CISATRACURIUM

Main information

  • Trade name:
  • CISATRACURIUM SXP cisatracurium (as besilate) 150mg/30mL injection solution in vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CISATRACURIUM SXP cisatracurium (as besilate) 150mg/30mL injection solution in vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 181599
  • Last update:
  • 14-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

181599

CISATRACURIUM SXP cisatracurium (as besilate) 150mg/30mL injection solution in vial

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

29/05/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CISATRACURIUM SXP cisatracurium (as besilate) 150mg/30mL injection solution in vial

Product Type

Single Medicine Product

Effective date

31/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

During surgical and other procedures and in intensive care to relax skeletal muscles, and to faciliate tracheal intubation and mechanical ventilation. An

adjunct to general anaesthesia, or sedation in intensive care units

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

18 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Store in Original

Container

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

Single vial

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Colourless to pale yellow or yellowish-greenish solution

Active Ingredients

cisatracurium besilate

6.7 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 07:41:40 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

________________________________________________________________________________

C: Products/Cisatracurium/CMI SXP oct12 14/10/12 Page

1 of 2

CISATRACURIUM SXP Injection Solution

cisatracurium (as besylate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about CISATRACURIUM

SXP. 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 SXP ask your

doctor or pharmacist.

Keep this information.

You may want to read it again.

This leaflet provides information about

CISATRACURIUM SXP. 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

SXP is used for

CISATRACURIUM SXP is used to

relax the body's muscles.

CISATRACURIUM SXP will

normally be given to you when you are

in surgery, or during other medical

procedures. CISATRACURIUM SXP

is only used in conjunction with an

anaesthetic, so you will be asleep

during the procedure.

If you have any questions about why

CISATRACURIUM SXP is used ask

your doctor.

How does

CISATRACURIUM SXP

work?

Cisatracurium besylate (the active

ingredient in CISATRACURIUM

SXP) belongs to a group of medicines

called "neuromuscular blockers".

CISATRACURIUM SXP 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 SXP 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 it

CISATRACURIUM SXP is not

suitable for everyone.

Before CISATRACURIUM SXP is

used make sure that your doctor

knows if:

1. You are allergic to:

cisatracurium besylate, atracurium

or benzenesulfonic acid.

any other muscle relaxants.

2. You are pregnant or

breastfeeding.

3. You suffer from myasthenia

gravis, or any other form of

neuromuscular disease.

4. You, or a relative have had

previous difficulties with

anaesthetics.

5. You are allergic to any other

muscle relaxant medicine.

6. You are taking any other

medication, including:

Antibiotics.

Anti-arrhythmics, which are used

to control irregular heart or rapid

heart beat.

Diuretics, used to increase your

volume of urine.

Magnesium or lithium salts.

Phenytoin or carbamazepine (for

fits).

Any other medicine that you buy

without a prescription from a

pharmacy, supermarket or health

food shop.

Your doctor will have a complete list

of the medicines that may cause

problems when taken with

CISATRACURIUM SXP.

When CISATRACURIUM SXP

must not be used

CISATRACURIUM SXP should not

be used after the expiry date printed

on the pack or if the packaging is

torn or shows signs of tampering.

Using CISATRACURIUM

CISATRACURIUM SXP is a

medicine that is given by injection.

CISATRACURIUM SXP will be

administered by an anaesthetist or

other highly trained doctor, usually

during surgery or other medical

procedures. The dosage will vary

according to many factors such as body

weight and the duration of the

procedure.

If you have any questions about the

dose that you will receive ask your

doctor.

In case of overdose

Overdoses of CISATRACURIUM

SXP lead to prolonged relaxation of

the body's muscles. This can be readily

________________________________________________________________________________

C: Products/Cisatracurium/CMI SXP oct12 14/10/12 Page

2 of 2

treated, however, this situation is

unlikely to occur because

CISATRACURIUM SXP is only

administered by an anaesthetist or

other highly trained doctor who will

closely monitor your progress.

After being treated with

CISATRACURIUM SXP

Your doctor will be able to tell you

whether there are any special

instructions after you have been treated

with CISATRACURIUM SXP.

Side effects

All medicines can have side effects.

Sometimes they are serious. Most of

the time they are not.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well after you have received

CISATRACURIUM SXP.

It is possible that CISATRACURIUM

SXP may cause the following side

effects:

Flushing of the face and upper

body.

Skin rashes.

Slow heart beat.

Low blood pressure.

Difficulty breathing.

During studies using

CISATRACURIUM SXP less than one

patient in every 200 treated

experienced these side effects.

Ask your doctor or pharmacist to

answer any questions you may have.

There is no evidence that

CISATRACURIUM SXP is addictive.

Storage

CISATRACURIUM SXP should be

stored by the hospital's pharmacy

between 2°C and 8°C and protected

from light.

CISATRACURIUM SXP does not

contain any antimicrobial preservative.

When diluted, the preparation should

be used immediately and any

remaining solution must be discarded

within 24 hours following dilution.

Product description

What it looks like

CISATRACURIUM SXP is a

colourless to pale yellow or yellowish-

greenish solution.

CISATRACURIUM SXP Injection 2

and 5 mg/mL are presented in glass

vials.

Ingredients

CISATRACURIUM SXP Injection 2

mg/mL contains 2 mg cisatracurium

(as besylate) in every mL.

CISATRACURIUM SXP Injection 5

mg/mL contains 5 mg cisatracurium

(as besylate) in every mL.

CISATRACURIUM SXP also

contains:

Benzenesulfonic acid and

Water for Injections.

Registration Number

CISATRACURIUM SXP

10mg/5mL: AUST R 181595

20mg/10mL: AUST R 181597

150mg/30mL: AUST R 181599

Sponsor

Southern Cross Pharma Pty Ltd

56 Illabunda Drive

Malua Bay NSW 2536

ABN 47 094 447 677

Date of preparation

14 October 2012