Country: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Pholcodine 1 mg/mL; ; ;
iNova Pharmaceuticals (New Zealand) Limited
Pholcodine 1 mg/mL
1 mg/mL
Oral solution
Active: Pholcodine 1 mg/mL Excipient: Citric acid Disodium edetate dihydrate Hyetellose Purified water Saccharin sodium Sodium benzoate Sodium citrate dihydrate Sorbitol Tutti frutti flavour 051880 A7
Bottle, plastic, amber PET bottle with ppp tamper evident wadded cap, 100 mL
Pharmacy only
Restricted
Ajinomoto OmniChem SA
Package - Contents - Shelf Life: Bottle, plastic, amber PET bottle with ppp tamper evident wadded cap - 100 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, PET amber bottle with pp tamper evident wadded cap - 200 mL - 24 months from date of manufacture stored at or below 30°C
2009-07-15
NEW ZEALAND DATA SHEET Page 1 of 4 1 PRODUCT NAME Duro-Tuss Dry Cough Liquid Regular 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 mL of the medicine contains 15 mg pholcodine as the active ingredient. Excipients with known effect: Sodium benzoate, saccharin sodium and sorbitol. For full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Oral solution. A colourless, slightly viscous liquid with fruity odour. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Temporary relief of dry coughs. 4.2 Dose and method of administration For oral administration. AGE DOSAGE HOW OFTEN Adults & children 12 years & over 10 – 15 mL Every 6 hours as required (Maximum 4 times a day) Children 6-11 years 5 – 10 mL Children under 6 years Do not use 4.3 Contraindications • Children under the age of 6 years. • Hypersensitivity to pholcodine or any of the excipients listed in section 6.1 . • Patients in, or at risk of developing respiratory failure, (may depress respiration). • Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention. • Patients with renal or hepatic failure. • Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5 ). 4.4 Special warnings and precautions for use Use with caution in patients with liver or renal disease. Pholcodine should be used with caution in patients with chronic or persistent cough, asthma including an acute asthma attack or where cough is accompanied by excessive secretions. Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine-containing products, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Duro-Tuss Dry Cough Liquid Regular should be withdrawn immediately. NEW ZEALAND DATA SHEET Page সম্পূর্ণ নথি পড়ুন