Octanate belongs to a group of medicines known as clotting factors. It contains human coagulation factor VIII, a special protein essential for blood clotting.Octanate is used to treat and prevent bleeding in patients with hemophilia A — a hereditary condition caused by a lack of factor VIII in the blood. In this condition, bleeding may last longer than normal due to the inability of the blood to clot properly.

Dosage for prevention of bleeding: In patients with severe haemophilia A, inject 20–40 IU of factor VIII per kg body weight every 2–3 days for long-term prophylaxis. The dose should be adjusted according to individual response; shorter intervals or higher doses may be required in some cases.

Dosage calculation: The exact dose depends on the patient’s body weight and the desired factor VIII level. Factor VIII activity is expressed as a percentage of normal plasma or in International Units (IU/dL). One IU/kg increases plasma factor VIII level by approximately 2% (or 2 IU/dL). To determine the required dose, measure the current plasma level and calculate accordingly. Always consult a physician if unsure about dose calculation or required increase in factor VIII levels.

Before and during factor VIII injection, monitor the patient’s pulse rate. If a significant increase in pulse occurs, reduce the injection speed or temporarily stop the infusion. After reconstitution, follow proper aseptic technique:

• Remove the protective cap from the filter needle and puncture the vial stopper
• Draw the solution into the syringe
• Clean the injection site with an alcohol swab
• Remove the filter needle and attach the injection needle
• Inject slowly into the vein at a rate of 2–3 mL per minute
• If a tourniquet is used, release it before starting the injection

If part of the dose remains unused, it should be discarded. Do not reuse the same injection needle or syringe. Always use the provided filter needle when drawing the solution. Using improper equipment may increase risks and reduce treatment effectiveness.

No interactions between Moroctocog alfa (AF-CC) (of recombinant DNA origin) and other medications have been reported.

Hypersensitivity to the active substance or any of the excipients. Known allergy to hamster protein.

Like all medicines, this product may cause side effects, although not everyone experiences them. Even though rare (up to 1 in 1,000 people), hypersensitivity or allergic reactions have been reported in patients receiving factor VIII-containing products.

Contact your doctor if you experience symptoms such as vomiting, burning or stinging at the infusion site, chest tightness, chills, rapid heartbeat (tachycardia), nausea, tingling sensation, flushing, headache, hives (urticaria), low blood pressure (hypotension), rash, restlessness, swelling of the face, lips, mouth, tongue or throat (angioedema), fatigue, or wheezing.

In very rare cases (up to 1 in 10,000 people), these reactions may progress to severe, life-threatening anaphylaxis, which may include shock along with the above symptoms. In such situations, seek immediate medical attention or call emergency services.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

To ensure proper traceability of biological medicinal products, the name and batch number of the administered product should be accurately recorded. It is strongly recommended that each time Moroctocog alfa (AF-CC) (r-DNA origin) is given, both the product name and batch number are documented to maintain a clear link between the patient and the specific batch used.Patients may use the peel-off labels provided on the vial or prefilled syringe to record the batch number in their personal records or when reporting any side effects.

Anti-fibrinolytic drugs

Keep this medicine out of the sight and reach of children. Do not use after the expiry date 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 to protect them from light. Use the reconstituted solution immediately and for single use only. Do not use if the solution appears cloudy or not fully dissolved. Do not dispose of medicines via wastewater or household waste. Consult your pharmacist for proper disposal methods to help protect the environment.