Octanate 1000 IU/10 ml

Octanate 1000 IU/10 ml | INDICATIONS AND USES

Octanate 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 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.

Octanate 1000 IU/10 ml | DOSAGE

Dosage for the prevention of bleeding: If you suffer from severe haemophilia A you should inject 20 to 40 IU of factor VIII per kg body weight every two or three days for 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 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. It is 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.

Octanate 1000 IU/10 ml | DRUG INTERACTIONS

No interactions of Moroctocog alfa (AF-CC) (r-DNA origin) with other medicinal products have been reported.

Octanate 1000 IU/10 ml | SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Even though rare (may affect up to 1 in 1,000 people), hypersensitivity or allergic reactions have been observed in patients treated with factor VIII containing products. Contact your doctor if you suffer from the symptoms: being sick (vomiting), burning and stinging at the infusion site, chest tightness, chills, faster heart beat (tachycardia), feeling sick (nausea), feeling of pins and needles (tingling), flushing, headache, hives (urticaria), low blood pressure (hypotension), rash, restlessness, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), tiredness (lethargy), wheezing. In very rare (may affect up to 1 in 10,000 people) cases, 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 this case please contact your doctor immediately or call for an ambulance.

Octanate 1000 IU/10 ml | USE DURING PREGNANCY AND LACTATION

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Octanate 1000 IU/10 ml | PRECAUTIONS & WARNINGS

In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. It is strongly recommended that every time Moroctocog alfa (AF-CC) (r-DNA origin) is administered to a patient, the name on the carton and batch number of the product are recorded in order to maintain a link between the patient and the batch number of the medicinal product. Patients can affix one of the peel-off labels found on the vial or prefilled syringe to document the batch number in their diary or for reporting any side effects

Octanate 1000 IU/10 ml | THERAPEUTIC CLASS

Anti-fibrinolytic drugs

Octanate 1000 IU/10 ml | STORAGE CONDITIONS

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 expiry date refers to the last day of that month. Store at 2°C-8°C. Do not freeze. Keep the vials in the outer carton in order to protect from light. Use the reconstituted solution immediately and for single use only. Do not use this medicine if you notice cloudy or incompletely dissolved solutions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.