CNS (Central Nervous System)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies].

CNS (Central Nervous System)

Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. An additional 0.4 mL/kg (0.2 mmol/kg) can be given within 20 minutes of the first dose [See DOSAGE AND ADMINISTRATION].

Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [See DOSAGE AND ADMINISTRATION].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [See DOSAGE AND ADMINISTRATION].

Dosage Chart

Dosing Guidelines

Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

Do not use the solution if it is discolored or particulate matter is present.

Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride, as provided in the Prefill Plus needle-free system. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

Repeat Dosing

Sequential use during the same diagnostic session has been studied in adult CNS use only. If the physician determines repeat dosing is required in non- CNS imaging in adults or pediatric patients, renal function should be normal and the time interval between repeat doses should be at least 7 hours to allow for clearance of the drug from the body [see CLINICAL PHARMACOLOGY].

Dosage forms and Strength

Sterile aqueous solution for intravenous injection; 287 mg/mL.

Storage and Handling

OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide in rubber stoppered vials and polypropylene syringes. OMNSICAN is supplied in the following sizes:

5 mL fill in 10 mL vial, box of 10 (NDC 0407-0690-05)
10 mL vial, box of 10 (NDC 0407-0690-10)
15 mL fill in 20 mL vial, box of 10 (NDC 0407-0690-15)
20 mL vial, box of 10 (NDC 0407-0690-20)
50 mL vial, box of 10 (NDC 0407-0690-55)
10 mL fill in 20 mL prefilled syringe, box of 10 (NDC 0407-0690-12)
15 mL fill in 20 mL prefilled syringe, box of 10 (NDC 0407-0690-17)
20 mL prefilled syringe, box of 10 (NDC 0407-0690-22)

Prefill Plus™ needle-free system
OMNISCAN 15 mL, box of 10 (NDC 0407-0691-62)
Contains: OMNISCAN 15 mL fill in 20 mL Single Dose Prefilled Syringe and 5 mL 0.9% Sodium Chloride Injection, USP I.V. Flush Syringe

Prefill Plus™ needle-free system
OMNISCAN 20 mL, box of 10 (NDC 0407-0691-63)
Contains: OMNISCAN 20 mL fill in 20 mL Single Dose Prefilled Syringe and 5 mL 0.9% Sodium Chloride Injection, USP I.V. Flush Syringe

Protect OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small cracks in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen.

Store OMNISCAN at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP],

Distributed by QE Healthcare Inc., Princeton, NJ, Manufactured by GE Healthcare AS, Oslo, Norway. OMNISCAN is a trademark of GE Healthcare. GE and the GE Monogram are trademarks of General Electric Company. OptiMARK® is a registered trademark of Mallinckrodt Inc. Magnevist® is a registered trademark of Berlex Laboratories, Inc. MultiHance® is a registered trademark of Bracco International B.V. ProHance® is a registered trademark of Bracco Diagnostics Inc. FDA rev date: 12/14/2007

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