Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
promethazine hydrochloride, Quantity: 25 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: disodium edetate; sodium metabisulfite; glacial acetic acid; sodium acetate; water for injections
Intramuscular, Intravenous
5x50mg/2mL
(S4) Prescription Only Medicine
INDICATION AS 8 January 2004: Promethazine Hydrochloride Injection BP 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 post-operative 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: pre-operative, post-operative and obstetric (during labour) sedation.
Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-08
DBL™ PROMETHAZINE HYDROCHLORIDE INJECTION BP D B L ™ P r o m e t h a z i n e H y d r o c h l o r i d e I n j e c t i o n B P CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING TREATED WITH DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP? DBL Promethazine Hydrochloride Injection BP contains the active ingredient promethazine hydrochloride. DBL Promethazine Hydrochloride Injection BP is used to treat allergic reactions, to relieve nausea, vomiting and dizziness and/or as a sedative. For more information, see Section 1. Why am I being treated with DBL Promethazine Hydrochloride Injection BP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP? Do not use if you have ever had an allergic reaction to promethazine hydrochloride, phenothiazine-derivative medicines or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before treatment with DBL Promethazine Hydrochloride Injection BP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Promethazine Hydrochloride Injection BP and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP GIVEN? Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight. It must only be given by a doctor or nurse. More instructions can be found in Section 4. How is DBL Promethazine Hydrochloride Injection BP given? in the full CMI. 5. WHAT SHOULD I KNOW DURING TREATMENT WITH DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP? THINGS YOU SHOULD DO • Remind any doctor, nurse, pharmacis Les hele dokumentet
Version: pfpprozi10719 supersedes: Version 10.0 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION – DBL™ PROMETHAZINE HYDROCHLORIDE INJECTION BP (PROMETHAZINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Promethazine hydrochloride 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 injections. EXCIPIENT(S) WITH KNOWN EFFECT Sodium metabisulfite For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL™ Promethazine Hydrochloride Injection BP is a clear, colourless solution of pH 5.0 to 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL™ Promethazine Hydrochloride Injection BP 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 post-operative 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: pfpprozi10719 supersedes: Version 10.0 Page 2 of 10 • pre-operative, post-operative and obstetric (during labour) sedation. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _ALLERGIC CONDITIONS _ _Adults:_ 25 mg to 50 mg by deep intramuscular injection or slow intravenous injection; may be repeated within two hours if necessary. Maximum dose up to 150 mg da Les hele dokumentet