Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Nicotinic acid 504.79mg
Apotex NZ Ltd
Nicotinic acid 504.79 mg
500 mg
Tablet
Active: Nicotinic acid 504.79mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Ethanol Lactose monohydrate Magnesium stearate Povidone
Bottle, plastic, HDPE bottle with polypropylene or HDPE cap, 100 tablets
Prescription
Prescription
Lonza AG
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with polypropylene or HDPE cap - 100 tablets - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with polypropylene or HDPE cap - 500 tablets - 48 months from date of manufacture stored at or below 30°C
1969-12-31
NEW ZEALAND DATA SHEET APO-NICOTINIC ACID Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 8 1. APO-NICOTINIC ACID (50MG & 500MG TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NAME AND STRENGTH OF THE ACTIVE SUBSTANCE Nicotinic acid 50 mg Nicotinic acid 500 mg Excipient with known effect Lactose Apo-Nicotinic acid contain Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Apo-Nicotinic acid is gluten free. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM APO-NICOTINIC ACID 50mg tablets are white, round, 7mm in diameter, flat faced with beveled edged. Each tablet contains 50mg nicotinic acid and typically weighs 130mg. APO-NICOTINIC ACID 500mg tablets are white, round, biconvex tablets, 12.5mm in diameter. Each tablet contains 500mg nicotinic acid and typically weighs 623mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Apo-Nicotinic Acid is indicated as a direct vitamin supplement, to treat conditions caused by nicotinic acid deficiency such as pellagra, and for the treatment of hyperlipidaemia. It is recommended for use only in patients with primary hyperlipidaemia (type IIa, IIb, III, IV or V hyperlipoproteinaemia). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Hyperlipidaemia For treatment regime begin with an oral dose of 100mg three times daily, which is gradually increased to an average dose of 1g three times daily with a maximum dose of 6 to 9 grams. Nicotinic Acid Deficiency A dose of up to 500mg per day has been used in the treatment and prevention of pellagra. A dose of 10mg - 20mg per day is suggested for the treatment of nicotinic acid deficiency. APO-NICOTINIC ACID Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 8 Use of nicotinic acid in children under 2 years of age is not recommended since cholesterol is required for normal development. METHOD OF ADMINISTRATION MAXIMUM TOLERATED DA Izlasiet visu dokumentu