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Document: leaflet MAH BRAND_PL 08801-0028 change

• leaflet MAH BRAND_PL 08801-0028
• leaflet MAH BRAND_PL 08801-0054

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Package Leaflet: Information for the User

REPLENINE'-VF 250 IU, 500 IU, 1000 IU

powder for solution for injection

HIGH PURITY FACTOR IX

Please read all of this leaflet carefully before you start 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet:

1.    What Replenine-VF is and what it is used for

2.    Before you use Replenine-VF

3.    How to use Replenine-VF

4.    Possible side effects

5.    How to store Replenine-VF

6.    Further information

1. WHAT REPLENINE-VF IS AND WHAT IT IS USED FOR

Replenine-VF is a high purity factor IX from human blood plasma obtained from screened donors. It is a white sterile powder, supplied with sterile water (Sterilised Water for Injections).

Replenine-VF is given by injection into a vein (intravenously) and is used to prevent and treat bleeding in patients with haemophilia B (an inherited shortage of factor IX in the blood). Your doctor will explain further why this medicine has been given to you.

2. BEFORE YOU USE REPLENINE-VF

DO NOT USE this medicine if you:

•    are allergic (hypersensitive) to factor IX or to any of the other ingredients (See Section 6 'Furtherinformation’).

Take special care with Replenine-VF if you:

•    suddenly have unusual bruising and feeling very unwell, which may need specialist medical attention

•    have heart or liver disease, which may need specialist medical attention

•    have a risk of blood clotting

•    have had surgery

•    have a high level of antibodies to factor IX (Your doctor may give you an alternative treatment. He/she will check the level of factor IX and antibodies in your blood before and after treatment, especially for your first injections).

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

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

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

Your doctor will be extremely careful about using Replenine-VF in new-born infants.

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.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are breast-feeding, tell your doctor. Your doctor will tell you if this product is necessary for you to take at this time.

Driving and using machines

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

Please note

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infection.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and for the non-enveloped hepatitis A and parvovirus B19 viruses.

It is strongly recommended that every time you recieve a dose of Replenine-VF the name and batch number of the product are recorded in order to maintain a record of the batches used.

3. HOW TO USE REPLENINE-VF

Always use this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure.

Adults

Replenine-VF should be administered directly into a vein. Use only the recommended injection equipment.

•    Your doctor will explain how much you should use.

•    The dose, especially the first dose, should be given slowly (approximately 3 mL per minute).

•    After reconstitution, the injection should be completed within one hour and the solution must not be stored.

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

The table gives the approximate doses of factor IX which are needed to stop bleeding in various conditions:

Condition	Initial dose of Replenine-VF (IU/kg body weight)
Minor spontaneous bleeding in joints and muscles.	17 to 34
Severe bleeding in joints and muscles, bruising, minor surgery, e.g. tooth extraction, cartilage repair.	25 to 51
Life-threatening bleeding, major surgery.*	51 to 85

Table 1- factor IX dosing instructions

•    In major surgery Replenine-VF may be given either as individual injections or by continuous infusion over several days (see also section: How much is given before, during and after major surgery?).

Children

Your doctor will recommend the appropriate dose for young children. Generally the calculation of doses for children should follow that for adults.

When to inject Replenine-VF

•    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.

•    Replenine-VF can also be injected as part of treatment to prevent bleeding starting.

•    If you are using this product for the first time, your doctor will supervise you.

Dissolving your medicine before use

Vial of Replenine-VF	Quantity of Water supplied	Quantity of Water for Half Volume
250 IU	5 mL	2.5 mL
500 IU	10 mL	5 mL
1000 iu	20 mL	10 mL

Table 2 - details of sterile water quantities

1.    Replenine-VF must only be dissolved in the sterile water provided with the product.

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

3.    Sterile water for use with Replenine-VF is provided in a glass vial with a stopper.

4.    Replenine-VF is supplied with the amount of sterile water as shown on the table.

5.    Your doctor will tell you if you can dissolve Replenine-VF in half the normal volume of sterile water.

How to Dissolve Replenine-VF

You can dissolve your product in two ways using the Transfer Device called Mix2Vial^TM:

(A)    Dissolving in Full Volume or

(B)    Dissolving with Half Volume

A) Dissolving in Full Volume

The Mix2Vial™ Transfer Device is provided with your product for needle-free, easy and safe use.

The Transfer Device supplied with your product is sterile and cannot be used more than once. When the reconstitution process is complete dispose of in your ‘sharps box'.

B) Dissolving with Half Volume

To use the Transfer Device when dissolving Replenine-VF in half volumes, it is first necessary to remove and discard half the volume of water from the vial of sterile water.

•    Remove the “flip-off”cover from the vial of sterile water and clean the top of the stopper with an alcohol swab.

•    Pierce the stopper of the vial of sterile water with a needle and syringe and draw up half the volume of sterile water.

•    Check that the correct amount is withdrawn. The needle and syringe can now be safely disposed of (in your ‘sharps box’).

•    The remaining sterile water in the vial will be used for reconstitution (half the original volume). See Table 2 for quantities of water.

To complete the dissolving process follow steps 1-6 in Section A above. The product is then ready for administration.

Do not use this medicine if:

•    the water is not pulled into the product vial with either method of reconstitution (this indicates a loss of vacuum in the vial, so the product must not be used).

•    the dissolved product and Sterilised Water for Injections form a gel or a clot (if this happens, please tell Bio Products Laboratory, reporting the batch number printed on the vial).

Do not use solutions which are cloudy or have bits in them.

Administration User Kit

This additional carton can be provided upon request from Bio Products Laboratory, which will include:

Alcohol swabs:    one is used to clean the vial stoppers after flipping off the caps. The other should be used to disinfect

your skin at the injection site.

Winged Infusion set: a butterfly No. 23 needle for administration of the product.

20 mL syringe:    the dissolved solution is withdrawn into the syringe. This size of syringe is provided to enable more than

one vial to be administered using one syringe.

Plaster:    to stick on the injection site after administration.

Injecting the Medicine

After the medicine is dissolved:

•    To inject the medicine, attach a suitable needle to the syringe.

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

-    the solution must not be stored after reconstitution.

-    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 supplied to make up the solution, never inject the water on its own, without first dissolving the powder in it.

How much is given before, during and after major surgery?

(See also the Table 1 on Page 2)

Before: Major surgery should only be performed when levels of factor IX and factor IX inhibitors (antibodies) in your blood can be tested.

If antibodies are not present, a dose is given before the operation to increase the level in your blood to between 80 and 100 lU/dL, usually about 65-85 IU per kg of body weight.

After: During the first few days after the operation, the plasma factor IX concentration will be checked at regular periods. A dose of Replenine-VF (factor IX) is usually given every 8 to 24 hours, as needed.

After the first few days, the number of doses may be reduced.

Treatment is usually continued for 7 days or longer, depending on the type of operation.

If the factor IX concentration does not reach the expected level (this will be tested by your doctor), or if it decreases faster than expected (within 12 hours), an inhibitor of factor IX may be present which stops it from working properly. Your doctor will arrange for the appropriate laboratory tests to see if there is such an inhibitor present.

If you use more Replenine-VF 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 Replenine-VF

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

If you stop using Replenine-VF

Always consult your doctor before deciding to stop your treatment.

As with all medicines, Replenine-VF may cause side effects, although not everybody gets them.

Hypersensitivity or allergic reactions have been observed infrequently in patients treated with factor IX containing products. If you get any of the following symptoms, stop the infusion and tell your doctor immediately:

swelling around the face and throat burning and stinging at the infusion site chills flushing

nausea or vomiting

Kidney problems (such as nephrotic syndrome) have been reported in some haemophilia B patients who have inhibitors (antibodies) to factor IX and a history of allergic reaction to factor IX containing products.

Inhibitors (antibodies) may develop to factor IX during treatment. This could mean that the treatment does not work properly. If bleeding does not stop after an injection, then speak to your doctor.

On rare occasions, fever has been observed (in fewer than 1 in 1,000 people).

The use of low purity factor IX products has been associated with heart attack, thrombosis and blood coagulation. The use of high purity factor IX, such as Replenine-VF, is rarely associated with such side effects.

In clinical trials with Replenine-VF, the following side effects have been reported in fewer than 1 in 10 people.

•    Reaction at the injection site, e.g. irritation, inflammation.

•    Headache.

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

5. HOW TO STORE REPLENINE-VF

•    Keep out of the reach and sight of children.

•    You should store the powder in its container and carton, in the dark in the refrigerator. Do not freeze. Short periods of storage at room temperature, in the dark, will not damage the product.

•    The vial of sterilised water that comes with the medicine should also be stored in the refrigerator. Do not freeze.

•    Do not use the medicine or the sterilised water after the expiry date, which is stated as “EXPIRY” on the containers. The expiry date refers to the last day of that month.

•    Do not use the sterilised water if any small bits can be seen in it.

•    Once reconstituted, Replenine-VF 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 containers. Ask your doctor for a special container (‘sharps box’) for this purpose and take it back to the doctor or pharmacist when full.

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

What Replenine-VF contains

The active substance is human coagulation factor IX.

The other ingredients are: protein, glycine, lysine, sodium, citrate, phosphate and chloride.

What Replenine-VF looks like and the contents of the pack

Replenine-VF is a white, crumbly, sterile powder and is packed in quantities of 250 International Units (IU), 500 IU or 1000 IU in glass vials. These vials are closed with a synthetic rubber stopper under vacuum, held on by a tamper-evident cap. Replenine-VF should only be reconstituted with Sterilised Water for Injections which is supplied with Replenine-VF in clear glass bottles.

Provided with the product is a Transfer Device called Mix2Vial™ to enable needle-free, easy and safe reconstitution.

An Administration User Kit can be provided upon request which contains: a sterile 20 mL plastic syringe, a single winged infusion set (butterfly needle), alcohol swabs and a sterile plastic dressing.

Marketing Authorisation Holder and manufacturer

Bio Products Laboratory Limited, Dagger Lane, Elstree, Herts. WD6 3BX, United Kingdom Marketing Authorisation Number PL 08801/0028

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

Bio Products Laboratory Limited,

Dagger Lane, Elstree, Herts. WD6 3BX, U.K. Tel: +44 (0)20 8957 2200