Patient Medication Information: uses, side effects, how to take - Omniscan
What is OMNISCAN 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.
How does OMNISCAN work?
OMNISCAN makes tissues in the body look brighter and lets the healthcare professional see
Serious Warnings and Precautions
Not for Intrathecal Use
If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as OMNISCAN can cause life-threatening side effects such as:
- Coma (prolonged loss of consciousness)
- Encephalopathy (changes in how your brain works)
- Seizures (temporary loss of consciousness and muscle control)
- Death
OMNISCAN is for intravenous (IV) use only.
Nephrogenic Systemic Fibrosis
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 kidney problems
- developing kidneys, such as newborns and infants
These patients should NOT use OMNISCAN unless the healthcare professional believes the possible benefits outweigh the potential risks.
After receiving OMNISCAN, your healthcare professional will monitor your health to check if you are at risk of developing NSF.
any abnormal tissues during the MRI and MRA procedures.
What are the ingredients in OMNISCAN?
Medicinal ingredients: Gadodiamide
Non-medicinal ingredients: Caldiamide sodium, hydrochloric acid, sodium hydroxide, water for injection
OMNISCAN comes in the following dosage forms:
Solution for intravenous injection, 287 mg / mL (0.5 mmol / mL)
Do not use OMNISCAN if:
- you have severe kidney disease or kidney problems
- for newborns and infants with developing kidneys
- you are allergic to gadodiamide or any other ingredients in OMNISCAN or any part of the container (see What are the ingredients in OMNISCAN?)
- OMNISCAN should NOT be injected directly into the brain or spine
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OMNISCAN. Talk about any health conditions or problems you may have, including if you:
are pregnant or are planning to become pregnant
- OMNISCAN will only be given to you during pregnancy if your healthcare professional decides it is absolutely necessary
- It is not known if OMNISCAN will harm your unborn baby
- are breastfeeding or planning to breastfeed
- have sickle cell disease
- have poor kidney function or kidney problems
- have diabetes
- have high blood pressure
- have seizures
are allergic or have had an allergic reaction to other contrast media products like
OMNISCAN
Other warnings you should know about:
Nephrogenic Systemic Fibrosis
- After taking a gadolinium-based contrast agent (GBCA) like OMNISCAN, you may develop a rare disease called Nephrogenic Systemic Fibrosis (NSF). It has only been seen in patients with severe kidney disease so far.
- NSF is a rare condition where the skin becomes thickened, coarse and hard which may make the bending of the joints more difficult.
NSF may spread to other organs and even cause death.
- Patients with severe kidney disease should NOT use OMNISCAN unless your healthcare professional believes the possible benefits outweigh the potential risks.
Talk to your healthcare professional and seek medical attention immediately if you experience any of the following symptoms following an MR imaging procedure:
Skin problems:
- swelling, hardening and tightening of skin
- reddened or darkened patches on skin
- burning or itching of skin
Eye problems:
- Yellow spots on the whites of the eyes
Bone and muscle problems:
- stiffness in the joints
- problems moving or straightening arms, hands, legs or feet
- pain deep in hip bone or ribs
- muscle weakness
- After receiving OMNISCAN, your healthcare professional will monitor your health to check if you are at risk of developing NSF.
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 healthcare professional will:
- carefully consider whether to use repeated doses
- use the lowest doses
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There are no known interactions with OMNISCAN at this time.
How to take OMNISCAN:
- OMNISCAN will be given to you by a healthcare professional in a healthcare setting.
Usual dose:
- The dose of OMNISCAN will depend on your weight. Your healthcare professional will use your weight to decide the dose.
Overdose:
If you think you, or a person you are caring for, have taken too much OMNISCAN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using OMNISCAN?
These are not all the possible side effects you may have when taking OMNISCAN. If you experience any side effects not listed here, tell your healthcare professional.
- nausea
- headache
- dizziness
- pain at site of injection
- feeling unwell (malaise)
- feeling tired (fatigue)
- feeling drowsy (somnolence)
- hot flashes
- dry mouth
- ringing noise in ears (tinnitus)
- diarrhea
- runny nose (rhinitis)
- itchy skin (pruritus)
- rash
- anxiety
- short term abnormal sense of smell (transient parosmia)
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | |
| Only if severe | In all cases | |
| VERY RARE | ||
Severe allergic (anaphylactoid) reactions, sometimes fatal: rash, heart problems, swelling of the mouth and throat, difficulty breathing | X | |
Heart problems: tachycardia (abnormally fast | X | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | |
| Only if severe | In all cases | |
| heartbeat), arrhythmia (abnormal heart rhythms), chest pain | ||
Nervous system problem: Paresthesia (burning or prickling sensation in hands, arms, legs or feet), Tremors (shaking or trembling movements in parts of the body), convulsion | X | |
| Renal problem: kidney failure | X | |
Respiratory problems: coughing, sneezing, throat irritation, bronchospasms (tightening of airways of lungs), respiratory distress, dyspnea | X | |
Skin and limb problems: Hypersensitivity (allergic reaction), skin swelling, face swelling, skin plaque, pruritus | X | |
| Nephrogenic systemic fibrosis (NSF): swelling, hardening and tightening of skin, red or dark patches on skin, yellow spots on whites of eyes, stiffness in joints, trouble moving limbs, pain in hip bone or ribs, muscle weakness | X | |
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.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.
Storage:
OMNISCAN will be stored by your healthcare professional between 15 to 30oC.
Keep out of reach and sight of children.
If you want more information about OMNISCAN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-800-387-7146.
