Octanate

Package leaflet: Information for the user

Octanate, 50 IU/ml, Powder and solvent for solution for injection

Human coagulation Factor VIII.
Octanate 100 IU/ml, Powder and solvent for solution for injection
Human coagulation Factor VIII.
Please 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Octanate is and what it is used for.
2. What you need to know before using Octanate.
3. How to use Octanate.
4. Possible side effects.
5. How to store Octanate.
6. Contents of the pack and other information.

1. What Octanate is and what it is used for

Octanate belongs to a group of medicines called "Coagulation factors" and contains Factor VIII of human plasma coagulation. This is a special protein involved in blood clotting.
Octanate is used for the treatment and prevention of bleeding in patients with haemophilia A. This is a condition in which bleeding may last longer than expected. This is due to an inherited deficiency of blood coagulation factor VIII.

2. What you should know before using Octanate

It is strongly recommended to record the name and batch number of the product each time you receive a dose of
Octanate, in order to keep a record of the batch used.
If you regularly/repeatedly use Factor VIII products derived from human plasma, your doctor may recommend
that you consider vaccination against hepatitis A and B.
Do not use Octanate
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.
Octanate contains a very small amount of other human proteins. Any medicine containing proteins that is injected
intravenously (administered by intravenous route) 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 medicines. Inhibitors, especially at high levels, may prevent the treatment from working properly, and
you or your child will be closely monitored for the development of such inhibitors. If Octanate does not control
bleeding in you or your child, inform your doctor immediately.
Information about the blood and plasma used for Octanate
When medicines are prepared from human blood or plasma, standard measures are used to prevent the transmission
of infections to patients. These measures include careful selection of blood and plasma donors to ensure exclusion
of those at risk of carrying infections, screening of individual donations and plasma pools for specific viral/
infection markers, and inclusion of manufacturing steps effective for virus inactivation/removal. Despite this, when
medicinal products prepared from human blood or plasma are administered, the possibility of transmission of
infectious agents cannot be completely excluded. This also applies to unknown or emerging viruses and 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 against the non-enveloped hepatitis A virus (HAV).
The measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection may be severe in pregnant women (fetal infection) and in individuals with
immunodeficiency or certain types of anaemia (e.g. sickle cell anaemia or abnormal red blood cell loss).
Other medicines and Octanate
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including
those not requiring a prescription.
No interactions between human blood coagulation Factor VIII products and other medicines are known. However,
do not mix Octanate with other drugs during infusion.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult
your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive vehicles or use machines have been observed.
Octanate contains
for 250 UI/vial:
less than 1 mmol of sodium (23 mg) (main component of table salt) per vial, i.e. it is practically 'sodium-free'.
for 500 and 1000 UI/vial:
up to 40 mg of sodium (main component of table salt) per vial. This corresponds to 2% of the maximum daily
recommended dietary intake for an adult.

3. How to use Octanate

Octanate must be administered intravenously after reconstitution with the provided solvent.
Treatment should be initiated under the supervision of a physician.

Dosage for prevention of bleeding
If you have severe haemophilia A, you should inject 20–40 IU of factor VIII per kg of body weight every two or three days for long-term prophylaxis. The dose should be adjusted according to your individual response. In some cases, shorter dosing intervals or higher doses may be required.

Dose calculation
Always use Octanate exactly as directed by your doctor. Consult your doctor or pharmacist if you are unsure.

Factor VIII activity refers to the amount of factor VIII present in plasma. This is expressed 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 present in one ml of normal human plasma. One IU of factor VIII per kg of body weight increases plasma factor VIII activity by 1.5%–2% of normal activity. To calculate your required dose, the level of factor VIII activity in your plasma is measured. This indicates by how much the activity needs to be increased. You are advised to consult your doctor if you are uncertain about how much your factor VIII activity should be increased or about how to calculate the dose.

The required dose is calculated using the following formula:
Required units = body weight (kg) × desired increase in factor VIII (%) (IU/dl) × 0.5

The dosage and frequency of administration must always take into account the clinical efficacy in the individual patient.

If any of the following bleeding events occur, factor VIII activity should not fall below the required plasma activity level (in % of normal) shown in the table below, for the corresponding duration.

The following table can be used to guide dosing during bleeding episodes and surgical procedures:

Your doctor will advise you on the dose and how often you should use Octanate.
Your response to factor VIII products may vary. The factor VIII level in the blood should therefore
be measured during treatment to determine the correct dose and frequency of infusion.

Use in children
Clinical studies have not identified special dosage requirements for children. For treatment and prophylaxis,
the dosage is the same in adults and children.

Instructions for home treatment

• Please read all instructions carefully and follow them precisely!
• Do not use Octanate after the expiry date stated on the label.
• Sterility must be maintained throughout the procedure described below.
• The reconstituted medicine should be inspected visually for particulate matter and discoloration before administration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain deposits.
• Use the prepared solution immediately to avoid microbial contamination.
• Use only the infusion set supplied. The 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 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 alcohol-impregnated swabs provided.
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 upside down. Place the blue part of the transfer set onto the top of the solvent vial and, without twisting, press firmly down until it locks into place (Fig. 2 + 3).

4. Place the powder vial on a flat surface and hold it firmly. Take the solvent vial attached to the transfer set and turn it upside down. Place the white part onto the top of the powder vial and, without twisting, press firmly down until it locks into place (Fig. 4). The solvent will automatically flow into the vial containing the powder.

Fig. 4

Fig. 4

5. With both vials still connected, gently invert the powder vial until the product is completely dissolved. Dissolution occurs within less than 10 minutes at room temperature. A slight foam may form 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 injection:
As a precaution, heart rate should be monitored before and during injection. If a marked increase in heart rate occurs, reduce the injection rate 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.

Once the solution has been transferred, hold the syringe plunger firmly (with the syringe pointing downward) and remove the syringe from the transfer set (Fig. 7).
Discard the empty vial with the white part of the transfer set.

Fig. 6 Fig. 7

2. Clean the chosen injection site with one of the alcohol-impregnated swabs provided.
3. Attach the infusion set supplied to the syringe.
4. Insert the injection needle into the selected vein. If you have used a tourniquet to make the vein more visible, the tourniquet must be released before starting the injection of Octanate.
5. Blood must not flow into the syringe due to the risk of fibrin clot formation.
6. Inject the solution slowly into the vein at a rate not exceeding 2–3 ml per minute.

If more than one vial of Octanate powder is used for a single treatment, the same infusion set and syringe may be reused. The transfer set is for single use only.
Any unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

If you use more Octanate than you should
No symptoms of overdose with human blood coagulation factor VIII have been reported.
However, the recommended dose should not be exceeded.

If you forget to take Octanate
Do not take a double dose to make up for a forgotten dose. Proceed immediately to the next dose and continue as advised by your doctor or pharmacist.
If you have any further questions about 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.
Hypersensitivity or allergic reactions, although rare (may affect up to 1 in 1,000 people), have been observed in patients treated with products containing factor VIII.
If you experience any of the following symptoms, contact your doctor:
feeling unwell (vomiting), burning and redness at the infusion site, chest tightness, chills, rapid heartbeat (tachycardia), feeling unwell (nausea), prickling sensation (tingling), hot flushes, headache, hives, low blood pressure (hypotension), skin rash, restlessness, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), tiredness (lethargy), shortness of breath.
In very rare cases (may affect up to 1 in 10,000 people), 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 listed above. In this case, contact your doctor immediately or call an ambulance.
Other rare side effects (may affect up to 1 in 1,000 people):
Fever
In children who have not previously been treated with factor VIII medicines, the development of inhibitory antibodies (see section 2) may be very common (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 uncommon (less than 1 in 100 patients). If this occurs, the medicine may no longer work properly and you or your child may experience persistent bleeding. If this happens, you must contact your doctor immediately.
For information on viral safety, see section 2. (Pay attention to Octanate – Information on blood and plasma used for Octanate).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Octanate

Keep this medicine out of the 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 that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer packaging to protect the product from light.
Use the reconstituted solution immediately and for a single administration only.
Do not use this medicine if you notice that the solutions are cloudy or not completely dissolved.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Octanate contains
The active substance is human coagulation factor VIII.

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

Description of the appearance of Octanate and contents of the pack
Octanate is presented as a powder and solvent for solution for injection.
The powder is white or light yellow and may also appear as a friable mass.
The solvent is a clear, colourless liquid.
The three available pack sizes differ in the amount of human blood coagulation factor VIII and solvent:

• 250 IU/vial: reconstituted with 5 ml, resulting in 50 IU/ml
• 500 IU/vial: reconstituted with 10 ml, resulting in 50 IU/ml
• 1000 IU/vial: reconstituted with 10 ml, resulting in 100 IU/ml

All packs include:

• 1 administration kit for intravenous use (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol-impregnated swabs

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56124 Pisa
Italy
For further information on this medicinal product, please contact the Local Representative of the Marketing Authorization Holder.

Manufacturers
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
SE 112 75 Stockholm
Sweden

Package leaflet: Information for the user

Octanate, 100 IU/ml, Powder and solvent for injectable solution

Human coagulation Factor VIII.
Octanate 200 IU/ml, Powder and solvent for injectable solution
Human coagulation Factor VIII.
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Octanate is and what it is used for
2. What you need to know before using Octanate
3. How to use Octanate
4. Possible side effects
5. How to store Octanate
6. Contents of the pack and other information

1. What Octanate is and what it is used for

Octanate belongs to a group of medicines called "Coagulation factors" and contains human blood coagulation Factor VIII. This is a special protein involved in blood clotting.
Octanate is used for the treatment and prevention of bleeding in patients with haemophilia A. This is a condition in which bleeding may last longer than expected. This is due to an inherited deficiency of blood coagulation Factor VIII.

2. What you should know before using Octanate

It is strongly recommended to record the name and batch number of the product each time you receive a dose of
Octanate, in order to maintain a record of the batch used.
If you regularly or repeatedly use products containing Factor VIII derived from human plasma, your doctor may
recommend that you consider vaccination against hepatitis A and B.
Do not use Octanate
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.
Octanate contains a very small amount of other human proteins. Any medicine containing proteins that is
administered intravenously (given by intravenous route) 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 medicines. Inhibitors, especially at high levels, can prevent the treatment from working properly, and
you or your child will be closely monitored for the development of such inhibitors. If Octanate does not control
bleeding in you or your child, inform your doctor immediately.
Information about the blood and plasma used for Octanate
When medicines are prepared from human blood or plasma, certain standard measures are used to prevent the
transmission of infections to patients. These measures include careful selection of blood and plasma donors to
ensure exclusion of those at risk of carrying infections, screening of individual donations and plasma pools for
specific viral/infection markers, and inclusion of manufacturing steps effective for virus inactivation/removal.
Nevertheless, when medicinal products prepared from human blood or plasma are administered, the possibility of
transmission of infectious agents cannot be completely excluded. This also applies to unknown or emerging
viruses and other types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus
(HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), and against the non-enveloped hepatitis A virus (HAV).
The measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19.
Infection with parvovirus B19 may be serious for pregnant women (fetal infection) and for individuals with
immunodeficiency or certain types of anaemia (e.g. sickle cell anaemia or abnormal breakdown of red blood cells).
Other medicines and Octanate
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
No interactions are known between products containing human blood coagulation Factor VIII and other
medicines. However, do not mix Octanate with other drugs during infusion.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
Driving and use of machines
No effects on the ability to drive vehicles or use machinery have been observed.
Octanate contains
up to 40 mg of sodium (a main component of table salt) per vial. This corresponds to 2% of the maximum
recommended daily dietary intake for an adult.

3. How to use Octanate

Octanate must be administered intravenously after reconstitution with the provided solvent.
Treatment should be initiated under the supervision of a physician.

Dosing for prevention of bleeding
If you have severe haemophilia A, you should inject 20–40 IU of factor VIII per kg of body weight every two or three days for long-term prophylaxis. The dose should be adjusted according to your individual response. In some cases, shorter dosing intervals or higher doses may be required.

Dose calculation
Always use Octanate exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure.

Factor VIII activity refers to the amount of factor VIII present in plasma. This is expressed as a percentage (relative to normal human plasma) or in International Units (IU).
Factor VIII dosing is expressed in IU.

One IU of factor VIII activity is equivalent to the amount of factor VIII present in 1 ml of normal human plasma. One IU of factor VIII per kg of body weight increases plasma factor VIII activity by 1.5%–2% of normal activity. To calculate your required dose, the level of factor VIII activity in your plasma is measured. This indicates by how much the activity needs to be increased. It is recommended that you consult your doctor if you are uncertain about how much your factor VIII activity should be increased or how to calculate the dose.

The required dose is calculated using the following formula:
Required units = body weight (kg) × desired increase in factor VIII (%) (IU/dL) × 0.5

The dose and frequency of administration must always take into account the clinical response in the individual patient.

If the following bleeding events occur, factor VIII activity must not fall below the required plasma activity level (in % of normal) shown in the table below, for the corresponding duration.

The following table can be used to guide dosing during bleeding episodes and surgical procedures:

Your doctor will advise you on the dosage and how often you should use Octanate.
Your response to factor VIII products may vary. Therefore, the factor VIII level in your blood should be measured
during treatment to determine the correct dosage and infusion frequency.

Use in children
Clinical studies have not identified any special dosage requirements for children. For treatment and prophylaxis,
the dosage is the same in adults and children.

Instructions for home treatment

• Please read all instructions carefully and follow them exactly!
• Do not use Octanate after the expiry date stated on the label.
• Sterility must be maintained throughout the procedure described below.
• The reconstituted medicine should be inspected visually for particulate matter and discoloration before administration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain deposits.
• Use the prepared solution immediately to avoid microbial contamination.
• Use only the infusion set supplied. The use of other injection/infusion devices 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 in the closed vials to reach room temperature.
2. Remove the pull-off caps from both vials and clean the rubber stoppers with one of the alcohol-impregnated swabs provided.
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 upside down. Place the blue part of the transfer set onto the top of the solvent vial and, without rotating, press firmly downward until it locks into place (Fig. 2 + 3).

4. Place the powder vial on a flat surface and

hold it firmly.
Take the solvent vial attached to the transfer set and turn it upside down.
Place the white part onto the top of the powder vial and, without rotating, press firmly downward until it locks into place (Fig. 4). The solvent will automatically flow into the powder vial.
Fig. 4

5. With both vials still connected, gently invert the powder vial until the product is completely dissolved. Dissolution occurs within less than 10 minutes at room temperature. A slight foam may form 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 injection:
As a precaution, heart rate should be monitored before and during injection. If a marked increase in heart 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.

Once the solution has been transferred, hold the syringe plunger firmly (with it facing downward) and remove the syringe from the transfer set (Fig. 7).
Discard the empty vial with the white part of the transfer set.

Fig. 6 Fig. 7

2. Clean the chosen injection site with one of the alcohol-impregnated swabs provided.
3. Attach the infusion set provided to the syringe.
4. Insert the injection needle into the selected vein. If you used a tourniquet to make the vein more visible, it must be released before starting the Octanate infusion.
5. Blood must not flow into the syringe due to the risk of fibrin clot formation.
6. Inject the solution intravenously slowly, at a rate no faster than 2–3 ml per minute.

If more than one vial of Octanate powder is used for a single treatment, the same infusion set and syringe may be reused. The transfer set is for single use only.
Any unused medicine and waste material must be disposed of in accordance with local regulations.

If you use more Octanate than you should
No symptoms of overdose with human blood coagulation factor VIII have been reported. However, the recommended dose should not be exceeded.

If you forget to take Octanate
Do not take a double dose to make up for the missed dose. Proceed immediately to the next dose and continue as advised by your doctor or pharmacist.

If you have any further questions about 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 will experience them.
Hypersensitivity or allergic reactions, although rare (may affect up to 1 in 1,000 people), have been observed in patients treated with products containing factor VIII.
If you experience any of the following symptoms, consult your doctor:
feeling unwell (vomiting), burning sensation and redness at the infusion site, tightness in the chest, chills,
rapid heartbeat (tachycardia), feeling unwell (nausea), prickling sensation (tingling), hot flushes, headache, hives,
low blood pressure (hypotension), skin rash, restlessness, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), tiredness (lethargy), shortness of breath.
In very rare cases (may affect up to 1 in 10,000 people), 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 side effects (may affect up to 1 in 1,000 people):
Fever
In previously untreated children with factor VIII-based medicines, the development of inhibitory antibodies (see section 2) may be very common (more than 1 in 10 patients); however, in patients who have previously received treatment with factor VIII (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this occurs, the medicine may no longer work properly and you or your child may experience persistent bleeding. If this happens, you must contact your doctor immediately.
For information on viral safety, see section 2. (Take care with Octanate – Information on blood and plasma used for Octanate).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Octanate

Keep this medicine out of the 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 that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vials in the outer packaging to protect the product from light.
Use the reconstituted solution immediately and for a single administration only.
Do not use this medicine if you notice that the solutions are cloudy or not completely dissolved.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Octanate contains
The active substance is human coagulation factor VIII.

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

Description of the appearance of Octanate and contents of the pack
Octanate is presented as a powder and solvent for solution for injection.
The powder is white or light yellow and may also appear as a friable mass.
The solvent is a clear, colourless liquid.

Two pack sizes are available, differing in the amount of human blood coagulation factor VIII and solvent:

100 IU/ml powder and solvent:

• Powder, 500 IU, in a vial with rubber stopper and flip-off seal
• 5 ml of solvent in a vial with rubber stopper and flip-off seal
• 1 intravenous administration kit (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol-impregnated swabs.

200 IU/ml powder and solvent:

• Powder, 1000 IU, in a vial with rubber stopper and flip-off seal
• 5 ml of solvent in a vial with rubber stopper and flip-off seal
• 1 intravenous administration kit (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol-impregnated swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56124 Pisa
Italy

Manufacturers
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
SE 112 75 Stockholm
Sweden

This medicinal product is authorised in the European Economic Area countries 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