Patient Medication Information: uses, side effects, how to take - Injectable Rocuronium Bromide
What the medication is used for:
Injectable Rocuronium Bromide 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:
Rocuronium bromide 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 Injectable Rocuronium Bromide 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 Injectable Rocuronium Bromide.
What the medicinal ingredient is:
rocuronium bromide
What the nonmedicinal ingredients are:
Sodium acetate trihydrate, sodium chloride, water for injections. May contain sodium hydroxide, and/or glacial acetic acid to adjust the pH to approximately 4.0. No preservative has been added.
What dosage forms it comes in:
Injectable Rocuronium Bromide 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 rocuronium bromide (10 vials per pack).
Your medical history can influence the way that Injectable Rocuronium Bromide 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 Injectable Rocuronium Bromide works.
Elderly / Children
Injectable Rocuronium Bromide 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 Injectable Rocuronium Bromide.
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 Injectable Rocuronium Bromide for you.
Usual Dose:
The doctor will determine the dose. You will be given Injectable Rocuronium Bromide 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:
Injectable Rocuronium Bromide is given by an adequately trained health care professional. It is not meant to be administered by yourself. Rocuronium Bromide Injection is injected in a vein as a solution. It is administered as one single injection or continuous infusion.
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.
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
ABOUT THIS MEDICATION
IMPORTANT: PLEASE READ
PRODUCT MONOGRAPH: Injectable Rocuronium Bromide Page 33 of 33
Only an adequately trained health care professional may give Injectable Rocuronium Bromide.
HOW TO STORE IT
Overdose:
As medical personnel will be monitoring your condition during the procedure it is unlikely that you will be given too much Injectable Rocuronium Bromide. 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) Injectable Rocuronium Bromide and speed-up your recovery by giving you a drug that reverses the effects of Injectable Rocuronium Bromide.
Injectable Rocuronium Bromide is handled only by qualified professionals.
Unopened vials: Store Injectable Rocuronium Bromide under refrigeration (2°C - 8°C) until ready to use. To facilitate use in the operating room, the unopened vials may be stored up to 90 days at room temperature (15°C-30° C).
Punctured vials: Punctured vials are stable for 30 days at 15°C – 30°C.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM Diluted solution: After dilution with infusion fluids in controlled and validated aseptic conditions, chemical and physical in-use stability has been demonstrated for 72 hours at 30°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours at 2 to 8°C. If the diluted solution has taken place in controlled and validated aseptic conditions, it can be used up to 72 hours at 30°C.
Like all medicines, Injectable Rocuronium Bromide can have side effects, although not everybody gets them.
AFTER SURGERY
SERIOUS 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
REPORTNG SIDE EFFECTS
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice
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 Injectable Rocuronium Bromide, contact your doctor or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,
Omega Laboratories Limited: 1-800-363-0584
Omega Laboratories Limited
11177 Hamon
Montreal, Canada