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WILATE 500/WILATE 1000 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): HUMAN COAGULATION FACTOR VIII

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2015.03.25 / 200x490mm / B.181.006.UK_01

Color: Black, Black 20%

B.181.006.UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pregnancy and breast-feeding

Wilate 500, 500 IU FVIII / 500 IU VWF, powder and
solvent for solution for injection

Ask your doctor or pharmacist for advice before using Wilate.

Wilate 1000, 1000 IU FVIII / 1000 IU VWF, powder and
solvent for solution for injection

Important information about some of the ingredients of Wilate

Human coagulation factor VIII / human von Willebrand factor
Read all of this leaflet carefully before you start using this
medicine.

This medicinal product contains up to 2.55 mmol sodium (58.7 mg)
per dose for 500 IU FVIII and VWF/vial and up to 5.1 mmol sodium
(117.3 mg) per dose for 1000 IU FVIII and VWF/vial. To be taken into
consideration if you are on a controlled sodium diet.

• Please keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you personally and you
should 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.

3. How to use Wilate

Wilate should be injected into a vein (administered intravenously)
after reconstitution with the supplied solvent. Treatment should be
started under medical control.

Dosage
In this leaflet:
1. What Wilate is and what it is used for
2. Before you use Wilate
3. How to use Wilate

Your doctor will advise you about your individual dosage and the
frequency with which you should use Wilate. Always use Wilate
exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

4. Possible side effects
5. How to store Wilate
6. Further information

1. What Wilate is and what it is used for

Wilate belongs to the pharmacotherapeutic group of medicines
called clotting factors and contains human blood coagulation factor
VIII (FVIII) and von Willebrand factor (VWF). Together these two
proteins are involved in blood clotting.

Von Willebrand disease
Wilate is used to treat and prevent bleeding in patients with von
Willebrand disease (VWD), which in fact is a family of related diseases.
All types of VWD are inborn, where bleeding can go on for longer
than expected. This is either due to a lack of VWF in the blood or due
to VWF that does not work the way it should.
Haemophilia A
Wilate is used to treat and prevent bleeding in patients with
haemophilia A. This is a condition in which bleeding can go on
for longer than expected. It is due to an inborn lack of FVIII in the
blood.

2. Before you use Wilate
Do not use Wilate
• if you are allergic (hypersensitive) to human blood coagulation
factor VIII, von Willebrand factor or any of the other ingredients
of Wilate.

If you use more Wilate than you should
No symptoms of overdose with human FVIII or VWF have been
reported. However, the recommended dosage should not be
exceeded.

If you forget to take Wilate
Do not take a double dosage to make up for a forgotten dosage.

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

4. Possible Side Effects

Like all medicines, Wilate can cause side effects, although not
everybody gets them.
• Even though uncommon, hypersensitivity or allergic reactions have
been observed. These may include:
burning and stinging at the infusion site, chills, flushing, headache,
hives (uticaria), low blood pressure (hypotension), tiredness
(lethargy), sickness (nausea), restlessness, increase of heart rate
(tachycardia), tightness of the chest, feeling of pins and needles
(tingling), vomiting, wheezing, sudden swellings in various parts
of the body (angiooedema).
If you suffer from any of the above-mentioned symptoms, please
inform your doctor.
You should stop using Wilate and see your doctor immediately, if
you experience symptoms of angiooedema, such as:
o swollen face, tongue or throat (pharynx)

Take special care with Wilate

o difficulties to swallow

• Any medicine, such as Wilate, which is prepared from human
blood (containing proteins) and which is injected into a vein
(administered intravenously) can cause allergic reactions. Please
pay attention to early signs of allergic reactions (hypersensitivity),
such as hives, skin rash, tightness of the chest, wheezing, low blood
pressure, or anaphylaxis (when any or all of the above symptoms
develop rapidly and are intense)

o hives and difficulties to breath

If these symptoms occur, stop the injection immediately and
contact your doctor.
• 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 (HBV) virus
and hepatitis C virus (HCV), and for the non-enveloped hepatitis A
virus (HAV). The measures taken may be of limited value against
non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women
(infection of the baby) and for individuals whose immune system
is depressed or who have some types of anaemia (e.g. sickle cell
disease or abnormal breakdown of red blood cells).
• It is strongly recommended that every time you receive a dose
of Wilate the name and the batch number of the product are
recorded in order to maintain a record of the batches used.
Your doctor may recommend that you consider vaccination against
hepatitis A and B if your regularly/repeatedly receive human plasmaderived FVIII/VWF products.

• On rare occasions, fever has been observed.
• In very rare cases, hypersensitivity may lead to a severe allergic
reaction called anaphylaxis (when any or all of the above symptoms
develop rapidly and are intense), which may include shock. In case
of an anaphylactic shock, treatment using the current medical
recommendations for shock is essential.

Von Willebrand disease (VWD)
• When using a FVIII-containing VWF product to treat VWD, the
continued treatment may cause an excessive rise in FVIII in the
blood. This may increase the risk that your blood flow will be
disturbed (thrombosis).
If you are a patient with known clinical or laboratory risk factors,
you have to be checked for early signs of thrombosis. Prevention
(prophylaxis) of thrombotic events should be decided by your
doctor, according to the current recommendations.
• Patients with VWD (especially type 3 patients) may develop
inhibitors (neutralising antibodies) to VWF during the treatment
with VWF. In these very rare cases inhibitors can stop Wilate
working properly.
In case your bleeding continues, your blood has to be tested for
these inhibitors.
Inhibitors may increase the risk of suffering severe allergic reactions
(anaphylactic shock). If you suffer an allergic reaction, you should
be tested for the presence of inhibitors.
Once inhibitors have been found in your blood, please contact a
physician with experience in the care of patients with bleeding
disorders. In patients with high amounts of inhibitors, another
kind of treatment might be useful and should be considered.

Haemophilia A
Von Willebrand disease (VWD)
• Please see section 4. (Von Willebrand disease (VWD)) for side
effects related to the treatment of VWD.
Haemophilia A
• Please see section 4. (Haemophilia A) for side effects related to
the treatment of haemophilia A.

Taking other medicines

• When using FVIII products to treat patients with haemophilia A,
the formation of inhibitors (neutralising antibodies) to FVIII is a
known complication. In these rare cases inhibitors can stop Wilate
working properly and bleeding may continue. Please contact
a specialised haemophilia centre if Wilate does not stop your
bleeding. Regular blood tests will be performed during treatment
to test for these inhibitors.
Inhibitors may increase the risk of suffering severe allergic reactions
(anaphylactic shock). If you suffer an allergic reaction, you should
be tested for the presence of inhibitors.

Although no influences on Wilate from other medicinal products
are known, please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines (including medicines
obtained without a prescription).

Uncommon: affects 1 to 10 users in 1,000

Please do not mix Wilate with any other medicines during the
injection.

Very rare: affects less than 1 user in 10,000

B.181.006.UK_GTP_01.indd 1

Rare: affects 1 to 10 users in 10,000

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There are insufficient data to recommend the use of Wilate in
previously untreated patients.
The experience of treatment with Wilate in children less than 6 years
of age is limited.
For information on viral safety see section 2. (Take special care with
Wilate).
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell you doctor or pharmacist.

5. How to store Wilate

Keep out of the reach and sight of children.

Instructions for Home Treatment
• Please read all the instructions and follow them carefully!
• Do not use Wilate after expiry date given on the label.
• During the procedure described below, sterility must be
maintained!
• The solution in the syringe should be clear or slightly pearly
shimmery. Do not inject solutions that are cloudy or have deposits.
• Use the prepared solution immediately, to prevent microbial
contamination.
• Only use the injection set provided. The use of other injection/
infusion equipment can cause additional risks and treatment
failure.
Instructions for Preparing the Solution:

Store powder and solvent vial in a refrigerator (2°C - 8°C).

1. Do not use the product directly from the refrigerator. Allow
the solvent and the powder in the closed vials to reach room
temperature.

Do not freeze.
Keep the vials in the outer carton to protect from light.

2. Remove the flip off caps from both vials and clean the rubber
stoppers with one of the provided alcohol swabs.

Do not use Wilate after the expiry date stated on the label.
Wilate can be stored at room temperature (max. +25°C) for 2 months.
In this case the shelf-life expires 2 months after the product has been
taken out of the refrigerator for the first time. The new shelf-life has
to be noted on the outer carton by you.

3. The Mix2vial™ is depicted in Fig. 1. Place the solvent vial on an
even surface and hold it firmly. Take the Mix2Vial™ and turn it
upside down. Place the blue part of the Mix2Vial™ on top of the
solvent vial and press firmly down until it snaps (Fig. 2 + 3).

The powder should be dissolved only directly before injection. The
stability of the solution has been demonstrated for 12 hours at room
temperature. Nevertheless, to prevent contamination, the solution
should be used immediately and on one occasion only. Any unused
product or waste must be disposed of correctly.

6. Further information

What Wilate contains

4. Place the powder vial on an even surface and
hold it firmly. Take the solvent vial with the
attached Mix2Vial™ and turn it upside down.
Place the transparent part on top of the powder
vial and press firmly down until it snaps (Fig. 4).
The solvent flows automatically into the powder
vial.

− The active substances are human coagulation factor VIII and human
von Willebrand factor
− The other ingredients are sodium chloride, glycine, sucrose, sodium
citrate and calcium chloride. Solvent: water for injections with
0.1% Polysorbate 80



What Wilate looks like and contents of the pack
5. With both vials still attached, gently swirl the
powder vial until the product is dissolved.

Freeze-dried powder: white or pale yellow powder or crumbly solid
Reconstituted solution: should be clear or slightly opalescent

The dissolving is completed in less than 10
minutes at room temperature. Slight foaming
might occur during preparation. Unscrew the
Mix2Vial™ into two parts (Fig. 5). Foaming will
disappear.

Wilate is supplied as a powder and solvent for solution for injection.
It comes in 2 pack sizes:
• Wilate 500, 500 IU FVIII and 500 IU VWF, powder and solvent
for solution for injection, contains nominally 500 IU human
coagulation factor VIII and 500 IU human von Willebrand factor
per vial. The product contains approximately 100 IU/ml human
coagulation factor VIII and 100 IU/ml human von Willebrand factor
when reconstituted with 5 ml of Water for Injections with 0.1%
Polysorbate 80 (Solvent).
• Wilate 1000, 1000 IU FVIII and 1000 IU VWF, powder and solvent
for solution for injection, contains nominally 1000 IU human
coagulation factor VIII and 1000 IU human von Willebrand factor
per vial. The product contains approximately 100 IU/ml human
coagulation factor VIII and 100 IU/ml human von Willebrand factor
when reconstituted with 10 ml of Water for Injections with 0.1%
Polysorbate 80 (Solvent).
Content of the package
1 vial with freeze-dried powder
1 vial with solvent
1 equipment pack with the following medical devices:
1 disposable syringe


Dispose the empty solvent vial with the blue part of the Mix2Vial™.

Instructions for Injection:
As a precaution, your pulse rate should be taken before and during
the injection. If a marked increase in your pulse rate occurs, reduce
the injection speed or interrupt the administration for a short time.
1. Attach the syringe to the transparent part of the Mix2Vial™.
Turn the vial upside down and draw the solution into the syringe
(Fig. 6).
The solution in the syringe should be clear or slightly pearly
shimmery.
Once the solution has been transferred, firmly hold the plunger
of the syringe (keeping it facing down) and remove the syringe
from the Mix2Vial™ (Fig. 7). Dispose the Mix2Vial™ and the
empty vial.

1 transfer set (Mix2VialTM)
1 infusion set
2 alcohol swabs
Marketing Authorisation Holder
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom
For any further information about this medicinal product, please
contact the local representative of the Marketing Authorisation
Holder:
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom
Manufacturer

Octapharma Pharmazeutika
Produktionsges.m.b.H.
Oberlaaerstr. 235
A-1100 Vienna
Austria

This leaflet was last approved in 03/2015.

2. Clean the chosen injection site with one of the provided alcohol
swabs
3. Attach the provided injection needle to the syringe.
4. Insert the injection needle into the chosen vein. If you have used
a tourniquet to make the vein easier to see, this tourniquet
should be released before you start injecting Wilate.
No blood must flow into the syringe due to the risk of formation
of fibrin clots.
5. Inject the solution into the vein at a slow speed, not faster than
2-3 ml per minute.
If you use more than one vial of Wilate powder for one treatment,
you may use the same injection needle and syringe again. The
Mix2Vial™ is for single use only.

This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland,
Germany, Greece, Hungary, Ireland, Italia, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovenia, Slovak Republic, Spain, Sweden, United Kingdom:
Wilate
Denmark: Wilnativ

Any unused product or waste material should be disposed of in
accordance with local requirements.
Wilate must not be mixed or injected (with the same infusion set)
with other medicinal products.
Only use the injection set provided. The use of other injection/
infusion equipment can cause additional risks and treatment failure
(FVIII/VWF adsorption to the internal surfaces of some infusion
equipment).

B.181.006.UK

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25.03.15 14:15

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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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