Ultravist 370 Injection

ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 ) • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast mammogr …

• Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. • For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography. • See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages
• Important Dosage and Administration Information • ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ] . • Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ] . • Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions ] . • Individualize the volume, concentration, and injection rate of ULTRAVIST according to the specific dosing tables [see Dosage and Administration ]
• Consider factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; also consider extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. • Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. …

ULTRAVIST injection is a clear, colorless to slightly yellow, odorless solution available in two concentrations: 300 mg Iodine per mL available as • 50 mL, 100 mL, 125 mL, and 150 mL in single-dose vials • 200 mL and 500 mL in pharmacy bulk packages • 200 mL and 500 mL in imaging bulk packages 370 mg Iodine per mL available as • 50 mL, 100 mL, 125 mL, and 150 mL in single-dose vials • 200 mL and 5 …

• The safety and efficacy of ULTRAVIST have been established
• In pediatric patients aged 2 years and older for radiographic evaluation of cardiac chambers and related arteries, excretory urography, and contrast computed tomography of head and body
• Use of ULTRAVIST in these age groups for these indications is supported by evidence from adequate and well-controlled studies
• In adults and additional safety data
• In pediatric patients aged 2 years and older, including data from published studies [see Adverse Reactions and Clinical Studies ]. …

In a clinical study of ULTRAVIST for CT, 96/434 (22.1%) of patients were 65 and over. 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. …

• Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after ULTRAVIST administration
• Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions ]
• Advise patients to inform their physician if they develop a rash after receiving ULTRAVIST [see Warnings and Precautions ] Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury [see Warnings and Precautions ]. …

None None

7.1 Drug-Drug Interactions Metformin In patients with renal impairment, biguanides 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, ULTRAVIST administration in patients with an 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 agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute only after renal function is stable. …

• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) • Acute Kidney Injury : Acute injury including renal failure can occur. Dose minimization and hydration may decrease risk. ( 5.3 ) • Cardiovascular Reactions : Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. …

The following adverse reactions are described elsewhere in the labeling: • Risks Associated with Intrathecal Use [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] • Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Thromboembolic Events [see Warnings and Precautions ( 5.5 )] • Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.8 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Common adverse rea …

8.1 Pregnancy Risk Summary There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data) . …

The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. Iopromide can be removed by dialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.