Conray 30

• It is used before an x-ray or an alike test.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad health problems, paralysis, and death have happened when contrast has been given into blood vessels in the spinal cord. Talk with the doctor.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Blood clots have happened with Conray 30 when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
• Seizures and death have happened when contrast has been given to people with bleeding in the brain. Talk with the doctor.
• Very bad kidney problems and sometimes death have happened when contrast has been given to people with multiple myeloma. Talk with the doctor.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with Conray 30. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you are 65 or older, use Conray 30 with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Use Conray 30 (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 Conray 30. Check with your doctor to see if you need to drink extra fluids before getting this medicine.
• Drink lots of noncaffeine liquids after using Conray 30 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.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physio-chemical properties of the contrast media, the dose and speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

Fatalities have been reported following the administration of iodine-containing contrast agents. Based upon clinical literature, the incidence of death is reported to range from one in 10,000 (0.01 percent) to less than one in 100,000 (0.001 percent).

The following adverse reactions have been observed in conjunction with the use of iodine-containing contrast agents.

The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth. These are usually of brief duration. Other reactions include the following:

Hypersensitivity reactions: Dermal manifestations of urticaria with or without pruritus, erythema and maculopapular rash. Dry mouth. Sweating. Conjunctival symptoms. Facial, peripheral and angioneurotic edema. Symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestations of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis. Rarely, these allergic-type reactions can progress into anaphylaxis with loss of consciousness and coma and severe cardiovascular disturbances.

Cardiovascular reactions: Generalized vasodilation, flushing and venospasm. Occasionally, thrombosis or rarely, thrombophlebitis. Red blood cell clumping and agglutination, crenation and interference in clot formation. Extremely rare cases of disseminated intravascular coagulation resulting in death have been reported. Severe cardiovascular responses include rare cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest. These severe reactions are usually reversible with prompt and appropriate management; however, fatalities have occurred.

Endocrine reactions: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.

Skin and Subcutaneous Tissue Disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)].

Technique reactions: Extravasation with burning pain, hematomas, ecchymosis and tissue necrosis, paresthesia or numbness, vascular constriction due to injection rate, thrombosis and thrombophlebitis.

Neurological reactions: Spasm, convulsions, aphasia, syncope, coma and death.

Other reactions: Headache, trembling, shaking, chills without fever and light-headedness. Temporary renal shutdown or other nephropathy.

Arterial digital subtraction angiography provides images similar in quality to conventional film-screen systems. The advantages of arterial DSA when compared to standard film angiography include the use of less contrast medium; the use of a lower concentration of contrast medium as provided by Conray 30; a decreased need for selective arterial catheterization and a shortened examination time. The limitations of arterial DSA include: reduced spatial resolution and limited field size.

Patient Preparation

No special patient preparation is required for arterial DSA. However, it is advisable to ensure that patients are well hydrated prior to examination.

Precautions

In addition to the general precautions described, the risks associated with arterial DSA are those usually attendant with catheter procedures. Following the procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Usual Dosage

It is advisable to inject at rates approximately equal to the flow rate of the vessel being injected. The following volumes, per injection, have been used, and may be repeated as necessary:

A total dose of 250 mL (representing 35.2 grams of iodine) should not be exceeded. Consideration should be given to the patient's clinical condition and whether large volumes of fluids may be detrimental to patient care.

Conray 30 is available in 150 mL bottles in packages of 12 (NDC 0019-0952-53).

Storage: Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs the container should be brought to room temperature. Intermittent shaking may be necessary to completely redissolve the crystals. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged.

This preparation 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 0952A0317
Revised 03/17

Guerbet

Applies to iothalamate: injection solution, intravenous solution, urethral solution

Applies to iothalamate: injectable solution

Dermatologic

Common (1% to 10%): Pruritus, urticarial, face edema
Uncommon (0.1% to 1%): Erythema, rash
Rare (less than 0.1%): Angioedema, diaphoresis
Frequency not reported: Ecchymosis and tissue necrosis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Diarrhea, dry mouth, tongue edema
Very rare (less than 0.01%): Dysphagia[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactoid reactions
Frequency not reported: Dermal manifestations (urticaria with or without pruritus, erythema, maculopapular rash); dry mouth, sweating, conjunctival symptoms; facial, peripheral, and angioneurotic edema; symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestations of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis[Ref]

Rarely, these allergic-type reactions can progress into anaphylaxis with loss of consciousness and coma and severe cardiovascular disturbances.[Ref]

Respiratory

Common (1% to 10%): Rhinitis
Uncommon (0.1% to 1%): Coughing, dyspnea
Rare (0.01% to 0.1%): Larynx edema
Very rare (less than 0.01%): Apnea, bronchospasm[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension
Rare (0.01% to 0.1%): Thrombophlebitis, tachycardia, ventricular fibrillation, pallor, vasodilation, cyanosis
Very rare (less than 0.01%): Disseminated intravascular coagulation resulting in death; arrhythmia; bradycardia; cardiac arrest, circulatory failure; abnormal ECG; heart block; phlebitis
Frequency not reported: Generalized vasodilation, flushing and venospasm; occasionally thrombosis; severe cardiovascular responses include rare cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest; extravasation with burning pain; hematomas; vascular constriction due to injection rate; thrombosis[Ref]

These severe reactions are usually reversible with prompt and appropriate management; however, fatalities have occurred.[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)[Ref]

Ocular

Uncommon (0.1% to 1%): Periorbital edema
Rare (0.01% to 0.1%): Conjunctivitis
Very rare (less than 0.01%): Vision disorders[Ref]

Local

Rare (less than 0.1%): Injection side reaction[Ref]

Nervous system

Rare (0.01% to 0.1%): Dizziness; paraesthesia; taste perversion
Very rare (less than 0.01%): Agitation, coma, convulsions, dyskinesia, paralysis, tremor, somnolence
Frequency not reported: Aphasia; syncope, paresis; paralysis resulting from spinal cord injury and pathology associated with syndrome of transverse myelitis; visual field losses which are usually transient but may be permanent; coma and death; headache, trembling, shaking, numbness[Ref]

Genitourinary

Very rare (less than 0.01%): Urinary incontinence[Ref]

Metabolic

Very rare (less than 0.01%): Thirst[Ref]

Musculoskeletal

Very rare (less than 0.01%): Involuntary muscle contractions, myalgia, leg pain
Frequency not reported: Spasm[Ref]

Other

Very common (10% or more): Hot flushes, pain
Rare (0.01% to 0.1%): Malaise
Very rare (less than 0.01%): Edema, abnormal crying
Frequency not reported: Chills without fever and lightheadedness[Ref]

Psychiatric

Very rare (less than 0.01%): Anxiety[Ref]

Renal

Very rare (less than 0.01%): Acute renal failure, decrease in renal function
Frequency not reported: Temporary renal shutdown or other nephropathy[Ref]

Hematologic

Frequency not reported: Red blood cell clumping and agglutination, crenation and interference in clot formation[Ref]

Some side effects of iothalamate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.