DBL™ Promethazine hydrochloride

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Promethazine hydrochloride 25 mg/mL

Saatavilla:

Pfizer New Zealand Limited

INN (Kansainvälinen yleisnimi):

Promethazine hydrochloride 25 mg/mL

Annos:

50 mg/2mL

Lääkemuoto:

Solution for injection

Koostumus:

Active: Promethazine hydrochloride 25 mg/mL Excipient: Glacial acetic acid Sodium acetate trihydrate Sodium edetate Sodium metabisulfite Water for injection

Kpl paketissa:

Ampoule, glass, 5 x 2mL, 10 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Sigma-Aldrich Ireland Ltd

Käyttöaiheet:

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.

Tuoteyhteenveto:

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

Valtuutus päivämäärä:

1989-09-07

Valmisteyhteenveto

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