Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
montelukast (montelukast sodium)
Denk Pharma GmbH & Co. KG
R03DC03
montelukast (montelukast sodium)
4mg
tablets chewable
(28/2x14/) in blister
Prescription
Registered
2022-11-03
_Denk-Air Junior 4 mg_ For children 2 to 5 years of age Chewable tablet – oral use Leukotriene receptor antagonist Active substance: montelukast Package leaflet: Information for the patient READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN- FORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child´s. – If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. WHAT DENK-AIR JUNIOR 4 MG IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES DENK-AIR JUNIOR 4 MG 3. HOW TO TAKE DENK-AIR JUNIOR 4 MG 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DENK-AIR JUNIOR 4 MG 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. What Denk-Air Junior 4 mg is and what it is used for What Denk-Air Junior 4 mg is Denk-Air Junior 4 mg is a medicine that blocks the binding of certain inflammatory mediators (leukotrienes). How Denk-Air Junior 4 mg works Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking the leukotrienes, Denk-Air Junior 4 mg alleviates the symptoms of asthma, and helps to control asthma. When Denk-Air Junior 4 mg should be used The doctor has prescribed Denk-Air Junior 4 mg for your child so as to prevent symptoms of asthma occurring during the day and night. • Denk-Air Junior 4 mg is used in children 2 to 5 years of age whose asthma symptoms could not be adequately controlled by previous medication and who require an additional medical treatment. • Denk-Air Junior 4 mg can also be used in children 2 to 5 years of age instead of inhalations containing cortisone (inhaled corticosteroids), under the following circum- stances: – if there ha Prečítajte si celý dokument
*ALL STATEMENTS MADE UNDER "DENK-AIR" APPLY - WHERE NOT OTHERWISE APPARENT FROM THE CONTEXT - TO DENK-AIR 10 MG, DENK-AIR JUNIOR 4 MG AND DENK-AIR JUNIOR 5 MG. 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS Denk-Air Junior 4 mg Denk-Air Junior 5 mg Denk-Air 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: montelukast _Denk-Air Junior 4 mg: _ Each chewable tablet contains 4 mg of montelukast (as montelukast sodium). Excipients with known effect: aspartame and sodium. _Denk-Air Junior 5 mg: _ Each chewable tablet contains 5 mg of montelukast (as montelukast sodium). Excipients with known effect: aspartame and sodium. _Denk-Air 10 mg: _ Each film-coated tablet contains 10 mg of montelukast (as montelukast sodium). Excipients with known effect: aspartame, sodium and sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Denk-Air Junior 4 mg: _ Chewable tablet. Pink, flat, round, chewable tablets with beveled edges, with embossing “4” on one side and plain on the other. _Denk-Air Junior 5 mg: _ Chewable tablet. Pink, flat, round, chewable tablets with beveled edges. _Denk-Air 10 mg: _ Film-coated tablet. Beige, round, biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DENK-AIR* is indicated in the treatment of asthma as add-on therapy in patients 2 years of age and over with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-symphatomimetics provide inadequate clinical control of asthma. 2 Denk-Air may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 14 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2). In patients 15 years of age and over for whom Denk-Air° is indicated in asthma, Denk-Air 10 mg fi Prečítajte si celý dokument