Details for: FLOLAN

Usual adult dose:

Your doctor will decide how much (i.e. dose) and the duration of FLOLAN therapy that is right for you. The amount you are given is based on your body weight, and your type of illness. Your dose may be increased or decreased depending on how well you respond to treatment.

FLOLAN should only be given by slow continuous infusion (drip) into a vein.

Overdose

Symptoms of overdose may include headache, nausea, vomiting, diarrhea, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/ dizziness), unconsciousness, or collapse.

Administration:

Initial Treatment
Your first treatment will be given to you in a hospital. This is because your doctor needs to monitor you and find the best dose for you.

You will start with an infusion of FLOLAN. The dose will be increased, until your symptoms are relieved, and any side effects are manageable. Once the best dose has been found, a permanent tube (also referred to as a line or central venous catheter) will be fitted into one of the large veins in your upper chest called a central vein. This is done because FLOLAN needs to be given by continuous controlled infusion.

Your doctor will decide which type of catheter is best suited for you. The catheter is a thin soft flexible tube that is inserted under a local anaesthetic in the operating room. Sterile conditions are maintained during this procedure to avoid the risk of infection. You will not feel it inside your body. The catheter has been tunnelled into place inside your chest. The catheter has a Dacron fibre cuff which is under the skin. This will hold the catheter in place and avoid infection. The catheter may also be sutured into position. The tip of the catheter lies in a vein that leads to the entrance of your heart. You can then be treated using an infusion pump that will deliver a prescribed amount of the drug through the catheter directly to your heart.

Your nurse will teach you how to care for the catheter, how to keep the skin around the catheter exit site clean and free from infection. You will learn how to change the dressing and to protect your skin. Your doctor and nurse will make sure that you are comfortable in caring for the catheter exit site. It is very important that you follow all of their instructions carefully (see ‘Caring for the Central Venous Catheter’ below).

Should you develop sudden fever, contact your doctor as soon as possible.

Continual Treatment
Your doctor or nurse will show you how to prepare and use FLOLAN and will also advise you how to stop treatment if necessary. Stopping FLOLAN must be done gradually. It is very important that you follow all their instructions carefully.

Steps for Reconstituting FLOLAN
FLOLANcomes as a powder in a glass vial. Before use, the powder must be dissolved (reconstituted) in the liquid (pH 12 STERILE DILUENT for FLOLAN) provided and used as directed by your doctor. FLOLAN should only be used with the supplies provided. Do not use FLOLAN if solution shows haziness, particulate matter, discolouration, or leakage. The liquid does not contain a preservative. If you have any of the dose left over, it must be thrown away.

The following instructions explain how to reconstitute FLOLAN. They should supplement the instructions given to you by your doctor or nurse.

FLOLAN must be reconstituted with pH 12 STERILE DILUENT for FLOLAN.

FLOLAN solution prepared with pH 12 STERILE DILUENT for FLOLAN must not be used with any preparation or administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG). Only use FLOLAN with the supplies provided.

Reconstituted FLOLAN solution should not be mixed with other solutions or medicines prior to or during administration.

Your doctor will tell you how much FLOLAN and pH 12 STERILE DILUENT for FLOLAN you will need to use when making up your daily supply. The general procedures for reconstituting FLOLAN solution are described below.

1. First, clean your worksite and gather your supplies. Wash your hands thoroughly and then open all the packages. Remove the vial caps from the vial containing pH 12 STERILE DILUENT for FLOLAN and clean the tops of the vials with alcohol swabs.
2. Once you finish cleaning the tops of your vials and opening your supplies, attach a needle to the syringe. Now break the syringe seal by gently pulling the plunger out slightly and then pushing it back. Draw air into the syringe; the amount of air that you draw into the syringe should be equal to the amount of pH 12 STERILE DILUENT for FLOLAN you’ve been instructed to withdraw from the vial. Insert the needle through the rubber seal of the vial and press the plunger down to inject the air into the vial. Once all the air has been injected, pull the plunger gently back up to withdraw the prescribed amount of pH 12 STERILE DILUENT for FLOLAN. Without withdrawing the needle, invert the vial and syringe and tap the syringe gently so that any air bubbles trapped in the syringe rise towards the top. If necessary, depress the plunger gently to force the air bubbles out and then withdraw sufficient additional pH 12 STERILE DILUENT for FLOLAN to restore the required volume in the syringe. Once the required volume has been drawn into the syringe, withdraw the needle.
3. Now insert the needle through the rubber seal of the FLOLAN vial and inject the pH 12 STERILE DILUENT for FLOLAN gently onto the side of the vial. Always direct the flow of pH 12 STERILE DILUENT for FLOLAN towards the side of the vial and inject it gently so that the FLOLAN doesn’t foam. Allow the pressure to equalize and withdraw the needle from the vial. Now, mix the FLOLAN by gently swirling the vial. Turn the vial upside down to catch any undissolved powder near the top. Never shake the vials. If you need to mix more than one vial of FLOLAN, simply repeat this process.
4. Your doctor or nurse will advise you on the amount of reconstituted FLOLAN to be withdrawn. First, by gently pulling the plunger back, fill the syringe with the amount of air that is equal to the amount of FLOLAN to be withdrawn. Remember to wipe the tops of the vials with an alcohol swab. Now, insert the needle through the seal of the FLOLANvial and inject the air. Then pull the plunger gently back to withdraw the reconstituted FLOLAN into the syringe. Remove any air that may be trapped in the syringe as described in step 2 above. Withdraw the needle and place the cap back on the syringe.
5. You are now ready to inject the FLOLAN into your cassette. Remove the end cap from the cassette tubing; then carefully remove the needle from the syringe, discard in an appropriate manner and attach the syringe to the cassette tubing. Now, while holding the cassette in one hand, you can use the tabletop as a third hand while you push down on the syringe to inject the solution into the cassette. Once the syringe is empty, clamp the cassette tubing near the syringe, disconnect the syringe and cap the tubing with the red cap.
6. Now you will withdraw the contents of the pH 12 STERILE DILUENT for FLOLAN vials and inject them into the cassette. Using a 60 cc syringe, attach a new needle to the syringe, break the seal on the syringe by pulling the plunger out and pushing it back in. Next, fill the syringe with the amount of air that is equal to the amount of pH 12 STERILE DILUENT for FLOLAN you will remove from the first vial. Remember to wipe the top of the pH 12 STERILE DILUENT for FLOLAN vial with an alcohol swab before you insert the needle. Once it is dry, insert the needle through the rubber seal, inject some of the air into the vial and allow the fluid to flow into the syringe. With the larger syringe, it may be easier to hold it in the vertical position. Push more air in as needed until you have withdrawn all of the contents of the vial. Remove any air that may be in the syringe as described in step 2 above. Once the vial is emptied, allow the pressure to equalize before you pull the needle out. If you don’t, you may lose fluid from the syringe or the vial and you would need to start the whole process over again. Withdraw the needle and place the cap back on the syringe.
7. Now you are ready to inject the first syringe full of pH 12 STERILE DILUENT for FLOLAN into the cassette. To do this, first uncap the cassette tubing. Then carefully remove the needle from the syringe, discard in an appropriate manner and attach the syringe to the cassette tubing. Unclamp the cassette tubing and then carefully inject the solution into the cassette. When the syringe is empty, clamp the cassette tubing near the syringe, disconnect the syringe and cap the cassette tubing. You will repeat this same process to transfer the contents of the required pH 12 STERILE DILUENT for FLOLAN vial as specified by your doctor or nurse into the cassette.
8. After you have completed the transfer of all the required pH 12 STERILE DILUENT for FLOLAN, leave the syringe attached to the cassette tubing while you mix the solution. Gently invert the cassette at least 10 times, thoroughly mixing the FLOLAN. Now you need to remove all the air from the cassette.
9. In order to remove the air inside the cassette, first you have to collect the air bubbles. Simply rotate the cassette around until all of the small bubbles join to form one big air pocket. Then tilt the cassette carefully so that the air pocket is in the corner where the tubing connects to the bag. To remove the air from the cassette, unclamp the tubing and pull back the plunger of the syringe until you see fluid fill the tubing. Then clamp the tubing near the connector, disconnect it and cap it with the red cap. To avoid any confusion, label the cassette with the date and time you made up the FLOLAN.

Now put the cassette into the refrigerator until it is time to use it. Store it on the top shelf to avoid spilling any food or drink onto your cassette. Always have a back-up cassette that is ready for use.

You may prepare extra cassettes, DO NOT use cassettes that have been stored in the refrigerator for more than 8 days.

Steps for Administering FLOLAN for Injection by a Continuous Infusion Pump
You will use a pump to receive medication by continuous delivery. The instructions for use may vary depending on the particular make and model of the pump you are using. To avoid any potential interruptions in FLOLAN delivery, you should have access to a back-up infusion pump and intravenous infusion sets.

Your doctor or nurse will give detailed instructions on how to use and care for the specific pump and accessories that you will use for administering the medicine (including changing the pump battery, cassette and tubing).

The use of a ‘cold pouch’ is not required for reconstituted solution made with pH 12 STERILE DILUENT for FLOLAN. When stored or in use the solution must not be exposed to light.

Steps for Caring for the Central Venous Catheter
Change the dressing on the catheter exit site 1 to 2 times per week or more frequently if needed.

You will need the following equipment: dressing set, 2 sterile containers, povidone-iodine antiseptic solution, gauze swabs, 70% alcohol, povidone-iodine antiseptic ointment, sterile cotton swabs, adhesive tape (non- allergenic), transparent dressing 10 cm x 12 cm or 6 cm x 7 cm.

Maintain sterile technique at all times. If you suspect that you have contaminated anything, discard the equipment and begin again.

1. Assemble equipment.
2. Stabilize catheter while removing old transparent dressing.
3. Open sterile dressing kit.
4. Pour alcohol into sterile container.
5. Pour povidone-iodine antiseptic solution into sterile container.
6. Squeeze povidone-iodine antiseptic ointment onto sterile field.
7. Open transparent dressings onto sterile field.
8. Remove old transparent dressing.
9. Clean the catheter exit site with povidone-iodine antiseptic solution soaked 2” x 2” gauze swabs, starting at the catheter exit site. Work outward in a circular extending motion extending to an 8 cm radius.
10. Repeat step 9 three times.
11. Never return to the catheter exit site using the same swab.
12. Repeat steps 9 and 10 using an alcohol soaked 2” x 2” gauze swab.
13. Apply povidone-iodine antiseptic ointment to the catheter exit site with a sterile cotton swab.
14. Apply new sterile transparent dressing.
15. Tape catheter to skin using ‘stress loop’.