PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline
PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline
PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline
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<strong>IMITREX</strong> <strong>DF</strong> ®(sumatriptan succinate tablets USP)50 mg and 100 mg sumatriptan<strong>IMITREX</strong> ®(sumatriptan succinate injection)6 mg sumatriptanSubcutaneous Injection and Autoinjector<strong>IMITREX</strong> ®(sumatriptan nasal spray)5 mg, 20 mg sumatriptan (as hemisulphate)PART I: HEALTH PROFESSIONAL INFORMATIONSUMMARY <strong>PRODUCT</strong> INFORMATIONRoute ofAdministrationOralSubcutaneousIntranasalDosage Form / Strength(sumatriptan succinate) Tablets USP50 mg and 100 mg(sumatriptan succinate) SubcutaneousInjection and Autoinjector6 mg(sumatriptan hemisulphate) Nasal Spray5 mg and 20 mgNonmedicinal Ingredientscroscarmellose sodium,dibasic calcium phosphateanhydrous, iron oxide red(100 mg only), magnesiumstearate,methylhydroxypropylcellulose, microcrystallinecellulose, sodiumbicarbonate, titaniumdioxide and triacetin.isotonic sodium chloridesolution containing waterfor injection.anhydrous dibasic sodiumphosphate, monobasicpotassium phosphate,purified water, sodiumhydroxide and sulphuricacid.October 21, 2014Page 3 of 58