CISATRACURIUM ACCORD

Cisatracurium Besilate Solution for Injection 2 mg/mL and 50 mg/mL


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Cisatracurium Accord. 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 Accord ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

This leaflet provides information about Cisatracurium Accord. 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 Accord is used for

Cisatracurium Accord is used to relax the body’s muscles. Cisatracurium Accord will normally be given to you when you are in surgery, or during other medical procedures. Cisatracurium Accord is only used in conjunction with an anaesthetic, so you will be asleep during the procedure.

If you have any questions about why Cisatracurium Accord is used ask your doctor.

How does Cisatracurium Accord work?

Cisatracurium besilate (the active ingredient in Cisatracurium Accord) belongs to a group of medicines called “neuromuscular blockers”.

Cisatracurium Accord 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 Accord 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 receiving Cisatracurium Accord

Cisatracurium Accord is not suitable for everyone.

When you must not be given it

Cisatracurium Accord should not be used after the expiry date printed on the pack.

Before you are given it

Tell your doctor if:

  1. You are allergic to:
  • cisatracurium besilate, atracurium or benzenesulfonic acid.
  • any other muscle relaxants.
  1. You are pregnant or breastfeeding.
  2. You suffer from myasthenia gravis, or any other form of neuromuscular disease.
  3. You, or a relative have had previous difficulties with anaesthetics.
  4. You are allergic to any other muscle relaxant medicine.
  5. 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 Accord.

How Cisatracurium Accord is given

How much is given

Cisatracurium Accord is a medicine that is given by injection. Cisatracurium Accord 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.

If you receive too much (overdose)

Overdoses of Cisatracurium Accord lead to prolonged relaxation of the body’s muscles. This can be readily treated, however, this situation is unlikely to occur because Cisatracurium Accord is only administered by an anaesthetist or other highly trained doctor who will closely monitor your progress.

After being treated with Cisatracurium Accord

Your doctor will be able to tell you whether there are any special instructions after you have been treated with Cisatracurium Accord.

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 Accord.

It is possible that Cisatracurium Accord 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 Accord less than one patient in every 200 treated experienced these side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Other side effects not listed above may also occur is some people.

There is no evidence that Cisatracurium Accord is addictive.

Storage

Cisatracurium Accord should be stored by the hospital’s pharmacy between 2° and 8°C and protected from light.

Cisatracurium Accord 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 Accord is a pale yellow or greenish yellow solution.

Cisatracurium Accord Injection 2 mg/mL and 5 mg/mL are presented in glass vials.

Not all presentations may be marketed.

Ingredients

Active Ingredient:
Cisatracurium besilate

Inactive Ingredients:
Benzenesulfonic acid
Water for injections

Name and Address of the Sponsor

Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia

Australian Register numbers

5 mg/2.5 mL: AUST R 222412

10 mg/5 mL: AUST R 222405

20 mg/10 mL: AUST R 222411

50 mg/25 mL: AUST R 222410

150 mg/30 mL: AUST R 222413

Date of Preparation

This leaflet was prepared on 03 September 2019.

Published by MIMS November 2019


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