Definity Dosage

Important Preparation and Administration Instructions

• There are two formulations, DEFINITY and DEFINITY RT, that have differences in preparation and storage. Ensure of the correct product when following the directions for preparation and storage.
• DEFINITY must be activated using the VIALMIX or VIALMIX RFID device before administration according to the instructions outlined below [see Dosage and Administration (2.5)].
• DEFINITY is for intravenous use only and must not be administered by intra-arterial injection [see Warnings and Precautions (5.3)].
• For adult patients, DEFINITY can be administered by either an intravenous bolus or infusion. The maximum dose is either two bolus doses or one single infusion. Do not administer the bolus and infusion dosing in combination or in sequence [see Dosage and Administration (2.2)].
• ​For pediatric patients, DEFINITY is administered by an intravenous bolus injection only. The maximum dose is two bolus doses [see Dosage and Administration (2.3)].

Recommended Dosage in Adult Patients

Recommended Dosage in Pediatric Patients

Imaging Instructions

Instructions for Activation, Preparation, and Handling of DEFINITY

1. Adhere to strict aseptic procedures during preparation.
2. Allow the DEFINITY vial to warm to room temperature before starting the activation procedure.
3. Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX device or VIALMIX RFID device.
   Note: Use only the drug activated in a properly functioning VIALMIX or VIALMIX RFID for a full 45 second activation cycle. Do not reactivate the vial if VIALMIX or VIALMIX RFID did not properly activate the vial. Never reactivate a successfully activated DEFINITY vial (see step 4). Refer to the VIALMIX or VIALMIX RFID User's Guide for illustrations of the activation procedure and a properly functioning VIALMIX or VIALMIX RFID.

4. Activated DEFINITY appears as a homogeneous milky white suspension with a presence of foam/bubbles. Use immediately after activation. If the product is not used within 5 minutes of activation, resuspend the microspheres by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe.

5. The activated DEFINITY may be used for up to 12 hours from the time of activation, but only after the microspheres are resuspended by hand agitation for 10 seconds. Store the activated DEFINITY at room temperature 20° to 25°C (68° to 77°F) in the original product vial.
6. Invert the vial and withdraw the activated homogeneous milky white suspension using the Intellipin (Dispensing Pin), the PINSYNC (Vented Vial Adapter 13mm), or 18 gauge to 20 gauge syringe needle from the middle of the liquid. Do not inject air into the DEFINITY Vial.
7. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe.
8. For infusion dosing in adult patients, dilute 1.3 mL of activated DEFINITY in 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP.
9. Parenteral drug products should be inspected visually for foreign particulate matter and discoloration prior to administration, whenever solution and container permit.

Instructions for RFID-Tagged Vials

The radio frequency identification (RFID) tag integrated on the back of the vial label when used with VIALMIX RFID allows for the exchange of product information such as activation time and activation rate. If the RFID tag is damaged or otherwise non-functional, the vial with the non-functional RFID tag cannot be activated with VIALMIX RFID. Discard the non-functional RFID-tagged vial. Do not activate RFID-tagged DEFINITY vials in the VIALMIX RFID within 6 inches (15 cm) of a pacemaker and/or defibrillator (see the VIALMIX RFID User's Guide).