Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
TRIAMCINOLONE ACETONIDE
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
R01AD11
55mcg
SPRAY
TRIAMCINOLONE ACETONIDE 55 mcg/actuation
NASAL
Prescription Only
RECIPHARM HC LIMITED
ACTIVE
1999-03-19
NASACORT®AQ _triamcinolone acetonide _ _ _ Nasal Spray sanofi aventis NASACORT®AQ [na’ za-cort] (triamcinolone acetonide) Nasal Spray For intranasal use only. Shake Well Before Using DESCRIPTION Triamcinolone acetonide, USP, the active ingredient in Nasacort® AQ Nasal Spray, is a corticosteroid with a molecular weight of 434.51 and with the chemical designation 9- Fluoro-11ß,16 α, 17,21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17- acetal with acetone (C 24 H 31 FO 6 ). NASACORT AQ Nasal Spray is an unscented, thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays. It will remain adequately primed for 2 weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. The contents of one 6.5 gram bottle provide 30 actuations, and the contents of one 16.5 gram bottle provide 120 actuations. AFTER EITHER 30 ACTUATIONS OR 120 ACTUATIONS, THE AMOUNT OF TRIAMCINOLONE ACETONIDE DELIVERED PER ACTUATION MAY NOT BE CONSISTENT AND THE UNIT SHOULD BE DISCARDED. Each 30 actuation bottle contains 3.575 mg of triamcinolone acetonide and each 120 actuation bottle contains 9.075 mg of triamcinolone acetonide. In the Information for Patients, patients are provided with a Read the complete document
SG/NAS/0622/SmPC1121 NASACORT ® AQ [na’ za-cort] (triamcinolone acetonide) Nasal Spray For intranasal use only. Shake Well Before Using DESCRIPTION Triamcinolone acetonide, USP, the active ingredient in NASACORT ® AQ Nasal Spray, is a corticosteroid with a molecular weight of 434.51 and with the chemical designation 9-Fluoro-11ß,16 α,17,21-tetrahydroxypregna-1, 4- diene-3, 20-dione cyclic 16, 17- acetal with acetone (C 24 H 31 FO6). NASACORT AQ Nasal Spray is an unscented, thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays. It will remain adequately primed for 2 weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. The contents of one 6.5 gram bottle provide 30 actuations, and the contents of one 16.5 gram bottle provide 120 actuations. AFTER EITHER 30 ACTUATIONS OR 120 ACTUATIONS, THE AMOUNT OF TRIAMCINOLONE ACETONIDE DELIVERED PER ACTUATION MAY NOT BE CONSISTENT AND THE UNIT SHOULD BE DISCARDED. Each 30 actuation bottle contains 3.575 mg of triamcinolone acetonide and each 120 actuation bottle contains 9.075 mg of triamcinolone acetonide. In the Information for Patients, patients are provided with a checkoff form to track usage. INDICATIONS AND USAGE NASACORT AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 4 years of age and older. CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this preparation contraindicates its use. SPECIAL WARNINGS AND PRECAUTION FOR Read the complete document