50 IU / ml and 100 IU / ml powder and solvent for solution for injection
Human coagulation factor VIII
What Octanate is and what it is used for
Octanate belongs to a group of medicines called coagulation factors and contains coagulation factor VIII from human blood. This is a special protein that causes the blood to coagulate.
Octanate is used to treat and prevent bleeding in patients with hemophilia A. This is a disease that causes you to bleed longer than you would normally expect. The disease is due to a hereditary deficiency of coagulation factor VIII in the blood.
What you need to know before using Octanate
Do not use Octanate
It is strongly recommended that names and batch numbers be recorded each time you receive a dose of Octanate so that a list of used batches is maintained. Your doctor may suggest vaccination against hepatitis A and hepatitis B if you are regularly / repeatedly treated with plasma-derived factor VIII products.
Do not use Octanate
if you are allergic to coagulation factor VIII from human blood or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Octanate.
Octanate contains very small amounts of other human proteins. All medicines containing proteins injected into a vein ( intravenous administration ) may cause allergic reactions (See section 4 – “Possible side effects”).
The development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent, especially at high levels, that the treatment works properly. You or your child will be closely monitored for the development of such inhibitors. If you or your child suffer from bleeding that cannot be controlled with Octanate, tell your doctor immediately.
Information on blood and plasma used to make Octanate
When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes
- a careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded;
- as well as testing of individual donations and plasma pools for signs of virus / infection.
- The manufacturers of these products also include steps in the management of blood and plasma that can inactivate or secrete any viruses .
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered effective against enveloped viruses such as HIV, Hepatitis B, and Hepatitis C virus and for the non-enveloped virus et Hepatitis A. The measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious in pregnant women ( fetal infection ) and individuals with weakened immune systems or patients with certain types of anemia (eg sickle cell anemia or hemolytic anemia ).
Other medicines and Octanate
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
There are no known interactions between products containing coagulation factor VIII from human blood and other medicinal products. However, octanate should not be combined with other drugs during infusion one.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No effects have been observed on the ability to drive and use machines.
Octanate contains excipients
per 250 IU / bottle:
less than 1 mmol sodium (23 mg) (the main ingredient in table salt/table salt) is per vial, ie essentially ‘sodium-free’.
per 500 and 1000 IU / bottle:
up to 40 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.
How to use Octanate
Octanate should be given intravenously after dilution with the supplied liquid.
Treatment should be started under the supervision of a physician.
Dosage to prevent bleeding
If you have severe hemophilia A, inject 20 to 40 IU factor VIII per kg body weight every two or three days for long-term preventive treatment. Dosage one should be adjusted according to your answer. In some cases, shorter dosing intervals or higher doses may be required.
Dose calculation
Always use Octanate exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Factor VIII activity refers to the amount of factor VIII in plasma. It is expressed either as a percentage (relative to normal human blood plasma) or in international units (IU). Dose one of factor VIII is expressed in IU.
One IU of factor VIII activity corresponds to the amount of factor VIII in one ml of normal human blood plasma. One IU factor VIII per kg body weight increases the factor VIII activity in plasma by 1.5% – 2% of normal activity. To calculate dose one, the level of factor VIII activity in your blood plasma is measured. This shows how much the activity needs to be increased. Talk to your doctor if you are unsure about how much your factor VIII activity needs to be increased or how to calculate dose one.
The required dose is calculated using the following formula:
Units needed = body weight (kg) x desired increase of factor VIII (%) (IU / dl) x 0.5
The size of the dose and how often it should be given (frequency) should always be guided by the clinical effect in the individual patient.
In the following bleeding events, the factor VIII activity should not fall below the level of plasma activity (in% of normal activity) given in the table below for the corresponding period. The table can be used for guidance regarding dosing in case of bleeding and surgical procedures:
| Severity of bleeding /Type of surgery | Required factor VIII level(%) (IU / dl) | Dosage frequency (hours between dosing ) /Duration of treatment (days ) |
|---|---|---|
| Bleeding | ||
| Bleeding into a joint (early home osteoarthritis), muscle bleeding, or bleeding in the mouth | 20 – 40 | Repeat 1 to 2 times a day for at least 1 day, until the pain subsides or healing is achieved. |
| More extensive bleeding into a joint (haemarthrosis), muscle haemorrhage, or hemorrhage (hematoma) | 30 – 60 | Repeat 1 to 2 times a day for 3-4 days or more, until the pain and disability have ceased. |
| Life-threatening bleeding, eg in the case of surgical procedures in the head, bleeding in the throat, heavy bleeding in the abdomen | 60 – 100 | Repeat the infusion once every 8 hours or once a day until the bleeding is under control. |
| Surgery | ||
| Minor intervention since. tooth extraction | 30 – 60 | Once a day for at least 1 day until healing is achieved. |
| Major interventions | 80 – 100 (before and after surgery) | Repeat the infusion once every 8 hours or once a day until good wound healing is obtained. Then treat for at least another 7 days to keep the factor VIII activity at 30% to 60%. |
Your doctor will tell you in what dose and how often you should use Octanate.
Your response to treatment with factor VIII products may vary. The factor VIII level in your blood should therefore be measured during treatment to calculate the correct dose and frequency of infusion.
Use for children
Clinical studies did not indicate any specific dosing needs for children. Dosage for children and adults is the same, both for treatment and for prophylaxis.
Instructions for home treatment
- Read all instructions carefully and follow them carefully!
- Do not use Octanate after the expiry date which is stated on the label
- Sterility must be maintained during the procedure described below
- Prepared medicinal products should be inspected visually for particulate matter and discoloration prior to administration .
- The solution in the syringe should be clear or slightly opalescent. Do not use solution that is cloudy or contains precipitates
- Use the reconstituted solution immediately to prevent microbial contamination
- Use only packaged infusion aids. The use of other injection / infusion sets may increase the risk and failure of treatment
Instructions for reconstitution
Do not use the product immediately after removing it from the refrigerator. Allow the diluent and powder in the unopened vials to reach room temperature.
2. Remove the caps from both bottles and wash the rubber stoppers with one of the included disinfection wipers.
3. The transfer set is depicted in Fig. 1. Place the diluent 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 on the diluent bottle and press firmly until it clicks (Fig. 2 + 3). Do not turn while connecting.
4. Place the vial of powder on a flat surface and hold it firmly. Take the diluent vial with the attached transfer set and turn it upside down. Place the white part on the stopper of the powder bottle and press firmly until it clicks (Fig. 4). Do not turn while connecting. The liquid automatically flows over to the powder bottle.
5. Rotate the powder bottle slowly with both bottles connected until the powder dissolves. The powder dissolves in less than 10 minutes at room temperature. Slight foaming may occur during dissolution. Unscrew the transfer set into two parts (Fig. 5). Then the foam disappears.
Discard the liquid bottle with the blue part of the transfer set attached.
Instructions for injection :
As a precaution, your heart rate should be taken before and during injection one. If the heart rate rises significantly, the injection rate should be reduced or administration temporarily interrupted.
1. Connect the syringe to the white part of the transfer set. Turn the bottle upside down and pull up the solution in 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 plunger down) and remove the syringe from the transfer set (Fig.7).
Discard the empty bottle along with the white part of the transfer seat.
2. Clean the selected injection site with one of the included disinfection wipers.
3. Connect the enclosed injection set to the syringe.
Insert the injection needle into the selected vein. If you have used a bandage to make the vein easier to see, this should be opened before you start injecting it.
5. Blood must not enter the syringe due to the risk of clot formation.
Slowly inject the solution into the vein, no more than 2-3 ml per minute.
If you use more than one bottle of Octanate powder at the same treatment time, the same injection needle and syringe may be used. The transfer set is for single use only.
Any unused product or waste material should be disposed of per local requirements.
If you use more Octanate than you should
No symptoms of human coagulation factor VIII overdose 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. Continue immediately with the next dose, and proceed as advised by your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
Hypersensitivity or allergic reactions are rare (may affect up to 1 in 1,000 people) but have been observed in patients treated with factor VIII
-containing medicines.
Contact a doctor if you get the following symptoms:
Vomiting), burning and stinging sensation at the infusion site, feeling of tightness in the chest, palpitations ( tachycardia ), chills, nausea, feeling of “creeping in the body”, redness of the skin, headache, hives ( urticaria ), low blood pressure ( hypotension ), rash, restlessness, swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing ( angioedema ), fatigue ( lethargy ), wheezing.
In very rare cases (may affect up to 1 in 10,000 people) this hypersensitivity can lead to a serious reaction called anaphylaxis which may include shock as well as some of the symptoms described above. Should this occur, inform 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 been previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less and the complication is less common (occurs in less than 1 in 100 users). If you or your child develop antibodies, the medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, consult a doctor immediately.
For information on virus safety, see section 2. (Take special care with Octanate – information on blood and plasma used to make Octanate).
How to store Octanate
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the original package. Sensitive to light.
Use the reconstituted solution immediately. For single use only.
Do not use this medicine if you notice cloudy or where the powder has not completely dissolved.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is coagulation factor VIII from human blood.
Volume and concentrations
| Octanate ®contents of the powder bottle (IE FVIII) | Diluent volume (to be added Octanate powder bottle) (ml) | The nominal concentration of the reconstituted solution(IU FVIII / ml) |
| 250 IU | 5 | 50 |
| 500 IU | 10 | 50 |
| 1000 IU | 10 | 100 |
The other ingredients in the powder are sodium citrate, sodium chloride, calcium chloride, and glycine. Solvent: water for injections.
What the medicine looks like and contents of the pack
Octanate is supplied as a powder and solvent for solution for injection.
The powder is white or pale yellow and may also be in a brittle, solid form.
The liquid is clear and colorless.
The three available pack sizes differ in the amount of coagulation factor VIII and liquid:
250 IU / bottle: 5 ml solution gives 50 IU / ml
500 IU / bottle: 10 ml solution gives 50 IU / ml
1000 IU / bottle: 10 IU solution ml gives 100 IU / ml.
All pack sizes include:
1 pack of intravenous injection equipment (1 transfer set, 1 infusion set, 1 disposable syringe)
2 disinfectant dryers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Octapharma AB
112 75 Stockholm
Tel: 08-566 43000
Customer contact: 020-311020
Manufacturer
Octapharma Pharmazeutika Produktionsges.mbH
Oberlaaerstr. 235
A-1100 Vienna
Austria
or
Octapharma SAS
70 – 72 Rue du Maréchal Foch
BP 33, F – 67381 Lingolsheim
France
or
Octapharma AB
112 75 Stockholm