Patient leaflet - Fanhdi 100 IU/ml powder and solvent for solution for injection
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. WHAT YOU NEED TO KNOW BEFORE YOU USE FANHDI®
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.
- The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If your or your child’s bleeding is not being controlled with Fanhdi®, tell your doctor immediately.
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.
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.
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.
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
Id2007-P2
11/03/2021
Color references
P-287
Background
White
Size | Structure (mm) 300 x 340
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 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. For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens your or your child’s medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.
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.
6. CONTENTS OF THE PACK AND OTHER 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 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.
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.
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 3980-3990 Cambridge Research Park 08150 Barcelona - SPAIN Beach Drive
Waterbeach
Cambridge, CB25 9PE
This leaflet was last revised in 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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P-2 Instituto Grifols, S.A. Can Guasc, 2 - Parets del Vallès 08150 Barcelona - SPAIN