国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Dexchlorpheniramine maleate 2mg
BioInnova NZ Limited
2 mg
Tablet
Active: Dexchlorpheniramine maleate 2mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Purified water
Restricted
Latest Regulatory Activity
Package - Contents - Shelf Life: Blister pack, PVC/PVDC ALU - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC ALU - 40 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2021-11-12
_Polargen Data Sheet _ _ 05 November 2023 _ Page 1 of 7 NEW ZEALAND DATA SHEET POLARGEN TABLETS, UNCOATED – DEXCHLORPHENIRAMINE MALEATE 2 MG 1. NAME OF THE MEDICINAL PRODUCT Polargen (dexchlorpheniramine maleate) is the dextro-isomer of chlorpheniramine maleate. It is an antihistamine with anticholinergic properties. Dexchlorpheniramine maleate (CAS no. 2438-32-6) is described chemically as (+)-2-[_p_-chloro- -[2- (dimethylamino)ethyl]benzyl]pyridine maleate (1:1). It has the empirical formula of C 16 H 19 ClN 2 .C 4 H 4 O 4 and the following structural formula: Dexchlorpheniramine maleate is a white, odourless, crystalline powder which in aqueous solution has a pH of between 4 and 5. It is freely soluble in water, soluble in alcohol and in chloroform, but only slightly soluble in benzene or ether. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT All formulations: dexchlorpheniramine maleate QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT Polargen Tablets: dexchlorpheniramine maleate 2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM POLARGEN TABLETS Uncoated, immediate release tablets for oral use. Do not halve tablet. _Polargen Data Sheet _ _ 05 November 2023 _ Page 2 of 7 White, round, flat, uncoated tablets with a score-line on one side & plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Polargen is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild uncomplicated allergic skin manifestations of urticaria and angioedema. Polargen may relieve itching due to skin conditions such as allergic eczema, pruritus ani, pruritus vulvae, atopic dermatitis, contact dermatitis, insect bites, dermographism and medicine reactions, including serum sickness. 4.2 DOSE AND METHOD OF ADMINISTRATION _POLARGEN TABLETS_ _ _ Adults and children over 12 years: One tablet every 6 hours After initial relief is obtained, dosage may be reduced 阅读完整的文件