Consumer Information for: SPY AGENT GREEN KIT FOR SPY ELITE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
SPY AGENT GREEN is used with the SPY Elite or Pinpoint medical devices while you are having surgery to help your doctor to see:
- blood flow into your tissues and organs,
- bile ducts, found outside your liver, or
- lymph nodes and lymph vessels during the treatment of uterine or cervical cancer.
What it does
SPY AGENT GREEN is a fluorescent dye that lights up, when a certain light is shone on it. By giving you SPY AGENT GREEN, your doctor will be able to see inside your body using specialized imaging equipment.
When it should not be used
Do not use SPY AGENT GREEN if:
- you are allergic to indocyanine green or sodium iodide.
- you have a history of allergy to iodides because of the risk of a severe allergic reaction (anaphylaxis).
What the medicinal ingredient is
Indocyanine green
What the non-medicinal ingredients are
Sodium iodide
What dosage form it comes in
SPY AGENT GREEN is supplied as a single use vial containing 25 mg of a freeze-dried powder. Each vial of SPY AGENT GREEN can only be used during one surgical procedure in one patient.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given SPY AGENT GREEN. Talk about any health conditions or problems you may have, including if you:
- are sensitive to iodides or iodinated imaging agents
- are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed
Interactions with this medication
The following may interact with SPY AGENT™ GREEN:
- sodium bisufite, including some heparin products
Proper use of this medication
How to take SPY AGENT™ GREEN:
Your healthcare professional will give the SPY AGENT GREEN to you in the operating room
either before or during your surgery.
Usual Dose
Your doctor will determine how much SPY AGENT GREEN you will be given. Depending on your surgical procedure, you will be given the following amounts of SPY AGENT GREEN:
- For seeing blood flow to and within tissues and organs, an injection in your vein of 1.25 mg to 5.0 mg.
- For seeing bile ducts, an injection in your vein of 2.5 mg.
- For seeing lymph nodes, tan injection in your cervix of 4 mg.
Overdose
Side effects and what to do about them
These are not all the possible side effects you may feel when given SPY AGENT GREEN. If you experience any side effects not listed here, contact your healthcare professional.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Allergic Reaction (hypersensitivity reaction): possibly life threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure | ✔ | ✔ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store at room temperature, 20° to 25°C.
Keep out of reach and sight 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 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
If you want more information about SPY AGENT™ GREEN:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.stryker.com, or by calling 1-800-324-4422.
Last Revised: NOV-28-2018
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| MYLAN-ACYCLOVIR | 02242463 | MYLAN PHARMACEUTICALS ULC | ACYCLOVIR 400 MG |
| MYLAN-ACYCLOVIR | 02242784 | MYLAN PHARMACEUTICALS ULC | ACYCLOVIR 200 MG |
| MYLAN-ACYCLOVIR | 02242464 | MYLAN PHARMACEUTICALS ULC | ACYCLOVIR 800 MG |