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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

OPTLEUK1

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,
– 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.

PANTONE 376C / BLACK

MyGPS Europe Ltd Tel: 020 863 9700

Job No. 1040

Client:

BPL

Contact:

Paul Hinde

Project Name:

Optivate Patient Information Leaflet

Client Order No. 265764
Date:

12/07/2012

Proof No.

2

Operator:

Hema Joshi

Doc. Size:

185 x 225mm

1040 BPL Optivate Patient information leaflet 2.indd 1

Proof Approved
Proof Unapproved

Signed

12/07/2012 16:01

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

8 – 16

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

12 – 24

How much do adults require to prevent bleeding?
20 to 40 IU/kg every 2 or 3 days is usually enough.
Children
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.

BLACK

MyGPS Europe Ltd Tel: 020 863 9700

Job No. 1040

Client:

BPL

Contact:

Paul Hinde

Project Name:

Optivate Patient Information Leaflet

Client Order No. 265764
Date:

12/07/2012

Proof No.

2

Operator:

Hema Joshi

Doc. Size:

185 x 225mm

1040 BPL Optivate Patient information leaflet 2.indd 2

Proof Approved
Proof Unapproved

Signed

12/07/2012 16:01

Quantity of Optivate®

Volume of Water Supplied

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.
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 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 21/2
minutes (5 minutes maximum).

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 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 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 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.

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’.

PANTONE 273 / BLACK

MyGPS Europe Ltd Tel: 020 863 9700

Job No. 1040

Client:

BPL

Contact:

Paul Hinde

Project Name:

Optivate Patient Information Leaflet

Client Order No. 265764
Date:

12/07/2012

Proof No.

2

Operator:

Hema Joshi

Doc. Size:

185 x 225mm

1040 BPL Optivate Patient information leaflet 2.indd 3

Proof Approved
Proof Unapproved

Signed

12/07/2012 16:01

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.

BLACK

MyGPS Europe Ltd Tel: 020 863 9700

Job No. 1040

Client:

BPL

Contact:

Paul Hinde

Project Name:

Optivate Patient Information Leaflet

Client Order No. 265764
Date:

12/07/2012

Proof No.

2

Operator:

Hema Joshi

Doc. Size:

185 x 225mm

1040 BPL Optivate Patient information leaflet 2.indd 4

Proof Approved
Proof Unapproved

Signed

12/07/2012 16:01

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

Bio Products Laboratory Limited
Dagger Lane, Elstree, Herts. WD6 3BX, U.K.
Tel: +44 (0) 20 8957 2200

Date of leaflet preparation: June 2012

Version: OPTLEUK1

BLACK PANTONE 273

MyGPS Europe Ltd Tel: 020 863 9700

Job No. 1040

Client:

BPL

Contact:

Paul Hinde

Project Name:

Optivate Patient Information Leaflet

Client Order No. 265764
Date:

12/07/2012

Proof No.

2

Operator:

Hema Joshi

Doc. Size:

185 x 225mm

1040 BPL Optivate Patient information leaflet 2.indd 5

Proof Approved
Proof Unapproved

Signed

12/07/2012 16:01

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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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