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
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• Speak to your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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
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 coagulation factors and contains human coagulation factor VIII. It is a special protein that increases the blood's ability to clot.
Octanate LV is used for the treatment and prevention of bleeding episodes in patients with haemophilia A. This is a condition in which bleeding lasts longer than expected due to a congenital deficiency of factor VIII in the blood.

2. Important information before using Octanate LV

It is strongly recommended that, each time a dose of Octanate LV is administered to the patient, the product name and batch number be recorded to maintain traceability of the batch used.
The physician may recommend considering vaccination against hepatitis A and B in patients receiving regular or repeated administration of human factor VIII products.

When not to use Octanate LV
if the patient is allergic to human blood coagulation factor VIII or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Octanate LV, consult a doctor, pharmacist, or nurse.
Octanate LV contains trace amounts of other human proteins. Any medicine containing proteins administered intravenously 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 any factor VIII-containing medicines. These inhibitors, especially at high titres, may interfere with effective treatment, and the patient will be closely monitored for their development. If bleeding is not properly controlled with Octanate LV, inform the doctor immediately.

Information regarding blood and plasma used in the manufacture of Octanate LV
During the production of medicines derived from human blood or plasma, specific measures are taken to prevent transmission of infections to patients. These include careful selection of blood and plasma donors to exclude those who may be carriers of infectious agents, as well as testing of all individual samples and pooled plasma for the presence of viruses/infections. Manufacturers of these products have also incorporated into the manufacturing process steps designed to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infection cannot be completely excluded. This includes unknown or newly emerging viruses or other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and non-enveloped hepatitis A virus (HAV). However, the methods used may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Infection with parvovirus B19 may be dangerous for pregnant women (risk of fetal infection) and for individuals with suppressed immune systems or those suffering from certain types of anaemia (e.g. sickle cell anaemia or excessive red blood cell destruction).

Other medicines and Octanate LV
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
No interactions between human coagulation factor VIII and other medicinal products are known. However, Octanate LV must not be mixed with other medicines during infusion.

Pregnancy and breastfeeding
Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery
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 common salt) per dose. This corresponds to 2% of the recommended maximum daily intake of 2 g sodium for an adult.

3. How to use Octanate LV

Octanate LV should be administered intravenously after reconstitution with the provided solvent.
Treatment should be initiated under medical supervision.
Dosing for prevention of bleeding: In long-term prophylaxis of bleeding in patients with
severe hemophilia A, factor VIII should be administered at a dose of 20 to 40 IU per kilogram of body weight
every 2 to 3 days. The dose should be adjusted according to the clinical response. In some cases,
administration at shorter intervals or with higher doses may be necessary.
Dose calculation:
Octanate LV should always be used according to the physician's instructions. In case of doubt, consult
your doctor or pharmacist again.
Plasma factor VIII activity corresponds to the concentration of factor VIII 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 1 ml
of normal human plasma. 1 IU of factor VIII per kilogram of body weight raises plasma factor VIII activity by 1.5%–2% of normal activity. To calculate the required dose, determine the patient's plasma factor VIII activity. This will allow determination of how much the activity should be increased. Consult your doctor if you are uncertain about how much factor VIII activity should be increased and how to calculate the appropriate dose.
The required dose is calculated using the following formula:
required number of units = body weight (kg) x required increase in factor VIII activity (%)
(IU/dl) x 0.5
The amount to be administered and the frequency of administration should always be adjusted according to the individual patient's clinical response.
In the following bleeding situations, plasma factor VIII activity should not fall below the indicated levels (as % of normal values) during the specified time periods.
The following table may be helpful in determining doses for bleeding episodes or surgical procedures:

The dose and frequency of administration of Octanate LV will be determined by the physician.
Response to factor VIII may vary among individual patients. Therefore, during treatment, monitoring of factor VIII levels is recommended to determine the appropriate dose and frequency of infusions.

Use in children
Clinical studies have not revealed any special dosing requirements in children.
Dosing is the same in adults and children, both for treatment and prophylaxis.

Instructions for home use

• Read all instructions carefully and follow them exactly!
• Do not use Octanate LV after the expiry date stated on the label.
• Aseptic conditions must be maintained during the procedure described below.
• Before administration, visually inspect the prepared solution for particulate matter or discoloration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain particulate matter.
• The prepared solution should be used immediately to avoid microbiological contamination.
• Use only the provided infusion set. Use of other injection/infusion equipment may cause additional risks and treatment failure.

Instructions for preparing the solution:

1. Do not use the product immediately after removing it from the refrigerator. Allow the solvent and powder vials to reach room temperature while still closed.
2. Remove the caps from both vials and clean the rubber stoppers with one of the provided alcohol-impregnated swabs.
3. The transfer set is shown in Fig. 1. Place the solvent vial on a flat surface and hold it firmly. Take the transfer set and turn it over. Place the blue part of the transfer set on top of the solvent vial and press firmly until it clicks into place (Fig. 2 + 3). Do not rotate while attaching.

Fig. 1 Fig. 2 Fig. 3

4. Place the powder vial on a flat surface and hold it firmly. Take the solvent vial with the attached transfer set and turn it upside down. Place the white part of the transfer set on top of the powder vial and press firmly until it clicks into place (Fig. 4). Do not rotate while attaching. The solvent will automatically flow into the powder vial.

Fig. 4

5. With both vials attached, gently rotate the powder vial until the product is completely dissolved. Dissolution is completed in less than 10 minutes at room temperature. Minor foaming may occur during preparation. Unscrew the transfer set into two parts (Fig. 5). The foam will disappear.

Discard the empty solvent vial with the blue part of the transfer set.
Fig. 5

Instructions for administering the injection:
As a precaution, pulse should be checked before and during the injection. If a significant increase in pulse rate occurs, reduce the injection speed or temporarily interrupt administration.

1. 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. After transferring the solution, firmly hold the plunger of the syringe (keeping it pointing downward) and remove the syringe from the transfer set (Fig. 7).

Discard the empty vial together with the white part of the transfer set.

Fig. 6 Fig. 7

2. Clean the selected injection site with one of the provided alcohol-impregnated swabs.
3. Attach the provided infusion set to the syringe.
4. Insert the needle into the selected vein. If a tourniquet was used to visualize the vein, loosen it before starting the injection of Octanate.
5. Blood must not enter the syringe due to the risk of fibrin clot formation.
6. Inject the solution slowly into the vein, no faster than 2–3 mL per minute. When using more than one Octanate powder vial during a single administration, the same infusion set and syringe may be reused. The transfer set is intended for single use only.

Any unused portions or waste materials must be disposed of in accordance with local regulations.

Use of a higher than recommended dose of Octanate LV
No symptoms of overdose with human coagulation factor VIII have been observed. However, exceeding the recommended dose is not advised.

Missed dose of Octanate LV
Do not administer a double dose to make up for a missed dose. Proceed immediately to the next dose and continue dosing as directed by the physician or pharmacist.
Contact your physician or pharmacist if you have any other questions regarding the use of this product.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Although rare (occurring in 1 to 10 out of 10,000 patients), hypersensitivity or allergic reactions have been observed in patients treated with products containing factor VIII.
Contact your doctor immediately if any of the following symptoms occur:
vomiting, burning sensation and stinging pain at the infusion site, feeling of pressure in the chest, chills,
tachycardia, nausea, tingling sensation, redness, headache, hypotension, urticaria, rash, restlessness,
facial swelling, swelling of the lips, mouth, tongue or throat, which may lead to difficulty in swallowing or
breathing (angioedema), fatigue (lethargy), wheezing.
Very rarely (occurring in less than 1 out of 10,000 patients), hypersensitivity may lead to a life-threatening allergic reaction called anaphylaxis, which may include shock and some or all of the symptoms described above. In such a case, contact your doctor immediately or call emergency services.
Other rare adverse reactions (occurring in 1 to 10 out of 10,000 patients):
Fever.
In children who have not previously been treated with factor VIII-containing medicines, inhibitory antibodies (see section 2) may develop very commonly (in more than 1 out of 10 patients). However, in patients who have previously been treated with factor VIII (for more than 150 days), the risk is uncommon (less than 1 out of 100 patients). If this occurs, the patient's medication may no longer work properly and prolonged bleeding may occur. If this happens, contact your doctor immediately.
Viral safety information, see section 2. (Particular caution should be exercised when using Octanate LV).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Octanate LV

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the
last day of the stated month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the outer packaging to protect from light.
The reconstituted solution should be used immediately and only during a single administration.
Do not use this medicine if the solution appears cloudy or is not completely dissolved.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

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

Other ingredients:
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 available as a powder and solvent for solution for injection.
The powder is white or pale yellow and may also appear as a compacted cake.
The solvent is a clear, colourless liquid.

Two available strengths of the medicinal product differ in the content of Factor VIII and solvent:

100 IU/mL powder and solvent

• Powder, 500 IU, in a vial with stopper and flip-off cap
• 5 mL solvent in a vial with stopper and flip-off cap
• 1 pack containing intravenous injection equipment (1 transfer set, 1 infusion set, 1 single-use syringe)
• 2 alcohol-impregnated swabs

200 IU/mL powder and solvent

• Powder, 1000 IU, in a vial with stopper and flip-off cap
• 5 mL solvent in a vial with stopper and flip-off cap
• 1 pack containing intravenous injection equipment (1 transfer set, 1 infusion set, 1 single-use syringe)
• 2 alcohol-impregnated swabs

Not all pack sizes may be available on the market.

Marketing Authorisation Holder
Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

Manufacturer
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Str. 235
1100 Vienna
Austria

Octapharma S.A.S
72 rue du Maréchal Foch
67380 Lingolsheim
France

Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Sweden

This medicinal product is registered in the Member States of the European Economic Community 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: Slovenia