Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Theophylline 125mg; ; Theophylline 125mg
iNova Pharmaceuticals (New Zealand) Limited
Theophylline 125 mg
125 mg
Modified release tablet
Active: Theophylline 125mg Excipient: Cellacefate Lactose monohydrate Magnesium stearate Active: Theophylline 125mg Excipient: Guar gum Magnesium stearate
Blister pack, PVC/PVDC, 100 tablets, 100 tablets
Prescription
Prescription
BASF PharmaChemikalien GmbH & Co KG
Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1982-02-17
NEW ZEALAND DATA SHEET NEULIN TM -SR NUELIN-SR Page 1 of 8 1 PRODUCT NAME NUELIN-SR 250 mg sustained release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains theophylline BP 250 mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Sustained release tablet. White, round, biconvex tablets marked 250 on one face and no markings on the other face. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications NUELIN-SR tablets are indicated for the relief and prophylaxis of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema. 4.2 Dose and method of administration Desirable therapeutic levels are considered to be between 10-20 µg/mL (55-110 µmol/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within the therapeutic range. Monitoring is recommended, in particular when dose levels exceed 1g daily in adults or 24 mg/kg daily in children. NUELIN-SR doses should be adjusted for factors known to affect theophylline clearance (see sections 4.4 and 4.5). Dose Adults: 13 mg/kg per 24 hours. _Paediatric Population _ Children over 2 years: Starting dose 16 mg/kg every 24 hours to a mean 20 mg/kg every 24 hours. Children under 2 years: Not to be given except on the advice of a physician. Children (from 6 months to 16 years) have a more rapid clearance of theophylline resulting in the need for higher per kg doses. _Special Populations _ Where possible patients should be commenced on a lower dose and gradually increased to the maintenance dose to minimise the incidence of side effects. Extra caution is required with the elderly as they may have slower clearance rates. Obese patients should be dosed on the basis of ideal rather than actual body weight. Smokers often require higher doses than non-smokers due to more rapid clearance of theophylline. _ _ NEW ZEALAND DATA SHEET NEULIN TM Preberite celoten dokument