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Cisatracurium-AFT Injection

Cisatracurium besylate


Consumer Medicine Information

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 besylate (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.

Before CISATRACURIUM-AFT is used make sure that your doctor knows if:

  1. You are allergic to:
  • cisatracurium besylate, 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 or rapid heart beat.
  • Diuretics, used to increase your volume of urine. These may be taken to reduce oedema (swelling).
  • Magnesium or lithium salts.
  • Phenytoin or carbamazepine (for fits).
  • Any other medicine that you are taking including any you may 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-AFT.

When CISATRACURIUM-AFT must not be used

CISATRACURIUM-AFT should not be used after the expiry date printed on the pack.

Using CISATRACURIUM-AFT

CISATRACURIUM-AFT is a medicine that is given by injection. CISATRACURIUM-AFT 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 your body weight and how long the procedure will take.

If you have any questions about the dose that you will receive ask your doctor.

In case of overdose

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

After being treated with CISATRACURIUM-AFT

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

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 been given CISATRACURIUM-AFT.

It is possible that CISATRACURIUM-AFT 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 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-AFT is addictive.

Storage

CISATRACURIUM-AFT will be stored by the hospital's pharmacy at between 2 °C and 8 °C (in the refrigerator. Do not freeze. Protect from light.

CISATRACURIUM-AFT 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 CISATRACURIUM-AFT looks like

CISATRACURIUM-AFT is a colourless to pale yellow or greenish yellow solution.

CISATRACURIUM-AFT is available as:

5 mg/2.5 mL in glass ampoules: AUST R 191832

10 mg/ 5mL in glass ampoules: AUST R 191831

20 mg/10 mL in glass ampoules: AUST R 191833

150 mg/30 mL in glass vials: AUST R 191834

Ingredients

CISATRACURIUM-AFT 5 mg/2.5 mL, 10 mg/5 mL, and 20 mg/10 mL contains cisatracurium besylate equivalent to 2 mg cistracurium in every mL.

CISATRACURIUM-AFT 150 mg/30 mL contains cisatracurium besylate equivalent to 5 mg cisatracuriumin every mL.

CISATRACURIUM-AFT also contains:

  • Benzene sulfonic acid, and
  • Water for Injections.

Manufacturer

CISATRACURIUM-AFT is supplied in Australia by:

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde NSW 2113

28 July 2015

Published by MIMS June 2017

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