Optimark

2.1 Dosing Guidelines 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)

  40

  8

  50

10

  60

12

  70

14

  80

16

  90

18

100

20

110

22

120

24

130

26

140

28

150

30

2.2 Drug Handling 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. 2.3 Imaging 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 (12.2)]. 2.1 Dosing Guidelines 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)

  40

  8

  50

10

  60

12

  70

14

  80

16

  90

18

100

20

110

22

120

24

130

26

140

28

150

30

2.2 Drug Handling 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. 2.3 Imaging 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 (12.2)].

2.1  Directions for Proper use of Pharmacy Bulk Package

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. Use the following procedure when transferring Optimark from the pharmacy bulk package to individual syringes:

Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique. Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent. Once the pharmacy bulk package is punctured, do not remove from the aseptic work area during the entire period of use. Penetrate the container closure only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents. Withdrawal of container contents should be accomplished without delay. A maximum time of 24 hours from initial closure entry is permitted to complete fluid transfer operations. Discard any unused Optimark 24 hours after the initial puncture of the bulk package. 2.2  Dosing Guidelines 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). 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)

40

8

50

10

60

12

70

14

80

16

90

18

100

20

110

22

120

24

130

26

140

28

150

30

2.3  Drug Handling 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. 2.4  Imaging 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 (12.2)].

2.1 Dosing Guidelines 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)

  40

  8

  50

10

  60

12

  70

14

  80

16

  90

18

100

20

110

22

120

24

130

26

140

28

150

30

2.2 Drug Handling 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. 2.3 Imaging 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 (12.2)]. 2.1 Dosing Guidelines 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)

  40

  8

  50

10

  60

12

  70

14

  80

16

  90

18

100

20

110

22

120

24

130

26

140

28

150

30

2.2 Drug Handling 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. 2.3 Imaging 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 (12.2)].