DBL™ Atracurium Besylate Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atracurium besilate 10 mg/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Atracurium besilate 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Atracurium besilate 10 mg/mL Excipient: Benzenesulfonic acid Water for injection

Units in package:

Ampoule, glass, 5x 2.5mL, 12.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Farmhispania SA

Therapeutic indications:

DBL™ Atracurium Besylate Injection is indicated as an adjunct to general anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5x 2.5mL - 12.5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, 5x 5mL - 25 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1999-10-21

Summary of Product characteristics

Version 5.0
Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL
™
Atracurium Besylate Injection
10 mg/mL
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
™
Atracurium Besylate Injection contains atracurium besilate 10 mg, in
each mL.
The solution also contains benzenesulfonic acid to adjust the pH.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL™ Atracurium Besylate Injection is a clear, colourless or faint
yellow, sterile solution
for injection
The pH is adjusted between 3.2 to 7.7.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
™
Atracurium Besylate Injection is indicated as an adjunct to general
anaesthesia, to
facilitate endotracheal intubation and to provide skeletal muscle
relaxation during surgery or
mechanical ventilation.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL
™
Atracurium Besylate Injection should only be administered
intravenously.
_DO NOT _
_GIVE DBL_
_™_
_ATRACURIUM BESYLATE INJECTION INTRAMUSCULARLY_
since this may result in tissue
irritation and there are no clinical data to support this route of
administration.
To
avoid
distress
to
the
patient,
DBL
™
Atracurium
Besylate
Injection
should
not
be
administered before unconsciousness has been induced. DBL
™
Atracurium Besylate Injection
should not be mixed in the same syringe, or administered
simultaneously through the same
needle, with alkaline solutions (eg barbiturate solutions).
To accurately monitor the degree of muscle relaxation and to minimise
the possibility of
overdose, the use of a peripheral nerve stimulator is recommended to
monitor muscle twitch
suppression and recovery in patients using DBL
™
Atracurium Besylate Injection during
anaesthesia.
Version 5.0
Page 2 of 17
INITIAL BOLUS DOSES FOR INTUBATION
An atracurium besilate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the
ED
95
), given as an
intravenous bolus injection, is the recommended initial dose for most
patients. Following this
dose, suitable conditions for non-emergency intubation can be expect