Indications

The pump is indicated for the continuous regional delivery of the following infusates with arterial administration:

• Cerona Therapeutics Floxuridine for Injection, USP
• Heparinized Saline
• Saline
• Bacteriostatic Water
• Glycerin Injection

The approved labeling for Cerona Therapeutics Floxuridine for Injection, USP stipulates the indications, contraindications, and warnings for use of the drug in the pump.

Bacteriostatic water or saline must be used to achieve the desired concentration of the drug. Heparinized saline can be used during an interruption of Hepatic Artery Infusion therapy to maintain catheter patency.

Glycerin infusion is indicated for patients who are receiving continuous Hepatic Arterial Infusion Chemotherapy. Glycerin infusion is employed as a placebo to keep the catheter patent or to extend the refill interval for patients who require therapy interruption or withdrawal.

The Intera 3000 Hepatic Artery Infusion Pump is indicated for use in the adult population only.

Contraindictions

The Intera 3000 Hepatic Artery Infusion Pump is contraindicated for use in patients with

• Known or suspected infection, bacteremia, septicemia or peritonitis.
• Known allergic reaction or other signs of intolerance to implanted devices.
• Emotional or psychiatric problems.
• Insufficient body size to accommodate the physical size of the pump.
• Cerona Therapeutics Floxuridine for Injection, USP should be used with added caution in patients with impaired hepatic or renal function.
• Patients with known disease extending beyond an area capable of infusion must be considered for systemic therapy with other chemotherapeutic agents.

Contraindications relating to the specific drug to be used must be observed and followed per the approved drug labeling.

Warnings

The pump must be implanted and refilled only by qualified medical personnel, knowledgeable in the surgical use and servicing of implantable devices and catheters, and trained specifically to implant or refill the pump.

Use of the pump by personnel not properly trained in its implantation and/or servicing may lead to serious consequences involving either under or over-delivery of drug to the patient. In the event of an over-delivery of drug refer to the approved drug labeling for appropriate action.

Utilization of the pump requires the proper handling (filling, storage and dispensing) of a significant volume/dosage of drug. This amount of drug can be extremely harmful to the patient if delivered suddenly or inappropriately.

Bolus access and pump refill procedures must be performed using the correct access needle. Never attempt to refill the pump using a special bolus needle. This use will result in giving a bolus injection to the patient and can cause a fatal drug overdose.

Precautions Regarding The Use Of The Pump

1. Inspect the sterile package carefully. Do not use if:
   • the package or seal appears damaged,
   • contents appear damaged, or
   • the expiration date has passed.
2. This device is for single use only. Do not reuse.
3. Use sterile technique in all phases of handling this product.
4. Never aspirate fluid from the pump. Aspiration will cause blood to be drawn into the catheter and result in occlusion.
5. Only use special bolus or non-coring needles to access the pump septum. It is critical to the integrity of the pump septum that no other needles be used to penetrate the septum.
6. It is important to precisely follow the pump refill instructions to successfully complete the pump refill procedure. If the needle is not properly positioned and verified as detailed in the pump refill procedures, drug extravasation can occur.
7. Before performing a bolus injection of any drug, review all warnings, precautions, indications, and contraindications on the drug labeling.
8. Do not use a mechanical pressure injector system to accomplish a bolus procedure. Pressures must not exceed 40 psi when administering a bolus injection or infusion. Use only 10 mL (or larger) syringes for injections and do not inject or infuse at a rate greater than 5 mL/min.
9. When the system is flushed with saline while performing a bolus procedure, the patient will receive a bolus dose of drug equal to the volume of drug contained in the internal bolus pathway of the pump, plus the volume of drug in the catheter. The volume of drug in the internal pathway is 0.3 mL. The volume of the drug contained in the catheter is calculated by multiplying the length (in cm) of the catheter by 0.003 mL/cm.

Drug extravasation can result if the instructions for use are not followed correctly during a pump refill (see Pump Refill Procedure section) or bolus procedure (see Bolus Procedure).

It is important that a Refill Kit be utilized for pump refill and that the refill procedure be carried out in accordance with the instructions provided in this pamphlet and in the Refill Kit. A special bolus needle must be utilized to successfully perform a bolus procedure.

Adverse Events

Possible adverse events of the pump are those potential risks associated with any implanted drug delivery device and include: catheter thrombosis, bolus path occlusion, vessel thrombosis, pump dislodgement, seroma, or recurrent hematoma, infection, extravasation, catheter shear, dislodgement or leakage, migration, arterial pseudoaneursym, arterial dissection, and extrahepatic perfusion.

Caution:

Federal law (USA) restricts this device to sale by or on the order of a physician.