Details for: GRANISETRON HYDROCHLORIDE INJECTION
Company: OMEGA LABORATORIES LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02322765 | GRANISETRON HYDROCHLORIDE INJECTION | GRANISETRON (GRANISETRON HYDROCHLORIDE) | 1 MG / ML | LIQUID | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
GRANISETRON HYDROCHLORIDE INJECTION is one of a
group called antiemetics and it can only be obtained with
a prescription from your doctor.
GRANISETRON HYDROCHLORIDE INJECTION is intended to
prevent nausea (feeling sick) and vomiting which may
occur after you receive cancer chemotherapy.
What it does
Cancer chemotherapies are thought to cause the release of serotonin, a natural substance in the body. Serotonin can cause you to feel sick and to vomit. Granisetron, the active ingredient in GRANISETRON HYDROCHLORIDE INJECTION, will stop the action of serotonin and help prevent you from feeling sick and vomiting.
When it should not be used
- Do not take this medicine if you are allergic to granisetron or any of the ingredients GRANISETRON HYDROCHLORIDE INJECTION contains.
- If you are taking apomorphine.
What the medicinal ingredient is
Granisetron hydrochloride
What the non-medicinal ingredients are
Each injection contains the following inactive
ingredients:
Sodium Chloride, Benzyl Alcohol, Citric Acid
Monohydrate, Water for Injection and Hydrochloric Acid
and/or Sodium Hydroxide for pH adjustment.
What dosage form it comes in
GRANISETRON HYDROCHLORIDE INJECTION is supplied in amber glass multi-use vials of 1 mL or 4 mL packaged in boxes of 1 vial. Each vial contains 1 mg/mL granisetron as hydrochloride.
Warnings and precautions
BEFORE you use GRANISETRON HYDROCHLORIDE INJECTION talk to your doctor or pharmacist if:
- you have any allergies to similar antiemetics such as dolasetron mesylate (Anzemet®) or ondansetron (Zofran®)
- you are pregnant, plan to become pregnant or are breastfeeding
- you have liver problems
- you have a history of heart problems
- you have been told by a doctor that you have a blockage of your gut or if you have severe constipation, pain or swelling in your stomach
- your are taking other medications, including drugs you can buy without a prescription and herbal products.
As GRANISETRON HYDROCHLORIDE INJECTION may cause drowsiness, you should avoid driving a car or operating hazardous machinery until you know it does not affect you.
Proper use of this medication
This medicine is only for you, the person for whom the prescription was written. Do not give this medication to others.
Usual adult dose
GRANISETRON HYDROCHLORIDE INJECTION will be given to you by hospital staff before and/or after your therapy.
Side effects and what to do about them
If you experience an allergic reaction (e.g. shortness of
breath, drop in blood pressure, skin lumps or hives),
contact your doctor immediately. Do not take any more
medicine unless instructed to do so by your doctor.
If you experience symptoms of heart problems such as
palpitations (fast, pounding or irregular heart beat), chest
pain, dizziness or fainting, tell your doctor or nurse
immediately.
You may experience headaches, constipation, weakness,
sleepiness, diarrhea or abdominal pain while taking
GRANISETRON HYDROCHLORIDE INJECTION. You may
also experience pain, anemia or fever while on
GRANISETRON HYDROCHLORIDE INJECTION therapy.
There is no need to stop the medicine but you should tell
your doctor about these symptoms.
This is not a complete list of side effects. For any
unexpected effects while taking GRANISETRON
HYDROCHLORIDE INJECTION, contact your doctor or
pharmacist.
How to store
GRANISETRON HYDROCHLORIDE INJECTION should be
stored at controlled room temperature (15-30°C). Discard
unused portion. Protect from light. The vial should be
used within 30 days once opened.
The expiry date of this medicine is printed on the label.
Do not use the medicine after this date. Keep your
medicine in a safe place out of the reach of children.
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, or
- 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 Ltd, at:
| Montreal: | (514) 335-0310 or 1-800-363-0584 |
| Ontario: | (905) 629-8980 or 1-800-268-1326 |
| Vancouver: | (604) 271-6228 or 1-877-271-6228 |
| By mail: | Omega Laboratories Ltd. 11 177 Hamon Montreal, QC H3M 3E4 |
This leaflet was prepared by Omega Laboratories
Limited.
Last revised: October 29, 2013.