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OPTIVATE 250 IU 500 IU 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): HUMAN FACTOR VIII / VON WILLEBRAND FACTOR

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Package Leaflet: Information for the User

Optivate 250 IU, 500 IU, 1000 IU
Powder and solvent for solution for injection
Human coagulation factor VIII
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.
• 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. This includes any possible side effects not listed in this
leaflet.
What is in this leaflet

1. What Optivate is and what it is used for

2. What you need to know before you use Optivate

3. How to use Optivate
4. Possible side effects

5. How to store Optivate
6. Contents of the pack and other information


1. What Optivate is and what it is used for


Optivate is a high purity factor VIII concentrate from human blood plasma obtained from screened donors.
It is a white or pale yellow sterile powder, supplied with sterilised water for injections.
Optivate is given by injection into a vein (intravenously) and is used to prevent and treat bleeding in
patients with haemophilia A (congenital factor VIII deficiency in the blood). Your doctor will explain
further why this medicine has been given to you.


2. What you need to know before you use Optivate

Do not use Optivate:
- if you are allergic (hypersensitive) to the human coagulation factor VIII or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
- If you have a larger or longer bleed than usual and the bleeding does not stop after an injection of
Optivate, speak to your doctor.
Some patients with a shortage of factor VIII may develop inhibitors (antibodies) to factor VIII during
treatment. This could mean that the treatment will not work properly. Your doctor will check regularly for
the development of these antibodies, and especially before an operation. Both before and after treatment with
this medicine, particularly for your first course of treatment, your doctor will probably carry out tests to
check the level of factor VIII in your blood.
- This medicine may contain small amounts of blood group antibodies originally present in the plasma from
the donors. This is normal and, in most cases, these antibodies do not cause any problems. However, if you
need large doses of Optivate, for example during surgery, and are blood group A, B, or AB, your doctor
may need to do a blood test to check if the medicine has had any effect on your red blood cells prescription.
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,
- the testing of each donation and pools of plasma for signs of virus/infections,
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- the inclusion of 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, and for the non-enveloped hepatitis A virus. 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 (fetal infection) and for individuals whose
immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic
anaemia).


It is strongly recommended that every time you receive a dose of Optivate , the name and 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 you
regularly/repeatedly receive human plasma-derived factor VIII products.


Other medicines and Optivate
These injections must not be mixed with other medicinal products in the same syringe. Tell your doctor if
you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor
for advice before taking this medicine.
Driving and using machines
There are no known effects of this product on the ability to drive or operate machinery.


3. How to use Optivate
Before injecting this medicine at home, you will have received training at your Haemophilia Centre on how
to do so. Use only the recommended injection equipment provided with your medicine.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor will explain to you how much you should use and when you should use it.
Your doctor will usually tell you your dose in terms of the number of full vials nearest to the dose most
suited to you. If further treatment is needed, doses may be repeated at intervals of 8, 12 or 24 hours, as
required. Your doctor will advise you if this is necessary. The table gives the approximate doses of factor
VIII which are needed to stop bleeding in various conditions:
Adults:
Condition

Initial dose of Optivate
(IU/kg bodyweight)

Minor spontaneous bleeding in joints
and muscles
Severe bleeding in joints and
muscles, haematoma (swelling caused
by collection of blood) in potentially
serious situations, blood in the urine

8 -16
12 – 24

How much do adults require to prevent bleeding?
20 to 40 IU/kg every 2 or 3 days is usually enough.
Children
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For children under the age of 6 years, your doctor will recommend the appropriate dose but the usual dose is
17 to 30 IU/kg. This can be given up to 3 times a week for prevention of bleeding.
When to inject Optivate
•The medicine should be injected when the first sign of bleeding occurs.
•The injection should be repeated as necessary to stop the bleeding.
•Each individual bleed should be judged on its own severity.
•If you are using this product for the first time, your doctor will supervise you.
Dissolving your medicine before use
Your medicine must only be dissolved in the sterilised water provided with the product.
Volume of Water Supplied
Quantity of Optivate
250 IU
2.5 mL
500 IU
5 mL
1000 IU
10 mL
1. Optivate must only be dissolved in the sterilised water provided with the product.
2. Before you remove the “flip-off” top, make sure that the vial of Optivate and the container of water
supplied with it are both at room temperature (between 20°C and 30°C).

3. Sterilised water for use with Optivate is provided in a glass vial with a stopper.

4. Optivate is supplied with the amount of sterilised water as shown on the table.
How to Dissolve Optivate
You can dissolve your product using the Transfer Device called Mix2VialTM:
The Mix2VialTM Transfer Device is provided with your product for needle-free, easy and safe use.

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The reconstitution is performed as follows:
Step 1
•Remove the cap from the product vial and clean the top
of the stopper with an alcohol swab.
•Repeat this step with the sterile water vial.
•Peel back the top of the Transfer Device package but
leave the device in the package.

Step 2
•Place the blue end of the Transfer Device on the water
vial and push straight down until the spike penetrates the
rubber stopper and snaps into place.
•Remove the plastic outer packaging from the Transfer
Device and discard it, taking care not to touch the
exposed end of the device.

Step 3
•Turn the water vial upside down with the device still
attached.
•Place the clear end of the Transfer Device on the
product vial and push straight down until the spike
penetrates the rubber stopper and snaps into place.

Step 4
•The sterile water will be pulled into the product vial by
the vacuum contained within it.
•Gently swirl the vial to make sure the product is
thoroughly mixed. Do not shake the vial.
•A clear or slightly pearl-like solution should be
obtained, usually in about 2 to 2 ½ minutes (5 minutes
maximum).
Step 5
•Separate the empty water vial and blue part from the
clear part by unscrewing anti-clockwise.
•Draw air into the syringe by pulling the plunger to the
required volume of water added.
• Connect the syringe to the clear part of the Mix2VialTM.
•Push the air in the syringe into the vial.
Step 6
•Immediately invert the vial of solution which will be
drawn into the syringe.
•Disconnect the filled syringe from the device.
•The product is now ready for administration. Follow the
normal safety practices for administration. Use the
product immediately after reconstitution, the product
must not be stored.

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Note: If you have to use more than one vial to make up your required dose, repeat Steps 1 to 6 withdrawing
the solution in the vial into the same syringe. The Transfer Device supplied with your product is sterile and
cannot be used more than once. When the reconstitution process is complete dispose of in your ‘sharps box’.
Do not use this medicine if:
- the water is not pulled into the product vial (this indicates a loss of vacuum in the vial, so the product must
not be used)
- if at step 6, there are any particles in the syringe, or if the solution is cloudy, or if a gel or clot forms (if this
happens, please tell Bio Products Laboratory, reporting the batch number printed on the vial).
If you use more Optivate than you should
If you think you may be using too much, stop the injection and tell your doctor. If you know you have used
too much, tell your doctor as soon as possible.
If you forget to use Optivate
Do not use a double dose to make up for a forgotten dose. Inject your normal dose as soon as you remember
and then continue dosing as instructed by your doctor or haemophilia nurse.


If you stop using Optivate
Always consult your doctor before deciding to stop your treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop the infusion and tell your doctor immediately or go to the emergency department of your nearest
hospital, if you get any of the following symptoms:
• Swelling around the throat
• Flushing
• Hives (nettle rash)
• Feeling lightheaded or dizzy (low blood pressure)
• Rapid heart beat
• Feeling sick or being sick
• Restlessness
• Tightness in the chest or wheezing
• Tingling sensation
These symptoms may worsen into severe shock. The above allergic-type reactions are very rare (fewer than
1 patient in every 10,000 patients treated get them).
Other known side effects are:
Adults and Children
Common (more than 1 in every 100 patients treated):
• Headache
• Feeling that everything is moving, spinning round or tilting (vertigo)
• Cough
• Sneezing
• Redness of the skin (rashes) or pain at the place where the medicine was injected
• Other skin rashes
• Swelling in the extremities of the body
• Itching
• Raised temperature (fever)
• Sudden shivering and feeling cold and rapid rise in temperature
• Stiffness in muscles and joints
• Sleepiness, lethargy or feeling unwell
If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet.
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5. How to store Optivate






Do not store above 25°C.
Do not freeze.
Keep the vial in the outer carton to protect from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the containers. The expiry date refers
to the last day of that month.
 Do not use this medicine if you notice small bits. Once reconstituted, Optivate must be used within
one hour.
 Do not throw away any medicines via wastewater or household waste. Your treatment centre will
provide a special container (‘sharps box’) to dispose of any solution that remains, any used syringes,
needles and empty containers. These measures will help to protect the environment.
6. Contents of the pack and other information


What Optivate contains
The active substance is human coagulation factor VIII.
The excipients are: sodium chloride, calcium chloride, sodium citrate, polysorbate 20 and trehalose
The other ingredient is human von Willebrand factor (VWF)


What Optivate looks like and contents of the pack

Optivate , in the form of a white or pale yellow powder in quantities of 250 IU (International Units), 500 IU
or 1000IU in glass vials. These vials are closed with a synthetic rubber stopper under vacuum, held with a
tamper-evident cap.
Optivate should only be reconstituted with sterilised water for injections which is supplied with Optivate
in clear glass bottles.
A Transfer Device called Mix2VialTM is also provided, to enable needle-free, easy and safe reconstitution.
Marketing Authorisation Holder and Manufacturer
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom.
This leaflet was last revised in
June 2012
For further information or if you have any questions about the use of this product, please contact BPL via the
Marketing Department at the address below or through info@bpl.co.uk.
Bio Products Laboratory Limited,
Dagger Lane,
Elstree,
Hertfordshire,
WD6 3BX, UK.
Tel: +44 (0) 20 8957 2200

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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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