Patient Medication Information: uses, side effects, how to take - AJ-Cisatracurium (Agila Jamp Canada, PM 00021344)
ABOUT THIS MEDICATION
What the medication is used for:
AJ-CISATRACURIUM (preservative-free) is used for
providing muscle relaxation during surgery, or during other medical procedures. AJ-CISATRACURIUM (preservative-free) is only used in conjunction with an anesthetic.
What it does:
AJ-CISATRACURIUM (preservative-free) 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:
Before surgery, be sure to tell all consulting physicians if you:
- are allergic to cisatracurium besylate;
are allergic to any other bis-benzylisoquinolinium
agents.
What the medicinal ingredient is:
cisatracurium besylate
What the non-medicinal ingredients are:
AJ-CISATRACURIUM (preservative-free) (single dose vials) also contains benzenesulfonic acid and water for injection.
What dosage forms it comes in:
AJ-CISATRACURIUM (preservative-free) is available as an injection in vials of 2 mg/mL (5 mL single dose vial)
WARNINGS AND PRECAUTIONS
Before you use • AJ-CISATRACURIUM (preservative-free) 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
- 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
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with AJ-CISATRACURIUM (preservative-free) 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 (preservative-free) is a medicine that is given by injection. AJ-CISATRACURIUM (preservative-free) 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.
Overdose:
Overdose of AJ-CISATRACURIUM (preservative-free)
lead to prolonged relaxation of the body’s muscles. This can be readily treated; however; this situation is unlikely to occur because AJ-CISATRACURIUM (preservative-free) is only administered by an anesthetist or other trained doctor who will closely monitor your progress.
IMPORTANT: PLEASE READ
AJ-CISATRACURIUM (Cisatracurium Besylate Injection) preservative-free Product Monograph Page 30 of 30 SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, AJ-CISATRACURIUM (preservative-free) can cause uncommon side effects which include flushing, skin rashes, feeling agitated, increased cough, nausea, and vomiting.
After exposure to AJ-CISATRACURIUM (preservative-free), you should contact your physician or anesthesia professional if you have any of the side effects listed in the table below.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom/Effect | Talk with your doctor or anesthesia professional | Stop taking drug and call your doctor or pharmacists | |||
| Only if Severe | In all Cases | ||||
| Common | Allergic Reactions | ☑ | |||
| ☑ | ||||
| ☑ | ||||
| ☑ | ||||
| ☑ | ||||
| ☑ | ||||
| Chills | ☑ | ||||
| Difficulty Breathing/ Choking | ☑ | ||||
| Dizziness | ☑ | ||||
| Elevated Blood Glucose | ☑ | ||||
| High Blood Pressure | ☑ | ||||
Jaundice/ Yellowing of the Eyeballs | ☑ | ||||
| Low Blood Pressure | ☑ | ||||
| Rapid Heartbeat | ☑ | ||||
| Seizures/ Seizure-like activity | ☑ | ||||
| Severe Itching | ☑ | ||||
| Slow Heartbeat | ☑ | ||||
Sudden fever with stiffness, pain and weakness in muscles | ☑ | ||||
| Wheezing | ☑ | ||||
This is not a complete list of side effects. For any unexpected effects while taking AJ-CISATRACURIUM (preservative-free), 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