"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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MRI Of Central Nervous System (CNS)
MRI of Liver
OptiMARK is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.
DOSAGE AND ADMINISTRATION
- Administer OptiMARK as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1).
- Use sterile technique to withdraw and administer OptiMARK.
- Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast.
- Discard unused portions of the drug.
Table 1 : Dosage Chart for OptiMARK Injection
|Body Weight Kilograms (kg)||0.1 mmol/kg Volume (mL)|
- Visually inspect OptiMARK for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.
- Do not mix OptiMARK with other medications or parenteral nutrition and do not administer OptiMARK in the same intravenous line as other medications because of the potential for chemical incompatibility.
- Complete the imaging procedure within 1 hour of the injection of OptiMARK.
- Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret OptiMARK MR images with companion non-contrast MR images [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
OptiMARK is supplied as a clear, colorless to slightly yellow solution for injection containing 330.9 mg gadoversetamide per mL (equivalent to 0.5 mmol/mL).
Storage And Handling
OptiMARK is a clear, colorless to slightly yellow solution containing 330.9 mg/mL (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. OptiMARK is supplied in 10 mL vials containing 5 mL or 10 mL of solution and is also provided in 20 mL vials containing 15 mL or 20 mL of solution. Each single dose vial is rubber stoppered with an aluminum seal and the contents are sterile. OptiMARK is supplied in 10 mL, 15 mL, 20 mL or 30 mL syringes containing 10 mL, 15 mL, 20 mL or 30 mL of solution respectively. Each syringe is sealed with rubber closures and the contents are sterile. Vials and syringes are contained in shipping cartons with the following configurations:
5 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-02)
10 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-04)
15 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-06)
20 mL in glass vials in cartons of 10 vials
(NDC Code 0019-1177-08)
10 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-11)
15 mL in plastic syringes in cartons of 10 syringes
(NDC Code 0019-1177-16)
20 mL in plastic syringes in
cartons of 10 syringes
(NDC Code 0019-1177-21)
30 mL in plastic syringes in
cartons of 10 syringes
(NDC Code 0019-1177-31)
OptiMARK should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. OptiMARK may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).
Manufactured and Distributed by: Mallinckrodt Inc. St. Louis, MO 63042 U.S.A. Issued 11/14This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/15/2014
Additional OptiMARK Information
Report Problems to the Food and Drug Administration
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