Consumer medicine information

Nimbex 10 mg/5 mL Solution for injection

Cisatracurium

BRAND INFORMATION

Brand name

Nimbex

Active ingredient

Cisatracurium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nimbex 10 mg/5 mL Solution for injection.

What is in this leaflet


This leaflet answers some common questions about Nimbex. It does not contain all of the available information.
Taking any medicine involves some risk. It is possible that all risks associated with this medicine might not have been detected, despite proper testing.
If you have any concerns about the use of Nimbex ask your doctor.
Keep this information.
You may want to read it again.
This leaflet provides information about Nimbex. 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 Nimbex is used for


Nimbex is used to relax the body’s muscles. Nimbex will normally be given to you when you are in surgery, or during other medical procedures. Nimbex is only used in conjunction with an anaesthetic, so you will be asleep during the procedure.
If you have any questions about why Nimbex is used ask your doctor.

How does Nimbex work?


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


Nimbex is not suitable for everyone.
Before Nimbex is used make sure that your doctor knows if:
1. You are allergic to:

  • cisatracurium besilate, 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 Nimbex.

When Nimbex must not be used


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

Using Nimbex


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

After being treated with Nimbex


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

Side effects


All medicines can have side effects. Sometimes they are serious. Most of the time they are not.
Tell your doctor as soon as possible if you do not feel well after you have received Nimbex.
It is possible that Nimbex may cause the following side effects:

  • Flushing of the face and upper body,
  • Slow heart beat,
  • Low blood pressure,
  • Skin rashes or ‘hives’ anywhere on the body,
  • Swelling of eyelids, face, lips mouth or tongue,
  • Difficulty breathing, collapse and shock.

Ask your doctor to answer any questions you may have.
Other side effects not listed above may also occur in some people.
There is no evidence that Nimbex is addictive.

Storage


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


Nimbex is a pale yellow or greenish yellow solution.
Nimbex Injection 2 mg/mL (all sizes) are presented in glass ampoules. Available in packs of 5 ampoules.
Nimbex Injection 5 mg/mL is presented in glass vials. Available in packs of 1 vial.

Ingredients


Nimbex Injection 2 mg/mL contains 2 mg cisatracurium besilate in every mL.
Nimbex Injection 5 mg/mL contains 5 mg cisatracurium besilate in every mL.
Nimbex also contains benzenesulfonic acid and water for Injections.

Sponsor


Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia.
Nimbex Australian Registration Numbers:
  • 5 mg/2.5 mL injection ampoule - AUST R 55913
  • 10 mg/5 mL injection ampoule - AUST R 55931
  • 150 mg/30 mL injection vial – AUST R 55934

This leaflet was revised in January 2023.

BRAND INFORMATION

Brand name

Nimbex

Active ingredient

Cisatracurium

Schedule

S4

 

1 Name of Medicine

Cisatracurium besilate.

2 Qualitative and Quantitative Composition

Nimbex injection is supplied in two strengths, either 2 mg or 5 mg of cisatracurium besilate per mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nimbex injection is a colourless to pale yellow or greenish solution, practically free from visible particulate matter.

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. Prolonged muscle paralysis and its consequences are expected to be the main signs of overdose with Nimbex injection.
Management. It is essential to maintain pulmonary ventilation and arterial oxygenation until adequate spontaneous respiration returns. Full sedation will be required since consciousness is not impaired by Nimbex injection. Recovery may be accelerated by the administration of anticholinesterase agents once evidence of spontaneous recovery is present.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Cisatracurium was evaluated for genotoxic potential in a battery of four tests. It was nongenotoxic in assays for clastogenic activity (in vitro human lymphocyte cytogenetics assay and a rat bone marrow cytogenetics assay) and an Ames Salmonella assay for gene mutations. As was the case with atracurium, the mouse lymphoma assay was positive.
Carcinogenicity. Carcinogenesis and fertility studies have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Cisatracurium besilate is a white to pale yellow powder. The chemical name of cisatracurium besilate is (1R,1'R,2R,2'R,)-2, 2'-(3,11-dioxo-4,10-dioxatridecamethylene) bis (1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium) dibenzenesulfonate. The molecular formula of cisatracurium besilate is C65H82N2O18S2 and it has a molecular weight of 1243.5.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCISABE.gif CAS number. 96946-42-8.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NIMBEXST.gif