FrancophonIA/ELRC3.0 huggingface dataset:
English: WHAT SINGULAIR IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO SINGULAIR IN ZA KAJ GA UPORABLJAMO
English: Important information about some of the ingredients of SINGULAIR
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila SINGULAIR
English: Both montelukast and fluticasone also improved asthma control on secondary variables assessed over the 12 month treatment period:
Slovenian: Oba, montelukast in flutikazon, sta izboljšala tudi nadzor sekundarnih spremenljivk astme, ki so jih ovrednotili v 12-mesečnem obdobju zdravljenja:
English: Asthma is a long-term disease.
Slovenian: Astma je kronična bolezen.
English: No dosage adjustment within this age group is necessary.
Slovenian: Znotraj te starostne skupine odmerkov ni treba prilagajati.
English: Treatment should be discontinued if lack of response is observed.
Slovenian: Zdravljenje je treba prekiniti, če opazite, da odziva ni.
English: • It is important that your child take all asthma medications prescribed by your doctor.
Slovenian: • Pomembno je, da otrok jemlje vsa zdravila za astmo, ki mu jih je predpisal zdravnik.
English: Studies in patients with renal impairment have not been undertaken.
Slovenian: Študij pri bolnikih z ledvično okvaro niso izvedli.
English: Results of P907 showed efficacy over placebo.
Slovenian: Rezultati študije P907 so pokazali večjo učinkovitost montelukasta od placeba.
English: LIST OF EXCIPIENTS Contains aspartame (E 951).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje aspartam (E 951).
English: By blocking leukotrienes, SINGULAIR improves asthma symptoms and helps control asthma.
Slovenian: Z zaviranjem levkotrienov zdravilo SINGULAIR izboljša simptome astme in pomaga nadzorovati astmo.
English: • 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.
Slovenian: • Vaš otrok ne sme jemati acetilsalicilne kisline (aspirina) ali protivnetnih zdravil (imenovanih tudi nesteroidni antirevmatiki ali NSAR), če mu le ti poslabšajo astmo.
English: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.
Slovenian: Montelukast je peroralno aktivna spojina, ki se z veliko afiniteto in selektivno veže na CysLT1 receptor.
English: Additionally, the CHMP requested, that the Applicant/MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Slovenian: Odbor CHMP je dodatno zahteval, da predlagatelj/imetnik dovoljenja za promet v poglavju 4.2 navede bolj podrobno navodilo, kako spremljati in vrednotiti učinke zdravljenja.
English: • difficulty breathing because of narrowed airways.
Slovenian: • Težko dihanje zaradi zožanih dihalnih poti.
English: • Your child should take only one tablet of SINGULAIR once a day as prescribed by your doctor.
Slovenian: • Otrok mora vzeti samo eno tableto SINGULAIR enkrat na dan, kot mu je predpisal zdravnik.
English: The effect was seen over 12 weeks of therapy.
Slovenian: Učinek je bil razviden v 12 tednih zdravljenja.
English: 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.
Slovenian: Če do kontrole (običajno v roku enega meseca) zadosten nadzor astme ni dosežen, je treba oceniti potrebo po dodatnem ali drugačnem protivnetnem zdravljenju glede na stopenjsko zdravljenje astme.
English: The wheezing observed in the younger age group could be attributed to a number of diagnoses (viral infection, RSV bronchiolitis, or early symptoms of classic asthma).
Slovenian: Piskajoče dihanje, ki ga opazimo pri mlajši starostni skupini, lahko pripišemo številnim diagnozam (virusna okužba, bronhiolitis zaradi RSV ali zgodnjim simptomom klasične astme).
English: These include reports in adults and children with a dose as high as 1000 mg (approximately 61 mg/kg in a 42 month old child).
Slovenian: Poročila so bila za odrasle in otroke z odmerkom vse do 1000 mg (približno 61 mg/kg pri 42 mesecev starem otroku).
English: Like all medicines, SINGULAIR can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo SINGULAIR neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: It is not known whether montelukast is dialyzable by peritoneal- or hemo-dialysis.
Slovenian: Ni znano, če se montelukast dializira s peritonealno dializo ali hemodializo.
English: Given the lack of efficacy data for this indication in patients younger than 2 years, the CHMP consulted with the Paediatric Committee regarding the extrapolation of data from studies conducted in older paediatric patients to assess the safety/efficacy of montelukast in very young paediatric patients.
Slovenian: Zaradi pomanjkanja podatkov o učinkovitosti za to indikacijo pri bolnikih, mlajših od 2 let, se je odbor CHMP posvetoval z Odborom za pediatrijo glede ekstrapolacije podatkov iz študij, opravljenih pri starejših otrocih, da bi ovrednotili varnost/učinkovitost montelukasta pri zelo majhnih otrocih.
English: The steady-state volume of distribution of montelukast averages 8-11 liters.
Slovenian: V stanju dinamičnega ravnovesja znaša volumen porazdelitve montelukasta povprečno 8 do 11 litrov.
English: Patients receiving montelukast had more days without asthma than those receiving placebo.
Slovenian: Bolniki, ki so prejemali montelukast, so bili več dni brez astme kot tisti, ki so prejemali placebo.
English: Study P910 (treatment duration 52 weeks) was carried out in 6 to 14-year old paediatric patients, study P907 in patients 2 to 6 years old.
Slovenian: Študija P910 (trajanje zdravljenja 52 tednov) je bila opravljena pri otrocih, starih od 6 do 14 let, študija P907 pa pri bolnikih, starih od 2 do 6 let.
English: The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one day.
Slovenian: Splošna priporočila: Terapevtski učinek zdravila SINGULAIR na parametre nadzora astme se pojavi v enem dnevu.
English: Two long term studies to support the monotherapy indication were presented.
Slovenian: Predloženi sta bili dve dolgoročni študiji, ki podpirata indikacijo kot samostojno zdravljenje.
English: The plasma clearance of montelukast averages 45 ml/min in healthy adults.
Slovenian: Plazemski očistek montelukasta pri zdravih odraslih znaša povprečno 45 ml/min.
English: SINGULAIR may be used during pregnancy only if it is considered to be clearly essential.
Slovenian: Zdravilo SINGULAIR se med nosečnostjo lahko uporablja le, če se oceni, da je to nedvomno nujno.
English: Therefore, the PDCO expressed the need to conduct studies to precisely define the patient population that should receive montelukast sodium for the treatment of mild persistent asthma.
Slovenian: Zato je Odbor za pediatrijo izrazil potrebo po izvedbi študij za natančno opredelitev populacije bolnikov, ki naj bi prejemala montelukast natrij za zdravljenje blage perzistentne astme.
English: Following an oral dose of radiolabeled montelukast, 86% of the radioactivity was recovered in 5-day fecal collections and <0.2% was recovered in urine.
Slovenian: Po peroralnem odmerku radioaktivno označenega montelukasta so 86 % celotne radioaktivnosti odkrili v blatu, ki so ga zbirali 5 dni, in < 0,2 % v urinu.
English: The following sections of the SPCs were presented for harmonisation: 4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.3 Contraindications, 4.4 Special Warnings and Precautions for Use, 4.8 Undesirable effects, and 6.5 Shelf life.
Slovenian: Za uskladitev so bila predložena naslednja poglavja povzetkov glavnih značilnosti zdravila: 4.1 Terapevtske indikacije, 4.2 Odmerjanje in način uporabe, 4.3 Kontraindikacije, 4.4 Posebna opozorila in previdnostni ukrepi, 4.8 Neželeni učinki in 6.5 Rok uporabnosti.
English: The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells including mast cells and eosinophils.
Slovenian: Cisteinil-levkotrieni (LTC4, LTD4, LTE4) so močni vnetni eikozanoidi, ki se sproščajo iz raznih celic, tudi iz mastocitov in iz eozinofilcev.
English: 28027 - Madrid Spain
Slovenian: 28027 - Madrid Španija
English: In a separate study, treatment with montelukast significantly decreased eosinophils in the airways (as measured in sputum).
Slovenian: V ločeni študiji je zdravljenje z montelukastom pomembno zmanjšalo število eozinofilcev v dihalnih poteh (merjeno v sputumu).
English: Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.
Slovenian: Študije z radioaktivno označenim montelukastom na podganah kažejo minimalno prehajanje prek krvno-možganske bariere.
English: • If you have any further questions, please ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: 28027- Madrid Spain
Slovenian: 28027- Madrid Španija
English: The contribution of metabolites to the therapeutic effect of montelukast is minimal.
Slovenian: Prispevek presnovkov k terapevtskemu učinku je minimalen.
English: In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8.
Slovenian: In vitro študije so pokazale, da je montelukast močan zaviralec CYP 2C8.
English: Your child should take SINGULAIR every evening.
Slovenian: • Otrok mora zdravilo SINGULAIR vzeti vsak večer.
English: Mild persistent asthma is defined as asthma symptoms more than once a week but less that once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes.
Slovenian: Blaga persistentna astma je definirana s simptomi več kot enkrat na teden, vendar ne vsak dan, nočnimi simptomi več kot dvakrat na mesec a manj kot enkrat na teden in normalno pljučno funkcijo med epizodami.
English: Given that activity limitation due to asthma is difficult to assess in very young children (aged < 2 years), the Applicant/MAH revised the indication to state that it refers only to children 2 years of age or older.
Slovenian: Ker je omejitev aktivnosti zaradi astme pri zelo majhnih otrocih (mlajših od 2 let) težko vrednotiti, je predlagatelj/imetnik dovoljenja za promet popravil indikacijo tako, da se nanaša le na otroke, stare najmanj 2 leti.
English: Cumulatively, 502 paediatric patients 2 to 5 years of age were treated with montelukast for at least 3 months, 338 for 6 months or longer, and 534 patients for 12 months or longer.
Slovenian: Skupno se je 502 pediatričnih bolnikov, starih 2 do 5 let, z montelukastom zdravilo vsaj 3 mesece, 338 bolnikov 6 mesecev ali dalj časa, 534 bolnikov pa 12 mesecev ali dalj časa.
English: The treatment effect by montelukast is smaller than that achieved with fluticasone, but the difference is small enough to be clinically not significant, and it can be compensated with better treatment compliance due to oral, once daily administration of montelukast as opposed to twice-daily inhalation of fluticasone.
Slovenian: Učinek zdravljenja z montelukastom je manjši od učinka flutikazona, vendar je razlika dovolj majhna, da se šteje za klinično nepomembno ter da jo lahko nadomestimo z boljšim upoštevanjem navodil za zdravljenje zaradi peroralnega dajanja montelukasta enkrat dnevno namesto vdihavanja flutikazona dvakrat dnevno.
English: The bronchodilation effect caused by a β-agonist was additive to that caused by montelukast.
Slovenian: Bronhodilatacijski učinek, povzročen z agonistom beta, je bil aditiven tistemu, ki ga je povzročil montelukast.
English: If your child is taking SINGULAIR, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
Slovenian: Če otrok jemlje zdravilo SINGULAIR, se prepričajte, da ne jemlje še katerega drugega zdravila, ki vsebuje isto zdravilno učinkovino, montelukast.
English: Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available.
Slovenian: Bolnikom je treba naročiti, da za zdravljenje akutnih napadov astme nikoli ne uporabijo peroralnega montelukasta in da imajo za ta namen vedno na voljo svoje običajno olajševalno zdravilo.
English: 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.
Slovenian: Varnost in učinkovitost sta bili dokazani v kliničnih preizkušanjih z 10 mg filmsko obloženo tableto, ki je bila aplicirana ne glede na čas obroka hrane.
English: • Do not open the sachet until ready to use.
Slovenian: • Vrečko odprite šele tik pred uporabo.
English: Improvement in patient-reported daytime and nighttime asthma symptoms scores was significantly better than placebo.
Slovenian: Izboljšanje ocen dnevnih in nočnih simptomov astme, o katerih so poročali bolniki, je bilo pomembno boljše kot pri placebu.
English: With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed.
Slovenian: Pri velikih odmerkih montelukasta (20- in 60- krat večji odmerek od priporočenega pri odraslih) so opazili zmanjšanje plazemske koncentracije teofilina.
English: It will help control your child's asthma.
Slovenian: To pomaga nadzorovati astmo.
English: No specific information is available on the treatment of overdose with montelukast.
Slovenian: O zdravljenju prevelikega odmerjanja montelukasta ni na voljo nobenih specifičnih informacij.
English: Singulair 4 mg oral granules was approved by 16 member states (not by AT, BE, CZ, DK, FR, HU, NL, PL, SK) in MRP in 2002.
Slovenian: Zdravilo Singulair 4 mg peroralna zrnca je bilo v postopku medsebojnega priznavanja leta 2002 odobreno v 16 državah članicah (ni bilo odobreno v AT, BE, CZ, DK, FR, HU, NL, PL, SK).
English: However, there were no data of studies comparing montelukast with active treatments in paediatric patients.
Slovenian: Vendar ni bilo podatkov iz študij, kjer bi primerjali montelukast z aktivnim zdravljenjem otrok.
English: • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
Slovenian: • Občutljivost dihalnih poti na številne dražljaje, kot so cigaretni dim, cvetni prah, mrzel zrak ali napor.
English: If mixed with food, SINGULAIR granules must not be stored for future use.
Slovenian: Če se zmešajo s hrano, se SINGULAIR zrnc ne sme shraniti v hladilniku za kasnejšo uporabo.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child's doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite otrokovega zdravnika ali farmacevta.
English: However, compared with beclomethasone, a high percentage of patients treated with montelukast achieved similar clinical responses (e.g., 50% of patients treated with beclomethasone achieved an improvement in FEV1 of approximately 11% or more over baseline while approximately 42% of patients treated with montelukast achieved the same response).
Slovenian: Vendar pa je v primerjavi z beklometazonom visok odstotek bolnikov, zdravljenih z montelukastom, dosegel podobne klinične odzive (npr: 50 % bolnikov, zdravljenih z beklometazonom, je doseglo izboljšanje FEV1 za približno 11 % ali več nad začetno vrednostjo, medtem ko je približno 42 % bolnikov, zdravljenih z montelukastom, doseglo isti odziv).
English: However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolized by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo.
Slovenian: Vendar pa so podatki iz klinične študije interakcij med zdravili z montelukastom in rosiglitazonom (raziskovalni substrat, ki predstavlja učinkovine, ki se primarno presnavljajo s CYP 2C8) pokazali, da montelukast in vivo ne zavira CYP 2C8.
English: • The other ingredients are: Mannitol, hyprolose (E 463), and magnesium stearate.
Slovenian: • Pomožne snovi so: manitol, hiproloza (E 463) in magnezijev stearat.
English: In animal toxicity studies, minor serum biochemical alterations in ALT, glucose, phosphorus and triglycerides were observed which were transient in nature.
Slovenian: V študijah toksičnosti na živalih so opazili manjše spremembe serumskih vrednosti ALT, glukoze, fosforja in trigliceridov, ki pa so bile prehodne.
English: Distribution.
Slovenian: Porazdelitev.
English: There were no gender or race-related differences in the effect.
Slovenian: Na učinek spol ali rasa preiskovancev nista vplivala.
English: Cmax is nearly 2-fold greater than in adults receiving a 10 mg tablet.
Slovenian: Cmax je skoraj 2-krat večja kot pri odraslih, ki zaužijejo 10 mg tableto.
English: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Lithuania
Slovenian: “Merck Sharp & Dohme”, UAB, Kestucio str. 59/27 LT-08124 Vilnius Litva
English: Your doctor has prescribed SINGULAIR to treat your child's asthma, preventing asthma symptoms during the day and night.
Slovenian: Zdravnik je vašemu otroku predpisal zdravilo SINGULAIR za zdravljenje astme, preprečevanje dnevnih in nočnih simptomov astme.
English: • phenobarbital (used for treatment of epilepsy)
Slovenian: • fenobarbital (za zdravljenje epilepsije)
English: The percentage of patients with systemic (mainly oral) corticosteroid use during the study period was 17.8% in the montelukast group and 10.5% in the fluticasone group.
Slovenian: Odstotek bolnikov, ki so tekom študije uporabljali sistemske (večinoma peroralne) kortikosteroide, je bil 17,8 % v skupini, ki je prejemala montelukast, in 10,5 % v skupini, ki je prejemala flutikazon.
English: Efficacy of montelukast is supported in paediatric patients 6 months to 2 years of age by extrapolation from the demonstrated efficacy in patients 2 years of age and older with asthma, and is based on similar pharmacokinetic data, as well as the assumption that the disease course, pathophysiology and the medicinal products's effect are substantially similar among these populations.
Slovenian: Učinkovitost montelukasta pri pediatričnih bolnikih, starih 6 mesece do 2 let, podpira ekstrapolacija dokazane učinkovitosti pri 2 leti in več starih bolnikih z astmo in temelji na podobnih farmakokinetičnih podatkih ter predpostavki, da so potek in patofiziologija bolezni ter učinki zdravila med tema populacijama bistveno podobni.
English: The safety profile in paediatric patients 6 months to 2 years of age did not change with treatment up to 3 months.
Slovenian: Varnostni profil pri pediatričnih bolnikih, starih 6 mesecev do 2 let, se pri zdravljenju do 3 mesece ni spremenil.
English: Box 214
Slovenian: P.O. Box 214
English: Montelukast was neither mutagenic in in vitro and in vivo tests nor tumorigenic in rodent species.
Slovenian: Montelukast ni bil ne mutagen v in vitro in in vivo preizkušanjih niti tumorogen pri glodalcih.
English: In a trend voting after the Applicant/MAH's Oral Explanation, the majority of the CHMP (26+2 positive, 3 negative votes) was in favour of accepting the indication as proposed by the Applicant/MAH, including the treatment of very young patients (6 months to 2 year old) when diagnosis of persistent asthma has been established.
Slovenian: V glasovanju po ustni obrazložitvi predlagatelja/imetnika dovoljenja za promet je bila večina Odbora (26+2 za, 3 proti) za sprejem indikacije, kakor jo je predlagal predlagatelj/imetnik dovoljenja za promet, z vključitvijo zdravljenja zelo majhnih otrok (starih od 6 mesecev do 2 let), če je postavljena diagnoza perzistentne astme.
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden, United Kingdom
Slovenian: To zdravilo je odobreno v naslednjih državah članicah EGP: v Avstriji, v Belgiji, v Bolgariji, na Cipru, na Češkem, na Danskem, v Estoniji, na Finskem, v Grčiji, na Irskem, na Islandiji, v Italiji, v Latviji, v Litvi, v Luksemburgu, na Madžarskem, na Malti, v Nemčiji, na Nizozemskem, na Norveškem, na Poljskem, na Portugalskem, v Romuniji, v Sloveniji, na Slovaškem, v Španiji, na Švedskem in v Veliki Britaniji - pod imenom SINGULAIR.
English: Further efficacy reports of two clinical studies (P176 and P072-02; double-blind, randomized, placebo-controlled, parallel group) were presented for both 4mg OG and CT formulations.
Slovenian: Predstavljeni sta bili tudi poročili o učinkovitosti iz dveh kliničnih študij (P176 in P072-02; dvojno zaslepljeni, randomizirani, nadzorovani s placebom, z vzporednimi skupinami) za obliki 4 mg peroralna zrnca in žvečljive tablete.
English: These occurred at dosages which provided >17-fold the systemic exposure seen at the clinical dosage.
Slovenian: Ti so se pojavili pri odmerkih, ki so povzročili > 17-kratno sistemsko izpostavljenost pri kliničnem odmerjanju.
English: What SINGULAIR is and what it is used for Before SINGULAIR is taken How to take SINGULAIR Possible side effects
Slovenian: Kaj je zdravilo SINGULAIR in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo SINGULAIR Kako jemati zdravilo SINGULAIR Možni neželeni učinki
English: This dose is equivalent to 25,000 times the recommended daily adult human dose (based on an adult patient weight of 50 kg).
Slovenian: Največji preizkušani odmerek ustreza 25.000-kratnemu priporočenemu dnevnemu odmerku za odraslega človeka (glede na 50 kg težkega odraslega).
English: SINGULAIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Slovenian: Zdravilo SINGULAIR je antagonist levkotrienskih receptorjev in zavira snovi, imenovane levkotrieni.
English: Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide.)
Slovenian: Zato ne pričakujemo, da bi montelukast izrazito spremenil presnovo učinkovin, ki jih presnavlja ta encim (npr. paklitaksela, rosiglitazona in repaglinida).
English: Montelukast is not expected to affect a patient's ability to drive a car or operate machinery.
Slovenian: Ne pričakujemo, da bi montelukast vplival na bolnikovo sposobnost vožnje in upravljanja s stroji.
English: • is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR (see
Slovenian: • če je alergičen na (preobčutljiv za) montelukast ali katerokoli drugo sestavino zdravila SINGULAIR (glejte poglavje 6 Dodatne informacije).
English: • The active substance is montelukast.
Slovenian: • Zdravilna učinkovina je montelukast.
English: 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.
Slovenian: S podaljšanjem zdravljenja v kliničnih preizkušanjih z manjšim številom bolnikov, ki so trajala do 2 leti pri odraslih in do 12 mesecev pri otrocih, starih 6 do 14 let, se varnostni profil ni spremenil.
English: Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is coadministered with inducers of CYP 3A4, such as phenytoin, phenobarbital and rifampicin.
Slovenian: Ker montelukast presnavlja CYP 3A4 je predvsem pri otrocih pri uporabi montelukasta skupaj z induktorji CYP 3A4, kot so fenitoin, fenobarbital in rifampicin, potrebna previdnost.
English: • Oral SINGULAIR is not meant to treat acute asthma attacks.
Slovenian: • Peroralne tablete SINGULAIR niso namenjene zdravljenju akutnih astmatičnih napadov.
English: The diagnosis of persistent asthma in very young children (6 months - 2 years) should be established by a paediatrician or pulmonologist.
Slovenian: Diagnozo perzistentne astme pri zelo majhnih otrocih (6 mesecev - 2 leti) mora postaviti pediater ali pulmolog.