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.lnhibitors 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.    HOWTO 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.

The other ingredients are:

For the powder: sodium citrate, sodium chloride, calcium chloride, glycine For the solvent: water for injections.

What Octanate LV looks like and contents of the pack

Octanate LV 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 2 available strengths differ in the amount of human blood coagulation factor VIII and solvent:

100 lU/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 lU/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.FI., Oberlaaer Str. 235, A-1100 Vienna

Austria

or

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

Octapharma AB, Elersvagen 40, SE 1 12 75 Stockholm, Sweden

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.

Package leaflet: Information for the user

Octanate LV100IU/ml Powder and Solvent for Solution for Injection

Human Coagulation Factor VIII

Octanate LV 200 lU/ml Powder and Solvent for Solution for Injection Human Coagulation Factor VIII

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

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

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.

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

B.1 20.000.UK 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 lU/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

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:

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.

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.

B.120,000,UK

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.

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.

If you use more Octanate LV than you should No symptoms of overdose with human coagulation factor VIII have been reported. Flowever, the recommend dosage should not be 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.

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. 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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