Patient Medication Information: uses, side effects, how to take - Rocuronium Bromide Injection (Sterimax)

What the medication is used for:

Rocuronium Bromide Injection 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 Injection 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 Rocuronium Bromide Injection 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 Rocuronium Bromide Injection.

What the medicinal ingredient is:

rocuronium bromide

What the non-medicinal ingredients are:

Sodium acetate trihydrate, sodium chloride, water for injection and nitrogen. It may contain sodium hydroxide and/or glacial acetic acid to adjust the pH to approximately 4.0.

What dosage forms it comes in:

Rocuronium Bromide Injection 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 box).

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 Rocuronium Bromide Injection 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 Rocuronium Bromide Injection works.
Elderly / Children
Rocuronium Bromide Injection 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 Rocuronium Bromide Injection.

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 Rocuronium Bromide Injection for you.

PROPER USE OF THIS MEDICATION

Usual Dose:

The doctor will determine the dose. You will be given Rocuronium Bromide Injection 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:

Rocuronium Bromide Injection 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.

Only an adequately trained health care professional may give Rocuronium Bromide Injection.

Overdose:

IMPORTANT: PLEASE READ

As medical personnel will be monitoring your condition during the procedure it is unlikely that you will be given too much Rocuronium Bromide Injection. 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) Rocuronium Bromide Injection and speed-up your recovery by giving you a drug that reverses the effects of Rocuronium bromide injection.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Rocuronium Bromide Injection 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

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 Rocuronium Bromide Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Rocuronium Bromide Injection is handled only by qualified professionals.

Unopened vials:

Rocuronium Bromide Injection should be stored under refrigeration (2°C - 8°C) up to 24 months 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.

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.

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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.

MORE INFORMATION

Canada

J3X 1P7

Varennes, Quebec

1565,

Boul. Lionel-Boulet

Strides Pharma Canada Inc.

Last revised:

May 14, 2020

1-888-318-0234

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