מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Promethazine hydrochloride 25 mg/mL
Pfizer New Zealand Limited
Promethazine hydrochloride 25 mg/mL
50 mg/2mL
Solution for injection
Active: Promethazine hydrochloride 25 mg/mL Excipient: Glacial acetic acid Sodium acetate trihydrate Sodium edetate Sodium metabisulfite Water for injection
Ampoule, glass, 5 x 2mL, 10 mL
Prescription
Prescription
Sigma-Aldrich Ireland Ltd
DBL™ Promethazine Hydrochloride Injection BP is indicated for the following conditions: Treatment of allergic reactions such as: uncomplicated allergic conditions of the immediate type, eg. Pruritus, urticaria and angioedema, when oraltherapy is impossible or contraindicated Treatment and prevention of vomiting including: motion sickness; drug induced nausea; prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery, such as procedures with a high incidence of postoperative vomiting (eg. gynaecological surgery, strabismus or middle ear surgery, and electroconvulsive therapy); in patients with a past history of motion sickness or post operative vomiting; and in patients in whom avoidance of vomiting is crucial (eg. Neurosurgery and eye surgery); Promethazine has sedative effects and it is also used in: preoperative, postoperative and obstetric (during labour) sedation.
Package - Contents - Shelf Life: Ampoule, glass, 2mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
1989-09-07
Version: pfdprozi10819 Supercede: 6.0 Page 1 of 10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME_ _ DBL ™ Promethazine Hydrochloride Injection, 50 mg/2 mL, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 25.0 mg promethazine hydrochloride, 0.10 mg disodium edetate, 1.30 microlitre glacial acetic acid, 27.2 mg sodium acetate and 1.32 mg sodium metabisulfite in water for injection. EXCIPIENT WITH KNOWN EFFECT • Sodium metabisulfite For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection DBL Promethazine Hydrochloride Injection is a clear, colourless solution of pH 5.0 - 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Promethazine Hydrochloride Injection is indicated for the following conditions: Treatment of allergic reactions such as: • uncomplicated allergic conditions of the immediate type, e.g., Pruritus, urticaria and angioedema, when oral therapy is impossible or contraindicated; Treatment and prevention of vomiting including: • motion sickness; • drug induced nausea; • prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery, such as procedures with a high incidence of postoperative vomiting (e.g., gynaecological surgery, strabismus or middle ear surgery, and electroconvulsive therapy); in patients with a past history of motion sickness or post operative vomiting; and in patients in whom avoidance of vomiting is crucial (e.g., Neurosurgery and eye surgery); Promethazine has sedative effects and it is also used in: Version: pfdprozi10819 Supercede: 6.0 Page 2 of 10 • preoperative, postoperative and obstetric (during labour) sedation. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE All routes of administration can cause damage to tissues (see section 4.3 and section 4.4). The preferred route of administration of DBL Promethazine Hydrochloride Injection is by deep intramuscular injection. Intramuscular injection may be painful. Promethazine should only be admin קרא את המסמך השלם