KOGENATE is a freeze-dried powder which contains 500 International Units (IU) of Factor VIII (rDNA) (bhk).

It contains also human albumin, glycine, calcium chloride and 18 mg of sodium chloride. KOGENATE must be dissolved in the Water for Injections supplied before it is administered.

This box contains one 10 ml vial of freeze-dried KOGENATE powder.

You should have received another box connected to this box which contains:

One 10 ml vial containing 2.5 ml of Water for Injections.

Two sterile alcohol swabs for single use.

The vial will appear to be only partially full but this is normal and does not mean that it contains the wrong amount of powder.

KOGENATE 500 contains Factor VlIl and is to be used to stop and/or prevent the bleeding you get with haemophilia A.

The Factor VlIl in KOGENATE is made by the process of genetic engineering as indicated by the initials (rDNA) (bhk) used above.

KOGENATE has been prescribed by your doctor to stop and/or prevent the bleeding you might get with haemophilia A.

Haemophilia A is a disease which results because your body does not produce enough Factor VlIl. Factor VlIl is a component in the blood which helps it to clot when you are bleeding. If the level of Factor VlIl is low in your blood, your body will have difficulty in stopping bleeding.

You can use KOGENATE if you have never been treated for haemophilia before, or if you have previously been treated for haemophilia and have no antibodies to Factor VlIl (inhibitors) which would neutralise Factor VlIl in your blood.

If you have been using KOGENATE and you develop Factor VlIl inhibitors, treatment may be continued as long as you still respond to KOGENATE and the inhibitors in your blood remain below a certain level (10 Bethesda Units). Speak to your doctor if you would like further information about this.

This product does not contain von Willebrand Factor, so it cannot be used in von Willebrand’s disease.

Do not use KOGENATE if you are allergic to any of the ingredients. If you are unsure about this, ask your doctor.

If you know that you are allergic to mouse or hamster protein, KOGENATE should not be used. Consult your doctor if you are unsure about this. Usually, if you are allergic to KOGENATE, a reaction will occur upon first use of the product. Allergic reactions can occur at the injection site such as a burning sensation, temporary redness or a rash or you may experience nausea, dizziness or a tight chest.

If you think that you are having an allergic reaction to KOGENATE, stop administering the product immediately and seek medical advice. Speak to your doctor regularly about your treatment. He/she may wish to carry out tests to ensure that your current dose of KOGENATE is sufficient to reach and maintain adequate Factor VlIl levels.

If your bleeding is not being controlled with KOGENATE, consult your doctor immediately. You may have developed Factor VlIl inhibitors and your doctor may wish to carry out tests to confirm this. Factor VlIl inhibitors are antibodies in the blood which act against the Factor VlIl you are using. This makes the Factor VlIl less effective in controlling bleeding.

If you are pregnant, planning a family or are breast-feeding, tell your doctor before using this product. If you have informed your doctor already, follow his/her instructions carefully.

There is no evidence that Factor VlIl may impair your ability to drive or to use machines.

The amount of KOGENATE you use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of Factor VlIl inhibitors that you may have and the Factor VIII level required.

Your doctor will calculate the dose of KOGENATE and the frequency you should use it to get the necessary level of Factor VlIl activity in your blood. He will do this according to your particular needs using the formulae below.

If you are infusing KOGENATE to stop a bleeding episode, the amount of KOGENATE you will need depends on the site and extent of your bleeding. For example, if you are suffering a minor haemorrhage, such as bleeding into a joint, the plasma level of Factor VlIl activity should not fall below 30 % of normal for at least one day. If your bleeding is more severe or you need an operation, the dose of KOGENATE and time of usage will increase.

If you are using KOGENATE to prevent bleeding (PROPHYLAXIS), your doctor will calculate the dose for you. This will usually be in the range of 10 to 50 IU of KOGENATE per kg of body weight administered at intervals of 2 to 3 days. However, in some cases, especially younger patients, shorter dosage intervals or higher doses may be necessary.

If you have a large number of Factor VlIl inhibitors, the dose of KOGENATE you are given by your doctor will be high to maintain the correct Factor VlIl activity in your blood. If this dose does not control your bleeding your doctor may consider the use of an additional product (activated) prothrombin complex concentrate. Speak to your doctor if you would like further information about this.

If you have been prescribed KOGENATE to use at home, your doctor will have ensured that you know how to administer it.

Follow the directions given by your doctor closely and use the instructions below as a guide:

1. Wash your hands thoroughly using soap and warm water.
2. Without opening either vial, warm the KOGENATE powder and the Water for Injections to room temperature. This can be done by taking the vials from the fridge and allowing them to stand in a room for approximately one hour or, if needed to treat a bleed sooner, the vials can be warmed by holding them in your hands.

Inject your normal dose as soon as you remember and then continue as prescribed by your doctor.

A number of rarely reported side-effects have been observed with KOGENATE. These include reactions at the injection site such as a burning sensation, temporary redness and rash. Also, tightness of the chest, dizziness and nausea have been reported and mildly reduced blood pressure, which may make you feel faint upon standing. If you experience any of these side-effects, consult your doctor for advice.

The formation of inhibitors (neutralising antibodies) to Factor VIII is a well-known, but rare complication in the management of haemophilia A. This occurs mainly in patients who were previously untreated before receiving KOGENATE. Therefore, you should inform your doctor if you were untreated prior to receiving KOGENATE, as he/she may wish to carefully monitor your progress.

KOGENATE powder should be stored in a refrigerator (2 to 8ºC) until the expiry date which is shown on the packaging.

In exceptional cases, KOGENATE powder may be removed from the fridge and kept at room temperature (up to 25ºC) for a maximum period of three months as long as it is kept in the original packaging. If you need to take your medicine from the fridge for a prolonged period of time, you must write the date of the end of the three month period on the space provided on the vial and/or the box immediately.

Do not refrigerate the KOGENATE solution alter it has been made up Preferably, the solution should be used immediately following preparation. However, if this is not possible the prepared solution should be used within four hours

Do not use KOGENATE alter the expiry date which is marked on the label of each vial and on the outer cartons.

If you find that you have any KOGENATE after its expiry date, return it to your local pharmacist who will dispose of it properly.

Bayer

Inject your normal dose as soon as you remember and then continue as prescribed by your doctor.

A number of rarely reported side-effects have been observed with KOGENATE. These include reactions at the injection site such as a burning sensation, temporary redness and rash. Also, tightness of the chest, dizziness and nausea have been reported and mildly reduced blood pressure, which may make you feel faint upon standing. If you experience any of these side-effects, consult your doctor for advice.

The formation of inhibitors (neutralising antibodies) to Factor VIII is a well-known, but rare complication in the management of haemophilia A. This occurs mainly in patients who were previously untreated before receiving KOGENATE. Therefore, you should inform your doctor if you were untreated prior to receiving KOGENATE, as he/she may wish to carefully monitor your progress.

KOGENATE powder should be stored in a refrigerator (2 to 8ºC) until the expiry date which is shown on the packaging.

In exceptional cases, KOGENATE powder may be removed from the fridge and kept at room temperature (up to 25ºC) for a maximum period of three months as long as it is kept in the original packaging. If you need to take your medicine from the fridge for a prolonged period of time, you must write the date of the end of the three month period on the space provided on the vial and/or the box immediately.

Do not refrigerate the KOGENATE solution alter it has been made up Preferably, the solution should be used immediately following preparation. However, if this is not possible the prepared solution should be used within four hours

Do not use KOGENATE alter the expiry date which is marked on the label of each vial and on the outer cartons.

If you find that you have any KOGENATE after its expiry date, return it to your local pharmacist who will dispose of it properly.

Bayer