bili povečano izločanje sline, simptomi v prebavilih, mehki iztrebki in ionsko neravnovesje.
The mean increase from baseline in % predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Povprečno povečanje od začetne vrednosti v % napovedanega FEV1 je bilo 0,6 % v skupini, ki je prejemala montelukast, in 2,7 % v skupini, ki je prejemala flutikazon.
Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients.
Montelukast je v primerjavi s placebom pri odraslih in pediatričnih bolnikih zmanjšal število eozinofilcev v periferni krvi.
If your child stops taking SINGULAIR
Če je otrok prenehal jemati zdravilo SINGULAIR
Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Podatki o učinkovitosti iz kliničnih preskušanj pri otrocih, starih od 6 mesecev do 2 let s perzistentno astmo, so omejeni.
The sachet should not be opened until ready to use.
Vrečko se lahko odpre šele tik pred uporabo.
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).
Sočasno zaužitje jabolčne čežane ali standardnega obroka z veliko maščobami in zrnc ni imelo klinično pomembnega vpliva na farmakokinetiko montelukasta, glede na AUC (1225,7 ng·h/ml z jabolčno čežano oz. 1223,1 ng·h/ml brez jabolčne čežane in 1191,8 ng·h/ml s standardnim obrokom z veliko maščobami oz. 1148,5 ng·h/ml brez obroka).
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).
Rahlo zmanjšanje telesne mase mladičkov so zabeležili v študiji plodnosti samic pri podganah pri odmerkih 200 mg/kg/dan (> 69-kratna klinična sistemska izpostavljenost).
• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
• Otrok mora zdravilo redno jemati tudi, če nima simptomov, ter tudi v primeruakutnega astmatičnega napada.
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.
Najpogostejši neželeni učinki so bili skladni z varnostnim profilom montelukasta in so vključevali bolečine v trebuhu, zaspanost, žejo, glavobol, bruhanje in psihomotorično hiperaktivnost.
Blisters (unit doses), in packages of: 49, 50 and 56 tablets.
Pretisni omoti (za enkratne odmerke) v škatlah po 49, 50 in 56 tablet.
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:
O naslednjih z zdravilom povezanih neželenih učinkih so v kliničnih študijah pri bolnikih, zdravljenih z montelukastom, poročali pogosto (≥ 1/100 do < 1/10), in sicer pogosteje kot pri bolnikih, ki so prejemali placebo:
Clinical Efficacy: Exercise-induced asthma
Klinična učinkovitost: astma zaradi telesne vadbe
Also IS and NO have granted marketing authorisation to this formulation.
Za to obliko sta dovoljenje za promet odobrili tudi IS in NO.
In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.
V študijah terapevtskih odmerkov so v stanju dinamičnega ravnovesja koncentracije presnovkov montelukasta v plazmi nemerljive tako pri odraslih kot otrocih.
Singulair 4 mg chewable tablets is available in all current EU member states (and in IS and NO) except in FR since the approval given in Mutual Recognition Procedure in 2000.
Zdravilo Singulair 4 mg žvečljive tablete je od svoje odobritve, pridobljene v postopku medsebojnega priznavanja leta 2000, na voljo v vseh trenutnih državah članicah EU (ter v IS in NO), razen v FR.
Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
Roza, ovalne, bikonveksne tablete, z vtisnjeno oznako SINGULAIR na eni in MSD 711 na drugi strani.
This leaflet was last approved in {DD.MM.YYYY.}
Navodilo je bilo odobreno {DD.MM.LLLL}.
even if their symptoms are the same as your child's.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
This medicinal product is to be given to a child under adult supervision.
Otrok mora zdravilo vzeti pod nadzorom odraslega.
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).
je odbor CHMP priporočil odobritev dopolnila dovoljenj(a) za promet z zdravilom Singulair in povezana imena (glejte Dodatek I), katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.
Montelukasta ne priporočamo za samostojno zdravljenje zmerne persistentne astme.
Take special care with SINGULAIR
Bodite posebno pozorni pri jemanju zdravila SINGULAIR
4 mg granules in 175 paediatric patients 6 months to 2 years of age.
4 mg zrnca pri 175 pediatričnih bolnikih, starih 6 mesecev do 2 let.
The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Povzetki glavnih značilnosti zdravila, ki jih je predlagal imetnik dovoljenja za promet, so bili v postopku medsebojnega priznavanja odobreni v „starih“ državah članicah ter v CY in IS.
10 mg film-coated tablets are available for adults 15 years of age and older.
10 mg filmsko obložene tablete so na voljo za bolnike, stare 15 let ali več.
Skin and subcutaneous tissue disorders eczematous dermatitis, rash
Bolezni kože in podkožja ekcematozni dermatitis, izpuščaj
However, your child may take liquids after swallowing the SINGULAIR granules.
Lahko pa otrok tekočino popije po zaužitju zrnc.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 vrečka
Use during pregnancy
Uporaba med nosečnostjo
In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
In vitro študije z mikrosomi človeških jeter kažejo, da so v presnovo montelukasta vpleteni citokrom P450 3A4, 2A6 in 2C9.
How should I give SINGULAIR granules to my child?
Kako morate otroku dati SINGULAIR zrnca
• To be taken by mouth
• Zdravilo se vzame skozi usta.
• Store in the original package in order to protect from light and moisture.
• Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
Montelukast showed improvement in the variables of asthma as compared to placebo.
Dokazano je bilo, da je montelukast v primerjavi s placebom povzročil izboljšanje spremenljivk astme.
What SINGULAIR looks like and contents of the pack 4 mg SINGULAIR chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
4 mg SINGULAIR žvečljive tablete so roza barve, ovalne, bikonveksne, z vtisnjenim napisom SINGULAIR na eni in MSD 711 na drugi strani.
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.
V povprečju se je v 12-mesečnem obdobju zdravljenja odstotek dni, ko olajševalno zdravilo ni bilo potrebno, povečal z 61,6 na 84,0 v skupini, ki je prejemala montelukast, in s 60,9 na 86,7 v skupini, ki je prejemala flutikazon.
SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
SINGULAIR žvečljive tablete vsebujejo aspartam, ki je izvor fenilalanina.
These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Pri bolnikih, ki so prejemali zdravilo SINGULAIR, so se pojavili pogosteje kot pri bolnikih, ki so prejemali placebo (tableta brez zdravilne učinkovine).
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.
V 12-mesečni študiji za primerjavo montelukasta in inhalacijskega flutikazona v učinkovitosti nadzora astme pri pediatričnih bolnikih, starih 6 do 14 let, z blago persistentno astmo, montelukast ni bil slabši od flutikazona v povečevanju odstotka dni, ko olajševalno zdravilo ni potrebno (primarni cilj študije).
Asthma includes:
Za astmo so značilni:
Adult Patients 15 years and older (two 12-week studies; n=795)
Odrasli bolniki 15 let in starejši (dve 12-tedenski študiji; n=795)
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
Compared with inhaled beclomethasone (200 µg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; β-agonist use: -28.28% vs -43.89%).
V primerjavi z inhalacijskim beklometazonom (200 µg dvakrat na dan s podaljškom) se je pri montelukastu pokazal hitrejši začetni odziv, čeprav je po 12 tednih študije beklometazon imel večji povprečni učinek zdravljenja (% spremembe glede na začetek za montelukast proti beklometazonu: za FEV1 7,49 % proti 13,3 %; za uporabo agonistov beta: -28,28 % proti43,89 %).
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).
Zmanjšanje bronhokonstrikcije ob naporu so ugotovili tudi v kratki študiji pri pediatričnih bolnikih, starih 6 do 14 let (največji padec FEV1 18,27 % proti 26,11 %; čas vrnitve FEV1 na vrednost v območju znotraj 5 % meje od FEV1 pred naporom 17,76 min proti 27,98 min).
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).
SINGULAIR zrnca se lahko zaužije tako, da se jih da direktno v usta ali pa se jih zmeša s polno žlico redke hrane (npr. Jabolčno čežano, sladoledom, korenčkom in rižem), ki mora biti hladna ali sobne temperature.
Body System Class
Organski sistem
In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
V študijah na živalih montelukast pri sistemski izpostavljenosti za več kot 24-krat večji od klinične ni vplival na plodnost ali razmnoževanje.
In paediatric patients 6 months to 2 years of age, Cmax is achieved 2 hours after administration of the 4 mg granules formulation.
Pri pediatričnih bolnikih, starih 6 mesecev do 2 leti, je cmax dosežena 2 uri po zaužitju 4 mg zrnc.
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).
Pomembno zmanjšanje bronhokonstrikcije ob naporu so ugotovili v 12-tedenski študiji pri odraslih (največji padec FEV1 22,33 % za montelukast proti 32,40 % za placebo; čas vrnitve FEV1 na vrednost v območju znotraj 5 % meje od FEV1 pred naporom 44,22 min proti 60,64 min).
In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
Pri otrocih, starih od 2 do 5 let, je lahko s telesno vadbo povzročena bronhokonstrikcija prevladujoča manifestacija perzistentne astme, ki zahteva zdravljenje s kortikosteroidi za vdihanje.
The Applicant/MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (25 years old, 6-14 years old) according to ICH E11 guideline.
PN 136/138, podpornih varnostnih podatkih PN 176 in ekstrapolaciji učinkovitosti na to starostno skupino na podlagi učinkovitosti, dokazane pri starejših otrocih (starih 2-5 let, 6-14 let) v skladu s priporočili ICH E11.
Administration of SINGULAIR granules:
Uporaba SINGULAIR zrnc:
Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%).
Študije pri odraslih so pokazale zmožnost montelukasta, da doprinese h kliničnemu učinku inhalacijskih kortikosteroidov (% spremembe glede na začetno vrednost za inhalacijski beklometazon in montelukast proti beklometazonu: za FEV1: 5,43 % proti 1,04 %; za uporabo agonistov beta:8,70 % proti 2,64 %).
Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.
Pokazalo se je, da montelukast pri živalih prehaja skozi posteljico in se izloča v mleko samic.
- the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg Chewable Tablets for patients aged 2 to 5 years on the following indications:
- odbor CHMP je menil, da je dovoljenje za promet z zdravilom možno uskladiti za zdravilo Singulair 4 mg žvečljive tablete za bolnike, stare od 2 do 5 let, za naslednje indikacije:
For children who have problems consuming a chewable tablet, an oral granule formulation is available.
Za otroke, ki imajo težave pri zaužitju žvečljive tablete, je zdravilo na voljo tudi v obliki zrnc za peroralno uporabo.
In a 12-month, placebo-controlled study in paediatric patients 2 to 5 years of age with mild asthma and episodic exacerbations, montelukast 4 mg once daily significantly (p≤0.001) reduced the yearly rate of asthma exacerbation episodes (EE) compared with placebo (1.60 EE vs. 2.34 EE, respectively), [EE defined as ≥3 consecutive days with daytime symptoms requiring β-agonist use, or corticosteroids (oral or inhaled), or hospitalization for asthma].
V 12-mesečni, s placebom kontrolirani študiji pri pediatričnih bolnikih, starih 2 do 5 let, z blago astmo in epizodnimi poslabšanji je montelukast v odmerku 4 mg enkrat na dan v primerjavi s placebom pomebno (p≤0,001) zmanjšal letni delež epizod poslabšanja (EP) astme (1,60 EP proti 2,34 EP); [EP je definirana kot ≥ 3 zaporedni dnevi z dnevnimi simptomi, zaradi katerih je potrebna uporaba agonistov beta ali kortikosteroidov (peroralnih ali inhalacijskih) ali bolnišnično zdravljenje astme].