药物信息为Optiray 350 (Mallinckrodt Inc.): INDIVIDUAL INDICATIONS, USAGE AND PROCEDURAL INFORMATION GENERAL ANGIOGRAPHY

Visualization of the cardiovascular system may be accomplished by any accepted radiological technique. Since intra-arterial digital subtraction angiography (IA-DSA) requires adjustments in the method of administration, this procedure is described separately.

Additional Precautions and Adverse Reactions: Extreme caution is advised in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine. Cardiovascular reactions that may occur with some frequency are bradycardia and either an increase or decrease in systemic blood pressure. Neurological reactions that may occur are: seizures, drowsiness, transient paresis, and mild disturbances in vision.

Central nervous system reactions with OPTIRAY in controlled clinical studies in cerebral arteriography that were considered drug-related and occurred with frequencies greater than 1% were: headache, bradycardia, blood pressure fluctuation, disorientation, nausea and vertigo.

Dosage and Administration: OPTIRAY 240, OPTIRAY 300 or OPTIRAY 320 is recommended for this procedure. The usual individual injection for visualization of the carotid or vertebral arteries is 2 to 12 mL, repeated as necessary. Aortic arch injection for a simultaneous four vessel study requires 20 to 50 mL. Total procedural doses should not usually exceed 200 mL.

Additional Precautions: Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all.

Dosage and Administration: OPTIRAY 300, OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual individual injection volumes for visualization of various peripheral arteries are as follows:

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Additional Precautions and Adverse Effects: In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis.

Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Dosage and Administration: OPTIRAY 320 is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Additional Precautions: Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

Adverse Reactions: There were no cardiovascular system reactions with OPTIRAY in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Dosage and Administration: OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

Additional Precautions: Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure. 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.

Dosage and Administration: OPTIRAY 350 or OPTIRAY 320 is recommended for this procedure. The usual single ventricular injection of OPTIRAY 350 or OPTIRAY 320 is 1.25 mL/kg of body weight with a range of 1 mL/kg to 1.5 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL.

All of the arteriographic procedures described above can be performed using digital subtraction techniques.

Dosage and Administration: OPTIRAY 160 is recommended for this procedure. As a general rule, the volume and concentration used for IA-DSA is about 50%, or less, of that used for conventional procedures. The actual dosage and flow rate will vary depending on the selectivity of the injection site and the area being examined.

The following suggested volumes per injection are intended only as a guide. Injections may be repeated as necessary. It is advisable to inject at rates approximately equal to the flow of the vessel being injected.

Dosage should not usually exceed 250 mL.

Additional Precautions: Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In order to minimize extravasation during injection, fluoroscopy is recommended.

Dosage and Administration: OPTIRAY 240, OPTIRAY 300, OPTIRAY 320 or OPTIRAY 350 is recommended for this procedure. The usual dose is 50 to 100 mL per extremity with smaller or larger volumes indicated in some cases. Dosage should not usually exceed 250 mL.

Following the procedure, the venous system should be flushed with Sodium Chloride Injection U.S.P. or 5% Dextrose in Water (D5W). Massage and elevation are also helpful for clearing the contrast medium from the extremity.