Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
montelukast sodium, Quantity: 4.16 mg
ORGANON PHARMA PTY LTD
Granules
Excipient Ingredients: magnesium stearate; mannitol; hyprolose
Oral
28 Sachets, 7 Sachets - sample pack
(S4) Prescription Only Medicine
For prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. Symptomatic treatment of seasonal allergic rhinitis
Visual Identification: WHITE, GRANULAR, COARSE, FREE-FLOWING HOMOGENEOUS SOLID.; Container Type: Sachet; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2002-11-13
S-WPC-MK0476-MF-112018 Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION SINGULAIR ® (MONTELUKAST SODIUM) TABLETS AND GRANULES 1 NAME OF THE MEDICINE Montelukast sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium, which is equivalent to 10.0 mg of montelukast, the free acid. Excipients with known effects: - lactose monohydrate Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is equivalent to 5.0 mg of montelukast, the free acid. Each 4 mg chewable tablet contains 4.16 mg of montelukast sodium, which is equivalent to 4.0 mg of montelukast, the free acid. Excipients with known effects: - aspartame Each packet of 4 mg oral granules contains 4.16 mg of montelukast sodium, which is equivalent to 4.0 mg of montelukast, the free acid. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 mg film-coated tablet - A beige biconvex rounded square film-coated tablet engraved with SINGULAIR on one side and MSD 117 on the other. 5 mg chewable tablet - A pink biconvex round chewable tablet engraved with SINGULAIR on one side and MSD 275 on the other. 4 mg chewable tablet - A pink, oval, biconvex chewable tablet with SINGULAIR debossed on one side and MSD 711 on the other. 4 mg oral granules - Coarse, white free-flowing granules sealed in a foil packet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. Symptomatic treatment of seasonal allergic rhinitis. S-WPC-MK0476-MF-112018 Page 2 of 18 4.2 DOSE AND METHOD OF ADMINISTRATION ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS SINGULAIR should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening. ADULTS 15 YEARS OF AGE AND OLDER The dosage for adults 15 Przeczytaj cały dokument