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OMNISCAN

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Overview

What is OMNISCAN?

OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection.

OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution in a Pharmacy Bulk Package. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)-11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N, N, N, O, O, O, O, O] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of CHGdNO∙xHO, and the following structural formula:

Pertinent physicochemical data for OMNISCAN are noted below:

OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.



What does OMNISCAN look like?



What are the available doses of OMNISCAN?

Sterile aqueous solution for intravenous injection; 287 mg/mL ()

What should I talk to my health care provider before I take OMNISCAN?

How should I use OMNISCAN?

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 [].

Pharmacy Bulk Package – Not for Direct Infusion ()

CNS – Adults and Pediatrics; 2-16 years of age: 0.2 mL/kg (0.1 mmol/kg) (, )

Body – Adults and Pediatrics; 2-16 years of age: Kidney: 0.1 mL/kg (0.05 mmol/kg) Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) (, )


What interacts with OMNISCAN?

Sorry No Records found


What are the warnings of OMNISCAN?

Sorry No Records found


What are the precautions of OMNISCAN?

Sorry No Records found


What are the side effects of OMNISCAN?

Sorry No records found


What should I look out for while using OMNISCAN?

OMNISCAN is contraindicated in patients with:

NOT FOR INTRATHECAL USE:

Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits [

see

].

NSF:


What might happen if I take too much OMNISCAN?

Clinical consequences of overdose with OMNISCAN have not been reported. The minimum lethal dose of intravenously administered OMNISCAN in rats and mice is greater than 20 mmol/kg (200 times the recommended human dose of 0.1 mmol/kg; 67 times the cumulative 0.3 mmol/kg dose). OMNISCAN is dialyzable.


How should I store and handle OMNISCAN?

Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide supplied in the following sizes:100 mL in +PAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-70)OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide supplied in the following sizes:100 mL in +PAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-70)