Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline)
Pfizer New Zealand Limited
Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline)
250 mg/10mL
Solution for injection
Active: Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline) Excipient: Edamine as 25mg/mL of aminophylline + extra q.s. to adjust pH (limit NMT 295 mg / g of theophylline) Water for injection
Ampoule, glass, 5 x 10mL, 50 mL
Prescription
Prescription
BASF PharmaChemikalien GmbH & Co KG
DBL™Aminophylline Injection is indicated for the treatment of reversible bronchospasm associated with chronic bronchitis, emphysema, bronchial asthma and chronic obstructive pulmonary disease. It may also be used for paroxysmal dyspnoea associated with left heart failure
Package - Contents - Shelf Life: Ampoule, glass, 5 x 10mL - 50 mL - 30 months from date of manufacture stored at or below 25°C - Ampoule, glass, 50 x 10mL - 500 mL - 30 months from date of manufacture stored at or below 25°C
1981-07-09
Version: pfdamini11123 Supercedes: pfdamini10422 Page 1 of 23 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Aminophylline Injection 250 mg/10 mL Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sterile solution of aminophylline (theophylline and ethylenediamine). Each mL contains 25 mg of aminophylline (equivalent to 20.63 mg of theophylline). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Aminophylline Injection 250 mg in 10 mL is a clear, colourless, solution for injection. The pH of the solution is between 8.8 and 10.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Aminophylline Injection is indicated for the treatment of reversible bronchospasm associated with chronic bronchitis, emphysema, bronchial asthma and chronic obstructive pulmonary disease. It may also be used for paroxysmal dyspnoea associated with left heart failure. 4.2 DOSE AND METHOD OF ADMINISTRATION DBL _ _ Aminophylline Injection may be administered by intravenous infusion, or by slow intravenous injection at a rate not exceeding 20 to 25 mg/min. Recommended doses are given as a guide only. Dosage must be individualised based on patient characteristics, clinical response, and steady state theophylline concentration. Doses should be calculated on lean (ideal) body weight. Oral theophylline therapy should be substituted for intravenous therapy as soon as adequate improvement has been made. A loading dose is generally administered over 20 to 30 minutes, followed by a maintenance dose. _Adults and children 6 months and over: _ For patients not currently undergoing aminophylline or theophylline therapy, a dose of 6 mg aminophylline/kg lean body weight should be infused over 20 to 30 minutes, to provide a peak Version: pfdamini11123 Supercedes: pfdamini10422 Page 2 of 23 serum theophylline concentration of approximately 10 microgram/mL (55 micromole/L). For patients currently undergoing aminophylline or theophylline therapy, a serum theophylline concentration should be obtained (see Sect Read the complete document