Zemuron - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Class:||Muscle relaxants, Neuromuscular blocking agents|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||rocuronium bromide, acetic acid, nitrogen, sodium acetate, sodium chloride, water for injections|
About this Medication
What the Medication is Used For
ZEMURON is one of a group of drugs called muscle relaxants for anesthesia. These drugs are used during an operation as part of the general anesthetic. When you have an operation your muscles may have to be completely relaxed. This makes it easier for the surgeon to perform the operation.
What it Does
ZEMURON blocks the nerve impulses to move your muscles. Because the muscles needed for breathing also become relaxed you will need help with your breathing (artificial respiration) during and after your operation until you can breathe on your own. At the end of surgery the effects of ZEMURON are allowed to wear off and you can start breathing on your own. Sometimes another drug is given to help speed this up.
When it Should not be Used
If you are hypersensitive (allergic) to rocuronium, the bromide ion or any of the other ingredients in ZEMURON.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Acetic acid, nitrogen, sodium acetate, sodium chloride, water for injections.
Each milliliter (mL) ZEMURON contains 1.72 mg sodium. No preservative has been added.
What Dosage Form it Comes In
ZEMURON is a colorless to slightly yellow/brown solution for injection or infusion containing 10 mg/mL rocuronium bromide. It is available in vials containing 50 mg (10 vials per pack) and 100 mg rocuronium bromide (10 vials per pack).
Not all pack sizes may be marketed.
Warnings and Precautions
Serious Warnings and Precautions
As for all drugs used during an operation, this drug should be administered only in a facility prepared to give resuscitation and life support by adequately trained health care professionals familiar with its actions, characteristics, and hazards.
Your medical history can influence the way that ZEMURON is given to you. Tell your doctor if you have now or have ever had any of the following:
- an allergy to muscle relaxants
- a decreased kidney function or kidney disease
- a heart disease or heart valve disease
- pulmonary hypertension
- oedema (fluid retention for example at the ankles)
- recent, severe vomiting, diarrhea, and “water pill” use
- a liver or gallbladder disease or decreased liver function
- diseases affecting nerves or muscles.
Tell your doctor if you have any other medical conditions, as they may influence how ZEMURON works.
Elderly / Children
ZEMURON can be used in children (from term newborns to adolescents) and elderly.
Pregnancy and Breast-Feeding
Tell your doctor if you are pregnant, or suspect that you are pregnant, or if you are breast-feeding.
Driving and Using Machines
Your doctor will inform you when it is safe to drive and operate potentially dangerous machinery after you have been administered ZEMURON.
Interactions With This Medication
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This will help your doctor to decide the correct dose of ZEMURON for you.
Proper Use of This Medication
The doctor will determine the dose. You will be given ZEMURON before and/or during a surgical procedure. The usual dose is 0.6 mg rocuronium bromide per kg body weight and the effect lasts about 30 to 40 minutes. Your doctor may adjust the dose according to your need during the surgery.
Method and Route of Administration
ZEMURON is given by an adequately trained health care professional. It is not meant to be administered by yourself. ZEMURON is injected in a vein as a solution. It is administered as one single injection or continuous infusion.
|Only an adequately trained health care professional may give ZEMURON.|
As medical personnel will be monitoring your condition during the procedure it is unlikely that you will be given too much ZEMURON. However, if this happens artificial respiration will be continued until you are able to breathe again on your own. It is possible to counteract the effects of (too much) ZEMURON and speed-up your recovery by giving you a drug that reverses the effects of ZEMURON.
Side Effects and What to do About Them
Like all medicines, ZEMURON can have side effects, although not everybody gets them.
After Surgery Side Effects and What to do About Them
For the following serious side effects, you must seek immediate emergency medical treatment.
- Allergic reactions (rash, swelling of the face, throat, lips, difficulty breathing).
- Feeling cold and/or clammy
- Difficulty breathing/choking/wheezing
- Muscle weakness or paralysis
- Rapid or slow heart beat
- Sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and weakness in your muscles
- Seizure/seizure-like activity
For the following serious side effects, call your doctor or pharmacist.
- Dizziness especially upon standing up quickly
- High or low blood pressure if measured
- Severe itching
- Increase or decrease in blood glucose if measured
- Jaundice/yellowing of the skin/eyeballs
This is not a complete list of side effects. For any unexpected effects after receiving ZEMURON, contact your doctor or pharmacist.
How to Store It
ZEMURON is handled only by qualified professionals.
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:
- 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
Postal Locator 0701E
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.
or at Merck Canada Inc. by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-800-369-3090, or
- Mail to: Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC H9H 4M7
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.
This document plus the full product monograph, prepared for health professionals can be found at www.merck.ca or by contacting the sponsor, Merck Canada Inc. at: 1-800-567-2594.