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Fanhdi 25 I.U./Ml Powder And Solvent For Solution For Injection

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A


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30°C 86°F


Instructions for use/handling

Follow these instructions unless otherwise indicated by your doctor.

Left-over product must never be kept for later use, nor stored in a refrigerator.

To prepare the solution:

1.    Warm the vial and syringe but not above 30 °C.

2.    Attach plunger to syringe containing solvent.

3.    Remove filter from packaging. Remove cap from syringe tip and attach syringe to filter.

4.    Remove vial adaptor from packaging and attach to syringe and filter.

5.    Remove cap from vial and wipe stopper with swabs provided.

6.    Pierce vial stopper with adaptor needle.

7.    Transfer all solvent from syringe to vial.

8.    Gently shake vial until all product is dissolved. As with other solutions for injection, do not use if product is not properly dissolved or particles are visible.

9.    Briefly separate the syringe/filter from vial/adaptor, to release the vacuum.

10.    Turn the vial upside down and draw the solution into the syringe.

11.    Prepare injection site, separate syringe and inject product using the butterfly needle provided. Injection rate should be 3 ml/min into a vein and never more than 10 ml/min to avoid side effects (see section 4 "Possible side effects").

Do not re-use administration sets.

GRIFOLS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fanhdi® 25 I.U./ml, 50 I.U./ml and 100 I.U./ml (1000 I.U./10 ml and 1500 I.U./15 ml)

Powder and solvent for solution for injection

HUMAN COAGULATION FACTOR VIII, Ph. Eur.

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, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. 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 or pharmacist.

In this leaflet:

1.    What Fanhdi® is and what it is used for

2.    Before you use Fanhdi®

3.    How to use Fanhdi®

4.    Possible side effects

5.    How to store Fanhdi®

6.    Further information







1. WHAT FANHDI® IS AND WHAT IT IS USED FOR

The name of this medicine is Fanhdi®. It contains factor VIII as the active ingredient. It is a white powder, which, when dissolved in sterile water (supplied with the product), will form a clear solution.

Fanhdi® is one of the group of medicines called clotting factors. It is used to increase the amount of factor VIII in your blood to stop or prevent bleeding.

Fanhdi® is used to treat and prevent bleeding due to haemophilia A (inborn deficiency of factor VIII). It may be used in acquired deficiency of factor VIII.

Fanhdi® contains von Willebrand factor. However, there are no data from clinical trials that support its use in von Willebrand disease.


2. BEFORE YOU USE FANHDI®

Do not use Fanhdi®

•    If you are allergic (hypersensitive) to human coagulation factor VIII or to any of the other ingredients of Fanhdi®.

•    If you have not been fully trained how to inject yourself by your doctor or haemophilia nurse.

If you want more detailed information then ask your doctor.

Take special care with Fanhdi®

•    Rarely you may have an anaphylactic reaction (a sudden severe allergic reaction) that can cause tightness of the chest, swelling of your face, lips, mouth or throat, difficulty breathing, dizziness on standing, skin rash, hives, dizziness, vertigo or nausea. If these symptoms occur, you must stop using the product immediately and contact your doctor.

•    Your doctor should perform some tests to make sure that the dosage of Fanhdi® you are receiving is enough to achieve and maintain appropriate factor VIII levels and thus stop any bleeding.

•    If your bleeding is not controlled with Fanhdi®, consult your doctor immediately. You may have developed factor VIII inhibitors, these are antibodies which block the clotting effect of factor VIII. Your doctor will perform some tests to confirm whether the inhibitors are present in your blood.

Special safety warning

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 infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. But they may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

Your doctor should recommend that you consider vaccination against hepatitis A and B if you regularly receive human plasma-derived Factor VIII products.


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

See also section 4.

Using other medicines

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

No interactions of fanhdi® with other medicines are known.

Pregnancy and breast-feeding

Based on the rare occurrence of haemophilia A in women, experience regarding the use of human coagulation factor Viii during pregnancy and breast-feeding is not available. ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

fanhdi® has little or no effect on your ability to drive and use machines.

5. HOW TO STORE FANHDI®

Keep out of the reach and sight of children.

Do not store above 30 °C. Do not freeze.

Do not use Fanhdi® after the expiry date which is stated on the vial label and carton after EXP.

Do not use Fanhdi® if you notice the solution is cloudy or has deposits. Generally the solution is clear or slightly opalescent. if the solution is discoloured or cloudy discard it.

You should use Fanhdi® immediately after its powder and solvent have been mixed. If not used immediately, the storage times and conditions are responsibility of the user, and must not be longer than 12 hours at 25 °C or 24 h at 2 to 8 °C. You should check with your doctor if you are not sure about the conditions of use.

Any unused product or waste material should be disposed of in accordance with local requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

3. HOW TO USE FANHDI®

Reconstitute the product as described at the end of this leaflet (please see pictograms on the back of the leaflet). The product must be given by intravenous route. The administration rate should be 3 ml/min and never more than 10 ml/min to avoid undesirable side effects.

The amount of Fanhdi® you should use depends on many factors, such as your weight, your clinical status and the type and severity of bleeding. Your doctor will calculate the dose, the frequency and the intervals of administration of Fanhdi® in order to reach the necessary level of factor VIII in your blood.

Your doctor will tell you the duration of your treatment with Fanhdi®.

You will be given full training before using Fanhdi® without the hospital supervision. Please refer to all your training materials or contact your local haemophilia centre for more information.

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

There are insufficient data from clinical trials to recommend the use of Fanhdi® in children less than 6 years of age.

If you use more Fanhdi® than you should

No cases of overdose with Fanhdi® have been reported. However, if you have used Fanhdi® more than required, consult your doctor or pharmacist immediately.

If you forget to use Fanhdi®

Proceed immediately with the following dose and continue at regular intervals as directed by your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop using Fanhdi®

Do not stop using Fanhdi® without consulting your doctor.

6. FURTHER INFORMATION What Fanhdi® contains

•    The active substance is human coagulation factor VIII. Fanhdi® is provided as powder for solution for injection. Each powder vial contains 250, 500, 1000 or 1500 I.U. human coagulation factor VIII.

•    The other ingredients are albumin, histidine and arginine. A solvent (water for injections) is supplied for reconstitution: 10 ml for the presentations of 250, 500 and 1000 I.U. or 15 ml for the presentation of 1500 I.U.

What Fanhdi® looks like and contents of the pack

Vial containing white or pale yellow powder and syringe with water for injections (solvent).

Presentations:

Fanhdi® 25 I.U./ml (250 I.U./10 ml)    PL 12930/0002

Fanhdi® 50 I.U./ml (500 I.U./10 ml)    PL 12930/0004

Fanhdi® 100 I.U./ml (1000 I.U./10 ml and 1500 I.U./15 ml) PL 12930/0005 Water for Injections    PL 4447/0016

Pack size: 1 lyophilised vial, 1 syringe pre-filled with solvent and accessories (vial adaptor, filter, 2 alcohol swabs and butterfly needle).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and Manufacturer: Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Valles 08150 Barcelona - SPAIN

Distributed by:

Grifols UK Ltd.

Byron House

cambridge Business Park Cambridge CB4 0WZ


This leaflet was last approved in January 2012

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fanhdi® can cause side effects, although not everybody gets them. On rare occasions, you may have some of the following side effects after the administration of Fanhdi®. Please contact your doctor immediately if you experience:

•    itching, local reactions at the injection site (e.g. burning and transitory reddening)

•    allergic reactions (e.g. tightness of the chest/feeling unwell, dizziness, nausea and slight drop of blood pressure than can make you feel dizzy when you are standing)

•    peculiar taste in your mouth

•    fever

•    faster heart beat (tachycardia)

occasionally an anaphylactic shock may occur. If you observe any of the following symptoms during the injection/perfusion, interrupt the injection/perfusion and contact your doctor immediately:

•    tightness of the chest/feeling unwell

•    swelling of your face, lips, mouth or throat, difficulty breathing

•    slight hypotension (slight drop of blood pressure with dizziness on standing)

•    skin rash, hives

•    dizziness

•    vertigo

•    nausea

Allergic reactions to the components of the product cannot be totally excluded. The formation of neutralising antibodies of factor VIII (inhibitors) is a well-known complication in the treatment of patients with haemophilia A. Study results show that first time users of factor VIII are mainly affected. You will be carefully monitored for the development of these inhibitors.

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