CISATRACURIUM JUNO cisatracurium (as besilate) 20mg/10mL Solution for Injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cisatracurium besilate, Quantity: 28.14 mg (Equivalent: cisatracurium, Qty 21 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

cisatracurium besilate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; benzenesulfonic acid

Administration route:

Intravenous

Units in package:

5 Pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cisatracurium injection 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: A colourless to pale yellow or greenish solution in Type 1 colourless and transparent glass ampoule; 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:

2016-01-29

Patient Information leaflet

CISATRACURIUM JUNO SOLUTION FOR
INJECTION
_CISATRACURIUM BESILATE_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cisatracurium Juno Injection.
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 JUNO INJECTION ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION.
You may want to read it again.
This leaflet provides information about
Cisatracurium Juno Injection. The statements
that are made in this leaflet cannot be
applied to any other medicine, even those
that are similar or appear to contain the
same ingredients.
WHAT CISATRACURIUM JUNO INJECTION
IS USED FOR
Cisatracurium Juno Injection is used to relax
the body’s muscles. Cisatracurium Juno
Injection will normally be given to you when
you are in surgery, or during other medical
procedures. Cisatracurium Juno Injection is
only used in conjunction with an anaesthetic,
so you will be asleep during the procedure.
IF YOU HAVE ANY QUESTIONS ABOUT WHY
CISATRACURIUM JUNO INJECTION IS USED ASK
YOUR DOCTOR.
_HOW DOES CISATRACURIUM JUNO INJECTION _
_WORK?_
Cisatracurium besilate (the active ingredient
in Cisatracurium Juno Injection) belongs to
a group of medicines called “neuromuscular
blockers”.
Cisatracurium Juno Injection 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 Juno Injection 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 USE CISATRAC

Summary of Product characteristics

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
CISATRACURIUM JUNO (CISATRACURIUM BESILATE) SOLUTION FOR
INJECTION
_ _
1 NAME OF THE MEDICINE
Cisatracurium besilate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisatracurium besilate is a white to pale yellow powder.
Cisatracurium Juno Injection is supplied in two strengths, either 2 mg
or 5 mg of cisatracurium
(as besilate) per mL. Cisatracurium Juno Injection does not contain
any preservative and is
intended for single patient use only.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Cisatracurium Juno Injection is a colourless to pale yellow or
greenish solution. It is available
in strengths of either 2 mg/mL (ampoules) or 5 mg/mL (vials).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisatracurium Juno Injection 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 Juno Injection contains no antimicrobial preservative
and is intended for single
patient use.
USE BY INTRAVENOUS BOLUS INJECTION
ADULTS AND ADOLESCENTS OVER 12 YEARS
_Tracheal intubation_. The recommended intubation dose of
Cisatracurium Juno Injection 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.
Table 1 summarises
mean pharmacodynamic data when cisatracurium besilate 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.
Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 2
TABLE 1
Enflurane or isoflurane anaesthesia may extend the clinically
effective duration of an ini