Pancuronium Bromide (AstraZeneca)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pancuronium bromide 2 mg/mL

Available from:

AstraZeneca Limited

INN (International Name):

Pancuronium bromide 2 mg/mL

Dosage:

4 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Pancuronium bromide 2 mg/mL Excipient: Acetic acid Sodium acetate trihydrate Sodium chloride Sodium hydroxide Water for injection

Units in package:

Polyamp, 2mL, 50 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Prime European Therapeuticals SpA - Euticals SpA

Therapeutic indications:

An adjunct to surgical anaesthesia to induce skeletal muscle relaxation to facilitate operative manipulations. The necessary conditions for intubation can be achieved with Pancuronium alone or following suxamethonium. To promote mechanical ventilation by reducing or eliminating spontaneous breathing effort in intensive care patients.

Product summary:

Package - Contents - Shelf Life: Polyamp, 2mL - 50 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1990-07-04

Summary of Product characteristics

1
Pancuronium Bromide Data Sheet 280818
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Pancuronium Bromide B.P. 2 mg/mL solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mL sterile solution of pH 3.5-4.2 containing 4 mg pancuronium
bromide.
Excipients with known effect: sodium chloride, sodium acetate, sodium
hydroxide.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection. Clear, colourless, particle-free solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An adjunct to surgical anaesthesia to induce skeletal muscle
relaxation to facilitate operative
manipulations. The necessary conditions for intubation can be achieved
with pancuronium
alone or following suxamethonium.
Pancuronium is also indicated to promote mechanical ventilation by
reducing or eliminating
spontaneous breathing effort in intensive care patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
The following dosage information is a guide only.
Pancuronium bromide injection BP is administered intravenously. The
dosage should be
individualised for each patient as there is wide variation in
individual response to muscle
relaxants. The potential effect of the anaesthetic or any other
concomitant medicine, clinical
state of the patient and the anticipated duration of the neuromuscular
block must be taken into
account when the dosage is determined.
It is recommended that a peripheral nerve stimulator be used to
monitor response to
pancuronium bromide to minimise the risk of overdosage.
Since potent inhalation agents or prior administration of
suxamethonium enhance the intensity
of blockade and duration of action of pancuronium bromide, these
factors should be
considered when selecting initial and incremental dosage.
In heavy or obese patients calculations based on mg/kg may lead to
overdosage.
For use in one patient on one occasion only. Discard any unused
contents of an opened
ampoule.
2
Pancuronium Bromide Data Sheet 280818
ADJUNCT TO GENERAL ANAESTHESIA
ADULTS AND CHILDREN OLDER THAN 1 MONTH
INI