Cysto-Conray II: Uses, Side Effects and Dosage

What is Cysto-Conray II used for?

Cysto-Conray II:

• is for diagnostic use only and is used to help identify an illness.
• makes contrast in the bladder and the urinary tract for certain X-rays procedures.
• is used in children and adults.

How does Cysto-Conray II work?

Cysto-Conray II is administered through the bladder. Cysto-Conray II creates contrast in your bladder and urinary tract that makes it easier for your doctor to make a diagnosis.

What are the ingredients in Cysto-Conray II?

Medicinal ingredients: Iothalamate Acid.

Non-medicinal ingredients: Edetate Calcium Disodium USP, Meglumine USP, Monobasic Sodium phosphate USP.

Cysto-Conray II comes in the following dosage forms:

250 mL Bottles of Iothalamate Meglumine Injection USP, 17.2% w/v

Do not use Cysto-Conray II if:

• You are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
• You have severe infection of the urinary tract.
• You have a blockage in your urinary tract

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Cysto-Conray II. Talk about any health conditions or problems you may have, including if you:

• have had a previous allergic reaction to a contrast agent or have a history of iodine sensitivity.
• have a history of bronchial asthma.
• have a history of allergies.
• have severe irritation of the urinary tract or blood in your urine.
• have thyroid tests planned. The iodine in Cysto-Conray II may interfere with your thyroid tests.

• are pregnant or could be pregnant. If you need to take Cysto-Conray II during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.

• are breast-feeding. It is not known if Cysto-Conray II is excreted in breast milk. You should bottle feed your baby for at least 24 hours after taking Cysto-Conray II.

Other warnings you should know about:

Thyroid function

Contrast media containing iodine, such as Cysto-Conray II, may change thyroid activity in some patients, both in adults and infants. This may cause:

• Hypothyroidism (i.e. too little thyroid hormones in the blood)
• Or hyperthyroidism (i.e. too much thyroid hormones in the blood)

Thyroid function in infants

Contrast media containing iodine may cause hypothyroidism in infants, especially infants born too soon that:

• Can continue for several weeks to a month after treatment
• Can harm growth and development
• Can harm mental growth
• May require treatment

• Can cause symptoms such as:

  • Fatigue, shortness of breath, low heart rate
  • Reduced appetite, feeling cold, weight gain
  • Muscle stiffness

Contact your doctor if these symptoms happen to you or your infant.

Your doctor may order blood tests for your infant after treatment to follow thyroid hormone levels in the blood.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take Cysto-Conray II:

Cysto-Conray II will always be used in a hospital or similar setting. It will only be administered to you under the supervision of a health professional skilled and experienced in the

particular procedure to be performed.

Usual dose:

• Your doctor will determine the amount of Cysto-Conray II to be used.
• The dose administered will depend on your weight, your age and the procedure.
• You may be given a laxative the night before your examination.
• You will need to empty your bladder before you receive Cysto-Conray II.
• Cysto-Conray II will be injected into your bladder.

Overdose:

If you think you have been given too much Cysto-Conray II, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

What are possible side effects from using Cysto-Conray II?

These are not all the possible side effects you may feel when taking Cysto-Conray II. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

• Irritation of the bladder or ureter

Uncommon side effects can include:

• Inflammation and bleeding of the bladder (known as hemorrhagic cystitis)

Serious side effects and what to do about them

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.

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/adverse-reaction-reporting.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:

Store at controlled room temperature. Protect from light and freezing. Discard unused portion within 8 hours. Keep out of reach and sight of children.

If you want more information about Cysto-Conray II:

• 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 1-844-208-7620.

This document prepared for health professionals is included with the product or may be obtained by contacting the sponsor, Liebel-Flarsheim Company LLC at 1-844-208-7620.

Liebel-Flarsheim Company LLC

8800 Durant Road

Raleigh, North Carolina

27616 USA

Cysto-Conray^® II is a trademark of Guerbet.

Revised: November 26, 2021