Octanate Lv
Package leaflet: Information for the user
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
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 LVcontains 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, donot 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 bleedingIf you suffer from severe haemophilia A you should inject 20 to 40 IU of factor VIII per kg body weight every two or three daysfor 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. Itis 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 between dosages) / Duration of therapy (in days) |
|
Bleeding |
|
|
|
Bleeding into a joint (early haemarthrosis), muscle bleeding or oral bleeding |
20 - 40 |
Repeat every 12 to 24 hours for at least 1 day, until the pain decreases or healing is achieved. |
|
More extensive bleeding into a joint (haemarthrosis), muscle bleeding or effusion of blood (haematoma) |
30 - 60 |
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. |
|
Surgery |
|
|
|
Minor |
30 - 60 |
Every 24 hours for at least 1 day, until healing is achieved. |
|
Major |
80 -
100 |
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%. |
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.
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.
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).
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.