FrancophonIA/ELRC3.0 huggingface dataset:
English: The signs of toxicity in animals were increased excretion of saliva, gastrointestinal symptoms, loose stools and ion imbalance.
Slovenian: Znaki toksičnosti pri živalih so bili povečano izločanje sline, simptomi v prebavilih, mehki iztrebki in ionsko neravnovesje.
English: The mean increase from baseline in % predicted FEV1 was 0.6% in the montelukast treatment group, and 2.7% in the fluticasone treatment group.
Slovenian: 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.
English: Montelukast, compared with placebo, decreased peripheral blood eosinophils in adult and paediatric patients.
Slovenian: Montelukast je v primerjavi s placebom pri odraslih in pediatričnih bolnikih zmanjšal število eozinofilcev v periferni krvi.
English: If your child stops taking SINGULAIR
Slovenian: Če je otrok prenehal jemati zdravilo SINGULAIR
English: Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Slovenian: Podatki o učinkovitosti iz kliničnih preskušanj pri otrocih, starih od 6 mesecev do 2 let s perzistentno astmo, so omejeni.
English: The sachet should not be opened until ready to use.
Slovenian: Vrečko se lahko odpre šele tik pred uporabo.
English: 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).
Slovenian: 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).
English: A slight decrease in pup body weight was noted in the female fertility study in rats at 200 mg/kg/day (>69-fold the clinical systemic exposure).
Slovenian: Rahlo zmanjšanje telesne mase mladičkov so zabeležili v študiji plodnosti samic pri podganah pri odmerkih 200 mg/kg/dan (> 69-kratna klinična sistemska izpostavljenost).
English: • It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
Slovenian: • Otrok mora zdravilo redno jemati tudi, če nima simptomov, ter tudi v primeruakutnega astmatičnega napada.
English: The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.
Slovenian: Najpogostejši neželeni učinki so bili skladni z varnostnim profilom montelukasta in so vključevali bolečine v trebuhu, zaspanost, žejo, glavobol, bruhanje in psihomotorično hiperaktivnost.
English: Blisters (unit doses), in packages of: 49, 50 and 56 tablets.
Slovenian: Pretisni omoti (za enkratne odmerke) v škatlah po 49, 50 in 56 tablet.
English: The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo:
Slovenian: 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:
English: Clinical Efficacy: Exercise-induced asthma
Slovenian: Klinična učinkovitost: astma zaradi telesne vadbe
English: Also IS and NO have granted marketing authorisation to this formulation.
Slovenian: Za to obliko sta dovoljenje za promet odobrili tudi IS in NO.
English: In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and children.
Slovenian: V študijah terapevtskih odmerkov so v stanju dinamičnega ravnovesja koncentracije presnovkov montelukasta v plazmi nemerljive tako pri odraslih kot otrocih.
English: 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.
Slovenian: 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.
English: Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side and MSD 711 on the other.
Slovenian: Roza, ovalne, bikonveksne tablete, z vtisnjeno oznako SINGULAIR na eni in MSD 711 na drugi strani.
English: This leaflet was last approved in {DD.MM.YYYY.}
Slovenian: Navodilo je bilo odobreno {DD.MM.LLLL}.
English: even if their symptoms are the same as your child's.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: This medicinal product is to be given to a child under adult supervision.
Slovenian: Otrok mora zdravilo vzeti pod nadzorom odraslega.
English: 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).
Slovenian: 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.
English: Montelukast is not recommended as monotherapy in patients with moderate persistent asthma.
Slovenian: Montelukasta ne priporočamo za samostojno zdravljenje zmerne persistentne astme.
English: Take special care with SINGULAIR
Slovenian: Bodite posebno pozorni pri jemanju zdravila SINGULAIR
English: 4 mg granules in 175 paediatric patients 6 months to 2 years of age.
Slovenian: 4 mg zrnca pri 175 pediatričnih bolnikih, starih 6 mesecev do 2 let.
English: The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Slovenian: 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.
English: 10 mg film-coated tablets are available for adults 15 years of age and older.
Slovenian: 10 mg filmsko obložene tablete so na voljo za bolnike, stare 15 let ali več.
English: Skin and subcutaneous tissue disorders eczematous dermatitis, rash
Slovenian: Bolezni kože in podkožja ekcematozni dermatitis, izpuščaj
English: However, your child may take liquids after swallowing the SINGULAIR granules.
Slovenian: Lahko pa otrok tekočino popije po zaužitju zrnc.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 vrečka
English: Use during pregnancy
Slovenian: Uporaba med nosečnostjo
English: In vitro studies using human liver microsomes indicate that cytochrome P450 3A4, 2A6 and 2C9 are involved in the metabolism of montelukast.
Slovenian: In vitro študije z mikrosomi človeških jeter kažejo, da so v presnovo montelukasta vpleteni citokrom P450 3A4, 2A6 in 2C9.
English: How should I give SINGULAIR granules to my child?
Slovenian: Kako morate otroku dati SINGULAIR zrnca
English: • To be taken by mouth
Slovenian: • Zdravilo se vzame skozi usta.
English: • Store in the original package in order to protect from light and moisture.
Slovenian: • Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: Montelukast showed improvement in the variables of asthma as compared to placebo.
Slovenian: Dokazano je bilo, da je montelukast v primerjavi s placebom povzročil izboljšanje spremenljivk astme.
English: What SINGULAIR looks like and contents of the pack 4 mg SINGULAIR chewable tablets are pink, oval, biconvex with SINGULAIR engraved on one side and MSD 711 on the other.
Slovenian: 4 mg SINGULAIR žvečljive tablete so roza barve, ovalne, bikonveksne, z vtisnjenim napisom SINGULAIR na eni in MSD 711 na drugi strani.
English: Averaged over the 12-month treatment period, the percentage of asthma RFDs increased from 61.6 to 84.0 in the montelukast group and from 60.9 to 86.7 in the fluticasone group.
Slovenian: 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.
English: SINGULAIR chewable tablets contain aspartame, a source of phenylalanine.
Slovenian: SINGULAIR žvečljive tablete vsebujejo aspartam, ki je izvor fenilalanina.
English: These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
Slovenian: Pri bolnikih, ki so prejemali zdravilo SINGULAIR, so se pojavili pogosteje kot pri bolnikih, ki so prejemali placebo (tableta brez zdravilne učinkovine).
English: 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.
Slovenian: 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).
English: Asthma includes:
Slovenian: Za astmo so značilni:
English: Adult Patients 15 years and older (two 12-week studies; n=795)
Slovenian: Odrasli bolniki 15 let in starejši (dve 12-tedenski študiji; n=795)
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: Compared with inhaled beclomethasone (200 µg twice daily with a spacer device), montelukast demonstrated a more rapid initial response, although over the 12-week study, beclomethasone provided a greater average treatment effect (% change from baseline for montelukast vs beclomethasone, respectively for FEV1: 7.49% vs 13.3%; β-agonist use: -28.28% vs -43.89%).
Slovenian: 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 %).
English: Reduction in EIB was also demonstrated in a short term study in paediatric patients 6 to 14 years of age (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min).
Slovenian: 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).
English: 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).
Slovenian: 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.
English: Body System Class
Slovenian: Organski sistem
English: In animal studies, montelukast did not affect fertility or reproductive performance at systemic exposure exceeding the clinical systemic exposure by greater than 24-fold.
Slovenian: V študijah na živalih montelukast pri sistemski izpostavljenosti za več kot 24-krat večji od klinične ni vplival na plodnost ali razmnoževanje.
English: In paediatric patients 6 months to 2 years of age, Cmax is achieved 2 hours after administration of the 4 mg granules formulation.
Slovenian: Pri pediatričnih bolnikih, starih 6 mesecev do 2 leti, je cmax dosežena 2 uri po zaužitju 4 mg zrnc.
English: Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min).
Slovenian: 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).
English: In 2 to 5 year old patients, exercise-induced bronchoconstriction may be the predominant manifestation of persistent asthma that requires treatment with inhaled corticosteroids.
Slovenian: 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.
English: The Applicant/MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (25 years old, 6-14 years old) according to ICH E11 guideline.
Slovenian: 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.
English: Administration of SINGULAIR granules:
Slovenian: Uporaba SINGULAIR zrnc:
English: Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1: 5.43% vs 1.04%; β-agonist use: -8.70% vs 2.64%).
Slovenian: 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 %).
English: Montelukast has been shown to cross the placental barrier and is excreted in breast milk of animals.
Slovenian: Pokazalo se je, da montelukast pri živalih prehaja skozi posteljico in se izloča v mleko samic.
English: - 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:
Slovenian: - 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:
English: For children who have problems consuming a chewable tablet, an oral granule formulation is available.
Slovenian: Za otroke, ki imajo težave pri zaužitju žvečljive tablete, je zdravilo na voljo tudi v obliki zrnc za peroralno uporabo.
English: In a 12-month, placebo-controlled study in paediatric patients 2 to 5 years of age with mild asthma and episodic exacerbations, montelukast 4 mg once daily significantly (p≤0.001) reduced the yearly rate of asthma exacerbation episodes (EE) compared with placebo (1.60 EE vs. 2.34 EE, respectively), [EE defined as ≥3 consecutive days with daytime symptoms requiring β-agonist use, or corticosteroids (oral or inhaled), or hospitalization for asthma].
Slovenian: 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].
English: • 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.
Slovenian: • Če otrok jemlje zdravila za astmo in se pri njem pojavi kateri od simptomov, kot so gripi podobna bolezen, mravljinčenje ali otrplost rok ali nog, poslabšanje pljučnih simptomov, in/ali izpuščaj, se morate posvetovati z zdravnikom.
English: In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
Slovenian: V redkih primerih imajo lahko bolniki, ki se zdravijo z antiastmatiki, vključno z montelukastom, sistemsko eozinofilijo, ki se včasih kaže s kliničnimi lastnostmi vaskulitisa, kot je Churg-Straussov sindromom.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised for Singulair 4mg Granules ( previously known as Oral Granules) for patients aged 6 months to 5 years on the following indications:
Slovenian: - odbor CHMP je menil, da je dovoljenje za promet z zdravilom možno uskladiti za zdravilo Singulair 4 mg zrnca (prej znano kot peroralna zrnca) za bolnike, stare od 6 mesecev do 5 let, za naslednje indikacije:
English: In a 12-week, placebo-controlled study in paediatric patients 2 to 5 years of age, montelukast 4 mg once daily improved parameters of asthma control compared with placebo irrespective of concomitant controller therapy (inhaled/nebulized corticosteroids or inhaled/nebulized sodium cromoglycate).
Slovenian: V 12-tedenski s placebom kontrolirani študiji pri pediatričnih bolnikih, starih 2 do 5 let, je montelukast v odmerku 4 mg enkrat na dan v primerjavi s placebom izboljšal parametre nadzora astme ne glede na sočasno kontrolno zdravljenje [inhalacijski (z uporabo razpršilnikov ali brez) kortikosteroidi ali inhalacijski (z uporabo razpršilnikov ali brez) natrijev kromoglikat].
English: In clinical studies, montelukast inhibits bronchoconstriction due to inhaled LTD4 at doses as low as 5 mg. Bronchodilation was observed within 2 hours of oral administration.
Slovenian: V kliničnih študijah je montelukast zaviral bronhokonstrikcijo izzvano z inhalacijo LTD4 že v 5 mg odmerkih.
English: Blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Slovenian: Pretisni omoti v škatlah po 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 in 200 tablet.
English: It is not known if SINGULAIR appears in breast milk.
Slovenian: Ni znano, če se zdravilo SINGULAIR izloča v materino mleko.
English: What SINGULAIR contains
Slovenian: Kaj vsebuje zdravilo SINGULAIR
English: For children 6 months to 5 years of age: One sachet of SINGULAIR 4 mg granules to be taken by mouth each evening.
Slovenian: Za otroke, stare 6 mesecev do 5 let: Eno vrečko SINGULAIR 4 mg zrnc je treba zaužiti vsak večer.
English: 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.
Slovenian: Po enkratni peroralni aplikaciji natrijevega montelukasta v odmerkih vse do 5.000 mg/kg (največji preizkušani odmerek) pri miših in podganah (15.000 mg/m2 pri miših in 30.000 mg/m2 pri podganah)
English: Treatment should be discontinued if a lack of response is observed.
Slovenian: V primeru pomanjkanja odziva je treba zdravljenje ukiniti.
English: Moreover the MAH submitted a proposal for harmonised chemical-pharmaceutical sections of the SPC and PL.
Slovenian: Poleg tega je imetnik dovoljenja za promet predložil predlog usklajenih kemijsko-farmacevtskih poglavij povzetkov glavnih značilnosti zdravila in navodila za uporabo.
English: Paediatric Patients 6 months up to 2 years old (one 6-week study; n=175)
Slovenian: Pediatrični bolniki 6 mesecev do 2 let (ena 6-tedenska študija; n=175)
English: The between group difference in LS mean increase in the percentage of asthma RFDs was statistically significant (2.8 with a 95% CI of -4.7, -0.9), but within the limit pre-defined to be clinically not inferior.
Slovenian: Razlika med skupinama v povečanju odstotka dni (izračunana z metodo mediane najmanjših kvadratov), ko olajševalno zdravljenje ni bilo potrebno, je bila statistično pomembna (-2,8 s 95-odstotnim IZ; -4,7, -0,9), vendar znotraj vnaprej definirane meje, da klinično ni slabši.
English: 4 mg chewable tablets are available as an alternative formulation for paediatric patients 2 to 5 years of age.
Slovenian: 4 mg žvečljive tablete so na voljo kot druga možna oblika za otroke, stare 2 do 5 let.
English: SINGULAIR granules are not intended to be dissolved in liquid for administration.
Slovenian: SINGULAIR zrnca niso namenjena raztapljanju v tekočini.
English: In clinical studies with SINGULAIR 4 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were:
Slovenian: V kliničnih študijah s SINGULAIR 4 mg žvečljivimi tabletami so najpogosteje poročali o naslednjih neželenih učinkih (ki so se pojavili pri vsaj 1 od 100 in manj kot 1 od 10 zdravljenih pediatričnih bolnikov), za katere so mislili, da so povezani z zdravilom SINGULAIR:
English: There are no data on the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (Child-Pugh score >9).
Slovenian: Za bolnike s hudo jetrno insuficienco (ocena po Child-Pugh lestvici > 9) ni farmakokinetičnih podatkov.
English: Clinical Efficacy: Monotherapy of asthma
Slovenian: Klinična učinkovitost: samostojno zdravljenje za astmo
English: In aspirin-sensitive asthmatic patients receiving concomitant inhaled and/or oral corticosteroids, treatment with montelukast, compared with placebo, resulted in significant improvement in asthma control (FEV1 8.55% vs -1.74% change from baseline and decrease in total β-agonist use -27.78% vs 2.09% change from baseline).
Slovenian: Pri za acetilsalicilno kislino občutljivih astmatikih, ki so sočasno prejemali inhalacijske in/ali peroralne kortikosteroide, je zdravljenje z montelukastom v primerjavi s placebom pomembno izboljšalo nadzor astme (FEV1 za 8,55 % proti -1,74 % glede na izhodišče in zmanjšanje celotne uporabe agonistov beta za -27, 78 % proti 2,09 % glede na začetek zdravljenja).
English: SINGULAIR contains aspartame, a source of phenylalanine.
Slovenian: Zdravilo SINGULAIR vsebuje aspartam, ki je vir fenilalanina.
English: • SINGULAIR granules can be given either: o directly in the mouth; o OR mixed with a spoonful of cold or room temperature soft food (for example, applesauce, ice cream, carrots and rice).
Slovenian: • SINGULAIR zrnca lahko: o date otroku direktno v usta ALI o jih najprej zmešate s polno žlico redke hrane (na primer jabolčno čežano, sladoledom, korenčkom in rižem), ki mora biti hladna ali sobne temperature.
English: General disorders and administration site conditions thirst
Slovenian: Splošne težave in spremembe na mestu aplikacije žeja
English: In clinical studies with SINGULAIR 4 mg granules, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were:
Slovenian: V kliničnih študijah s SINGULAIR 4 mg zrnci so najpogosteje poročali o naslednjih neželenih učinkih (ki so se pojavili pri vsaj 1 od 100 in manj kot 1 od 10 zdravljenih pediatričnih bolnikov), za katere so mislili, da so povezani z zdravilom SINGULAIR: