Consumer Medicine Information

MonoFIX^®-VF

Human coagulation factor IX, freeze-dried.

What is in this leaflet

This leaflet answers some common questions about MonoFIX^®-VF. It does not contain complete information about MonoFIX^®-VF. It does not take the place of talking to your doctor. If you have any concerns about using this product, please talk to your doctor. Follow your doctor's advice, even if it is different from what this leaflet says.

Please read this leaflet carefully and keep it for future reference. However, the information in this leaflet is subject to change. Please check with your haemophilia treatment centre if there is any new information about this medicine that you should know since you were last treated with this medicine.

What MonoFIX^®-VF is used for

MonoFIX^®-VF contains purified and concentrated factor IX, a protein which is essential for normal blood clotting. MonoFIX^®-VF is used in patients with haemophilia B or Christmas disease, a bleeding disorder, in which there are reduced levels of the clotting factor. Also, it is available for use in surgery.

Individuals with factor IX levels lower than normal have difficulty in forming blood clots, with these clots often taking longer to be made than normal. Sometimes the individual may bleed unexpectedly into their joints, muscles or internal organs.

Ask your haemophilia treatment centre if you have any questions about why MonoFIX^®-VF has been prescribed for you.

Before your doctor gives you MonoFIX^®-VF

SPECIAL WARNING

This product is made from human blood. When products are made from human blood and injected into you, it is possible that viruses or other substances could be present in the product and cause an illness. These could be viruses such as hepatitis, HIV , or parvovirus B19. There could also be other infectious agents some of which may not yet have been discovered.

To reduce the risk of this happening extra steps are taken when manufacturing this product. Strict controls are applied when selecting blood donors and donations. The product is specially treated to remove and kill viruses. This special treatment is considered effective against certain viruses known as enveloped viruses (such as HIV and hepatitis B and C), and also the non-enveloped virus, hepatitis A. The effect against the non-enveloped virus parvovirus B19 may be limited.

Vaccines are available against some of these viruses and your doctor will be able to help you decide whether it is worthwhile having any of those vaccines.

Please discuss the risks and benefits of this product with your doctor.

SPILLAGE OR BREAKAGES

Should a break in the container or spillage occur, due precautions should be taken to avoid contamination of cuts and abrasions, as well as to avoid inhalation or swallowing of the spillage. Adequate disinfection can be obtained with the application of 1% sodium hypochlorite for 15 minutes. Commercial bleaches may be diluted appropriately as recommended to obtain this concentration.

Tell your doctor if you:

• have allergies to any medicines
• are taking or using any other medicines. These include medicines bought from pharmacies, supermarkets and health food stores
• have any other medical conditions
• are pregnant or breast feeding
• become pregnant during your treatment.

If you want further information, consult your doctor or haemophilia treatment centre.

How to use MonoFIX^®-VF

The dosage and administration of MonoFIX^®-VF must be carefully controlled. Your doctor will be responsible for determining what dose is appropriate to your condition.

MonoFIX^®-VF will usually be given in a hospital. Should your doctor decide that treatment at home is appropriate, your haemophilia treatment centre will provide detailed instructions on how to use MonoFIX^®-VF.

The following procedures are given as a guide only:

How to prepare MonoFIX^®-VF

Allow the vial of MonoFIX^®-VF and ampoule of Water for Injections 10 mL to reach room temperature prior to use, which may take one hour. Do not warm in hot water.

1. Remove jewellery, watches, rings, etc.
2. Wash hands with soap and water, dry with a clean towel.
3. Select an appropriate work area with good lighting and a surface which can be cleaned (such as a kitchen table).
4. Using a clean cloth or paper towel, clean the preparation area with methylated spirits.
5. Gather the equipment to be used.

Equipment

• MonoFIX^®-VF. Check expiry date on bottle. Do not use if expired.
• Water for Injection contained in package with MonoFIX^®-VF. Check expiry date on plastic ampoule. Do not use if expired.
• Filter needle (contained in package with MonoFIX^®-VF).
• Two alcohol wipes.
• Sharps container.
• Plastic syringe(s).
• Adhesive tape.
• Cotton balls.
• Intravenous injection set.
• Gloves.

Preparing the injection

The injection is best prepared by following each of the steps outlined in turn.

1. Wash hands with soap and water, dry with a clean towel.
2. Ensure MonoFIX^®-VF and WFI are at room temperature.
3. Remove protective cap from MonoFIX^®-VF bottle.
4. Wipe the rubber stopper with the alcohol wipe and allow to dry for two minutes. Do not leave alcohol wipe resting on the stopper. Do not touch the rubber stopper with your fingers.
5. Using aseptic technique, remove the top of the plastic ampoule of Water for Injection by grasping the rectangular top and applying a brisk rotating/twisting action to remove the protective cap. Using a suitable syringe, draw up the 10 mL of Water for Injection by inserting the syringe nozzle into the open neck of the plastic ampoule, utilising the luer lock connection.
6. Attach the filter needle supplied to the syringe containing the Water for Injection. Remove the protective cap from the filter needle and insert the exposed needle into the centre of the rubber stopper of the bottle of MonoFIX^®-VF. Do not touch the exposed needle or any of the rubber stoppers with your fingers.
7. The water will be drawn into the vial by the vacuum contained within the MonoFIX^®-VF bottle.
8. If water is not drawn into the vial it means that there is no vacuum in the bottle and the seal may be faulty. Do not use the product and return it to your haemophilia treatment centre or New Zealand Blood Service. After all the water has left the syringe, carefully remove the syringe from the filter needle whilst leaving the filter needle in the MonoFIX^®-VF bottle.
9. Gently swirl the MonoFIX^®-VF bottle until all of the material is dissolved. Do not shake the MonoFIX^®-VF bottle. Take care not to touch the exposed top of the needle.
10. Ensure the contents of the bottle are completely dissolved. If clots or a gel form do not use the product but return it to your haemophilia treatment centre or New Zealand Blood Service.
11. Draw back 10 mL of air into the syringe.
12. Reattach the syringe to the filter needle in the MonoFIX^®-VF bottle.
13. Inject the 10 mL of air into the MonoFIX^®-VF bottle.
14. Invert the bottle and draw the MonoFIX^®-VF solution into the syringe.
15. Whilst keeping the filter needle in the MonoFIX^®-VF bottle, disconnect the syringe.
16. Place the filter needle and empty MonoFIX^®-VF bottle directly into the sharps container.

Note: Filter needles are intended to filter the contents of a single bottle of MonoFIX^®-VF only.

If multiple bottles of MonoFIX^®-VF are to be given a separate filter needle must be used for each bottle. However, one large syringe may be used to contain MMonoFIX^®-VF.

Do not use the filter needle for injection.

Do not refrigerate MonoFIX^®-VF once it has been prepared.

Use MonoFIX^®-VF as soon as you can after preparation. The solution must not be stored and the infusion should be completed within 3 hours. This is important because bacteria could grow in the solution if it is left for longer periods and lead to infection in the blood. Any unused portion remaining in the vial must be discarded appropriately.

Injection administration procedure guidelines

The injection is best given by following each of the steps outlined in turn.

Should any of the symptoms listed under "Unwanted effects" develop, stop the infusion immediately and contact your haemophilia treatment centre.

1. Apply tourniquet. Select injection site.
2. Wash hands with soap and water, dry with a clean towel.
3. Cleanse the skin area with an alcohol wipe, allow to dry.
4. Put on gloves.
5. Insert intravenous needle into vein.
6. Secure needle with adhesive tape.
7. Attach the syringe containing MonoFIX^®-VF to the intravenous needle.
8. Draw blood back into the syringe, to check the needle is in the vein, and to remove air from the intravenous line.
9. Remove tourniquet.
10. Administer the MonoFIX^®-VF solution slowly (approximately 3 mL per minute or as tolerated).
11. Carefully remove adhesive tape.
12. Carefully remove the intravenous needle with syringe attached and place directly into the sharps container.
13. Apply pressure to the injection site using a cotton ball for one to two minutes. Apply dressing if necessary.
14. Discard all used sharps into the sharps container, and dispose of the other used equipment appropriately.
15. Wash hands with soap and water, dry with a clean towel.

Unwanted effects

Along with their intended effects, medicines may cause some unwanted effects, which can sometimes be serious. Furthermore, individual patients may react differently to the same dose of the same medicine. This applies to MonoFIX^®-VF. A constituent of this formulation (heparin) may lead to maternal bleeding episodes, thereby causing an increased incidence of foetal loss and prematurity.

Although severe reactions after MonoFIX^®-VF injection are rare, high doses of factor IX may on rare occasions cause heart attacks, and blood clots. Ask your haemophilia treatment centre if you need more information.

Stop using this product immediately and contact your haemophilia treatment centre if any of the following side effects occur:

• Fever
• Chills
• Dizziness or nausea
• Itching
• Rash
• Tightness of the chest
• Wheezing

Contact your doctor immediately if you experience any of these symptoms at any time: fever, loss of appetite, extreme tiredness, abdominal pain, jaundice (yellow skin and eyes), dark urine, joint pains and skin rashes.

Overdose

Overdosage may enhance the risk of heart attacks and blood clots. If you have questions, consult your haemophilia treatment centre.

How to store MonoFIX^®-VF

Store at 2°C to 8°C (Refrigerate. Do not freeze). Protect from light. MonoFIX^®-VF must not be used after the expiry date printed on the label.

Further information

This is not all the information that is available on MonoFIX^®-VF. If you have any more questions or are not sure about anything, ask your haemophilia treatment centre.

PRODUCT DESCRIPTION

What it looks like

MonoFIX^®-VF is a white powder contained in a glass vial. The product comes with an ampoule of Water for Injection for reconstitution, and a special filter needle.

Ingredients

Each vial of MonoFIX^®-VF contains 500 IU of factor IX. It also contains 100 IU of heparin sodium and 12.5 IU of antithrombin III. Other ingredients include human plasma proteins, sodium phosphate, sodium citrate and sodium chloride.

NAME AND ADDRESS OF SPONSOR

CSL (New Zealand) Limited
PO Box 62 590
Central Park
Auckland
NEW ZEALAND

NAME AND ADDRESS OF MANUFACTURER

CSL Limited ACN 051 588 348
at: 189-209 Camp Road
Broadmeadows 3047 VIC
AUSTRALIA

NAME AND ADDRESS OF DISTRIBUTOR

New Zealand Blood Service Limited
169 Manukau Road
Epsom
Auckland
NEW ZEALAND

This leaflet was prepared in July 1999.

® Registered trademark of CSL Limited.