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

Active substance(s): HUMAN COAGULATION FACTOR VIII

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B.120.000.UK

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 LV - Information
about the blood and plasma used for Octanate LV).
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via www.mhra.
gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5.  HOW TO STORE OCTANATE LV
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 for single use only.
Do not use this medicine if you notice cloudy or incompletely dissolved solutions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

Package leaflet: Information for the user

The powder is white or pale yellow, also appearing as a friable solid.
The solvent is a clear, colourless liquid.
The 2 available strengths differ in the amount of human blood coagulation factor VIII and
solvent:
100 IU/ml powder and solvent:
–– Powder, 500 IU, in a vial with a stopper and a flip off cap
–– 5 ml solvent in a vial with a stopper and a flip off cap
–– one disposable syringe, one transfer set Mix2VialTM, one injection set, and two alcohol
swabs
200 IU/ml powder and solvent:
–– Powder, 1000 IU, in a vial with a stopper and a flip off cap
–– 5 ml solvent in a vial with a stopper and a flip off cap
–– one disposable syringe, one transfer set Mix2VialTM, one injection set, and two alcohol
swabs
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester M2 1AB
United Kingdom
Manufacturer
Octapharma Pharmazeutika Produktionsges.m.b.H., Oberlaaer Str. 235, A-1100 Vienna
Austria

Octanate LV 100 IU/ml Powder and Solvent for Solution for Injection
Human Coagulation Factor VIII
Octanate LV 200 IU/ml 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 further questions, 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. See section 4.
What is in this leaflet
1. What Octanate LV is and what it is used for
2. What do you need to know before you use Octanate LV
3. How to use Octanate LV
4. Possible side effects
5. How to store Octanate LV
6. Contents of the pack and other information

or

1.  WHAT OCTANATE LV IS AND WHAT IT IS USED FOR

6.  CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Octanate LV contains
The active substance is the human blood coagulation factor VIII.
Volume and concentrations

or

Octanate LV 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 LV 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.

Octapharma AB, Elersvägen 40, SE 112 75 Stockholm, Sweden

Octanate LV® powder
vial size (IU FVIII)

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

Nominal concentration of
reconstituted solution
(IU FVIII/ml)

500 IU

5

100

1000 IU

5

200

The other ingredients are:
For the powder: sodium citrate, sodium chloride, calcium chloride, glycine
For the solvent: water for injections.

This medicinal product is authorised in the member states of the EEA under the following
names:
–– Octanate LV: Austria, Cyprus, Denmark, France, Greece, Luxembourg, The Netherlands,
Malta, Poland, Portugal, Romania, Spain, Sweden, The United Kingdom
–– Octafil LV: Finland
–– Octanate: Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, Lithuania
–– Octanate Kons: Slovenia
This leaflet was last revised in October 2014.

What Octanate LV looks like and contents of the pack
Octanate LV is presented as a powder and solvent for solution for
injection.
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2.  WHAT DO YOU NEED TO KNOW BEFORE YOU USE OCTANATE LV
It is strongly recommended that every time you receive a dose of Octanate LV 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 products.
Do not use Octanate LV
if you are allergic to human blood coagulation factor VIII or to any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Octanate LV.
Octanate LV 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 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 LV
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 LV
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 LV 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 LV 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 LV
Octanate LV 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

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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 LV 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:
Your doctor will advise you about the dosage and the frequency with which you should use
Octanate LV.
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.

Degree of bleeding/ Type
of surgical procedure

Bleeding
Bleeding into a joint (early
haemarthrosis), muscle
bleeding or oral bleeding
More extensive bleeding
into a joint (haemarthrosis),
muscle bleeding or effusion
of blood (haematoma)
Life-threatening bleeding
such as in head surgery,
bleeding in the throat,
major abdominal bleeding
Surgery
Minor
including tooth extraction
Major

Factor VIII
level
required
(%) (IU/dl)

Frequency of dosage (hours between
dosages) / Duration of therapy
(in days)

20 – 40

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.

30 – 60

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.
Repeat infusion every 8 to 24 hours until
adequate wound healing, then therapy for
at least another 7 days to maintain factor
VIII activity at 30% to 60%.

80 – 100
(before and
after an
operation)

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 LV in previously untreated patients (PUPs) are
limited. A clinical study is ongoing. So far 10.3 % of PUPs treated with Octanate
LV developed inhibitors. PUPs need to be tested for the possible development of
antibodies (e.g. Bethesda test) when treated.
Instructions for Home Treatment
–– Please read all the instructions and follow them carefully!
–– Do not use Octanate LV 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.
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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.
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 Octanate LV.
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.

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

Fig. 1

If you use more than one vial of Octanate LV powder for one
treatment, you may use the same injection set and syringe again.
The Mix2Vial™ is for single use only.

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.
3. Attach the provided injectionset to the syringe

5

If you use more Octanate LV than you should
No symptoms of overdose with human coagulation factor VIII have
been reported. However, the recommend dosage should not be
Fig. 6
Fig. 7
exceeded.
If you forget to take Octanate LV
Do not take a double dose to make up a forgotten dose. Proceed with the next dose
immediately and continue as advised by your doctor or pharmacist.
Fig. 2

Fig. 3

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

4.  POSSIBLE SIDE EFFECTS

Fig. 4

Fig. 5

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Even though rare (affects 1 to 10 users in 10,000), hypersensitivity or allergic reactions have
been observed in patients treated with factor VIII containing products.
Contact your doctor if you suffer from the symptoms:
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.
In very rare (affects less than 1 user in 10,000) 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 contact your doctor immediately
or call for an ambulance.
Other rare side effects (affects 1 to 10 users in 10,000)
Fever
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

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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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