"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
GCTB generally occurs in a"...
CNS (Central Nervous System)
OptiMARK™ Injection is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography.
DOSAGE AND ADMINISTRATION
OptiMARK™ Injection should be administered 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.
Table 6: Dosage Chart for OptiMARK™ Injection
|Body Weight||0.1 mmol/kg Volume (mL)|
|Kilograms (kg)||Pounds (lb)|
The imaging procedure should be completed within 1 hour of the injection of OptiMARK™ Injection. The safety of repeat doses has not been studied. OptiMARK™ MRI images should be interpreted in comparison to unenhanced MRI (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Trials).
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.
Concurrent medications or Parenteral Nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility.
When OptiMARK™ Injection is to be injected using plastic disposable syringes, the contrast should be drawn into the syringe and used immediately.
This product has not been evaluated for use in magnetic resonance angiography.
OptiMARK™ Injection should be drawn into the syringe and administered using sterile technique. If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. To ensure complete injection of the contrast medium the injection should be followed by a 5 mL normal saline flush. Unused portions of the drug must be discarded.
OptiMARK™ Injection is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, 0.5 mmol/mL of gadoversetamide. OptiMARK™ Injection 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™ Injection 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™ Injection 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™ Injection 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. Mallinckrodt Inc. St. Louis, MO 63042 U.S.A. www.Mallinckrodt.com. Revised 05/13
Last reviewed on RxList: 9/9/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional OptiMARK Information
Report Problems to the Food and Drug Administration
Find out what women really need.