Octanate LV 100 IU/ml powder and solvent for solution for injection
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Octanate LV is and what it is used for
- 2. What you need to know before using Octanate LV
- 3. How to use Octanate LV
- **Instructions for preparing the solution:**
- 1. Do not use the product directly from the refrigerator. Allow the solvent and powder in the vials to reach room temperature while still closed.
- 4. Possible adverse effects
- 5. Storage of Octanate LV
- 6. Contents of the container and additional information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Octanate LV 100 IU/ml, powder and solvent for injectable solution
Human coagulation Factor VIII
Octanate LV 200 IU/ml, powder and solvent for injectable solution
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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
- If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet. See section 4.
Contents of this leaflet:
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What Octanate LV is and what it is used for
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What you need to know before using Octanate LV
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How to use Octanate LV
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Possible side effects
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How to store Octanate LV
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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 coagulation factors and contains human 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 last longer than expected. It is caused by an inherited deficiency of blood coagulation factor VIII.
2. What you need to know before using Octanate LV
It is highly recommended that each time you receive a dose of Octanate LV, you record the product name and batch number in order to keep 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 Factor VIII products.
Do not use Octanate LV:
if you are allergic to human coagulation Factor VIII or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Octanate LV.
Octanate LV contains very small amounts of other human proteins. Any medicine containing proteins administered intravenously (by infusion into a vein) may cause allergic reactions (see section 4, “Possible side effects”).
The development of inhibitors (antibodies) is a known complication that may occur during treatment with all Factor VIII-containing medicines. These inhibitors, especially in large amounts, may prevent treatment from working properly, so you and your child will be carefully monitored for the development of such inhibitors. If bleeding in you or your child is not controlled by Octanate LV, consult your doctor immediately.
Information about the blood and plasma used for Octanate LV
When medicines derived from human plasma or blood are administered, certain measures are taken to prevent transmission of infections to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, testing for specific markers of infection in individual donations and pooled plasma, and inclusion of steps in the manufacturing process to remove or inactivate viruses. Despite these measures, the possibility of transmitting infectious agents cannot be completely ruled out when medicines derived from human blood or plasma are administered. This also applies to emerging or unknown viruses and other types of infections.
These measures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), as well as against the non-enveloped hepatitis A virus (HAV). However, the measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be serious for pregnant women (infection of the fetus) and for individuals with weakened immune systems or patients with certain types of anemia (e.g. sickle cell disease or abnormal destruction of red blood cells).
Use of Octanate LV with other medicines:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
No interactions between human coagulation Factor VIII and other medicines are known. However, Octanate LV should not be mixed with other medicines during infusion.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and use of machines:
No effects on the ability to drive or operate machinery have been observed.
Octanate LV contains
up to 40 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 2% of the maximum daily intake of sodium recommended for an adult.
3. How to use Octanate LV
Octanate LV must be administered intravenously after reconstitution with the solvent provided.
Treatment should be initiated under medical supervision.
Dose for preventing bleeding. If you have severe haemophilia A, you should be injected with 20 to 40 IU of factor VIII per kilogram of body weight every two or three days for long-term prevention. Your dose will be adjusted according to your response. In some cases, shorter administration intervals or higher doses may be required.
Dose calculation:
Follow exactly the instructions for administration of Octanate LV given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Factor VIII activity refers to the amount of factor VIII present in plasma. It is expressed either as a percentage (relative to normal human plasma) or in International Units (IU). The dose of factor VIII is expressed in IU.
One International Unit (IU) of factor VIII activity is equivalent to the amount of factor VIII present in one ml of normal human plasma. One IU of factor VIII per kg of body weight raises plasma factor VIII activity by 1.5%–2% of normal activity. To calculate the dose you need, the plasma factor VIII activity level must be determined. This will indicate the amount of activity that needs to be increased. Ask your doctor if you have any doubts about how much factor VIII activity needs to be increased or how to calculate your dose.
The required dosage can be determined using the following formula:
Units required = body weight (kg) × desired increase in factor VIII (%) (IU/dL) × 0.5
The amount to be administered and the frequency of administration should always be guided by clinical efficacy for each individual patient.
In the case of the following bleeding episodes, factor VIII activity should not fall below the indicated plasma activity level (as % of normal) during the corresponding period.
The following table can be used as a guide for dosing during bleeding episodes and surgery:
Bleeding severity / Type of surgical procedure | Necessary factor VIII level (%) (IU/dL) | Dosing frequency (hours between doses) / Duration of therapy (in days) |
Bleeding: | ||
Joint bleeding (early hemarthrosis), muscle bleeding, or oral bleeding. | 20 - 40 | Repeat every 12 to 24 hours. |
More extensive joint bleeding (hemarthrosis), muscle bleeding, or blood effusion (hematoma). | 30 - 60 | Repeat infusion every 12 to 24 hours for 3–4 days or longer, until pain and disability have resolved. |
Life-threatening bleeding, such as brain surgery, throat bleeding, or severe abdominal bleeding. | 60 - 100 | Repeat infusion every 8 to 24 hours until the danger is past. |
Surgery: | ||
Minor, including tooth extraction. | 30 - 60 | Every 24 hours, for a minimum of 1 day until healing is achieved. |
Major | 80 – 100 (before and after surgery) | Repeat infusion every 8–24 hours until adequate wound healing is achieved, followed by therapy for at least 7 additional days to maintain factor VIII activity between 30% and 60%. |
Your doctor will determine the dose and frequency with which you should use Octanate LV.
Your response to factor VIII products may vary. Therefore, factor VIII levels should be monitored during treatment to determine the correct dose and appropriate infusion frequency.
Use in children
Clinical studies did not identify any special dosing requirements for children. The dosing is the same for both adults and children, whether for treatment or prophylaxis.
Instructions for outpatient treatment
- Please read all instructions carefully and follow them exactly
- Do not use Octanate LV after the expiry date stated on the packaging
- Sterility must be maintained throughout the procedure described below
- Visually inspect the reconstituted solution for the presence of particles or discoloration before administration
- The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain precipitates
- Use the prepared solution immediately to avoid microbial contamination
- Use only the infusion set provided. The use of other injection/infusion equipment may pose additional risks and may lead to treatment failure
Instructions for preparing the solution:
1. Do not use the product directly from the refrigerator. Allow the solvent and powder in the vials to reach room temperature while still closed.
- Remove the flip-off caps from the vials and clean the rubber stoppers with one of the alcohol-impregnated wipes provided.
- The transfer device is shown in Fig. 1. Place the solvent vial on a flat surface and hold it firmly. Take the transfer device and turn it upside down. Place the blue part of the transfer device onto the top of the solvent vial and press firmly until a click is heard (Fig. 2 + 3). Do not twist when attaching.
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Dissolution is complete within less than 10 minutes at room temperature. A slight foam may appear during preparation. Unscrew the two parts of the transfer device (Fig. 5). The foam will disappear. Discard the empty solvent vial together with the blue part of the transfer device. |
Injection instructions:
As a precaution, your pulse rate should be measured before and during the injection. If your pulse rate increases significantly, reduce the injection rate or interrupt administration for a short period of time.
- Attach the syringe to the white part of the transfer set. Turn the vial upside down and draw the solution into the syringe (Fig. 6). The solution should be clear or slightly opalescent. Once the solution has been transferred, firmly hold the syringe plunger (keeping it pushed down) and remove the syringe from the transfer set (Fig. 7). Discard the empty vial together with the white part of the transfer set.
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Clean the injection site with one of the alcohol swabs provided.
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Attach the infusion set provided to the syringe.
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Insert the injection needle into the selected vein. If you used a tourniquet to make the vein more visible, release the tourniquet before beginning to inject Octanate LV.
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Blood should not flow into the syringe, due to the risk of fibrin clot formation.
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Inject the solution into the vein slowly, at a rate not exceeding 2–3 mL per minute.
If more than one vial of Octanate LV powder is used for one treatment, the same injection kit and syringe may be used. The transfer set is for single use only.
Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.
If you use more Octanate LV than you should
No symptoms of overdose have been reported with human coagulation factor VIII. However, it is recommended not to exceed the recommended dose.
If you forget to use Octanate LV
Do not take a double dose to make up for a missed dose. Administer the next dose immediately and continue following your doctor’s or pharmacist’s instructions.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Octanate LV can cause adverse effects, although not everyone experiences them.
Although rare (affects 1 to 10 patients per 10,000), hypersensitivity or allergic reactions have been observed in patients treated with products containing factor VIII.
Contact your doctor if you experience any of the following symptoms:
malaise (vomiting), irritation and stinging at the injection site, chest tightness, chills, faster heartbeat (tachycardia), nausea, tingling sensation (pins and needles), hot flushes, headache, hives, decreased blood pressure (hypotension), skin rash, restlessness, swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema), tiredness (lethargy), whistling sounds.
In very rare cases (affects fewer than 1 patient per 10,000), 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 such a case, contact your doctor immediately or call an ambulance.
Other rare adverse effects (affects 1 to 10 patients per 10,000):
Fever
In children who have not previously been treated with factor VIII-containing medicines, inhibitor antibodies may develop very frequently (more than 1 in 10 patients); however, in patients who have previously received factor VIII treatment (more than 150 days of treatment), the risk is infrequent (less than 1 in 100 patients). If this occurs, the medicines you or your child are taking may no longer work properly, and you or your child may experience persistent bleeding. In such a case, contact your doctor immediately.
For information regarding viral safety, see section 2. (Special precautions with Octanate LV – information on blood and plasma used for Octanate LV).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet.
You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Octanate LV
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between +2 - 8°C).
Do not freeze.
Keep vials in the outer packaging to protect from light.
Use Octanate LV immediately after reconstitution and on a single occasion only.
Do not use this medicine if you notice cloudy solutions or solutions that are not completely dissolved.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Octanate LV
The active substance is human coagulation factor VIII.
Volume and concentrations:
Amount of Octanate LV® powder vial (IU FVIII) | Amount of diluent (to be added to the Octanate LV® powder vial) (ml) | Declared concentration of the reconstituted solution (IU FVIII/ml) |
500 IU | 5 | 100 |
1000 IU | 5 | 200 |
The other components are:
For the powder: sodium citrate, sodium chloride, calcium chloride and glycine.
For the solvent: water for injections.
Appearance of the medicinal product and contents of the container
Octanate LV is presented as a powder and solvent for injectable solution.
The powder is white or pale yellow, or may also appear as a friable mass.
The solvent is a clear, colourless liquid.
The available pack sizes differ in the amount of human 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.
- Solvent, 5 ml in a vial, with a stopper and a flip-off cap.
- 1 kit of intravenous injection equipment (1 transfer device, 1 infusion set, 1 disposable syringe)
- 2 alcohol swabs.
200 IU/ml powder and solvent:
- Powder, 1000 IU, in a vial, with a stopper and a flip-off cap.
- Solvent, 5 ml in a vial, with a stopper and a flip-off cap.
- 1 kit of intravenous injection equipment (1 transfer device, 1 infusion set, 1 disposable syringe)
- 2 alcohol swabs.
Not all pack sizes may be available.
Marketing Authorisation Holder
Octapharma S.A.
Avda. Castilla, 2. (P.E. San Fernando)
Ed. Dublin, 2nd Floor
28830 San Fernando de Henares
Madrid
Manufacturer:
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235
A-1100 Vienna
Austria
or
Octapharma S.A.S
70 - 72 Rue du Maréchal Foch
BP 33, F - 67381 Lingolsheim
France
or
Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm
Sweden
This medicinal product is authorised in the European Economic Area member states under the following names:
- Octanate LV: Austria, Cyprus, Denmark, France, Netherlands, Malta, Poland, Romania, Spain, Sweden, United Kingdom.
- Octafil LV: Finland
- Octanate: Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Portugal
- Octanate Kons: Republic of Slovenia
Date of the most recent review of this leaflet: December 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS)
http://www.aemps.gob.es/