GE Healthcare is committed to providing a variety of contrast media products –  Products that help meet your patient and procedural needs

Broad portfolio of products across modalities

 

 

 

 

 

 

CT, computed tomography; MRI, magnetic resonance imaging.

Available in a range of concentrations, package sizes, and types to meet your procedural needs

GE Healthcare offers a versatile line of contrast media products indicated for use in diagnostic imaging procedures, including:

  • Optison (Perflutren Protein-Type A Microspheres Injectable, Suspension, USP)
  • Omnipaque (iohexol)
  • Visipaque (iodixanol)
  • Omniscan (gadodiamide)

Indications include intravenous, intra-arterial, body cavity, intrathecal, intra-articular,  rectal, and oral uses

There are many considerations when making an iodinated contrast medium selection

A number of patient challenges may affect the selection of an appropriate contrast medium.
GE Healthcare is your trusted partner in X-ray/CT contrast media solutions.
With more than 30 years of experience providing diagnostic imaging solutions, GE Healthcare offers iodinated contrast media, with a choice of osmolality, that help meet the individual needs of your patients.
 

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At GE Healthcare, we recognize that being a sustainability leader is more than just creating products that provide environmental and operating benefits to our customers. Through our Ecomagination initiative, we also demonstrate our commitment to using our limited resources efficiently across the entire life cycle of our products.

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Products

Omnipaque logo.

Visit the product page to learn more about  Omnipaque.

Procedure after procedure, Omnipaque, available as both an injection and oral solution, can meet most of your contrast needs, providing you with safety and efficacy for multiple indications and an extensive range of environmentally friendly packaging options.

Please see Important Safety Information, including Boxed Warning, and full Prescribing Information for Omnipaque.

Visipaque logo.

Visipaque is an intravascular contrast media solution, indicated for use in computed tomography and interventional procedures in a variety of clinical settings.

Please see Important Safety Information, including Boxed Warning, and full Prescribing Information for Visipaque.

product-product-categories-contrast-media-optison-optison-logo.jpg

Visit the product page to learn more about  Optison.

Optison is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

Please see Important Safety Information, including Boxed Warning, and full Prescribing Information for Optison.

Visit the product page to learn more  Omniscan.

Omniscan is GE Healthcare’s gadolinium-based contrast media injection indicated for use in magnetic resonance imaging scans.

Please see Important Safety Information, including Boxed Warning, and full Prescribing Information for Omniscan.

Professional Resources and Disclosures

Important Safety Information About Optison

PRODUCT INDICATIONS: Optison is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration [see WARNINGS and PRECAUTIONS (5.1)].

  • Assess all patients for the presence of any condition that precludes Optison administration [see CONTRAINDICATIONS (4)]

  • Always have resuscitation equipment and trained personnel readily available [see WARNINGS and PRECAUTIONS (5.1)]

CONTRAINDICATIONS: Do not administer Optison to patients with known or suspected hypersensitivity to perflutren, blood, blood products, or albumin. WARNINGS AND PRECAUTIONS Serious Cardiopulmonary Reactions: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Optison administration, and monitor all patients for acute reactions. Hypersensitivity Reactions: Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration, including shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Optison administration, and monitor all patients for hypersensitivity reactions. Systemic Embolization: When administering Optison to patients with a cardiac shunt, microspheres can bypass filtering of the lungs and enter the arterial circulation. Assess patients with shunts for embolic phenomena following Optison administration. Optison is only for intravenous administration; do not administer Optison by intra-arterial injection. Ventricular Arrhythmia Related to High Mechanical Index: High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. Optison is not recommended for use at mechanical indices greater than 0.8. Transmissible Infectious Agents: This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral disease or CJD have ever been identified for albumin. ADVERSE REACTIONS: Serious adverse reactions related to cardiopulmonary and hypersensitivity reactions are described in the WARNINGS AND PRECAUTIONS section. The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Postmarketing Experience: Cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress, or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions. USE IN SPECIFIC POPULATIONS  Pregnancy: There are no data on Optison use in pregnant women to inform any drug-associated risks. Lactation: There are no data on the presence of perflutren protein-type A microspheres in human milk, the effects on the breastfed infant, or the effects on milk production.  The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Optison and any potential adverse effects on the breastfed infant from Optison or from the underlying maternal condition. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Of the total number of subjects in a clinical study of Optison, 35% were 65 years of age and older, while 14% were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

 

Prior to Optison administration, please read the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

Important Safety Information About Omnipaque

Indications and Use – Omnipaque (iohexol)

Intrathecal Administration Adults: Omnipaque 180, 240, and 300 • Myelography (lumbar, thoracic, cervical, total columnar) • Computed tomography (CT) (myelography, cisternography, ventriculography) Pediatrics: Omnipaque 180 • Myelography (lumbar, thoracic, cervical, total columnar) • CT (myelography, cisternography) Intravascular Administration Adults: Omnipaque 140 • Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels. Omnipaque 240 • CT head imaging • Peripheral venography (phlebography). Omnipaque 300 • Aortography including studies of the aortic arch, abdominal aorta and its branches • CT head and body imaging • Cerebral arteriography • Peripheral venography (phlebography) • Peripheral arteriography • Excretory urography. Omnipaque 350 • Angiocardiography (ventriculography, selective coronary arteriography) • Aortography, including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches • CT head and body imaging • Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels • Peripheral arteriography • Excretory urography. Pediatrics: Omnipaque 240 • CT head and body imaging. Omnipaque 300 • Angiocardiography (ventriculography) • Excretory urography • CT head and body imaging. Omnipaque 350 • Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) • Aortography, including the aortic root, aortic arch, ascending and descending aorta. Oral or Rectal Administration Adults: Omnipaque 350 • Oral radiographic examination of the gastrointestinal tract. Pediatrics: Omnipaque 180, 240, and 300 • Oral and rectal radiographic examination of the gastrointestinal tract. Oral administration in conjunction with intravenous administration: Diluted Omnipaque Injection Adults: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Omnipaque Oral Solution Adults: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Intra-articular Administration Adults: Omnipaque 240, 300, and 350 • Arthrography. Body Cavity Administration Adults: Omnipaque 240 • Endoscopic retrograde pancreatography (ERP) and endoscopic retrograde cholangiopancreatography (ERCP) • Herniography • Hysterosalpingography. Omnipaque 300 • Hysterosalpingography. Pediatrics: Omnipaque 240, 300, and 350 diluted • Voiding cystourethrography (VCU).

Important Safety Information About Omnipaque (iohexol)

WARNING: RISKS WITH INADVERTENT
INTRATHECAL ADMINISTRATION OF
Omnipaque Injections 140 and 350 mgI/mL

See full Prescribing Information for complete Boxed Warning.

Omnipaque Injections 140 and 350 are contraindicated for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema (4, 5.1).

CONTRAINDICATIONS:  Omnipaque 140 and Omnipaque 350 are contraindicated for intrathecal use. Omnipaque Oral Solutions 9 and 12 are contraindicated for parenteral administration.

WARNINGS AND PRECAUTIONS Risks Associated With Inadvertent Intrathecal Administration: Omnipaque Injections 140 and 350 are contraindicated for intrathecal use. Inadvertent intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. Risks Associated With Inadvertent Parenteral Administration of Omnipaque Oral Solution: Omnipaque Oral Solutions 9 and 12 are contraindicated for parenteral administration. Adverse reactions such as hemolysis may occur if administered intravascularly. Do not administer Omnipaque Oral Solutions 9 and 12 parenterally. Hypersensitivity Reactions: Omnipaque can cause life-threatening or fatal hypersensitivity reactions, including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within three minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agents and known allergies (ie, bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents, and always have emergency resuscitation equipment and trained personnel available prior to Omnipaque administration. Monitor all patients for hypersensitivity reactions. Contrast-Induced Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after parenteral administration of Omnipaque. Risk factors include preexistng renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, and repetitive and/or large doses of an iodinated contrast agent. Use the lowest necessary dose of Omnipaque in patients with renal impairment. Adequately hydrate patients prior to and following parenteral administration of Omnipaque. Do not use laxatives, diuretics, or preparatory dehydration prior to Omnipaque administration. Cardiovascular Adverse Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the parenteral administration of Omnipaque. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Based on clinical literature, reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%). Use the lowest necessary dose of Omnipaque in patients with congestive heart failure, and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions. Thromboembolic Events: Angiocardiography • Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast media. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for thromboembolic events include length of procedure, catheter and syringe material, underlying disease state, and concomitant medications. To minimize thromboembolic events, use meticulous angiographic techniques, and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases the risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism. Extravasation and Injection-Site Reactions: Extravasation of Omnipaque during intravascular injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms. Thyroid Storm in Patients With Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of Omnipaque. Hypertensive Crisis in Patients With Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. Monitor patients when administering Omnipaque intravascularly if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available. Sickle Cell Crisis in Patients With Sickle Cell Disease: Iodinated contrast agents, when administered intravascularly, may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following Omnipaque administration, and use Omnipaque only if the necessary imaging information cannot be obtained with alternative imaging modalities. Severe Cutaneous Adverse Reactions (SCARs): SCARs may develop from one hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase, and time to onset may decrease, with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate SCARs. Avoid administering Omnipaque to patients with a history of a SCAR to Omnipaque.

ADVERSE REACTIONS: INTRATHECAL ADMINISTRATION Adults: The most frequently reported adverse reactions were headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, and dizziness. Pediatric Patients: The most frequently reported adverse reactions were headache, vomiting, and backache. INTRAVASCULAR ADMINISTRATION Adults: Arrhythmias, including premature ventricular contractions (PVCs) and premature arterial contractions (PACs), pain, vision abnormalities (including blurred vision and photomas), and nausea. Pediatric Patients: Vomiting • Oral Administration of Undiluted Omnipaque 350 for Radiographic Examination of the Gastrointestinal Tract Adults: Diarrhea, nausea, vomiting, abdominal pain, flatulence, and headache. The adverse reactions were found to mostly affect the gastrointestinal system with diarrhea, vomiting, nausea, and abdominal pain. Fever, hypotension, and urticaria were also reported. Oral Administration for Computed Tomography (CT) of the Abdomen in Conjunction With Intravenous Administration Adults: In a controlled clinical study involving 44 adult patients receiving oral administration of diluted Omnipaque (4-9 mgI/mL), in conjunction with intravenously injected Omnipaque 300, for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting. Pediatric Patients: In clinical studies involving 69 pediatric patients receiving oral administration of diluted Omnipaque (9-29 mgI/mL), in conjunction with intravenously administered Omnipaque 240 and Omnipaque 300, for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting (1.4%). Body Cavity Use Adults: In controlled clinical studies involving 285 adult patients for various body cavity examinations using Omnipaque 240, 300, and 350, the most frequent adverse reactions were administration-site reactions: Pain (26%) and swelling (22%)were exclusively reported for arthrography and were generally related to the procedure rather than the contrast medium. Patients also experienced heat (7%). All other adverse reaction occurred at a rate less than or equal to 1%. Pediatric Patients: No adverse reactions associated with the use of Omnipaque for voiding cystourethrogram (VCU) procedures were reported in 51 pediatric patients studied.

Postmarketing Experience General Immune System Disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock, including life-threatening or fatal anaphylaxis. General Disorders and Administration-Site Conditions: Pyrexia, chills, pain and discomfort, asthenia, administration-site conditions, including extravasation. Intrathecal Administration Nervous System Disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia. Musculoskeletal and Connective Tissue Disorders: Pain, muscle spasms, or spasticity. Psychiatric Disorders: Confusional state, agitation, and anxiety. Eye Disorders: Transient visual impairment, including cortical blindness. Renal Reactions: Acute kidney injury. Intravascular Administration Cardiovascular Disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm, including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain. Hemodynamic Reactions: Vasospasm and thrombophlebitis following intravenous injection. Blood and Lymphatic System Disorders: Neutropenia. Nervous System Disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia. Psychiatric Disorders: Confusional state, agitation. Eye Disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation. Renal Reactions: Acute kidney injury, toxic nephropathy (cervical intraepithelial neoplasia), transient proteinuria, oliguria or anuria, increased serum creatinine. Gastrointestinal Disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement. Endocrine Reactions: Hyperthyroidism. 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. Respiratory, Thoracic, and Mediastinal Disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack. Skin and Subcutaneous Tissue Disorders: Contrast media reactions range from mild (eg, pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe: (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis [SJS/TEN], bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis [AGEP], and drug reaction with eosinophilia and systemic symptoms [DRESS]). Oral Administration Gastrointestinal Disorders: Dysphagia, abdominal pain. Body Cavity Administration Gastrointestinal Disorders: Pancreatitis. Musculoskeletal and Connective Tissue Disorders: Arthritis (arthrography).

Drug-Drug Interactions – Metformin: In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, Omnipaque administration in patients with an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure,  and reinstitute metformin only after renal function is stable. Radioactive Iodine: Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for six to eight weeks. Beta-Adrenergic Blocking Agents: The use of beta-adrenergic blocking agents lowers the threshold for, and increases the severity of, contrast reactions and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Because of the risk of hypersensitivity reactions, use caution when administering Omnipaque to patients taking beta-blockers. Drugs That Lower Seizure Threshold: Drugs that lower seizure threshold, especially phenothiazine derivatives, including those used for their antihistaminic or antinauseant properties, are not recommended for use with intrathecal administration of Omnipaque. Central Nervous System (CNS) Active Drugs: Drugs such as monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs. Such medications should be discontinued at least 48 hours before myelography, should not be used for the control of nausea or vomiting during or after myelography, and should not be resumed for at least 24 hours post-procedure. In nonelective procedures in patients on these drugs, consider prophylactic use of anticonvulsants.

USE IN SPECIFIC POPULATIONS Pregnancy: There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts. Lactation: Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding, and pumping and discarding breast milk, for 10 hours (approximately 5 elimination half-lives) after Omnipaque administration, to minimize drug exposure to a breastfed infant. Pediatric Patients: In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults. Pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age. Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to pediatric patients, including infants. Some patients were treated for hypothyroidism. Geriatric Use: In clinical studies of Omnipaque for computed tomography (CT), 52/299 (17%) of patients were 70 and older. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Prior to Omnipaque administration, please read the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch .

Important Safety Information About Visipaque

PRODUCT INDICATIONS AND USE

Intra-Arterial Procedures

Adult and pediatric patients 12 years of age and older: Intra-arterial digital subtraction angiography (270 and 320 mg iodine/mL); angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg iodine/mL). Pediatric patients less than 12 years of age: Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg iodine/mL)

Intravenous Procedures

Adult and pediatric patients 12 years of age and older: Computed tomography (CT) imaging of the head and body and excretory urography (270 and 320 mg iodine/mL); peripheral venography (270 mg iodine/mL); coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected coronary artery disease (320 mg iodine/mL). Pediatric patients less than 12 years of age: CT imaging of the head and body and excretory urography (270 mg iodine/mL).


WARNING: NOT FOR INTRATHECAL USE

See full Prescribing Information for complete Boxed Warning.

Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

 

CONTRAINDICATION: Visipaque Injection is contraindicated for intrathecal use.

WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Visipaque can cause life-threatening or fatal hypersensitivity reactions, including anaphylaxis. Most severe reactions develop shortly after the start of the injection, but reactions can occur up to hours later. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents, and always have emergency resuscitation equipment and trained personnel available prior to Visipaque administration. Monitor all patients for hypersensitivity reactions. Contrast-Induced Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after Visipaque administration. Use the lowest necessary dose of Visipaque in patients with renal impairment. Adequately hydrate patients prior to and following Visipaque administration. Do not use laxatives, diuretics, or preparatory dehydration prior to Visipaque administration. Cardiovascular Adverse Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the use of Visipaque. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Use the lowest necessary dose of Visipaque in patients with congestive heart failure, and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions. Thromboembolic Events: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast agents. Use meticulous angiographic techniques, and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism. Extravasation and Injection-Site Reactions: Extravasation of Visipaque Injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms. Thyroid Storm in Patients With Hyperthyroidism: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of Visipaque. Hypertensive Crisis in Patients With Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Monitor patients when administering Visipaque if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available. Sickle Cell Crisis in Patients With Sickle Cell Disease: Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following Visipaque administration, and use Visipaque only if the necessary imaging information cannot be obtained with alternative imaging modalities. Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs) may develop from one hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate SCARs. Avoid administering Visipaque to patients with a history of a SCAR to Visipaque. Pediatric Use: Pediatric patients at high risk of adverse reactions during and after administration of contrast agents include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, chronic heart failure, or a serum creatinine >1.5 mg/dL. Patients with immature renal function or dehydration may be at increased risk due to prolonged elimination of iodinated contrast agents. Geriatric Use: While no overall differences in safety or effectiveness were observed in patients >65 years, greater sensitivity regarding some older individuals cannot be ruled out. As Visipaque is substantially excreted by the kidney, the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Lactation: There are no data on the presence of iodixanol in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Visipaque and any potential adverse effects on the breastfed infant from Visipaque, or from the underlying maternal condition. Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding, and pumping and discarding breast milk for 10 hours after Visipaque administration, to minimize drug exposure to a breastfed infant.

ADVERSE REACTIONS: Serious, life-threatening, and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast agents, including Visipaque Injection. Most deaths occur during injection or five to 10 minutes later. Rare reports of anaphylaxis have been documented during postmarketing surveillance. As with other contrast agents, Visipaque is often associated with sensations of discomfort, warmth, or pain. The reported incidence of adverse reactions to contrast agents in patients with a history of allergy is twice that of the general population. Patients with a history of a previous reaction to contrast agents are three times more susceptible than other patients.

DRUG INTERACTIONS Metformin: In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, Visipaque administration in patients with an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine: Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for six to eight weeks. Beta-Adrenergic Blocking Agents: The use of beta-adrenergic blocking agents lowers the threshold for and increases the severity of contrast reactions, and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Because of the risk of hypersensitivity reactions, use caution when administering Visipaque to patients taking beta-blockers. Oral Cholecystographic Contrast Agents: Renal toxicity has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular iodinated contrast agents. Postpone the administration of Visipaque in patients who have recently received an oral cholecystographic contrast agent.

OVERDOSAGE: The adverse effects of contrast media overdose may be life-threatening, affecting mainly the pulmonary and cardiovascular systems.

Prior to Visipaque administration, please read the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

Important Safety Information About Omniscan

PRODUCT INDICATIONS: Omniscan Injection is indicated for intravenous use in MRI to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues; and within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.

WARNING — NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of Omniscan has caused convulsions, coma, sensory, and motor neurologic deficits.

WARNING — NEPHROGENIC SYSTEMIC FIBROSIS (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not administer Omniscan to patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/min/1.73m2) or acute kidney injury (AKI). Screen patients for AKI and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension, or diabetes), estimate GFR via laboratory testing. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

 

CONTRAINDICATIONS: Omniscan is contraindicated in patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m2), AKI, or prior hypersensitivity reaction to Omniscan.

WARNINGS AND PRECAUTIONS - Hypersensitivity: Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory, and/or cutaneous manifestations, resulting in death have occurred. Acute Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hours of dosing. The risk of renal failure may increase with increasing dose. Impaired Visualization: GBCAs such as Omniscan might impair the visualization of lesions that are seen on the noncontrast MRI.

ADVERSE REACTIONS: In adult clinical trials, the most frequent adverse reactions were nausea, headache, and dizziness. In pediatric clinical trials, the adverse reactions were similar to those reported in adults. Postmarketing ExperienceNervous System: Inadvertent intrathecal use causes convulsions, coma, paresthesia, and paresis. General: Nephrogenic systemic fibrosis. Renal and Urinary System Disorders: In patients with preexisting renal insufficiency: Acute renal failure, renal impairment, and increased blood creatinine.

SPECIFIC POPULATIONS - Pregnancy: Adequate and well-controlled studies in pregnant women have not been conducted. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering Omniscan to a nursing woman. Pediatric Use: The safety and efficacy of a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients two years of age and older, based on adequate and well-controlled studies of Omniscan in adults, a pediatric CNS imaging study, and safety data in the scientific literature. The optimal dosing regimen and imaging times in patients younger than two years of age have not been established. Geriatric Use: Clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity in the elderly cannot be ruled out. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The risk of toxic reactions to Omniscan is greater in patients with impaired renal function. Renal/Hepatic Impairment: Dose adjustments in renal or hepatic impairment have not been studied. Caution should be exercised in patients with impaired renal insufficiency.

Prior to Omniscan administration, please read the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2), or the FDA at 800 FDA 1088 or www.fda.gov/medwatch

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