Details for: OMNISCAN
Company: GE HEALTHCARE CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02172771 | OMNISCAN | GADODIAMIDE | 287 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Summary Safety Review - Gadolinium-Based Contrast Agents - Assessing the Potential Risks of Congenital Anomalies, Stillbirth and Neonatal Death
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
Omniscan is a contrast agent for use in magnetic resonance
imaging (MRI) of the central nervous system and other body
parts.
Omniscan can also be used in magnetic resonance
angiography (MRA) to view abnormal blood vessels
What it does
Omniscan helps tissues appear brighter in MRI and MRA so the doctor can better visualize the tissues and any abnormalities.
When it should not be used
Do not use Omniscan if you are allergic to gadodiamide or any other ingredients in the formulation (see below for list of nonmedicinal ingredients).
What the medicinal ingredient is
Gadodiamide
What the non-medicinal ingredients are
Caldiamide sodium, hydrochloric acid, sodium hydroxide, water for injection
What dosage form it comes in
Omniscan is available in a solution for intravenous injection containing 287 mg/mL of gadodiamide (0.5 mmol./mL).
Warnings and precautions
Serious Warnings and Precautions
Gadolinium-based contrast agents (such as Omniscan) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with:
- severe kidney disease or acute kidney injury
- mmature renal function, such as newborns and infants
Your doctor will monitor your health after administering Omniscan, if you are considered to be at risk for developing NSF.
BEFORE you are given Omniscan talk to your doctor if any of the following situations apply to you. The doctor will decide whether the intended examination is possible or not:
- You are pregnant or could be pregnant
- You are breastfeeding or intend to breastfeed
- You have sickle cell disease
- You have poor kidney function or kidney problems
- You have diabetes
- You have high blood pressure
- You have seizures
- You are allergic or have had a hypersensitivity (allergic) reaction to contrast media products similar to Omniscan
There have been post-market reports of a rare disease called Nephrogenic Systemic Fibrosis (NSF) following gadolinium-based contrast agent (GBCA) use.
NSF is a rare condition which has only been observed so far in patients with severe kidney disease. At present, there is no evidence that other patient groups are at risk of developing the condition. Due to NSF the skin becomes thickened, coarse and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.
Patients with severe kidney disease should avoid the use of Omniscan unless the health care professional believes the possible benefits outweigh the potential risks. Those who have already had an MR imaging procedure and who have any of the following symptoms should seek medical attention as soon as possible:
- Swelling, hardening and tightening of the skin
- Reddened or darkened patches on the skin
- Burning or itching of the skin
- Yellow spots on the whites of the eyes
- Stiffness in the joints, problems moving or straightening arms, hands, legs or feet
- Pain deep in the hip bone or ribs
- Weakness of the muscles
Accumulation of gadolinium in the brain
Recent information shows that gadolinium (as in Omniscan) may build up in the brain after multiple uses and:
- The effect on the brain is unknown right now.
- Your doctor will:
- carefully consider whether to use repeated doses
- use the lowest dose
Interactions with this medication
Drug interaction studies have not been done with Omniscan.
Proper use of this medication
Usual Dose
Omniscan should be administered by a healthcare professional as a bolus ( all at once) intravenous injection at a dose of 0.2 mL/kg for MRI of the central nervous system or for MRA. A dose of 0.6 mL/kg is to be administered as a bolus injection for MRI of the body.
Overdose
Side effects and what to do about them
Common side effects reported with Omniscan include nausea, headache and dizziness.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | |
|---|---|---|---|
| Anaphylactoid reactions, sometimes fatal | |||
| Symptoms include rash, heart problems, swelling of the mouth and throat, difficulty breathing | ✘ | ||
This is not a complete list of side effects. For any unexpected effects while taking Omniscan contact your doctor or pharmacist.
How to store
Omniscan will be stored by your healthcare professional at controlled room temperature between 15-30oC.
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 three 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, GE Healthcare Canada Inc. at: 1-800-387-7146
This leaflet was prepared by GE Healthcare
Last revised: May 22, 2019