Rocuronium bromide

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rocuronium bromide 10 mg/mL;  

Available from:

Max Health Limited

INN (International Name):

Rocuronium bromide 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Rocuronium bromide 10 mg/mL   Excipient: Glacial acetic acid Sodium acetate trihydrate Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Sicor de Mexico SA de CV

Therapeutic indications:

Rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, and paediatric patients from term newborn infants to adolescents. In adults, rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated. In adults, rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 5 mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 10mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 5mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 2.5mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 10mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1, 2.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 30°C. Do not refrigerate. Do not freeze. 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2014-08-05

Summary of Product characteristics

Rocuronium bromide Medsurge-data sheet v0.1 February 2023
Page 1 of 14
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Rocuronium bromide 50 mg/5 mL solution for injection Medsurge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL rocuronium bromide solution for injection contains 10 mg
rocuronium bromide.
For a List of excipients see section 6.1
3 PHARMACEUTICAL FORM
Rocuronium bromide Medsurge is supplied as a clear, colourless to pale
yellow solution for
intravenous injection.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rocuronium is indicated as an adjunct to general anaesthesia to
facilitate endotracheal
intubation during routine induction, to provide muscle relaxation and
to facilitate mechanical
ventilation in adults, and paediatric patients from term newborn
infants to adolescents.
In adults, rocuronium is also indicated as an adjunct to general
anaesthesia to facilitate
endotracheal
intubation
during
rapid
sequence
induction
when
suxamethonium
is
contraindicated.
In adults, rocuronium is also indicated as an adjunct in the intensive
care unit (ICU) to
facilitate mechanical ventilation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
Like other neuromuscular blocking agents, rocuronium bromide should
only be administered
by, or under supervision of, experienced clinicians who are familiar
with the action and use of
these agents.
The dosage of rocuronium bromide should be individualized in each
patient. The method of
anaesthesia and the expected duration of surgery, the method of
sedation and the expected
duration of mechanical ventilation, the possible interaction with
other medicines that are
administered concomitantly and the condition of the patient should be
taken into account
when determining the dose. The use of an appropriate neuromuscular
monitoring technique
is recommended for the evaluation of neuromuscular block and recovery.
Inhalational anaesthetics do potentiate the neuromuscular blocking
effects of rocuronium
bromide. This potentiation, however, becomes clinically relevant in
the course of anaes