TRACRIUM atacurium besilate 50mg/5mL injection ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atracurium besilate, Quantity: 10 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; benzenesulfonic acid

Administration route:

Intravenous

Units in package:

5 x 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tracrium is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation, and to facilitate mechanical ventilation in Intensive Care Unit (ICU) patients.

Product summary:

Visual Identification: A clear slightly yellow solution, practically free from particles.; Container Type: Ampoule; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-06-12

Patient Information leaflet

_ _
1
TRACRIUM FOR INJECTION
_atracurium besilate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
TRACRIUM. It does not
contain all of 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 being
given TRACRIUM against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TRACRIUM IS
USED FOR
TRACRIUM will be given to
you or your child during
surgery. It is used together
with anaesthetic
medicines to
relax the body’s muscles
TRACRIUM belongs to a group
of medicines called
“neuromuscular blockers”.
TRACRIUM works by blocking
the effects of one of the body’s
chemical messengers called
acetylcholine. Acetylcholine is
involved in muscle contraction.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
TRACRIUM HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed TRACRIUM for
another reason.
There is no evidence that
TRACRIUM is addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT RECEIVE _
_TRACRIUM _
•
YOU MUST NOT RECEIVE
TRACRIUM IF YOU HAVE
EVER HAD AN ALLERGIC
REACTION TO ATRACURIUM
BESILATE OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic
reaction may be mild or
severe. They usually
include some or all of the
following:
wheezing, swelling of the
lips/mouth, difficulty in
breathing, hayfever, lumpy
rash ("hives") or fainting.
_BEFORE YOU RECEIVE IT _
YOU MUST TELL YOUR DOCTOR IF:
•
YOU HAVE HAD ANY ADVERSE
REACTIONS DURING AN
OPERATION.
•
YOU HAVE HAD ANY TYPE OF
ALLERGIC REACTION TO
MUSCLE RELAXANTS, OR TO
ANY MEDICINES USED
DURING AN OPERATION.
•
YOU ARE ALLERGIC TO ANY
OTHER MEDICINES OR ANY
OTHER SUBSTANCE, SUCH AS
FOODS, DYES OR
PRESERVATIVES.
•
IF YOU OR A RELATIVE HAVE
HAD PREVIOUS DIFFICULTIES
WITH ANAE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TRACRIUM (ATRACURIUM BESILATE)
INJECTION
1
NAME OF THE MEDICINE
Atracurium besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRACRIUM injection, 10 mg atracurium besilate in each mL.
Each 2.5 mL glass ampoule contains 25 mg of atracurium besilate and
each 5 mL glass
ampoule
contains
50
mg
of
atracurium
besilate.
The
pH
is
adjusted
to
3.2-3.7
with
benzenesulfonic acid.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TRACRIUM injection is a sterile solution in water. It is a clear
slightly yellow solution; practically
free from particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TRACRIUM is a highly selective, competitive or non-depolarising
neuromuscular blocking
agent which is used as an adjunct to general anaesthesia to enable
tracheal intubation to be
performed and to relax skeletal muscles during surgery or controlled
ventilation, and to
facilitate mechanical ventilation in Intensive Care Unit (ICU)
patients.
4.2
D
OSE AND METHOD OF ADMINISTRATION
To
avoid
distress
to
the
patient,
TRACRIUM
should
not
be
administered
before
unconsciousness has been induced. TRACRIUM should not be mixed in the
same syringe,
or administered simultaneously through the same needle, with alkaline
solutions (e.g.
barbiturate solutions).
TRACRIUM
should
be
administered
intravenously.
DO
NOT
GIVE
TRACRIUM
INTRAMUSCULARLY. Intramuscular administration of TRACRIUM may result
in tissue
irritation and there is no clinical data to support this route of
administration.
BOLUS DOSES FOR INTUBATION AND MAINTENANCE OF NEUROMUSCULAR BLOCKADE
USE IN ADULTS
The initial dosage for adults ranges from 0.3 to 0.6 mg/kg (depending
on the duration of full
block required) and will provide adequate relaxation for 15 to 35
minutes.
2
A TRACRIUM dose of 0.5 to 0.6 mg/kg (2.2 to 2.6 times the ED
95
), given as an intravenous
bolus injection provides suitable conditions for non-emergency
intubation in 2 to 2.5 minutes
in most patients which is comparable to other drugs of