DBL ATRACURIUM BESYLATE 50mg/5mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atracurium besilate, Quantity: 50 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: benzenesulfonic acid; water for injections

Administration route:

Intravenous

Units in package:

5 x 5.0mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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:

Visual Identification: A clear colourless to faint yellow solution free from visible particulates.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-12-19

Patient Information leaflet

DBL™ ATRACURIUM
BESYLATE INJECTION
_Atracurium besilate (at-tra-CUR-ee-um)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given DBL
Atracurium Besylate Injection
(Atracurium), even if you have had
this medicine before.
This leaflet answers some common
questions about DBL™ Atracurium
Besylate Injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DBL
Atracurium Besylate Injection
against the benefits they expect it
will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
DBL ATRACURIUM BESYLATE
INJECTION, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
YOU MAY NEED TO READ IT AGAIN.
WHAT IS DBL
ATRACURIUM BESYLATE
INJECTION USED FOR
Atracurium (at-tra-CURE-ee-um) is a
muscle relaxant medicine. It is
usually used together with a general
anaesthetic to assist the use of a
mechanical ventilator.
It is used prior to surgery to provide
muscle relaxation during surgery or
to provide muscle relaxation for
medically assisted breathing. It will
be given to you or your child when
you/they are asleep during surgery.
It works by blocking acetylcholine,
one of the body’s chemical
messengers. Acetylcholine is
involved in muscle contraction.
However, your doctor may have
prescribed Atracurium Besylate
Injection for another purpose.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
DBL
ATRACURIUM
BESYLATE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL™
ATRACURIUM BESYLATE INJECTION IF
YOU ARE ALLERGIC TO
•
medicines containing atracurium
besilate
•
medicines containing
benzenesulfonic acid
•
other muscle relaxant medicines.
If you have an allergic reaction you
may have breathing difficulties, a
skin rash, and swelling of the lips or
tongue.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD

Summary of Product characteristics

Version: pfpatrai11021
Supersedes: pfpatrai10619
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ ATRACURIUM
BESYLATE
(ATRACURIUM
BESILATE) INJECTION
1.
NAME OF THE MEDICINE
Atracurium besilate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Atracurium Besylate Injection is a clear, colourless or faint
yellow, sterile solution
containing atracurium besilate 10 mg, in each mL of Water for
Injections. The solution also
contains benzenesulfonic acid to adjust the pH to 3.2 to 3.7.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
DBL Atracurium Besylate Injection is sterile solution for injection.
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
DOSAGE
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 (e.g. barbiturate solutions).
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 expected
within 2 to 2.5 minutes
in most patients which is comparable to other drugs of this class.
Maximum neuromuscular
blockade is generally achieved approximately 3 to 5 minutes after
administration. Under
balanced anaesthesia, this initial dose usually results in complete
neuromuscular blockade for
about 20 to 35 minutes. Spontaneous recovery to 25% of control is
generally achieved
approximately 35 to 45 minutes after administration and complete
recovery is usually achieved
within