FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited data from available pregnancy databases do not suggest a causal relationship between SINGULAIR and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Slovenian: Majhno število podatkov iz razpoložljivih podatkovnih baz z nosečnostmi ne kaže vzročne povezave med zdravilom SINGULAIR in malformacijami (t.j.
English: For children who have problems consuming a chewable tablet, a granule formulation is available (see SINGULAIR 4 mg granule SPC).
Slovenian: Za otroke, ki žvečljive tablete težko zaužijejo, so na voljo zrnca (glejte Povzetek glavnih značilnosti za SINGULAIR 4 mg zrnca).
English: The MAH selected the sections which presented major divergences and were the scope of the harmonisation through the referral procedure.
Slovenian: Uskladitev povzetkov glavnih značilnosti zdravila Imetnik dovoljenja za promet je izbral poglavja, ki so se najbolj razlikovala in so bila predmet usklajevanja v postopku napotitve.
English: Use in pregnancy
Slovenian: Uporaba v nosečnosti
English: 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).
Slovenian: V 8-tedenski študiji pri pediatričnih bolnikih, starih 6 do 14 let, je montelukast v odmerku 5 mg enkrat na dan v primerjavi s placebom pomembno izboljšal dihalno funkcijo (FEV1 za 8,71 % proti 4,16 % glede na začetno vrednost; dopoldanski PEFR za 27,9 l/min proti 17,8 l/min glede na začetno vrednost) in zmanjšal potrebo po uporabi agonistov beta za uporabo "po potrebi" (za -11,7 % proti +8,2 % glede na začetek zdravljenja).
English: The between-group difference in LS mean increase in FEV1 was -0.02 L with a 95% CI of -0.06, 0.02.
Slovenian: Razlika med skupinama v povečanju FEV1 (izračunana z metodo mediane najmanjših kvadratov) je bila -0,02 l s 95-odstotnim IZ (-0,06, 0,02).
English: There were no adverse experiences in the majority of overdose reports.
Slovenian: V večini poročil o prevelikem odmerjanju neželenih učinkov ni bilo.
English: • rifampicin (used to treat tuberculosis and some other infections) Taking SINGULAIR with food and drink
Slovenian: • rifampicin (za zdravljenje tuberkuloze in nekaterih drugih okužb).
English: HOW TO TAKE SINGULAIR
Slovenian: KAKO JEMATI ZDRAVILO SINGULAIR
English: • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis;
Slovenian: • slabo počutje, bolečine v sklepih ali mišicah, mišični krči, suha usta, siljenje na bruhanje, bruhanje, slaba prebava, driska, hepatitis;
English: • Mix all of the contents of the SINGULAIR granules into a spoonful of cold or room temperature soft food, taking care to see that the entire dose is mixed with the food.
Slovenian: • Če SINGUALAIR zrnca zmešate s hrano, bodite pozorni, da s hrano zmešate celoten odmerek.
English: 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.
Slovenian: Po zaužitju 4 mg žvečljive tablete je pri pediatričnih bolnikih, starih 2 do 5 let, cmax dosežena po 2 urah po aplikaciji na tešče.
English: Respiratory, thoracic, and mediastinal disorders asthma
Slovenian: Bolezni dihal, prsnega koša in mediastenialnega prostora astma
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: 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.
Slovenian: Pri 10 mg filmsko obloženi tableti je pri odraslih povprečna največja plazemska koncentracija (cmax) dosežena 3 ure (tmax) po aplikaciji na tešče.
English: The between group difference in LS means was significant: 7.3% with a 95%CI of 2.9; 11.7.
Slovenian: Razlika med skupinama (izračunana z metodo mediane najmanjših kvadratov) je bila pomembna: 7,3 % s 95-odstotnim IZ (2,9, 11,7).
English: Patients should be evaluated after 2 to 4 weeks of treatment with montelukast.
Slovenian: Bolnike je treba pregledati po 2 do 4 tednih zdravljenja z montelukastom.
English: The CHMP agreed with the following proposed indication for 4mg oral granules:
Slovenian: CHMP se strinja z naslednjo predlagano indikacijo za 4 mg peroralna zrnca:
English: • increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations;
Slovenian: • povečano nagnjenje h krvavitvam, modrice, vozličaste rdeče podkožne vnetne spremembe največkrat na golenih (nodozni eritem), palpitacije (neprijeten občutek ob močnem utripanju srca);
English: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the United Kingdom
Slovenian: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the Velika Britanija
English: The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital.
Slovenian: Pri osebah, ki so sočasno prejemale fenobarbital, se je površina pod krivuljo plazemska koncentracijačas (AUC) za montelukast zmanjšala za približno 40 %.
English: Montelukast also decreased "as-needed" β-agonist use and corticosteroid rescue for worsening asthma compared with placebo.
Slovenian: Montelukast je v primerjavi s placebom zmanjšal tudi uporabo agonistov beta za uporabo "po potrebi" in uporabo s kortikosteroidov kot rešitev v primeru poslabšanja astme.
English: If taken in connection with food, SINGULAIR should be taken 1 hour before or 2 hours after food.
Slovenian: Zdravilo SINGULAIR je treba vzeti 1 uro pred ali 2 uri po obroku.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorization Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: Additionally, the following side effects were reported in clinical studies with either SINGULAIR 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets:
Slovenian: Poleg tega so v kliničnih študijah bodisi s SINGULAIR 10 mg filmsko obloženimi tabletami ali 5 mg ali 4 mg žvečljivimi tabletami poročali še o naslednjih neželenih učinkih:
English: The difference in LS means for the change from baseline in the % predicted FEV1 was significant: -2.2% with a 95% CI of -3.6, -0.7.
Slovenian: Razlika med spremembama od začetne vrednosti v % napovedanega FEV1 (izračunana z metodo mediane najmanjših kvadratov) je bila pomembna: -2,2 % s 95-odstotnim IZ (-3,6, -0,7).
English: No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z ledvično insuficienco ali blago do zmerno okvaro jeter odmerkov ni treba prilagajati.
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, The Netherlands
Slovenian: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, Nizozemska
English: Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets:
Slovenian: Zato se CHMP strinja z naslednjo predlagano indikacijo za 4 mg žvečljive tablete:
English: Lack of effect on growth rate is also a benefit of montelukast.
Slovenian: Koristen učinek montelukasta je tudi, ker ne vpliva na hitrost rasti.
English: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Slovenian: Merck Sharp & Dohme B.V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem Nizozemska
English: There were no side effects reported in the majority of overdose reports.
Slovenian: Pri večini primerov prevelikega odmerjanja niso poročali o nobenih neželenih učinkih.
English: SINGULAIR can treat your child's asthma only if he/she continues taking it.
Slovenian: Zdravilo SINGULAIR lahko zdravi astmo le, če otrok nadaljuje z jemanjem zdravila.
English: One 4 mg chewable tablet daily to be taken in the evening.
Slovenian: Ena 4 mg žvečljiva tableta enkrat na dan, zvečer.
English: 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.
Slovenian: V študijah pri kuncih so pri sistemski izpostavljenosti > 24-krat večji od klinične sistemske izpostavljenosti kliničnemu odmerekku v primerjavi s kontrolnimi živalmi opazili večjo pojavnost nepopolne zakostenitve.
English: 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
Slovenian: 5 mg žvečljive tablete so na voljo za otroke, stare 6 do 14 let.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SINGULAIR 4 mg granules montelukast
Slovenian: IME ZDRAVILA IN POT(I) UPORABE SINGULAIR 4 mg zrnca montelukast
English: There have been reports of acute overdose in post-marketing experience and clinical studies with montelukast.
Slovenian: Po prihodu zdravila na trg in v kliničnih študijah z montelukastom so poročali o akutnem prevelikem odmerjanju.
English: For children 6 months to 2 years old, SINGULAIR 4 mg granules are available.
Slovenian: Za otroke, stare 6 mesecev do 2 let, so na voljo SINGULAIR 4 mg zrnca.
English: • SINGULAIR granules can be taken without regard to the timing of food intake.
Slovenian: • SINGULAIR zrnca se lahko zaužije ne glede na obrok hrane.
English: The following adverse reactions have been reported in post-marketing use: Blood and lymphatic system disorders: increased bleeding tendency.
Slovenian: Po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih: Bolezni krvi in limfatičnega sistema: povečano nagnjenje h krvavitvam Bolezni imunskega sistema: preobčutljivostne reakcije vključno z anafilaksijo, jetrna infiltracija eozinofilcev
English: INFORMATION IN BRAILLE SINGULAIR 4 mg
Slovenian: PODATKI V BRAILLOVI PISAVI SINGULAIR 4 mg
English: • swelling (inflammation) in the lining of the airways.
Slovenian: • Otekanje (vnetje) sluznice v dihalnih poteh.
English: No dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency.
Slovenian: Pri starejših bolnikih ali pri bolnikih z blago do zmerno jetrno insuficienco odmerkov ni treba prilagajati.
English: Subsequently, Section 4.4 of Singulair 4mg OG SPC was revised to include the following wording:
Slovenian: Naknadno je bilo popravljeno poglavje 4.4 povzetka glavnih značilnosti zdravila Singulair 4 mg peroralna zrnca z vključitvijo naslednjega besedila:
English: Granules
Slovenian: Zrnca
English: The dosage for paediatric patients 2-5 years of age is one 4 mg chewable tablet daily to be taken in the evening.
Slovenian: Odmerek za otroke, stare 2 do 5 let, je ena 4 mg žvečljiva tableta na dan - zvečer.
English: The following wording was therefore accepted for Section 4.2, 4 mg CT and 4 mg OG:
Slovenian: Zato je bilo sprejeto naslednje besedilo poglavja 4.2 za 4 mg žvečljive tablete in 4 mg peroralna zrnca:
English: Tell your doctor if your child is taking the following medicines before starting SINGULAIR:
Slovenian: Preden bo vaš otrok začel jemati zdravilo SINGULAIR, njegovemu zdravniku povejte, če jemlje še kaj od sledečega:
English: The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Slovenian: SINGULAIR 4 mg zrnc ne priporočamo mlajšim od 6 mesecev.
English: EXCIPIENT: ASPARTAME (E 951) 1.2 MG PER TABLET.
Slovenian: Pomožna snov: aspartam (E951) 1,2 mg na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: You should check with your child's doctor or pharmacist if you are not sure.
Slovenian: Če niste prepričani, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
English: For children 6 to 14 years old, SINGULAIR 5 mg chewable tablets are available.
Slovenian: Za otroke, stare 6 do 14 let, so na voljo SINGULAIR 5 mg žvečljive tablete.
English: Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets and 4mg oral granules:
Slovenian: Zato se CHMP strinja z naslednjo predlagano indikacijo za 4 mg žvečljive tablete in 4 mg peroralna zrnca:
English: 4 mg granules are available for paediatric patients 6 months to 5 years of age.
Slovenian: 4 mg zrnca so na voljo za otroke, stare 6 mesecev do 5 let.
English: Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
Slovenian: Vsaka tableta vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.
English: Nervous system disorders: dizziness drowsiness, paraesthesia/hypoesthesia, seizure.
Slovenian: Bolezni živčevja: omotica, dremavost, parestezija/hipestezija, epileptični napad Srčne bolezni: palpitacije
English: 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).
Slovenian: V študijah pri odraslih je montelukast v odmerku 10 mg enkrat na dan v primerjavi s placebom pomembno izboljšal jutranji forsirani ekspiratorni volumen v prvi sekundi izdiha (FEV1) (za 10,4 % proti 2,7 % glede na začetno vrednost), dopoldansko hitrost največjega pretoka zraka med izdihom (PEFR) (za 24,5 l/min proti 3,3 l/min glede na začetno vrednost) in pomembno zmanjšal potrebo po uporabi agonistov beta (za -26,1 % proti -4,6 % glede na začetek zdravljenja).
English: The between group difference in LS means for the percentage of days with β-agonist use was significant: 2.7 with a 95% CI of 0.9, 4.5.
Slovenian: Razlika med skupinama v odstotku dni z uporabo agonistov beta (izračunana z metodo mediane najmanjših kvadratov) je bila pomembna: 2,7 s 95-odstotnim IZ (0,9, 4,5).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Izpolniti nacionalno.]
English: Patients should seek their doctors' advice as soon as possible if they need more inhalations of short-acting β-agonists than usual.
Slovenian: Če potrebujejo več inhalacij kratko delujočih agonistov beta kot običajno, morajo bolniki poiskati zdravniško pomoč takoj, ko je mogoče.
English: Therefore the final revised indication for 4mg CT and 4mg OG is as follows:
Slovenian: Zaradi tega je končna, popravljena indikacija za 4 mg žvečljive tablete in 4 mg peroralna zrnca naslednja:
English: Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Slovenian: Chaussée de Waterloo 1135 B- 1180 Bruselj Belgija
English: • 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.
Slovenian: • Zdravilo SINGULAIR se uporablja za zdravljenje 6 mesecev do 5 let starih bolnikov, ki za ustrezen nadzor astme potrebujejo dodatno zdravilo.
English: CHEWABLE TABLET.
Slovenian: Žvečljiva tableta
English: For the 5 mg chewable tablet, the Cmax is achieved in 2 hours after administration in adults in the fasted state.
Slovenian: Pri 5 mg žvečljivi tableti je pri odraslih cmax dosežena po 2 urah po aplikaciji na tešče.
English: However, if your child misses a dose, just resume the usual schedule of one tablet once daily.
Slovenian: Če otrok ni dobil enega odmerka, nadaljujte z običajnim razporedom jemanja, z eno tableto enkrat na dan. Ne dajte mu dvojnega odmerka, da bi nadomestili izpuščenega.
English: • SINGULAIR is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
Slovenian: • Zdravilo SINGULAIR se uporablja za zdravljenje 2 do 5 let starih bolnikov, ki za ustrezen nadzor astme potrebujejo dodatno zdravilo.
English: SINGULAIR as prophylaxis of asthma for 2 to 5 year old patients in whom the predominant component is exercise-induced bronchoconstriction.
Slovenian: Zdravilo SINGULAIR kot profilaksa za astmo pri otrocih, starih od 2 do 5 let, pri katerih je prevladujoča komponenta s telesno vadbo povzročena bronhokonstrikcija.
English: DATE OF first AUTHORIZATION/RENEWAL OF the AUTHORIZATION [TO BE COMPLETED NATIONALLY]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolniti nacionalno.]
English: The SINGULAIR 4 mg chewable tablet is not recommended below 2 years of age.
Slovenian: SINGULAIR 4 mg žvečljivih tablet ne priporočamo za uporabo pri mlajših od 2 let.
English: SINGULAIR granules can be taken without regard to the timing of food intake.
Slovenian: SINGULAIR zrnca se lahko zaužije ne glede na obrok hrane.
English: • 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.
Slovenian: • Zdravilo SINGULAIR se lahko uporablja tudi kot zamenjava za inhalacijske kortikosteroide pri 2 do 5 let starih bolnikih, ki v zadnjem času za astmo niso jemali peroralnih kortikosteroidov in za katere se je pokazalo, da niso zmožni uporabe inhalacijskih kortikosteroidov.
English: Paediatric Patients 2 to 5 years old (one 12-week study; n=461) (one 48-week study; n=278)
Slovenian: Pediatrični bolniki 2 do 5 let (ena 12-tedenska študija; n=461) (ena 48-tedenska študija; n=278)
English: • The other ingredients are:
Slovenian: Navodilo vsebuje:
English: This medicine expires at the end of the month shown.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolniti nacionalno.]
English: Your doctor will determine how SINGULAIR should be used depending on the symptoms and severity of your child's asthma.
Slovenian: Zdravnik bo glede na simptome in stopnjo astme, ki jo ima vaš otrok, določil, kako mora otrok zdravilo SINGULAIR jemati.
English: Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast.
Slovenian: Vsaka vrečka zrnc vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.
English: For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and SINGULAIR 4 mg granules are available.
Slovenian: Za otroke, stare 2 do 5 let, so na voljo SINGULAIR 4 mg žvečljive tablete in SINGULAIR 4 mg zrnca.
English: Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Slovenian: Zdravilo Singulair je indicirano tudi kot profilaksa za astmo, kjer je prevladujoča komponenta bronhokonstrikcija, povzročena s telesno vadbo.
English: Singulair 4 mg granulado 4 mg Granules
Slovenian: Singulair 4 mg granulado 4 mg Zrnca
English: Clinical Efficacy: Add-on use
Slovenian: Klinična učinkovitost: uporaba kot dodatno zdravljenje
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Slovenian: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU Velika Britanija
English: • Always have your child take SINGULAIR as your doctor has told you.
Slovenian: • Poskrbite, da otrok zdravilo vedno jemlje tako, kot mu je predpisal zdravnik.
English: For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and 4 mg granules are available.
Slovenian: Za otroke, stare 2 do 5 let, so na voljo SINGULAIR 4 mg žvečljive tablete in 4 mg zrnca.
English: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Slovenian: Merck Sharp & Dohme Ltd ; Hertford Road, Hoddesdon, Hertfordshire EN119BU, Velika Britanija
English: The dosage is the same for both male and female patients.
Slovenian: Podatkov za bolnike s hudo okvaro jeter ni. Odmerjanje je enako za bolnike obeh spolov.
English: However, liquids may be taken subsequent to administration.
Slovenian: Lahko pa se tekočino popije po zaužitju zrnc.
English: • Do not use this medicine after the date shown by the six numbers following EXP on the blister.
Slovenian: • Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vrečki poleg oznake EXP. Prvi dve številki označujeta mesec, zadnje štiri pa leto.
English: The dosage for paediatric patients 6 months to 5 years of age is one sachet of 4 mg granules daily to be taken in the evening.
Slovenian: Odmerek za otroke, stare 6 mesecev do 5 let, je ena vrečka 4 mg zrnc na dan - zvečer.
English: Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
Slovenian: Splošne težave in spremembe na mestu aplikacije: astenija/utrujenost, splošno slabo počutje, edem Zelo redko so tekom zdravljenja z montelukastom pri astmatikih poročali o primerih ChurgStraussovega sindroma (glejte poglavje 4.4).
English: Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
Slovenian: Bolezni prebavil: diareja, suha usta, dispepsija, navzea, bruhanje Bolezni jeter, žolčnika in žolčevodov: zvišane vrednosti serumskih transaminaz (ALT, AST), holestatski hepatitis
English: Paediatric Patients 6 to 14 years old (one 8-week study; n=201) (two 56-week studies; n=615)
Slovenian: Pediatrični bolniki 6 do 14 let (ena 8-tedenska študija; n=201) (dve 56-tedenski študiji; n=615)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ONE CHEWABLE TABLET CONTAINS MONTELUKAST SODIUM, WHICH IS EQUIVALENT TO 4 MG MONTELUKAST.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.
English: Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for patients (4 mg OG, CT: 2 to 5 year old) 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.
Slovenian: Zdravilo Singulair se lahko uporabi tudi kot alternativa nizkim odmerkom vdihanih kortikosteroidov za bolnike (4 mg peroralna zrnca, žvečljive tablete: 2 do 5 let starosti) z blago perzistentno astmo, ki nimajo nedavne anamneze resnih astmatičnih napadov, ki so zahtevali uporabo peroralnih kortikosteroidov, ter z dokazano nezmožnostjo uporabe kortikosteroidov za vdihavanje.
English: 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).
Slovenian: O uporabi montelukasta kot alternativi za majhne odmerke inhalacijskih kortikosteroidov pri otrocih z blago persistentno astmo lahko razmislimo le pri bolnikih, ki v zadnjem času niso imeli hudih napadov astme, ki bi zahtevali uporabo peroralnih kortikosteroidov, in pri katerih se je izkazalo, da niso sposobni uporabljati inhalacijskih kortikosteroidov (glejte poglavje 4.1).
English: White granules
Slovenian: Bela zrnca.
English: Singulair mini 4 mg Granulat4 mg Granules
Slovenian: Singulair mini 4 mg Granulat4 mg Zrnca
English: NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 mg granules
Slovenian: IME ZDRAVILA SINGULAIR 4 mg zrnca
English: MARKETING AUTHORIZATION HOLDER [To be completed nationally.]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Izpolniti nacionalno.]
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of granules contains montelukast sodium, which is equivalent to 4 mg montelukast.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vrečka zrnc vsebuje natrijev montelukast, ki ustreza 4 mg montelukasta.