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1. Dried Factor Viii Fraction Type 8y 25 Iu/Ml Powder For Solution For Injection
2. Dried Factor Viii Fraction Type 8y 25 Iu/Ml Powder For Solution For Injection

PATIENT INFORMATION LEAFLET 8YL18

DRIED FACTOR VIII FRACTION, TYPE 8Y

Human Factor VIII and von Willebrand Factor (VWF)

Please read all of this leaflet carefully before using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, please ask your doctor.

-    This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Is this leaflet hard to see or read? Phone +44 (0)20

8957 2200.

In this leaflet:

1.    What Dried Factor VIII Fraction (8Y) is and what it is used for

2.    Before you use 8Y

3.    How to use 8Y

4.    Possible side effects

5.    How to store 8Y

6.    Further i nformation

Dried Factor VIII fraction (8Y) is a concentrate of Factor VIII and von Willebrand Factor (VWF) prepared from blood plasma from screened donors and then heat-treated.

8Y is given by injection into a vein (intravenously) and is used to prevent and treat bleeding in patients with haemophilia A (an inherited shortage of Factor VIII in the blood) or von Willebrand disease (VWD). Your doctor will explain further why this medicine has been given to you.

You must not be given this medicine if you are:

•    allergic (hypersensitive) to Factor VIII or von Willebrand Factor (VWF) or to any of the other ingredients in the product (See Section 6 'What 8Y contains’)

Special care must be taken with 8Y if you:

•    develop an allergic reaction (see Section 4 ‘Possible side effects’ for a list of these) stop the treatment immediately and tell your doctor.

•    are blood group A, B or AB and need large doses of the medicine. Your doctor will carry out regular blood tests to check your red blood cells because this medicine contains small amounts of blood group antibodies which are present in the plasma that the medicine is made from.

•    have a shortage of Factor VIII from birth,

you may develop inhibitors (antibodies) to Factor VIII during treatment. This could mean that the treatment will not work properly. If bleeding does not stop after an injection, speak to your doctor.

•    are going to have an operation. Before surgery, your doctor will check your blood for inhibitors.

•    have von Willebrand disease. In some people, Dried Factor VIII does not control bleeding. You may also be more prone to thrombosis; your doctor will advise you on this.

Your doctor will check the level of Factor VIII in your blood before and after treatment, especially for your first injections. Your doctor may also check the level of von Willebrand Factor at the same time.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

These injections must not be mixed with other medicinal products given intravenously.

Your doctor will advise you about any vaccinations you may need as a routine precaution when using a blood plasma product.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding. You should not use this medicine during pregnancy or when breastfeeding unless recommended by your doctor.

Driving and using machines

There are no known effects of this product on your ability to drive or operate machinery.

Before injecting this medicine at home you will have received training at your haemophilia centre. Always use this medicine exactly as your doctor has told you to. You should check with your doctor if you are not sure.

When injecting, take special care to keep all needles sterile.

Adults

The solution of 8Y should be administered directly into a vein. Use only the recommended injection equipment provided with your medicine.

If you develop an allergic reaction (see Section 4 ‘Possible side effects’ for a list of these) stop the treatment immediately and tell your doctor.

•    Your doctor will explain how much you should use and when to use it.

•    The dose, especially the first dose, should be given slowly (not more than 3 mL per minute).

•    After making up the solution with water, the injection should be completed within one hour. The solution must not be stored.

•    If further treatment is needed, doses may be repeated at intervals of 8, 12 or 24 hours, as required to maintain the desired concentration of Factor VIII. Your doctor will advise you if this is necessary. If you are being treated for von Willebrand disease, your doctor will advise you of your specific dosing intervals.

3.1 How much 8Y to use

Factor VIII deficiency

The table below gives the approximate doses of 8Y which are needed for Factor VIII deficiency,

in various conditions, to stop the bleeding. The dose depends on the patient’s body weight (IU means International Unit). To calculate your dose, multiply your weight by the units in the table.

The above doses are only rough guides.

•    Your doctor will explain to you how much you should use and when you should use it.

•    Your doctor will usually tell you your dose in terms of the number of full vials nearest to the dose most suited to you.

•    If further treatment is needed, doses may be repeated at intervals of 8, 12 or 24 hours, as required. Your doctor will advise you if this is necessary.

How much do you give a child?

Your doctor will recommend the appropriate dose for children.

von Willebrand disease

The dose is usually 40-80 IU/kg body weight of VWF (or 20-40 IU/kg of Factor VIII). Your doctor will advise you on the appropriate dose to be given and how often you may need to repeat doses.

When to inject 8Y

•    The medicine should be injected when the first sign of bleeding occurs.

•    The injection should be repeated as necessary to stop the bleeding.

•    Each individual bleed should be judged on its own severity.

The information in the section below is

provided for guidance. Full training in

preparation and injection of this medicine will

have been provided by your medical team.

Dissolving your medicine before use

1.    8Y must only be dissolved in the sterile water provided with the product.

2.    Before you remove its “flip-off” top, make sure that the vial of 8Y and the container of water supplied with it are both at room temperature (between 20-30°C).

3.    Remove the caps from the 8Y vial and the vial of sterile water.

4.    Clean the tops of the vial stoppers with a spirit swab.

5.    Either one of the following two methods can be used to transfer the water to the 8Y powder:

A.    Pierce the stopper of the vial of sterile water with a needle (but not the filter needle) and syringe and draw up the required volume of water (see table). Transfer the water to the vial containing the dried Factor VIII by piercing the stopper with the needle which will automatically draw the water from the syringe into the vial as it is under vacuum. Remove the syringe from the needle before removing the needle from the vial of 8Y.

B.    Remove the protective guard from one end of the transfer needle and push it through the stopper of the sterile water. Then turn these two upside down and remove the cover guard from the other end of the transfer needle. Push the vial of dried Factor VIII onto the transfer needle and the water will be drawn up into the vial of powder. When the water has finished moving into the vial of powder (there will be some water left in the water vial) first pull

the water vial off the transfer needle before removing this needle from the vial of 8Y.

6. As the water enters the vial of powder, gently swirl the vial around to wet the powder, but do not shake it.

7.    If more than one vial is required to make up the dose, the contents of the required number of vials are pooled together. Throw away any unused water.

8.    Continue swirling the vial around gently until the powder is completely dissolved. A clear or slightly pearl-like solution should be obtained within 15 minutes.

9.    The solution should be used immediately, and injection must be completed within one hour.

Do not use this medicine if the:

A.    water is not pulled into the vial (this indicates a loss of vacuum in the vial, so the powder must not be used).

B.    dissolved powder and sterile water form a gel or a clot (if this happens, please tell Bio Products Laboratory, reporting the batch number printed on the vial).

C.    solution is cloudy or has bits in it.

Injecting the medicine

After the medicine is dissolved:

•    Clean the stopper again with a spirit swab.

•    Draw the medicine into a plastic, disposable syringe through the sterile filter needle

provided (this will remove any tiny particles).

•    To inject the medicine, attach a suitable needle or “butterfly” to the syringe.

•    The dose, especially the first dose, should be given slowly (no more than 3 mL per minute) into your vein.

If you have to use more than one vial to make up your dose, you need to draw up the solution in each vial into one syringe for your injection, but you must use a new sterile filter needle to draw the contents of each vial up into the plastic syringe.

Remember:

•    the solution must not be stored.

•    you must finish injecting the dose into a vein within one hour of dissolving the medicine.

•    the solution must not be added to any other fluids, blood or any other medicine.

•    you should only use the sterile Water for Injections to make up the solution but you must never inject the water on its own, without the powder.

If you use more 8Y than you should

If you think you may be using too much, stop the injection and tell your doctor.

If you know you have used too much, tell your doctor as soon as possible.

If you forget to use 8Y

Do not use a double dose to make up for a forgotten dose.

If you stop using 8Y

Always consult your doctor before deciding to stop your treatment.

As with all medicines, 8Y may cause side effects, although not everybody gets them.

Hypersensitivity or allergic reactions have been observed rarely in patients treated with Factor VIII containing products. If you get any of the following symptoms, stop the injection and tell your doctor immediately:

•    allergic type reactions. The early signs of this are nettle rash, tightness of the chest, wheezing, low blood pressure (lightheadedness).

•    an increase in body temperature.

•    development of antibodies.

Occasionally flushing, nausea (feeling sick), coughing, slow or fast pulse rate, taste disturbance, drowsiness, blurred vision, headache and lower back pain are seen.

Patients with Blood groups A, B or AB receiving large doses should be tested for any evidence of destruction of the patients red blood cells.

VWD patients who develop bruising should stop injection immediately and contact the doctor.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Please note

The possibility of infection from using medicines made from human blood plasma cannot be totally ruled out. This warning includes known, unknown and new viruses as well as some other germs. Several different steps have been taken to make this possibility very unlikely. These include the careful selection of donors and testing of the plasma they provide for specific types of infection. Furthermore, the method used to produce the medicine from their blood plasma includes steps to kill or remove viruses like HIV, hepatitis B and hepatitis C.

The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

It is strongly recommended that every time you receive a dose of 8Y the name and batch number of the product are recorded in order to maintain a record of the batches used.

•    Keep out of the reach and sight of children.

•    You should store the powder in its container in its carton to protect it from light, in the refrigerator (2-8°C). Do not freeze. Short periods (up to 2-3 months) of storage at room temperature (up to 25°C, but not higher), in the dark, will not damage the product. Do not freeze.

•    The container of sterilised water that comes with the medicine can be stored between 2°C -25°C. Do not freeze.

•    Do not use the medicine or the sterilised water after the expiry date which is printed as “EXP” on the containers (the expiry date refers to the last day of that month).

•    Do not use any solution if any small bits can be seen in it.

•    Once made up with water, Dried Factor VIII must be used within one hour.

Disposal

After injection of the correct dose, dispose of any solution that remains, along with used syringes, needles and water containers. Your treatment centre will provide a special container for this purpose. Arrangements will be made for collection of the clinical waste.

The medicine is supplied with a glass vial of water (10 mL or 20 mL, Sterilised Water for Injections) to dissolve the medicine.

Marketing Authorisation Holder and Manufacturer

Bio Products Laboratory Limited

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom

Marketing Authorisation Number PL 08801/0021

This leaflet was last approved in

November 2012

For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through info@bpl.co.uk.

Medicines should not be disposed of via wastewater or household waste.

What 8Y contains

The active substances are Factor VIII and von Willebrand Factor (VWF).

The other ingredients are: fibrinogen, sucrose, tris, glycine, heparin, sodium chloride, sodium citrate, calcium chloride and various human plasma proteins.

What 8Y looks like and the contents of the pack

Dried Factor VIII is a white or pale yellow, crumbly, sterile powder, available as single dose vials containing either 250 IU or 500 IU in glass vials. These vials are closed with a synthetic rubber stopper under vacuum, held on by an aluminium ring and flip off cover.

Bio Products Laboratory Limited

Dagger Lane, Elstree, Herts. WD6 3BX, U.K.

Tel: +44 (0)20 8957 2200

Version: 8YL18