Cysto-Conray II

For all uses of Cysto-Conray II (iothalamate meglumine):

• If you have an allergy to iothalamate meglumine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are dehydrated, have been eating poorly, or have used a laxative or water pill before Cysto-Conray II.
• If you have had a skin reaction to this medicine or another drug like it in the past.
• If you are taking metformin, talk with doctor.
• If you are breast-feeding. Do not breast-feed for 24 hours after getting Cysto-Conray II.

If used before an x-ray of a joint:

• If you have an infection in or near the joint being x-rayed.

If used before an x-ray of the liver or bile duct:

• If you have a blood clotting problem, talk with your doctor.

If used before an endoscopy:

• If you have pancreatitis, talk with your doctor.
• If you have a certain bile duct problem (cholangitis).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cysto-Conray II with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Cysto-Conray II (iothalamate meglumine) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is given as a shot into a vein or artery only.
• Other drugs may be given before this medicine to help avoid side effects.
• You will need to be sure that you are not dehydrated before getting Cysto-Conray II. Check with your doctor to see if you need to drink extra fluids before getting this medicine.
• Drink lots of noncaffeine liquids after using Cysto-Conray II unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Sneezing.
• Stuffy nose.
• Cough.
• Choking.
• Shortness of breath.
• Blue or gray skin color.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Seizures.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Feeling of warmth.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Cysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt) and has the following structural formula:

Each milliliter of Cysto-Conray II contains 172 mg of iothalamate meglumine, equivalent to 81 mg (8.1% w/v) of organically bound iodine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer.

Cysto-Conray II is hypertonic under conditions of use and is supplied in containers from which the air has been displaced by nitrogen. The pH of Cysto-Conray II is
6.6 to 7.6.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged.

This product is sensitive to light and must be protected from strong daylight or direct exposure to the sun.

As with all contrast media, the containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.

Manufactured by:
Liebel-Flarsheim Company LLC
Raleigh, NC 27616 

Made in USA

GBT 0862A0916
Revised 09/16     

Guerbet

Not For Intravascular Administration
Sterile Solution

Cysto-Conray® ll
250 mL
NDC 0019-0862-50

Iothalamate Meglumine Injection USP 17.2%
81 mg/mL Organically Bound Iodine
For Retrograde Cystography and Cystourethrography

NOT FOR INTRATHECAL USE
Rx Only

Protect from light • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 
Each mL contains 172 mg iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer, and 0.115 mg monobasic sodium phosphate as a buffer.
Single dose container • Discard unused portion
Usual Dosage: See Package Insert.

10230916

Guerbet

Manufactured by:
Liebel-Flarsheim Company LLC
Raleigh, NC 27616

Made in USA