Consumer Information for: CISATRACURIUM OMEGA SINGLE DOSE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE are used for providing muscle relaxation during surgery, or during other medical procedures. CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE are only used in conjunction with an anesthetic.
What it does
CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE belong to a group of medicines called neuromuscular blockers. They work by blocking the effects of acetylcholine, a chemical involved in muscle contraction. This relaxes muscles in the body before surgery or insertion of a breathing tube.
When it should not be used
CISATRACURIUM OMEGA SINGLE DOSE should not be used in neonates (infants less than 1 month of age), low birth weight infants. Cisatracurium is not indicated for children less than 2 years old. Before surgery, be sure to tell all consulting physicians if you:
- are allergic to cisatracurium besylate;
- are allergic to any bis-benzylisoquinolinium agents;
CISATRACURIUM OMEGA MULTI-DOSE should not be used in neonates (infants less than 1 month of age), low birth weight infants. Cisatracurium is not indicated for children less than 2 years old. Before surgery, be sure to tell all consulting physicians if you:
- are allergic to cisatracurium besylate;
- are allergic to any bis-benzylisoquinolinium agents;
- are allergic to benzyl alcohol;
What the medicinal ingredient is
cisatracurium besylate
What the non-medicinal ingredients are
CISATRACURIUM OMEGA SINGLE DOSE also contains benzenesulfonic acid, and water for injection.
CISATRACURIUM OMEGA MULTI-DOSE also contains benzenesulfonic acid, benzyl alcohol and water for injection.
What dosage form it comes in
CISATRACURIUM OMEGA SINGLE DOSE is available as an injection in vials of 2 mg/mL (5 mL single dose vial). CISATRACURIUM OMEGA MULTI-DOSE is available as an injection in vials of 2 mg/mL (10 mL multiple-dose vial).
Warnings and precautions
BEFORE you use CISATRACURIUM OMEGA SINGLE DOSE or CISATRACURIUM OMEGA MULTI-DOSE 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 (eg, Lambert-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
CISATRACURIUM OMEGA MULTI-DOSE contains benzyl alcohol, which could be lethal to neonates (infants less than 1 month of age), low birth weight infants. Cisatracurium is not indicated for children less than 2 years old.
Interactions with this medication
Drugs that may interact with CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE 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
CISATRACURIUM OMEGA SINGLE DOSE or CISATRACURIUM OMEGA MULTI-DOSE is a medicine that is given by injection. CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE will be administered by an anaesthetist 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 anesthetised (lost all awareness) for your surgery or procedure.
Overdose
Side effects and what to do about them
Like all medicines, CISATRACURIUM OMEGA SINGLE DOSE and CISATRACURIUM OMEGA MULTI-DOSE can cause uncommon side effects which include flushing, skin rashes, feeling agitated, increased cough, nausea, and vomiting.
After exposure to CISATRACURIUM OMEGA SINGLE DOSE or CISATRACURIUM OMEGA MULTI-DOSE, you should contact your physician or anesthesia professional if you have any of the side effects listed in the table below.
| Symptom / effect | Talk with your doctor or anesthesia professional Only if severe | Talk with your doctor or anesthesia professional In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Allergic Reactions | ✔ | ||
| - Rash | ✔ | ||
| - Hives | ✔ | ||
| - Swelling of the face, throat, lips | ✔ | ||
| Difficulty breathing | ✔ | ||
| Difficulty swallowing | ✔ | ||
| 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 CISATRACURIUM OMEGA SINGLE DOSE or CISATRACURIUM OMEGA MULTI-DOSE, contact your doctor or pharmacist.
How to store
CISATRACURIUM OMEGA SINGLE DOSE should be stored under refrigeration (2°C to 8°C) and protected from light to preserve potency. PROTECT FROM FREEZING.
If removed from refrigeration to room temperature storage (25°C), CISATRACURIUM OMEGA SINGLE DOSE must be used within 21 days, even if re-refrigerated.
CISATRACURIUM OMEGA MULTI-DOSE should be stored under refrigeration (2°C to 8°C) and protected from light to preserve potency. PROTECT FROM FREEZING.
If removed from refrigeration to room temperature storage (25°C), CISATRACURIUM OMEGA MULTI-DOSE must be used within 21 days, even if re-refrigerated.
Reporting 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:
- 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
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 obtained by contacting the sponsor, Omega Laboratories Limited, by:
Telephone: (514) 335-0310 or 1-800-363-0584
Mail: Omega Laboratories Limited
11 177 Hamon
Montreal, QC H3M 3E4
This leaflet was prepared by Omega Laboratories Limited.
Last revised: June 27, 2013
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