DBL™ Hyoscine Injection BP

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyoscine hydrobromide trihydrate 0.4 mg/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Hyoscine hydrobromide trihydrate 0.4 mg/mL

Dosage:

0.4 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Hyoscine hydrobromide trihydrate 0.4 mg/mL

Units in package:

Ampoule, glass, 5 x 1mL, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 1mL - 5 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1987-03-19

Summary of Product characteristics

Version: pfdhysci10221
Supersedes: pfdhysci10620
Page 1 of 8
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Hyoscine Injection 0.4 mg/mL Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Hyoscine Injection BP is a sterile solution of Hyoscine
hydrobromide trihydrate in Water
for Injections. Each mL contains 0.4 mg of Hyoscine hydrobromide
trihydrate in Water for
Injections.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
DBL Hyoscine Injection BP is a clear, colourless to straw coloured,
sterile solution.
The pH of the solution is between 3.8 and 4.2.
4.
CLINICAL PARTICULARS
4.1THERAPEUTIC INDICATIONS
DBL Hyoscine Injection BP is indicated as a preoperative medication to
produce sedation and
amnesia. It is also used preoperatively to inhibit salivation and
excessive secretions of the
respiratory tract.
Hyoscine hydrobromide is also indicated for the treatment of selected
cases of nausea and
vomiting resulting from motion sickness, although oral or transdermal
administration is more
frequently used for this indication.
4.2 DOSE AND METHOD OF ADMINISTRATION
_Adult dose:_ The usual adult dose is 0.3 - 0.6 mg given i.m., s.c.,
or i.v. This dose may be
repeated 3 -
4 times a day. When used as an antiemetic doses up to 1 mg have been
administered. A reduced dosage may be required in elderly or
debilitated patients or those with
hepatic or renal insufficiency.
_Paediatric dose:_ The usual paediatric dose is 6 mcg/kg body weight,
or 200 mcg/m
2
surface
area, i.m., s.c., or i.v.
Version: pfdhysci10221
Supersedes: pfdhysci10620
Page 2 of 8
METHOD OF ADMINISTRATION
DBL Hyoscine Injection BP is administered by the intramuscular,
subcutaneous or intravenous
injection. When given intravenously, the drug should be diluted with
sterile water for injection
and injected slowly with caution.
When used for preoperative medication, hyoscine hydrobromide should be
administered 30 to
60 minutes prior to induction of anaesthesia.
4.3 CONTRAINDICATIONS
DBL Hyoscine
Injec