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Optimark (Gadoversetamide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CNS (Central Nervous System)

OptiMARK Injection is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.

Liver

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 Weight0.1 mmol/kg
Kilograms (kg)Pounds (lb)Volume (mL)
40888.0
5011010.0
6013212.0
7015414.0
8017616.0
9019818.0
10022020.0
11024222.0
12026424.0
13028626.0
14030828.0
15033030.0

Imaging

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).

Drug Handling

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.

This product has not been evaluated for use in magnetic resonance angiography.

Pharmacy Bulk Package Preparation: NOT FOR DIRECT INFUSION

The 50 mL Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes.

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.

When OptiMARK Injection is to be injected using plastic disposable syringes, the contrast should be drawn into the syringe and used immediately.

  • a) The transfer of OptiMARK Injection from the Pharmacy Bulk Package must be performed in an aseptic work area such as a laminar flow hood using appropriate aseptic technique.
  • b) Once the Pharmacy Bulk Package is punctured, it should not be removed from the aseptic work area during the entire 24 hour period of use.
  • c) The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours.
  • d) Any unused OptiMARK Injection must be discarded 24 hours after the initial puncture of the bulk package.
  • e) IV tubing and syringes used to administer OptiMARK Injection must be discarded at the conclusion of the radiological examination.

HOW SUPPLIED

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 50 mL glass bottles containing 50 mL of solution. Each bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configurations:

50 mL in glass bottles in cartons of 5 bottles       (NDC Code 0019-1177-50)

Storage

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).

This product is covered by U.S. Patent No. 5130120, 5137711, 5508388. The use of this product is covered by U.S. Patent No. 5130120 and 5137711.

OptiMARK is a trademark of Mallinckrodt Inc.
Omniscan is a registered trademark of GE Healthcare AS
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.

Copyright 1998, Mallinckrodt Inc.
All rights reserved

Manufactured and Distributed by:
Mallinckrodt Inc.
St. Louis, MO 63042 U.S.A.

Printed in U.S.A.

tyco
Healthcare

MALLINCKRODT

Mallinckrodt Inc.
St. Louis, MO 63042 U.S.A.
www.Mallinckrodt.com

MKR 11PB0908
Revised 09/08
Printed in U.S.A.

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