Gadavist

Gadavist Manufacturers

• Bayer Healthcare Pharmaceuticals Inc.
  

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  Gadavist | Altaire Pharmaceuticals Inc.

  

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  Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 to 2 drops (in single instillations) in each eye before operating.
  Deep Ophthalmic Anesthesia: 1 drop in each eye every 5 to 10 minutes for 5-7 doses.

  NOTE: The use of an eye patch is recommended.

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• Bayer Healthcare Pharmaceuticals Inc.
  

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  Gadavist | Bayer Healthcare Pharmaceuticals Inc.

  

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  2.1 Recommended Dose

  The recommended dose of Gadavist for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.

  Table 1: Volume of Gadavist Injection by Body Weight

  Body Weight

  Volume to be Administered, mL

  lb

  kg

  5.5

  2.5

  0.25

  11

  5

  0.5

  22

  10

  1

  33

  15

  1.5

  44

  20

  2

  55

  25

  2.5

  66

  30

  3

  77

  35

  3.5

  88

  40

  4

  99

  45

  4.5

  110

  50

  5

  132

  60

  6

  154

  70

  7

  176

  80

  8

  198

  90

  9

  220

  100

  10

  242

  110

  11

  264

  120

  12

  286

  130

  13

  308

  140

  14

  2.2 Administration Guidelines • Gadavist is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Closely examine Table 1 to determine the volume to be administered. Use sterile technique when preparing and administering Gadavist. • Administer Gadavist as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second. • Follow Gadavist injection with a normal saline flush to ensure complete administration of the contrast. • Contrast-enhanced MRI can commence immediately following contrast administration. 2.3 Drug Handling • Visually inspect Gadavist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged. • Do not mix Gadavist with other medications and do not administer Gadavist in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility. • Instructions of the device manufacturer must be followed. Pharmacy Bulk Package Preparation • Pharmacy Bulk Packages are not for use in direct intravenous infusions. • After the Pharmacy Bulk Package has been opened, Gadavist remains stable for 24 hours at 20–25°C (68–77°F). • The Pharmacy Bulk Package contains many single doses and is used with an appropriate transfer device for filling empty sterile syringes. • The transfer of Gadavist from the Pharmacy Bulk Package must be performed in an aseptic work area, such as a laminar flow hood, using aseptic technique. • 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. • IV tubing and syringes used to administer Gadavist must be discarded at the conclusion of the radiological examination.

  The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours. Discard any unused portion in accordance with regulations dealing with the disposal of such materials.

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