国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Ephedrine sulfate 30 mg/mL
Pfizer New Zealand Limited
Ephedrine sulfate 30 mg/mL
30 mg/mL
Solution for injection
Active: Ephedrine sulfate 30 mg/mL Excipient: Sodium chloride Water for injection
Ampoule, glass, 5 x 1mL, 5 dose units
Class B2 Controlled Drug
Class B2 Controlled Drug
Siegfried PharmaChemikalien Minden GmbH
Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 1mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C
1984-03-08
Hosp 7.0 Page 1 of 8 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL ™ Ephedrine Sulfate Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL ™ Ephedrine Sulfate Injection is a sterile solution of Ephedrine Sulfate in Water for Injections. Each mL contains 30 mg of Ephedrine Sulfate and 3 mg of Sodium Chloride in Water for Injections. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL ™ Ephedrine Sulfate Injection is a sterile solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL ™ Ephedrine Sulfate Injection is indicated in the treatment of shock unresponsive to fluid replacement. It is also indicated in the treatment of hypotension secondary to spinal anaesthesia. DBL ™ Ephedrine Sulfate Injection has also been used in the treatment of bronchial asthma and reversible bronchospasm although more selective agents (beta- adrenergic agonists) are now available. 4.2 DOSE AND METHOD OF ADMINISTRATION DBL ™ Ephedrine Sulfate Injection is administered by the intramuscular, subcutaneous or intravenous route. Patients in shock may require intravenous administration to ensure absorption of the drug. When administered intravenously, the injection should be given slowly. Care should be taken to avoid extravasation, since this may result in tissue necrosis and sloughing. Ephedrine sulfate should be administered in the lowest effective dose. The parenteral adult dose should not exceed 150 mg in 24 hours. As a pressor: _Adult dose:_ The usual adult dose is 25-50 mg (range 10-50 mg) administered intramuscularly or subcutaneously. Additional doses should be based on patient response. The intravenous route may be used if an immediate response is required. The dosage for the intravenous route is 10-25 mg which may be repeated every 5-10 minute until the desired response is obtained. _Paediatric dose:_ The recommended paediatric dose is 3 mg/kg/day or 100 mg/m 2 /day via the intravenous or subcutaneous route, given in 4-6 divided doses. Hosp 7.0 Page 2 of 8 During th 阅读完整的文件