2 DOSAGE AND ADMINISTRATION For each imaging procedure, specific dosage forms, concentrations, and presentations are recommended. Individualize the concentration and volume according to the specific dosing tables and accounting for factors such as age, body weight, and condition of the patient, and the equipment and imaging technique used.
9 ) See full prescribing information for complete dosing and administration information. 2) ]. 9) ] . Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
4) ]. Use aseptic technique for all handling and administration of OMNIPAQUE injection. 6°F) or room temperature (20°C to 25°C, 68°F to 77°F). 11) ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Each container of OMNIPAQUE injection and OMNIPAQUE oral solution in single-dose containers are intended for one procedure only. Discard any unused portion. 2 Recommended Dosage for Intrathecal Procedures in Adults The recommended doses for intrathecal procedures in adults are shown in Table 1.
Administer over 1 minute to 2 minutes. If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast. Table 1. 11) ]. 3 Recommended Dosage for Intra-arterial Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 2.
Table 2. 11) ]. 4 Recommended Dosage for Intravenous Procedures in Adults The recommended doses for intravenous procedures in adults are shown in Table 3. Table 3. 11) ]. 12) ]. 5 Recommended Dosage for Oral Procedures in Adults Recommended Dosage for Radiographic Examination of the GI Tract in Adults The recommended dose for radiographic examination of the GI tract in adults is 50 mL to 100 mL of OMNIPAQUE injection 350 mg iodine/mL administered undiluted orally.
Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMINIPAQUE Injection in Adults The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous doses for CT of the abdomen and pelvis in adults are shown in Table 4.
Table 4. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Adults Concentration (mg Iodine/mL) Volume to Administer Administration Instructions Oral Dose Using Diluted OMNIPAQUE Injection 6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE Injection See Table 5 for dilution instructions of OMNIPAQUE injection 500 mL to 1,000 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 5 ). Oral Dose Using OMNIPAQUE Oral Solution 9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution 500 mL to 1,000 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
12) ]. 100 mL to 150 mL Administer up to 40 minutes AFTER consumption of the oral dose. Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Adults Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, or juice just prior to administration according to Table 5.
Discard any unused portion after the procedure. Table 5. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen in Adults Concentration of Diluted OMNIPAQUE injection (mg iodine/mL) Dilution Method 1 Dilution Method 2 Dilution Method 3 Volume of OMNIPAQUE 240 mg Iodine/mL (mL) Volume of Added Liquid Use water, carbonated beverage, milk, or juice.
6 Recommended Dosage for Intraarticular Procedures in Adults The recommended doses for intraarticular procedures in adults are shown in Table 6. Use passive or active manipulation to disperse the medium throughout the joint space. Table 6.
11) ]. 5 mL to 15 mL Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations. 7 Recommended Dosage for Body Cavity Procedures in Adults The recommended doses for body cavity procedures in adults are shown in Table 7.
Volume to administer may vary depending on individual anatomy and/or disease state. Table 7. 11) ]. 8 Recommended Dosage for Intrathecal, Intra-arterial, and Intravenous Procedures in Pediatric Patients Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Weeks and Older Recommended doses based on age for intrathecal procedures in pediatric patients aged 2 weeks and older are shown in Table 8.
Administer over 1 minute to 2 minutes. If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast.
Table 8:
Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older Imaging Procedure Injection Type Age Concentration (mg Iodine/mL) Volume to Administer Myelography Lumbar Thoracic Cervical Total Columnar CT cisternography Lumbar 2 weeks up to 3 months 180 Use single-dose containers .
2 mL to 4 mL 3 months up to 36 months 4 mL to 8 mL 3 years up to 7 years 5 mL to 10 mL 7 years up to 13 years 5 mL to 12 mL 13 years to 18 years 6 mL to 15 mL Recommended Dosage for Intra-arterial Procedures in Pediatric Patients The recommended doses for intra-arterial procedures in pediatric patients are shown in Table 9.
Table 9. 11) ]. 5 mL/kg) 5 mL/kg up to a total volume of 250 mL Aortography (aortic root, aortic arch, and descending aorta) 350 1 mL/kg 5 mL/kg up to a total volume of 250 mL Pulmonary Angiography 350 1 mL/kg 5 mL/kg up to a total volume of 250 mL Recommended Dosage for Intravenous Procedures in Pediatric Patients The recommended doses for intravenous procedures in pediatric patients are shown in Table 10.
Table 10. 11) ]. 12) ]. 9 Recommended Dosage for Oral or Rectal and Body Cavity Procedures in Pediatric Patients Recommended Dosage for Radiographic Examination of the GI Tract in Pediatric Patients The recommended doses for radiographic examination of the GI tract are shown in Table 11.
Administer orally or rectally. Table 11. 11) ] . 5 mL to 30 mL May be a larger volume than the volume given orally (up to 300 mL) 3 months to 3 years 180 , 240 , or 300 Up to 60 mL 4 years to 10 years Up to 80 mL Greater than 10 years Up to 100 mL Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMNIPAQUE in Pediatric Patients The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous dose for CT of the abdomen and pelvis in pediatric patients are shown in Table 12.
Table 12. Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Pediatric Patients Concentration (mg Iodine/mL) Volume to Administer Administration Instructions Maximum Dose by Age or Body Weight Oral Dose Using Diluted OMNIPAQUE Injection 9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE Injection See Table 13 for dilution instructions of OMNIPAQUE injection 180 mL to 750 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered (see Table 13 ). less than 3 years old: 5 grams iodine 3 years old to 18 years old: 10 grams iodine Oral Dose Using OMNIPAQUE Oral Solution 9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution 180 mL to 750 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
12) ]. 2 mL/kg body weight (with a range of 1 mL/kg to 2 mL/kg) Administer up to 60 minutes AFTER consumption of the oral dose. 3 mL/kg (maximum single dose: 116 mL) Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 13.
Discard any unused portion after the procedure. Table 13. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients Concentration of Diluted OMNIPAQUE injection (mg iodine/mL) Dilution Method 1 Dilution Method 2 Dilution Method 3 Volume of OMNIPAQUE 240 mg iodine/mL (mL) Volume of Added Liquid Use water, carbonated beverage, milk, infant formula, or juice.
8) ] . The concentration of diluted OMNIPAQUE injection may vary depending upon the patient's size and age and with the technique and equipment used. Volume ranges of diluted OMNIPAQUE injection 50 mg iodine/mL and 100 mg iodine/mL are shown in Table 14.
Dilute OMNIPAQUE injection with Sterile Water for Injection according to Table 15, utilizing aseptic technique, just prior to use. Discard any unused portion after the procedure. Table 14. Volume Ranges of Diluted OMNIPAQUE Injection for VCU in Pediatric Patients Concentration of Diluted OMNIPAQUE Injection See Table 15 below for dilution instructions of OMNIPAQUE injection.
(mg iodine/mL) Volume to Administer 50 50 mL to 600 mL by intravesical administration 100 50 mL to 300 mL by intravesical administration Table 15. 8) ] . When used as an IBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as an Imaging Bulk Package.
This container is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. See device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.
9% Sodium Chloride Injection USP in a room designated for radiological procedures that involve administration of a contrast agent. Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with the OMNIPAQUE IBP.
9% Sodium Chloride Injection USP container. 9% Sodium Chloride Injection containers are punctured, do not remove them from the work area during the entire period of use. Maintain the OMNIPAQUE IBP in an inverted position such that container contents are in continuous contact with the dispensing set.
9% Sodium Chloride Injection USP, and all associated disposables for the contrast media transfer set. A maximum time from initial puncture is 8 hours. Discard any unused portion. 11 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Pharmacy Bulk Package OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles contain many single doses and may be used as a Pharmacy Bulk Package (PBP).
When used as a PBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as a Pharmacy Bulk Package. This container is not for direct infusion; it is for use in pharmacy admixture service to dispense aliquots using a suitable dispensing set under a laminar flow hood or equivalent clean air compounding area using aseptic technique.
Penetrate the container closure only one time, utilizing a suitable transfer device and aseptic technique. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations.
Do not remove the container from the aseptic area during the entire 8-hour period. 6°F), after the closure has been entered. Discard any unused portion after 8 hours from the initial closure entry. 12 Directions for Use of the 150 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL with an Automated Contrast Injection System or Contrast Management System OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 150 mL bottles may be used with a contrast media management system cleared for use with OMNIPAQUE injection 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
See device labeling for information on device indications, instructions for use, and techniques to help assure safe use. Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the contrast media management system cleared for use with OMNIPAQUE 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
Once the container is punctured, do not remove the bottle from the work area during the entire period of use. Maximum use time is 4 hours after initial puncture. Each bottle is for one procedure only. Discard unused portion.