Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Dexchlorpheniramine maleate 0.4 mg/mL;
Bayer New Zealand Limited
Dexchlorpheniramine maleate 0.4 mg/mL
2 mg/5mL
Syrup
Active: Dexchlorpheniramine maleate 0.4 mg/mL Excipient: Apricot flavour 15502857 Blood orange flavour SC481962 Ethanol Menthol Methyl hydroxybenzoate Ponceau 4R Propyl hydroxybenzoate Purified water Sodium chloride Sodium citrate dihydrate Sorbitol Sucrose
Bottle, glass, 100mL, 100 mL
Restricted
Restricted
Schering-Plough Company
Hayfever and year round allergies: Sneezing, Watery itchy eyes Itchy skin from Hives, Insect bites.
Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 500 mL - 36 months from date of manufacture stored at or below 25°C
1969-12-31
_Polaramine CMI _ _9 October 2017_ Consumer Medicine Information 1 POLARAMINE DEXCHLORPHENIRAMINE MALEATE TABLETS 2 MG & SYRUP 0.4 MG/ML WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Polaramine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Polaramine against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT POLARAMINE IS USED FOR Polaramine relieves symptoms associated with allergic rhinitis (including hayfever), such as sneezing, runny or itchy nose, and burning or itchy eyes. Polaramine may also be used to relieve symptoms associated with hives (also known as chronic urticaria). These symptoms include itching, redness and lumps on the skin. Polaramine can also be used to treat drug reactions. Polaramine belongs to a class of medicines known as antihistamines. Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances which the body is allergic to. Your doctor or pharmacist may have prescribed Polaramine for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY POLARAMINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Polaramine is addictive. Polaramine tablets and syrup can be bought without a doctor’s prescription. _Polaramine CMI _ _9 October 2017_ Consumer Medicine Information 2 BEFORE YOU TAKE POLARAMINE _WHEN YOU MUST NOT TAKE IT _ Do not take Polaramine if: • YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, difficulty in breathing or faintness. • YOU ARE ALSO TAKING MEDICINES USED TO TREAT DEPRESSION SUCH AS MO Lugege kogu dokumenti
_ _ _Polaramine Data Sheet _ _17 February 2020_ NEW ZEALAND DATA SHEET Page 1 of 7 POLARAMINE ® TABLETS, FILM-COATED – DEXCHLORPHENIRAMINE MALEATE 2 MG SYRUP - DEXCHLORPHENIRAMINE MALEATE 2 MG/5 ML (0.4 MG/ML) 1. NAME OF THE MEDICINAL PRODUCT Polaramine (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-α-[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 Polaramine Tablets: dexchlorpheniramine maleate 2 mg Polaramine Syrup: dexchlorpheniramine maleate 2 mg in 5 mL (0.4 mg/mL) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM POLARAMINE TABLETS Film-coated, immediate release tablets for oral use. _Polaramine Data Sheet _ _17 February 2020_ Page 2 of 7 Off-white, round, bevelled tablets with a score-line on one side. The score line is not intended for breaking the tablet. POLARAMINE SYRUP Syrup for oral use. A clear, red syrup with an orange-like odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Polaramine is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild uncomplicated allergic skin manifestations of urticaria and angioedema. Polaramine may relieve itching due to skin conditions such as allergic eczema, pruritus ani, pruritus vulvae, atopic dermatitis, contact dermatitis, insect bit Lugege kogu dokumenti