Europe — EMA
Haemoctin
Haemoctin is an intravenous human factor VIII solution for hemophilia A treatment. Find indications, safety profile, and usage guidelines.
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What is Human Coagulation Factor Viii?
Haemoctin is a prescription solution for injection containing human coagulation factor VIII, supplied as a sterile intravenous preparation. It is used to replace deficient factor VIII in patients with hemophilia A or acquired factor VIII deficiency. The product is manufactured in the European Union and is classified as a coagulation factor drug. It is indicated for both prophylactic and on‑demand therapy and is administered under medical supervision.
What is Human Coagulation Factor Viii used for?
Haemoctin is indicated for the management of bleeding disorders related to factor VIII deficiency.
- Treatment of bleeding episodes in patients with congenital hemophilia A. - Routine prophylaxis to prevent spontaneous joint and muscle bleeds in hemophilia A. - Management of peri‑operative hemostasis for surgical procedures in hemophilia A patients. - Control of bleeding in acquired hemophilia A associated with autoantibodies. - Adjunct therapy for patients undergoing invasive dental or minor surgical interventions.
What are the side effects of Human Coagulation Factor Viii?
The safety profile of Haemoctin reflects the typical reactions observed with factor VIII replacement products.
Common: - Mild headache or fatigue. - Low‑grade fever. - Localized injection site erythema or swelling. - Transient increase in liver enzymes. - Nausea or mild abdominal discomfort.
Serious: - Development of inhibitors (neutralizing antibodies) to factor VIII. - Anaphylactic or severe allergic reactions. - Thromboembolic events, including deep‑vein thrombosis. - Disseminated intravascular coagulation (rare). - Severe hemolysis or renal impairment.
What precautions apply to Human Coagulation Factor Viii?
Clinicians should consider several precautions when prescribing Haemoctin.
- Assess for a history of inhibitors to factor VIII before initiating therapy. - Monitor for signs of allergic reaction, especially during the first infusion. - Use caution in patients with a history of thrombotic events or cardiovascular disease. - Evaluate liver and renal function periodically during long‑term treatment. - Avoid concurrent use with other pro‑coagulant agents unless medically justified. - Educate patients on proper storage and handling of the injectable solution.
What does Human Coagulation Factor Viii interact with?
Potential drug interactions with Haemoctin should be reviewed before treatment.
Avoid: - Concurrent administration of high‑dose activated pro‑thrombin complex concentrates, which may increase thrombotic risk. - Use of antifibrinolytic agents (e.g., tranexamic acid) without medical supervision in patients with known inhibitors.
Use with caution: - Immunosuppressive therapies that could affect inhibitor development. - Concomitant use of other clotting factor concentrates. - Medications that alter hepatic metabolism, such as certain antivirals. - Vaccines administered intramuscularly, which may increase bleeding risk at the injection site.
Frequently asked questions
What is the active ingredient in Haemoctin?+
For which condition is Haemoctin primarily prescribed?+
How is Haemoctin administered?+
Can Haemoctin be used for surgical prophylaxis?+
What are common side effects of Haemoctin?+
What serious adverse reactions should be monitored?+
Should patients be screened for inhibitors before starting Haemoctin?+
Is Haemoctin safe for use during pregnancy?+
What precautions are needed for patients with a history of thrombosis?+
Are there any drug interactions that require avoidance?+
How should Haemoctin be stored?+
Can Haemoctin be used in pediatric patients?+
Product details
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