+PLUSPAK 100% recyclable packaging
Protecting and optimizing iodine
Looking for medical information?
Indications and Important Safety Information
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
Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
• OMNIPAQUE 140 and OMNIPAQUE 350 are contraindicated for intrathecal use.
• OMNIPAQUE Oral Solutions 9 and 12 are contraindicated for parenteral administration.
• OMNIPAQUE body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected.
WARNINGS AND PRECAUTIONS:
• Hypersensitivity Reactions: Life-threatening or fatal hypersensitivity reactions, including anaphylaxis can occur. Most severe reactions develop within 3 minutes of injection start, but reactions can occur hours later. Increased risk exists in patients with previous reaction to contrast agents and known allergies (ie, bronchial asthma, drug, food allergies) or other hypersensitivities. Always have emergency resuscitation equipment and trained personnel available. Monitor all patients for hypersensitivity reactions.
• Contrast-Induced Acute Kidney Injury: Acute injury, including renal failure, may occur after parenteral administration. Risk factors include renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, and repetitive and/or large doses of an iodinated contrast agent. Minimize dose and maintain adequate hydration.
• Cardiovascular Adverse Reactions: Life-threatening or fatal cardiovascular reactions, including hypotension, shock, and cardiac arrest have occurred with the parenteral administration. Most deaths occur during injection or 5-10 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. Monitor all patients for severe cardiovascular reactions.
• Thromboembolic Events: Angiocardiography - Serious, rarely fatal, events causing myocardial infarction and stroke can occur during a procedure as increased thrombosis and activation of the complement system occurs. Risk factors include procedure length, catheter/syringe material, underlying disease, concomitant medications. Use meticulous angiographic techniques, minimize length of procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents. Avoid angiocardiography in patients with homocystinuria.
• Extravasation and Injection-Site Reactions: Extravasation 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, 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.
• Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media. Among patients 0 to 3 years of age exposed to iodinated contrast media, thyroid dysfunction has been reported in 1% to 15% depending on the age of the patient and the dose of the iodinated contrast agent. Monitor these patients for thyroid function abnormalities and treat as clinically needed.
• Hypertensive Crisis in Patients with Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. 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 (SCAR): SCAR may develop from 1 hour to several weeks after IV contrast administration. These 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 to patients with a history of a SCAR to OMNIPAQUE.
USE IN SPECIFIC POPULATIONS:
Please consult the full Prescribing Information before using OMNIPAQUE in patients who are: pregnant or may be pregnant, lactating, pediatric or geriatric.
• Intrathecal: Headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, dizziness.
• Intravascular: Pain, vision abnormalities, (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea.
• Oral:Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache.
• Body cavity: Pain, swelling, heat sensation.
• Postmarketing adverse events seen include: Hypersensitivity and manifestations such as rash, pruritus, urticaria and dyspnea, chest pain, swelling.
• Metformin: Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function in patients with renal impairment. Stop metformin at the time of, or prior to, injection of OMNIPAQUE. Reevaluate eGFR 48 hours after imaging procedure. 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.
• Beta-Adrenergic Blocking Agents: 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. 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 like monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs 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.
Prior to Omnipaque administration, please read the full Prescribing Information including Boxed Warning for Omnipaque. Also read the full Prescribing Information for Omnipaque Imaging Bulk Package and Omnipaque Pharmacy Bulk Package.
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 FOR VISIPAQUE (iodixanol) INJECTION
WARNING: NOT FOR INTRATHECAL USE
CONTRAINDICATION: Visipaque injection is contraindicated for intrathecal use.
WARNINGS AND PRECAUTIONS:
• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Most severe reactions develop shortly after the start of the injection, but reactions can occur up to hours later. Always have emergency equipment and trained personnel available.
• Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.
• Cardiovascular 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.
• Thromboembolic Events: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast agents.
• 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.
• 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.
• Hypertensive Crisis in Patients With Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. 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.
• 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). 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. Thyroid dysfunction in pediatric patients 0 to 3 Years of Age: Monitor these patients for thyroid function abnormalities and treat as clinically needed.
• 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.
• 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 common adverse reactions (incidence greater than 0.5%) in adult patients after Visipaque injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.
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)
Adult and pediatric patients 12 years of age and older: Computed tomography (CT) imaging of the head and body (270 and 320 mg iodine/mL); 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 artery disease (320 mg iodine/mL). Pediatric patients less than 12 years of age: CT imaging of the head and body (270 mg iodine/mL); excretory urography (270 mgiodine/mL)
Product indications and use
Important Safety Information
History of clinically important hypersensitivity reactions to Clariscan.
Warnings and precautions
Nephrogenic Systemic Fibrosis (NSF):
- • NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.
- • Anaphylactic and anaphylactoid reactions have been reported with gadoterate meglumine, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of gadoterate meglumine administration and resolved with prompt emergency treatment.
- • Before Clariscan administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Clariscan.
- • Administer Clariscan only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
- • Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver and spleen. The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs.
- • Consequences of gadolinium retention in the brain have not been established. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
- • In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.
- • Ensure catheter and venous patency before the injection of Clariscan. Extravasation into tissues during Clariscan administration may result in tissue irritation. Pre-filled syringes must not be frozen. Frozen syringes should be discarded.
Pharmacy Bulk Package Preparation:
- • Do not use the Pharmacy Bulk Package for direct intravenous infusion.
- • Do not use if tamper-evident ring is broken or missing.
- • Perform the transfer of Clariscan from the Pharmacy Bulk Package in an aseptic work area, such as laminar flow hood and using aseptic technique and suitable transfer device. Penetrate the closure only one time.
- • Once the container closure is punctured, do not remove the Pharmacy Bulk Package from the aseptic work area.
- • The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.
- • Use each individual dose of Clariscan promptly following withdrawal from the Pharmacy Bulk Package.
- • Use the contents of the Pharmacy Bulk Package within 24 hours after initial puncture.
- • The most common adverse reactions (≥ 0.2%) associated with gadoterate meglumine in clinical trials were nausea, headache, injection site pain, injection site coldness and rash.
- • Serious adverse reactions in the postmarketing experience have been reported with gadoterate meglumine. These serious adverse reactions include but are not limited to: arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma and convulsion.
Use in specific populations
- • Pregnancy: Because of the potential risks of gadolinium to the fetus, use Clariscan only if imaging is essential during pregnancy and cannot be delayed. Advise pregnant women of the potential risk of fetal exposure to GBCAs.
- • Lactation: While no data is available for gadoterate meglumine, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
- • Pediatric Use: The safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data. Safety of gadoterate meglumine has not been established in preterm neonates.
Please read the full Prescribing Information for Clariscan including Boxed Warning and the full Prescribing Information including Boxed Warning for Clariscan Pharmacy Bulk Package, which includes the patient Medication Guide for additional important safety information.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
*This pointer statement may change based on how the material is being presented
IMPORTANT SAFETY INFORMATION
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
• Assess all patients for the presence of any condition that precludes OPTISON administration
• Always have resuscitation equipment and trained personnel readily available
• WARNINGS AND PRECAUTIONS: 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).
• 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.
• 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.
• 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.
• 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.
• ADVERSE EVENTS: The most frequently reported adverse reactions in clinical trials were headache, nausea and/or vomiting, warm sensation or flushing and dizziness. Cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported in post-approval use. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions. Please see the full Prescribing Information, including Boxed Warning for additional important safety information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1), or the FDA at 800 FDA 1088 or https://www.fda.gov/medwatch
Important Safety Information
CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
CT motion is specifically indicated for use in CT procedures for the delivery of approved contrast media - GE Healthcare Inc. contrast media as supplied in Imaging Bulk Packages (IBP). CT Motion is also approved for use with some single dose contrast media.
Pump tubing-flex is used for a maximum time of twenty four (24) hours. when used with approved contrast media in IBP, a maximum of 19 bottles of contrast media can be used or maximum time of twenty four (24) hours of Pump tubing-flex, or whichever comes first, with a maximum of eight (8) hours per contrast media or saline container.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Important Safety Information
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
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to:
- Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues
- Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space
MRI contrasts, such as Omniscan may be an appropriate choice for eligible patients and procedures based on its clinical profile and a long tradition of patient and clinician experience. Benefits of Omniscan include:
- It has been used in a clinical setting for more than 15 years in more than 40 million contrast-enhanced MRI scans.1
- Available in +PLUSPAKTM polymer bottle packaging.
1. Data on file. GE Healthcare. 2011.