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FANHDI 50 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): FACTOR VIII

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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 ºC.
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.

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30°C 86°F

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fanhdi® 25 IU/ml, 50 IU/ml and 100 IU/ml
(1000 IU/10 ml and 1500 IU/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 because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Fanhdi® is and what it is used for
2. What you need to know before you use Fanhdi®
3. How to use Fanhdi®
4. Possible side effects
5. How to store Fanhdi®
6. Contents of the pack and other information

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

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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.

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2. WHAT YOU NEED TO KNOW BEFORE YOU USE FANHDI®

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Do not use Fanhdi®
• If you are allergic to human coagulation factor VIII or to any of the other ingredients of this medicine (listed in section 6).
• 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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.
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.

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Other medicines and Fanhdi®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.

Instituto Grifols, S.A. Can Guasc, 2 - Parets del Vallès 08150 Barcelona - SPAIN

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Fanhdi® contains sodium
The residual content of sodium in Fanhdi®, arising from the manufacturing process, does not exceed 23 mg per vial in
the 250, 500 and 1000 IU presentations, and 34.5 mg per vial in the 1500 IU presentation. This is equivalent to 1.15%
and 1.72% respectively of the recommended maximum daily intake of sodium for an adult. However, depending on the
body weight of the patient and the posology, the patient may receive more than one vial.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

3. HOW TO USE FANHDI®

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 IU/ml (250 IU/10 ml)
PL 12930/0002
Fanhdi® 50 IU/ml (500 IU/10 ml)
PL 12930/0004
Fanhdi® 100 IU/ml (1000 IU/10 ml and 1500 IU/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.

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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.
Use in children
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 that
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card Scheme, Website: https://yellowcard.mhra.gov.uk. By
reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE FANHDI®
Keep this medicine out of the sight and reach of children.
Do not store above 30 ºC. Do not freeze.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Do not use this medicine 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 ºC or 24 h at 2 to 8 ºC.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to protect the environment.

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 IU 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 IU or 15 ml for the presentation of 1500 IU.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer:
Distributed by:
Instituto Grifols, S.A.
Grifols UK Ltd.
Can Guasc, 2 - Parets del Vallès
Byron House
08150 Barcelona - SPAIN
Cambridge Business Park
Cambridge CB4 0WZ

This leaflet was last revised in December 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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