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WILATE 450 / WILATE 900 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

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2015.03.24 / 200x490 / B.181.003.UK_05

Color: Black, Black 20%

B.181.003.UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pregnancy and breast-feeding

Wilate 450, 450 IU FVIII / 400 IU VWF, powder and
solvent for solution for injection

Ask your doctor or pharmacist for advice before using Wilate.

Wilate 900, 900 IU FVIII / 800 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 450 IU FVIII and 400 IU VWF/vial and up to 5.1 mmol
sodium (117.3 mg) per dose for 900 IU FVIII and 800 IU 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.

• 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 tested for these
inhibitors.

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).

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.

• 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.

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.

Your doctor may recommend that you consider vaccination against
hepatitis A and B if your regularly/repeatedly receive human plasmaderived FVIII/VWF products. Von Willebrand disease (VWD)

Haemophilia A

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

B.181.003.UK_GTP_05.indd 1

• 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.

Uncommon: more than 1 of 1,000, but less than 1 of 100 patients
Rare: more than 1 of 10,000, but less than 1 of 1,000 patients
Very rare: less than 1 of 10,000 patients, including isolated reports

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Instructions for Treatment

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.

Please read all the instructions and follow them carefully!

For information on viral safety see section 2. (Take special care with
Wilate).

Instructions for preparing the Wilate solution (reconstitution):

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

1. Warm the solvent and the powder in the closed
vials up to room temperature. If a water bath is
used for warming, care must be taken to avoid
water coming into contact with the rubber
stoppers (latex-free) or the caps of the vials. The
temperature of the water bath should not be
higher than +37°C.

Keep out of the reach and sight of children.
Store powder and solvent vial in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer carton to protect from light.

2. Remove the caps from the powder vial and the
solvent vial (Fig. A) and clean the rubber stoppers
with an alcohol swab.

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.
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
− 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

3. Place the solvent vial on a flat surface. Attach
the double-ended needle with the wavy edging
on the solvent vial (“Wave to Water”) and push
down as far as will go (Fig. B).

4. Place the concentrate vial on a flat surface.
Remove the protective cover from the doubleended needle, making sure not to touch the
exposed tip of the needle. Hold the solvent vial
with the double-ended needle upside-down and
quickly perforate the centre of the concentrate
vial rubber stopper with the needle and push
down as far as will go (Fig. C). The vacuum inside
the concentrate vial draws in the solvent.

5. Remove the solvent vial and the double-ended
needle from the powder vial (Fig. D). Wilate
dissolves quickly therefore only rotate the vial
slowly.

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

Wilate is supplied as a powder and solvent for solution for injection.
It comes in 2 pack sizes:
• Wilate 450, 450 IU FVIII and 400 IU VWF, powder and solvent
for solution for injection, contains nominally 450 IU human
coagulation factor VIII and 400 IU human von Willebrand factor
per vial. The product contains approximately 90 IU/ml human
coagulation factor VIII and 80 IU/ml human von Willebrand factor
when reconstituted with 5 ml of Water for Injections with 0.1%
Polysorbate 80 (Solvent).
• Wilate 900, 900 IU FVIII and 800 IU VWF, powder and solvent
for solution for injection, contains nominally 900 IU human
coagulation factor VIII and 800 IU human von Willebrand factor
per vial. The product contains approximately 90 IU/ml human
coagulation factor VIII and 80 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

Please
use
immediately.

the

The solution
opalescent.

should



reconstituted
be

clear

solution
to

slightly

Do not use solutions that are cloudy, or where
the powder did not dissolve completely.

Instructions for injection:
As a safety measure, the patient´s pulse rate
should be measured before and during the
injection. If a marked increase in the pulse rate
occurs, the injection speed must be slowed down
or the treatment must be interrupted.

1. Remove the protective cover from the filter and
perforate the rubber stopper of the concentrate
vial (Fig. E).

1 equipment pack with the following medical devices:
1 disposable syringe
1 transfer set (1 double-ended needle and 1 filter needle)

2. Retract the piston of the syringe to draw in air.

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

3. Remove the closure from the filter and attach
the syringe to the filter (Fig. Fa).

4. Inject the air into the vial (Fig. Fb).

5. Turn the vial with the attached syringe upsidedown and draw the solution up into the syringe
(Fig. G).

6. Remove the syringe from the filter.

7. Clean the injection site with an alcohol swab.

Manufacturer

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

This leaflet was last approved in 03/2015.

8. Attach the Butterfly to the syringe (Fig. H). Insert
the butterfly into the chosen vein and inject the
solution at a slow speed of 2-3 ml per minute.

9. If the patient receives more than one vial of the
concentrate, the same butterfly can be used. The
syringe can also be used for several concentrate
vials. Always use a new filter when drawing up
the solution.

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.181.003.UK

B.181.003.UK_GTP_05.indd 2

24.03.15 12:26

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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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