Consumer medicine information

Cisatracurium Juno

Cisatracurium

BRAND INFORMATION

Brand name

Cisatracurium Juno

Active ingredient

Cisatracurium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cisatracurium Juno.

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 Cisatracurium Juno Injection

Cisatracurium Juno Injection is not suitable for everyone. Before Cisatracurium Juno Injection is used make sure that your doctor knows 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 Juno Injection.

When Cisatracurium Juno Injection must not be used

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

Using Cisatracurium Juno Injection

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

After being treated with Cisatracurium Juno Injection

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

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 Juno Injection.

It is possible that Cisatracurium Juno Injection 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 Juno Injection 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 Juno Injection is addictive.

Storage

Cisatracurium Juno Injection should be stored by the hospital’s pharmacy between 2° and 8°C and protected from light. Do not freeze.

The product contains no antimicrobial preservative and therefore should be used immediately on dilution, or failing this should be stored at 2 to 8°C for no more than 24 hours, after which time unused solution should be discarded.

Product description

What Cisatracurium Juno Injection looks like

Cisatracurium Juno Injection is a pale yellow or greenish solution.

Cisatracurium Juno Injection 2 mg/mL (all sizes) are presented in glass ampoules.

Cisatracurium Juno Injection 5 mg/mL is presented in glass vials.

Ingredients

Cisatracurium Juno Injection 2 mg/mL contains 2 mg cisatracurium (as besilate) in every mL.

Cisatracurium Juno Injection 5 mg/mL contains 5 mg cisatracurium (as besilate) in every mL.

Cisatracurium Juno Injection also contains:

  • Benzenesulfonic acid, and
  • Water for Injections.

Name and address of the sponsor

Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne,
VIC 3121

For Medical information purposes please contact 1800 620 076 or email medical-enquiries@junopharm.com.au

Date of preparation of this leaflet May 2023.

Published by MIMS June 2023

BRAND INFORMATION

Brand name

Cisatracurium Juno

Active ingredient

Cisatracurium

Schedule

S4

 

1 Name of 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

4.9 Overdose

Symptoms and signs. Prolonged muscle paralysis and its consequences are expected to be the main signs of overdose with Cisatracurium Juno 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 Cisatracurium Juno 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 Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Cisatracurium was evaluated for genotoxic potential in a battery of four tests. It was non-genotoxic 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 studies have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

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/CSCISBES.gif CAS number. 96946-42-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes

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