Preparation and
Administration of DIGIFab®1
Use and Storage
- Each vial of DIGIFab® contains 40 mg of digoxin immune Fab protein and is intended
for one-time use only. - From a microbiological point of view, the product should be used immediately after reconstitution.
- Store between 2° and 8°C.
- Do not freeze.
- Keep vial in outer carton in order to protect from light.
Reconstitution
Reconstitute each vial of DIGIFab with 4 mL Sterile
Water for Injection.
Gently mix to obtain a solution containing approximately
10 mg/mL digoxin immune Fab protein.
Add the reconstituted product to an appropriate
volume of 0.9% sodium chloride for injection.
Infusion
The final solution of reconstituted and diluted DIGIFab® should be infused intravenously over a 30-minute period.
- As with any intravenous protein product, infusion-related reactions or hypersensitivity reactions are possible. It is recommended that patients are monitored for signs and symptoms of anaphylaxis and an acute allergic reaction. Medical support must be readily available when DIGIFab® is administered.
- If an anaphylactic reaction occurs during an infusion then administration of DIGIFab® must be stopped immediately.
