Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Chlorphenamine maleate 0.4 mg/mL; Chlorphenamine maleate 0.4 mg/mL
Douglas Pharmaceuticals Limited
Chlorphenamine maleate 0.4 mg/mL
2mg/5mL
Elixir
Active: Chlorphenamine maleate 0.4 mg/mL Excipient: Amaranth Ethanol Nipastat Propylene glycol Purified water Raspberry flavour 117668 Saccharin sodium Sodium cyclamate Sorbitol as sorbitol solution 70% Vanillin Active: Chlorphenamine maleate 0.4 mg/mL Excipient: Amaranth Ethanol Nipastat Propylene glycol Purified water Raspberry flavour C3056 Saccharin sodium Sodium cyclamate Sorbitol as sorbitol solution 70% Vanillin
Bottle, plastic, 2L pack (not marketed), 2 L
Restricted
Restricted
Kongo Chemical Co., Ltd
Package - Contents - Shelf Life: Bottle, plastic, - 2 L - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 mL - 36 months from date of manufacture stored at or below 30°C
1973-03-14
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Histafen elixir 2 mg/5 mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Histafen elixir 2 mg/5 mL contains 0.4 mg/ml of chlorphenamine maleate (chlorpheniramine maleate) EXCIPIENT(S) WITH KNOWN EFFECT Histafen elixir contains amaranth, ethanol and sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Red thin liquid with the characteristic odour of raspberry. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Chlorphenamine maleate is indicated for allergic skin disorders including urticaria, pruritus, insect bites, some drug allergies and contact allergies to plants. It is also effective in relieving the symptoms of seasonal and perennial allergic rhinitis such as sneezing, nasal itch and conjunctivitis. 4.2. DOSE AND METHOD OF ADMINISTRATION Adults and children over six years of age: 5ml up to eight times daily. 4.3. CONTRAINDICATIONS • Hypersensitivity to Chlorphenamine maleate or any of the ingredients listed in section 6.1. • Acute attacks of asthma. • Do not use in children under six years of age. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Because of the antimuscarinic properties, antihistamines should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. 2 | P a g e 4.5. INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION Administration of Histafen elixir with other CNS depressants such as alcohol, barbiturates, hypnotics, opioid analgesics, sedatives and antipsychotics may enhance sedation. Histafen elixir will enhance the antimuscarinic action of atropine, tricyclic antidepressants and Monoamine Oxidase inhibitors (MAOIs). There is evidence to suggest that antihistamines such as Chlorphenamine maleate could mask the warning signs of damage caused by ototoxic medicines such as aminoglycosides. Histafen may suppress the cutaneous histamine response to allergen extracts. Its use should be stopped several days before skin testing. 4.6. FERTILITY, PREGNANCY Прочитайте повний документ