Cisatracurium-AFT, 10mg/5mL, Solution for injection/infusion, Ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cisatracurium besilate, Quantity: 0.268 % w/v

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

cisatracurium besilate

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: water for injections; benzenesulfonic acid

Administration route:

Intravenous

Units in package:

5mL 1 ampoule, 5mL 5 ampoule

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cisatracurium-AFT is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

Product summary:

Visual Identification: Colourless to pale yellow or greenish yellow solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-01-25

Patient Information leaflet

1
CISATRACURIUM-AFT INJECTION
CISATRACURIUM BESILATE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CISATRACURIUM-AFT. It
does not
contain all of the available information.
Reading this leaflet does not take the place of talking to your doctor
or pharmacist.
Taking any medicine involves some risk. It is possible that all risks
associated with this
medicine
might not have been
detected, despite proper
testing. Only
your doctor or
pharmacist is able to weigh up all of the relevant facts, and you
should consult them if
you have any queries.
IF YOU HAVE ANY CONCERNS ABOUT THE USE OF CISATRACURIUM-AFT ASK YOUR
DOCTOR
OR PHARMACIST.
KEEP THIS INFORMATION. You may want to read it again.
This leaflet provides information about CISATRACURIUM-AFT. This
information should
not be applied to any other medicine, even those that are similar or
appear to contain the
same ingredients.
WHAT CISATRACURIUM-AFT IS USED FOR
CISATRACURIUM-AFT is used to relax the body's muscles.
CISATRACURIUM-AFT will
normally be given to you when you are in surgery, or during other
medical procedures.
CISATRACURIUM-AFT is only used in conjunction with an anaesthetic, so
you will be
asleep during the procedure.
IF YOU HAVE ANY
QUESTIONS ABOUT WHY CISATRACURIUM-AFT IS USED ASK YOUR
DOCTOR.
_HOW DOES CISATRACURIUM-AFT WORK?_
Cisatracurium besilate (the active ingredient in CISATRACURIUM-AFT)
belongs to a
group of medicines called "neuromuscular blockers".
CISATRACURIUM-AFT works by
blocking the effects of one of the body's chemical
messengers called acetylcholine. Acetylcholine is involved in muscle
contraction.
By relaxing your body's muscles CISATRACURIUM-AFT makes it easier for
you to be
kept asleep (under anaesthesia) or sedation.
Your doctor will be able to provide you with more information.
_BEFORE YOU ARE GIVEN CISATRACURIUM-AFT_
_ _
CISATRACURIUM-AFT IS NOT SUITABLE FOR EVERYONE.
2
BEFORE CISATRACURIUM-AFT IS USED MAKE SURE THAT YOUR DOCTOR KNOWS IF:
1.
YOU ARE ALLERGIC TO:
•
cisatracurium besilate, atracurium or benze

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
CISATRACURIUM-AFT (CISATRACURIUM BESILATE)
SOLUTION FOR INJECTION/ INFUSION
1
NAME OF THE MEDICINE
Cisatracurium besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisatracurium-AFT is supplied in two strengths, either 2 mg or 5 mg
(as the besilate salt)
of cisatracurium besilate per mL.
For the full list of excipients, see 6.1 List of excipients
3
PHARMCEUTICAL FORM
Cisatracurium-AFT is a colourless to pale yellow or greenish yellow
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisatracurium-AFT is indicated for use during surgical and other
procedures and in
intensive
care
to
relax
skeletal
muscles,
and
to
facilitate
tracheal
intubation
and
mechanical ventilation. It is used as an adjunct to general
anaesthesia, or sedation in the
intensive care unit.
4.2
DOSE AND METHOD OF ADMINISTRATION
Cisatracurium-AFT contains no antimicrobial preservative and is
intended for single use
in one patient only. Discard any residue.
USE BY INTRAVENOUS BOLUS INJECTION
_Dosage in adults _
Tracheal intubation
The recommended intubation dose of
Cisatracurium-AFT for adults is 0.15 mg/kg
bodyweight. This dose produces good to excellent conditions for
tracheal intubation 120
seconds following injection.
Higher doses will shorten the time to onset of neuromuscular block.
The following table,
Table 1 summarises mean pharmacodynamic data when cisatracurium was
administered
at
doses
of
0.1
to
0.4
mg/kg
bodyweight
to
healthy
adult
patients
during
opioid
(thiopentone/fentanyl/midazolam) or propofol anaesthesia.
2
Table 1
Initial
cisatracurium
dose (mg/kg
body weight)
Anaesthetic
background
Time to 90%
T
1
*
suppression
(min)
Time to
maximum
T
1
*
s
uppression
(min)
Time to
spontaneous T
1
*
recovery (min)
0.1
Opioid
3.4
4.8
45
0.15
Propofol
2.6
3.5
55
0.2
Opioid
2.4
2.9
65
0.4
Opioid
1.5
1.9
91
* Single twitch response as well as the first component of the
Train-of-Four response of the
adductor pollicis muscle following the supramaximal electrical
stimulation of the ulnar
nerve
Enflurane or