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OCTANATE 100 IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Active substance(s): HUMAN FACTOR VIII

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B.120.007.UK

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet.

Package leaflet: Information for the user
Octanate 50 IU/ml Powder and Solvent for Solution for Injection
Human Coagulation Factor VIII
Octanate 100 IU/ml Powder and Solvent for Solution for Injection
Human Coagulation Factor VIII

All pack sizes include:
one disposable syringe, one transfer set Mix2VialTM, one injection needle, and two alcohol swabs
Not all pack sizes may be marketed.

5. How to store Octanate
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 label. The expiry date refers
to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer carton in order to protect from light.
Use the reconstituted solution immediately and on one occasion only.
Do not use this medicine if you notice cloudy or incompletely dissolved solutions.
Any unused product or waste material should be disposed of in accordance with local
requirements.

Marketing Authorisation Holder
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester M2 1AB
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
Manufacturer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235
A-1100 Vienna
Austria

6. Contents of the pack and other information
What Octanate contains
The active substance is the human blood coagulation factor VIII.
Volume and concentrations
Octanate®
powder vial size
(IU FVIII)

Solvent vial size
(to be added to Octanate®
powder vial)
(ml)

Nominal concentration of
reconstituted solution
(IU FVIII/ml)

250 IU

5

50

500 IU

10

50

1000 IU

10

100

The other ingredients are:
For the powder: sodium citrate, sodium chloride, calcium chloride, glycine
For the solvent: water for injections.
What Octanate looks like and contents of the pack
Octanate is presented as a powder and solvent for solution for injection.
The powder is white or pale yellow, also appearing as a friable solid.
The solvent is a clear, colourless liquid.
The three available pack sizes differ in the amount of human blood coagulation factor VIII and
solvent:
• 250 IU/vial: reconstitution with 5 ml leads to 50 IU/ml
• 500 IU/vial: reconstitution with 10 ml leads to 50 IU/ml
• 1000 IU/vial: reconstitution with 10 ml leads to 100 IU/ml

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Please keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet
1. What Octanate is and what it is used for
2. What do you need to know before you use Octanate
3. How to use Octanate
4. Possible side effects
5. How to store Octanate
6. Contents of the pack and other information

or
Octapharma S.A.S
70 - 72 Rue du Maréchal Foch
BP 33, F - 67381 Lingolsheim
France

1. What Octanate is and what it is used for

or
Octapharma AB
SE 112 75 Stockholm
Sweden
This medicinal product is authorised in the member states of the EEA under the following names:
• Octanate: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg,
The Netherlands, Malta, Norway, Poland, Portugal, Republic of Slovenia, Romania, Slovak
Republic, Spain, Sweden, The United Kingdom
• Octafil: Finland
This leaflet was last revised in September 2012

Octanate belongs to a group of medicines called clotting factors and contains human blood
coagulation factor VIII. This is a special protein involved in blood clotting.
Octanate 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 hereditary lack
of coagulation factor VIII in the blood.

2. What do you need to know before you use Octanate
• It is strongly recommended that every time you receive a dose of Octanate 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 or repeatedly receive human-derived Factor VIII prodcuts.
Do not use Octanate
• if you are allergic to human blood coagulation factor VIII or to any of the other ingredients of
this medicine (listed in section 6).

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Octanate.
• Octanate contains very small amounts of other human proteins. Any medicine which contains
proteins and which is injected into a vein (administered intravenously) can cause allergic
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reactions (See Section 4., “Possible side effects”).
• Individuals with haemophilia A can develop factor VIII
inhibitors (neutralising antibodies) (See Section 4., “Possible
side effects”).
Information about the blood and plasma used for Octanate
• 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).
Other medicines and Octanate
• Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
• Human blood coagulation factor VIII products are not known to interact with other medicinal
products. Nonetheless, do not combine Octanate with other medicines during infusion.
Pregnancy and breast-feeding
• Ask your doctor or pharmacist for advice before using any medicine.
Driving and using machines
• No effects on ability to drive and use machines have been observed.
Octanate contains
less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free` for 250 IU/vial and
contains up to 1.75 mmol sodium (40 mg) per dose for 500 and 1000 IU/vial. To be taken into
consideration by patients on a controlled sodium diet.

3. How to use Octanate
Octanate should be administered intravenously after reconstitution with the supplied solvent.
Treatment should be started under medical supervision.

Dosage for the prevention of bleeding If you suffer from severe haemophilia A you should
inject 20 to 40 IU of factor VIII per kg body weight every two or three days for long-term
prevention. Your dosage should be adjusted according to your response. In some cases shorter
dosage intervals or higher dosages may be necessary.
Dosage calculation
Always use Octanate exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Factor VIII activity refers to the amount of factor VIII present in the plasma. It is expressed either
as a percentage (relative to normal human blood plasma) or in International Units (IU). The
dosage of factor VIII is expressed in IU.
One IU of factor VIII activity is equivalent to the amount of factor VIII in one ml of normal human
blood plasma. One IU of factor VIII per kg body weight raises the plasma factor VIII activity by
1.5% - 2% of normal activity. To calculate your dosage, the level of factor VIII activity in your
blood plasma is measured. This will indicate by how much the activity needs to be increased.
Please consult your doctor if you are uncertain how much your factor VIII activity has to be
increased or how to calculate your dosage.
The dosage required is calculated using the following formula:
Required units = body weight (kg) x desired increase in factor VIII (%)
(IU/dl) x 0.5
Your dosage and how often it must be administered (frequency) should always be oriented by
the clinical efficacy in the individual patient.
In the following bleeding events, factor VIII activity should not fall below the plasma activity
level (in % of normal) shown in the following table, for the corresponding period.
This table can be used to guide dosing in bleeding episodes and for surgery:
Degree of bleeding/
Type of surgical procedure

Factor VIII level Frequency of dosage (hours
required (%)
between dosages) /
(IU/dl)
Duration of therapy (in days)

Bleeding
Bleeding into a joint (early
haemarthrosis), muscle bleeding
or oral bleeding

20 - 40

More extensive bleeding into
a joint (haemarthrosis), muscle
bleeding or effusion of blood
(haematoma)

30 - 60

Repeat every 12 to 24 hours for at
least 1 day, until the pain decreases
or healing is achieved.
Repeat infusion every 12 to 24 hours
for 3-4 days or more until pain and
disability have resolved.

Life-threatening bleeding such
as in head surgery, bleeding in
the throat, major abdominal
bleeding

60 - 100

Repeat the infusion every 8 to 24
hours until the threat is resolved.

30 - 60

Every 24 hours for at least 1 day,
until healing is achieved.

Surgery
Minor
including tooth extraction
Major





80 - 100
Repeat infusion every 8 to 24 hours
(before and after until adequate wound healing, then
therapy for at least another 7 days to
an operation)
maintain factor VIII activity at 30%
to 60%.

Your doctor will advise you about the dosage and the frequency with which you should use
Octanate.
Your response to factor VIII products may vary. The factor VIII level in your blood should therefore
be measured during the treatment to calculate the correct dosage and frequency of infusion.
Use in children
A clinical study (including 15 patients of 6 years of age or less) did not identify any
special dosage requirements for children.
Clinical data on the use of Octanate in previously untreated patients (PUPs) are limited.
A clinical study is ongoing. So far 10.3% of PUPs treated with Octanate developed
inhibitors. PUPs need to be tested for the possible development of antibodies (e.g.
Bethesda test) when treated.








on top of the solvent vial and press firmly down until it snaps (Fig. 2+3).

Instructions for Home Treatment
Please read all the instructions and follow them carefully!
Do not use Octanate 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:
1. Do not use the product directly from the refrigerator. Allow the solvent and the powder in the
closed vials to reach room temperature.

5. Inject the solution into the vein at a slow speed, not faster than 2-3 ml per
minute.

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.

5. With both vials still attached, gently swirl the powder vial until the product is
dissolved.
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.

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.
2. Clean the chosen injection site with one of the provided alcohol swabs.

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

3. Attach the provided injection needle to the syringe

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™

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

B.120.006.UK

injecting Octanate.
No blood must flow into the syringe due to the risk of formation of fibrin clots.

B.120.006.UK

If you use more than one vial of Octanate powder for one treatment, you may use
the same injection needle and syringe again. The Mix2Vial™ is for single use only.
If you use more Octanate than you should
No symptoms of overdose with human coagulation factor VIII have been reported.
However, the recommend dosage should not be exceeded.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
• Even though rare, hypersensitivity or allergic reactions have been observed in patients
treated with factor VIII containing products. Early signs of allergic reactions can include:
being sick (vomiting), burning and stinging at the infusion site, chest tightness, chills, faster
heart beat (tachycardia), feeling sick (nausea), feeling of pins and needles (tingling), flushing,
headache, hives (urticaria), low blood pressure (hypotension), rash, restlessness, swelling of
the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
(angioedema), tiredness (lethargy), wheezing.
If you suffer from any of the above-mentioned symptoms, please inform your doctor.
• In very rare cases, this hypersensitivity may lead to a severe life-threatening allergic reaction
called anaphylaxis, which may include shock, as well as some or all of the symptoms described
above. In this case please contact your doctor immediately or call for an ambulance.
• Fever may occur in rare cases.
• If you suffer from haemophilia A you may develop inhibitors (neutralising antibodies) to factor
VIII. If such antibodies occur, they might prevent your medicine from working properly and
bleeding may continue. In such rare cases, it is recommended that a specialised haemophilia
centre be contacted immediately. You should be carefully monitored for the development of
inhibitors by appropriate clinical observations and laboratory tests.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 an inhibitor.
• For information on viral safety see section 2. (Take special care with Octanate - Information
about the blood and plasma used for Octanate).

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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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