Informations for option: Willfact 2000 I.U Powder And Solvent For Solution For Injection, show other option

Select option:

1. Willfact 2000 I.U Powder And Solvent For Solution For Injection
2. Willfact 2000 I.U Powder And Solvent For Solution For Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

WILLFACT 2000 IU

Powder and solvent for solution for injection

Human von Willebrand factor

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 Willfact is and what it is used for

2.    Before you use Willfact

3.    How to use Willfact

4.    Possible side effects

5.    How to store Willfact

6.    Further information

1.    WHAT WILLFACT IS AND WHAT IT IS USED FOR

Willfact is a medicine used to stop bleeding that contains human von Willebrand factor (VWF) as active ingredient.

Willfact is indicated in the prevention and treatment of surgical or other bleeding in patients with von Willebrand disease when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

2.    BEFORE YOU USE WILLFACT Contraindications

Do not use Willfact

•    if you are hypersensitive (allergic) to human von Willebrand factor or to one of the ingredients of Willfact.

•    if you suffer from haemophilia A.

Take special care with Willfact:

Your treatment with Willfact should always be supervised by a physician experienced in the treatment of haemostatic disorders.

If you experience heavy bleeding and a blood examination shows that your Factor VIII blood value is reduced, you will receive the VWF preparation in addition to a Factor VIII preparation within the first twelve hours.

Allergic reactions

As with every protein medicine for intravenous use derived from human blood or plasma, hypersensitivity reactions in the form of an allergy may occur. During your injection, you will be observed specifically to determine whether you experience any early signs of hypersensitivity, e.g. stinging, hives (generalised urticaria), tightness of the chest, wheezing, drop in blood pressure (hypotension) and allergic severe reactions (anaphylaxis). If these symptoms occur, the injection will be interrupted immediately.

Risk of thrombosis

Blood vessels may also become blocked by blood clots (thromboses). This risk exists particularly if your previous medical history or laboratory results indicate that you present certain risk factors. In this case you will be monitored very carefully for the early signs of thrombosis, and a preventative treatment (prophylaxis) against vein blockages by blood clots should be introduced.

When using a Factor VIII-containing VWF product, your physician should be aware that the treatment may cause an excessive rise in FVIII:C. If you receive such FVIII-containing VWF product, your physician should monitor your FVIII:C plasma level regularly. This ensures that your FVIII:C plasma level is not sustained excessive, which may increase the risk of thrombotic events.

Limited effectiveness

It is possible that, in patients with von Willebrand disease, especially type 3 patients, proteins may be formed that neutralise the effect of VWF. These proteins are called antibodies or inhibitors. If the laboratory results give corresponding indications, or if the bleeding does not stop despite a sufficient dose of Willfact, your physician will check whether VWF inhibitors are being formed in your body. If these inhibitors are present in high concentration, treatment with VWF may not be effective, and other treatment options should be considered. The new treatment will be provided by a physician who has experience in the treatment of haemostatic disorders.

Safety of the raw material in Willfact (plasma)

The use of medicines derived from human blood or plasma is by definition associated with the risk of infections. Various standard measures are taken to counter this, including the targeted selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, the possibility of transmitting of infective agents cannot be totally excluded when medicinal products prepared from human blood or plasma are administered. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). The measures taken 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 with immunodeficiency or certain forms of anaemia.

Vaccinations

If you are treated regularly with human plasma-derived von Willebrand factor, appropriate vaccinations (hepatitis A and hepatitis B) are recommended.

Recording of batch number

Every time Willfact is administered, the physician or one of his/her employees will record the name and batch number of the product in order to be able if necessary to trace precisely which batch(s) you have received. The batch number indicates the production run in which the batch of product in question was produced.

Using other medicines

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

Using Willfact with food and drink

There are no known interactions of VWF preparations with foods or drinks. Therefore you do not have to avoid any specific foods or drinks.

Pregnancy and breast-feeding

Willfact should be used during pregnancy and breastfeeding only if it is clearly indicated. The safety of Willfact during pregnancy and breastfeeding has not been evaluated in controlled clinical studies. Animal studies are not sufficient to establish its safety with respect to fertility, pregnancy and development of the child during pregnancy and after birth.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No effects on ability to drive or use machines have been observed.

Important information about some of the ingredients of Willfact

Willfact contains 13.8 mg of sodium per vial.

You should take it into consideration if you are on a salt-free or low-salt diet.

3. HOW TO USE WILLFACT

Treatment should only be initiated under the supervision of a physician experienced in the treatment of haemostatic disorders.

Dosage

The dose you take depends on your health condition and body weight.

The first dose of Willfact is 40 to 80 IU/kg for the treatment of haemorrhage or trauma, in conjunction with the required amount of factor VIII product, calculated according to your baseline plasma level of FVIII:C, in order to achieve an appropriate plasma level of FVIII:C, immediately before the intervention or as soon as possible after the onset of the bleeding episode or severe trauma.

If required, you will receive further doses of Willfact of 40 to 80 IU/kg per day in one or two injections daily over one to several days.

Willfact can also be administered as long-term prophylaxis; the dose level is also determined individually in this case. Willfact doses between 40 and 60 IU/kg administered two to three times per week reduce the number of haemorrhagic episodes.

Please talk to your doctor if you feel that the effect of Willfact is too strong or too weak.

If you use more Willfact than you should:

No symptoms of overdose with Willfact have been reported.

However, the risk of thrombosis cannot be excluded in case of major overdose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Willfact can cause side effects, although not everybody gets them.

The assessment of side-effects is based on the following frequency specifications:

Very common: Affects more than 1 user in 10.

Common: Affects 1 to 10 users in 100.

Uncommon: Affects 1 to 10 users in 1,000.

Rare: Affects 1 to 10 users in 10,000.

Very rare: Affects less than 1 user 10,000.

Not known: Frequency cannot be estimated from the available data.

Although the safety of Willfact is considered good, allergic or anaphylactic reactions could occur.

The following side-effects occurred “uncommonly”:

•    Accelerated heartbeat (tachycardia)

•    Tightness of the chest

•    Headache

•    Restlessness

•    Tingling

•    Wheezing

•    Nausea

•    Vomiting

•    Quincke’s oedema (angiooedema)

•    Nettle rash (generalised urticaria)

•    Hives

•    Drop in blood pressure (hypotension)

•    Burning and stinging at the infusion site

•    Chills

•    Flushing/heat

•    Hypersensitivity - or allergic reactions

In some cases, the aforementioned signs may progress to severe allergic reaction (anaphylaxis) including shock.

•    Listlessness (lethargy)

The following side-effects were observed “rarely”:

•    Fever

Antibodies (inhibitors) against VWF: very rarely, proteins may be formed in patients with von Willebrand disease, especially type 3 patients, which neutralise the effect of VWF. These proteins are called antibodies or inhibitors. However, this has never been observed during Willfact treatment. Patients treated with VWF should be carefully monitored by their doctors for the development of inhibitors by appropriate clinical observations and laboratory tests. If such inhibitors occur, the condition will manifest itself as an inadequate clinical response. The antibodies form antibody-antigen complexes and occur concomitantly to anaphylactic reactions.

After correction of the factor Willebrand deficiency, you must be monitored for early signs of thrombosis or disseminated intravascular coagulation and receive treatment to prevent thrombosis in situations involving an increased risk of thrombosis (after operations, during confinement to bed, in cases of deficiency in a coagulation inhibitor or fibrinolytic enzyme).

If you receive FVIII-containing VWF preparations, the risk of thrombosis may also be increased due to persistently elevated FVIII:C plasma levels.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE WILLFACT

•    Store in the original package in order to protect from light. Do not store above 25°C. Do not freeze.

•    The product should be used immediately after reconstitution. However, its stability has been demonstrated for 24 hours at 25°C.

•    Keep product out of the reach and sight of children.

•    Do not use the product after the expiry date stated on the vial label and carton.

•    Do not use Willfact if you notice that the solution is cloudy or that it contains any deposit.

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

6.    FURTHER INFORMATION What Willfact contains

The active substance is: human von Willebrand factor (2000 IU/vial), expressed in International Units (IU) of Ristocetin Cofactor activity (VWF:RCo). After reconstitution with 20 ml of water for injections, one vial contains 100 IU human von Willebrand factor per 1 ml.

Before the addition of albumin, the specific activity is greater than or equal to 50 IU of VWF:RCo/mg of total protein.

The other ingredients are:

Powder: human albumin, arginine hydrochloride, glycine, sodium citrate and calcium chloride dihydrate.

Solvent: water for injections.

What Willfact looks like and contents of the pack

Willfact is presented as powder and solvent for solution for injection (2000 IU/20 ml).

One pack of Willfact contains one vial with 2000 IU human von Willebrand factor and one vial with 20 ml water for injections for reconstitution with a transfer system.

Marketing Authorisation Holder and Manufacturer

LFB-BIOMEDICAMENTS 3, avenue des Tropiques,

BP 305 - LES ULIS,

91958 Courtabmuf Cedex FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria    Willfact 100 I.E./ml Pulver und Losungsmittel zur Herstellung einer

Injektionslosung Czech Republic    Willfact

Denmark    Willfact

Estonia    Willfact

Germany    WILLFACT 2000 I.E.

Hungary    Willfact

Latvia    Willfact

Lithuania    Willfact 100 TV/ ml, milteliai ir tirpiklis injekciniam tirpalui

Norway    Willfact

Poland    Willfact

Portugal    Willfact

Slovenia    Willefact    2000 i.e Prasek in vehikel za raztopino za injiciranje

Slovak Republic    Willfact

Spain    Willfact

Sweden    Willfact

United Kingdom    Willfact

This leaflet was last approved in {12/2014}.

<..............................................................................................................>

The following information is intended for medical or healthcare professionals only: Reconstitution:

The currently applicable guidelines for aseptic procedures must be followed. The transfer system is only used to reconstitute the drug, as described below. It is not intended in administering the drug to the patient.

The solution should be clear or slightly opalescent, colourless or slightly yellowish. Cloudy solutions or solutions with deposits must not be used.

Administration:

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