PATIENT INFORMATION LEAFLET

PLEASE READ THIS CAREFULLY BEFORE USING

HAEMATE® P What does Haemate P contain?

Haemate P is a freeze-dried powder that contains 500 or 1000 International Units (IU) of human plasma coagulation factor VIII. It also contains 1200 or 2400 IU of von Willebrand factor (measured as ristocetin co-factor activity), glycine Ph. Eur., sodium citrate Ph. Eur., sodium chloride Ph. Eur., and Human albumin Ph. Eur.

Haemate P must be dissolved in the Water for Injections supplied before it is injected.

Bottles of product and liquid will appear partly empty but this is normal and does not mean that there is the wrong amount of powder or solution.

This is one of a group of products intended to stop bleeding in haemophiliacs.

Why have I been prescribed Haemate P by my doctor?

Haemate P has been prescribed to stop or prevent bleeding that you might get because of a lack of factor VIII (Haemophilia A) or von Willebrand’s factor (von Willebrand’s Disease) in your blood. In some types of von Willebrands Disease you may also lack factor VIII in your blood. Both of these factors are proteins which are part of the body’s natural way of forming clots to stop bleeding, so if they are absent or low in your blood you will have difficulty in stopping bleeding. You may have a deficiency from birth or acquired it later in life.

When should I not receive Haemate P?

Do not use Haemate P if you are allergic to any of the ingredients. If you are unsure about this, ask your doctor. Usually, if you are allergic to Haemate P it will show up the first or second time that you use it. Possibly you may feel sick, dizzy or feel a tightness in your chest, or develop a rash.

How much Haemate P should I use or be given?

The amount of Haemate P you need to use depends on several factors such as your weight, the severity of your haemophilia or von Willebrand’s disease, the site and severity of your bleed, and the possible need to prevent bleeding, for example before dentistry or an operation. These conditions will determine the level of factor VIII/von Willebrand factor that is needed. The amount will also be affected should you develop an inhibitor. Your doctor will calculate the dose of Haemate P and how often you need to inject to obtain the correct levels in your blood to meet your specific needs.

For Haemophilia A, the amount of Haemate P you will need depends on the site and severity of your bleeding. For example if you are suffering from a minor bleed into a joint, the plasma level of factor VIII should be raised to and maintained at 30% of normal until bleeding stops. If you need an operation or bleeding is more severe, levels of 40 to 100% of normal are needed.

The amount you need will be calculated using a formula:

Required Units = body weight (kilograms) X desired factor VIII rise (% or IU/dL) X 0.5.

If you are using Haemate P to prevent bleeding (prophylaxis), your doctor will calculate a dose for you. This will normally be 20 to 60 IU Haemate P per kilogram body weight at intervals of 2 to 3 days. The exact dose and dose interval will depend on the severity of your condition and age.

If you have an inhibitor to factor VIII, you will need a higher dose to maintain and correct the factor VIII levels in your blood.

For von Willebrand’s disease, again the dose will be calculated by your doctor according to the extent and site of your bleed. For example, 40 to 80 IU of von Willebrand factor:ristocetin co-factor per kilogram of your body weight would be given every eight to twelve hours for 10-12 days after surgery or childbirth. This corresponds to approximately 17 to 33 IU of factor VIII per kilogram body weight.

How is Haemate P given?

Haemate P is given by injection or infusion into a vein.

If you have been prescribed Haemate P to use at home your doctor or haemophilia centre nurse will have to make sure that you know how to give it.

If you are in any doubt about injecting Haemate P, go back to your doctor or Haemophilia Centre for more advice and training before attempting to give yourself any treatment.

Follow the directions given to you by your doctor/haemophilia nurse and you can use the directions given at the end of this leaflet as a guide.

What side effects may I experience?

A number of rarely reported undesirable effects have occurred with the use of Haemate P. These include chills, swelling, a local burning sensation, redness, irritation or rash at the injection site or across your body. Sometimes, tightness of the chest, wheezing, dizziness, headache, vomiting, lethargy (tiredness), nausea, restlessness, increased heartbeat, tingling and mildly reduced blood pressure may also occur. In some cases an increase in body temperature is seen. If the effects are severe, stop your injection immediately and contact your doctor.

It is possible that you may develop antibodies (inhibitors) to factor VIII which will make your treatment less effective. This is particularly seen in patients who have not been previously treated with factor VIII preparations. You should inform your doctor if you were untreated before being given Haemate P as he/she might wish to carefully follow your early progress. If an inhibitor develops, treatment with Haemate P may be continued at a higher dose as long as you continue to respond. Alternatively, your doctor may decide to change the frequency and the dose of your treatment to try and get rid of your inhibitors (immune tolerance treatment). Speak to your doctor if you need more information on this.

Large doses of Haemate P may contain substances that do not mix with your red blood cells. Again, contact your doctor immediately if you feel breathless, faint or ill following a large dose of Haemate P or if you experience any other undesirable effects.

How should Haemate P be stored?

Haemate P should be stored in a refrigerator (+2 -+8ºC) in the original packaging until the expiry date printed on the carton.

In exceptional cases, you can store Haemate P at room temperature (not above 30°C) for up to a maximum of 6 months, provided that this is still within the expiry period given on the label. If you need to do this, immediately write the date of removal from the refrigerator and the new expiry date on the carton. Throw this product away if you have not used it by the revised expiry date.

DO NOT FREEZE YOUR HAEMATE P.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

As Haemate P is made from human blood plasma what about viruses?

Haemate P is made from the blood plasma of healthy donors who have been carefully screened to ensure that they are negative for antibodies to hepatitis viruses and the AIDS virus. Furthermore, the pasteurisation process includes a heat treatment of 60°C for 10 hours in solution and other steps to kill or remove viruses. High rates of virus inactivation or removal have been shown. However, no procedure has been shown to be totally effective in removing hepatitis infectivity from human plasma coagulation factor VIII.

Appropriate hepatitis vaccination against Hepatitis A and B is recommended for patients in regular receipt of medicinal products made from human blood plasma and you should ask your doctor about this if you have any concerns.

Remember this medicine is for you and only your doctor can prescribe it for you. It should not be given to others as it may harm them, even if their symptoms are the same as yours.

Directions on Administering Haemate P

Wash your hands thoroughly using soap and warm water.

Without opening either vial, warm the Haemate P powder and the liquid to room temperature. This can be done by allowing the vials to stand at room temperature for about an hour after removing from the refrigerator, or, if required quickly by holding in your hands for a few minutes. DO NOT expose the vials to direct heat or stand the vials on a radiator. The vials must not be heated above body temperature (37ºC).

Carefully remove the protective caps from the vials containing powder and liquid and clean the exposed rubber stoppers with antiseptic. Allow to dry before opening the Mix2Vial package, then follow the instructions given below for using the Mix2Vial.