Patient Medication Information: uses, side effects, how to take - Definity
What is DEFINITY used for?
DEFINITY is used to:
- Make it easier to see your heart when using an ultrasound machine.
- Make it easier to see your liver and kidneys when using an ultrasound machine.
How does DEFINITY work?
DEFINITY is a liquid that has tiny bubbles in it. These bubbles are easy to see using an ultrasound machine. So injecting these bubbles makes it easier to see your heart, liver or kidneys.
What are the ingredients in DEFINITY?
Medicinal ingredients: Lipid-encapsulated perfluoropropane microspheres
Non-medicinal ingredients: Glycerin
Propylene glycol
Sodium chloride
Sodium phosphate dibasic, heptahydrate
Sodium phosphate monobasic, monohydrate
Water for injection
DEFINITY comes in the following dosage forms:
Suspension, 150 mcL/mL
Do not use DEFINITY if:
Serious Warnings and Precautions
Some people have had serious problems with their heart or lungs and some have died while getting DEFINITY or after getting it.
There will be equipment and trained personnel ready to help in case you do have a problem with your heart or lungs. |
|---|
- you are allergic to this drug or to any of its ingredients, including any non-medicinal ingredient.
- your healthcare professional determines that you have right-to-left, bi-directional, or transient right-to-left cardiac shunts.
- DEFINITY should not be injected directly into an artery.
- You have had a procedure called lithotripsy to break up kidney stones within the last 24 hours.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DEFINITY. Talk about any health conditions or problems you may have, including if you:
- have a history of drug allergies, asthma or hay fever, and multiple allergies.
- have any chronic lung disorders such as COPD.
- have a cardiac shunt.
- were born with a heart defect, have recent worsening of heart or lung condition, or if you have had an allergic reaction to DEFINITY before, or to other echocardiographic contrast agents or their ingredients, including polyethylene glycol.
- have any family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, acute myocardial ischemia, heart failure with reduced left-ventricular ejection fraction or if you have had symptomatic arrhythmias.
- have sickle cell disease.
are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if DEFINITY passes in breast milk.
- experience palpitations or fainting spells after injection of DEFINITY.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DEFINITY:
- DEFINITY may add to the QTc prolonging effects of other drugs such as erythromycin, some antipsychotics, and tricyclic antidepressants.
- Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents.
How to take DEFINITY:
- DEFINITY will be given to you by a healthcare professional in a healthcare setting.
Usual dose:
You will get a single 10 mcL/kg dose of DEFINITY by intravenous injection. A second 10 mcL/kg dose might be given 5 minutes after the first injection if you need it. These injections are done in 30-60 seconds and are followed by an injection of 10 mL of saline.
You could also get DEFINITY by an intravenous infusion. DEFINITY is mixed with preservative-free saline
(1.5 mL added to 50 mL of saline). This is injected slowly over a few minutes. The total dose given is between 14.4 mcL/kg (90 kg person) to 21.7 mcL/kg (60 kg person).
Overdose:
During clinical trials there were no overdoses of DEFINITY.
| If you think you, or a person you are caring for, have been given too much DEFINITY, 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 DEFINITY?
These are not all the possible side effects you may have when taking DEFINITY. If you experience any side effects not listed here, tell your healthcare professional.
The following side effects were most frequently seen (in at least 0.5% of patients):
- Headache
- Back pain
- Nausea
- Loose stools
- Chest pain
- Injection site reactions
- Dizziness
- Flushing
- Fatigue
- Difficulty breathing
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
| Cardiopulmonary reactions including fatalities: difficulty breathing, chest discomfort during treatment | ✓ | ✓ | |
| Serious allergic reactions: swelling of the tongue, eyes, face, airways or throat, difficulty breathing, chest tightness, or feel faint during the treatment. | ✓ | ✓ | |
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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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:
Your healthcare professional will store this product for you as appropriate.
If you want more information about DEFINITY:
- 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 the manufacturer at 1-800-811-5500.