AJ-Cisatracurium (Agila Jamp Canada, PM 00021345): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• AJ-CISATRACURIUM is used for providing muscle

  relaxation during surgery, or during other medical procedures. AJ-CISATRACURIUM is only used in conjunction with an anesthetic.

What it does:

AJ-CISATRACURIUM belongs to a group of medicines called neuromuscular blockers. It works by blocking the effects of acetylcholine, a chemical involved in muscle contraction. This relaxes muscles in the body before surgery of insertion of a breathing tube.

When it should not be used:

AJ-CISATRACURIUM should not be used in neonates (infants less than 1 month of age) or low birth weight infants. Before surgery, be sure to tell all consulting physicians if you:

• are allergic to cisatracurium besylate;

• are allergic to any other bis-benzylisoquinolinium

  agents;

• are allergic to benzyl alcohol.

What the medicinal ingredient is:

cisatracurium besylate

What the non-medicinal ingredients are:

AJ-CISATRACURIUM (multiple-dose vials) also contains benzenesulfonic acid, benzyl alcohol, and water for injection.

What dosage forms it comes in:

AJ-CISATRACURIUM is available as an injection in vials of 2 mg/mL (10 mL multiple-dose vial)

WARNINGS AND PRECAUTIONS

Before you use • AJ-CISATRACURIUM talk to your doctor or pharmacist if:

• You have difficulty with intubations
• You are susceptible to malignant hyperthermia
• You have kidney or liver problems

• You are pregnant, plan to become pregnant, or are breast-feeding

• You are taking any prescription or non-prescription medications or herbal medicines
• You are allergic to cisatracurium besylate, other medications or substances (e.g., benzyl alcohol)
• You have muscle weakness or partial paralysis on one side of the body or partial paralysis affecting the lower limbs (e.g., Labert-Eaton syndrome, myasthenia gravis)
• You have an electrolyte disturbance or acid-base imbalance or tissue wasting, or are debilitated
• You have had a burn injury requiring medical treatment

AJ-CISATRACURIUM multiple-does vial contains benzyl alcohol, which could be lethal to neonates (infants less than 1 month of age) and low birth weight infants.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with • AJ-CISATRACURIUM include:

• succinylcholine
• inhalation anesthetics (e.g., isoflurane, enflurane)
• anticonvulsants (e.g., phenytoin, carbamazepine)
• antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin)
• anti-arrhythmics (e.g., procainamide and quinidine)
• lithium and magnesium salts
• local anesthetics

PROPER USE OF THIS MEDICATION

Usual dose:

AJ-CISATRACURIUM is a medicine that is given by injection. AJ-CISATRACURIUM will be administered by an anesthetist or other trained professional during surgery or other medical procedures. The dosage will vary according to many factors such as body weight, age and the duration of the procedure. It will be given to you once you are anesthetized (lost all awareness) for your surgery or procedure.

IMPORTANT: PLEASE READ

AJ-CISATRACURIUM (Cisatracurium Besylate Injection) Product Monograph Page 31 of 31 Overdose:

• Overdose of AJ-CISATRACURIUM lead to prolonged

  relaxation of the body’s muscles. This can be readily treated; however; this situation is unlikely to occur because AJ-CISATRACURIUM is only administered by an anesthetist or other trained doctor who will closely monitor your progress.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, AJ-CISATRACURIUM can cause uncommon side effects which include flushing, skin rashes, feeling agitated, increased cough, nausea, and vomiting.

After exposure to AJ-CISATRACURIUM, you should contact your physician or anesthesia professional if you have any of the side effects listed in the table below.

This is not a complete list of side effects. For any unexpected effects while taking AJ-CISATRACURIUM, contact your doctor or pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found by contacting the sponsor, Agila-Jamp Canada Inc, at 1-866-399-9091.

Agila Jamp Canada Inc.

1380-203 Newton

Boucherville, Québec

J4B 5H2

Last revised: July 17, 2013