Haemocomplettan^® P

Therapy and prophylaxis of haemorrhagic diatheses in:

• Congenital hypo-, dys- or afibrinogenaemia
• Acquired hypofibrinogenaemia resulting from
• disorders of synthesis in cases of severe liver parenchyma damage
• increased intravascular consumption e.g. as a result of disseminated intravascular coagulation, hyperfibrinolysis
• increased blood loss

Haemocomplettan® P is presented as a powder for solution for injection or infusion for intravenous administration containing 1g or 2g human fibrinogen per vial.

The product contains 20 mg/ml human fibrinogen after reconstitution with 50 ml water for injections for Haemocomplettan® P 1g or 100 ml water for injections for Haemocomplettan® P 2g.

PROPHYLAXIS¹

To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to raise fibrinogen levels to 1 g/l and maintain fibrinogen at this level until haemostasis is secure and above 0.5 g/l until wound healing is complete.

TREATMENT OF BLEEDING¹

Adult

Perioperative                   : 2g or 30mg/kg body weight
Severe Haemorrhage    : 4-8g may be required

Pediatric                          

Dosage should be determined according to the body weight and clinical need.

There is a risk of thrombosis when patients with congenital deficiency are treated with human fibrinogen, particularly with high dose or repeated dosing. Patients given human fibrinogen should be observed closely for signs or symptoms of thrombosis. In patients with a history of coronary heart disease or myocardial infarction, in patients with liver disease, in peri- or post-operative patients, in neonates, or in patients at risk of thromboembolic events or disseminated intravascular coagulation, the potential benefit of treatment with human plasma fibrinogen should be weighed against the risk of thromboembolic complications. Caution and close monitoring should also be performed. If allergic or anaphylactic-type reactions occur, the injection/ infusion should be stopped immediately. In case of anaphylactic shock, standard medical treatment for shock should be implemented. In the case of replacement therapy with coagulation factors in other congenital deficiencies, antibody reactions have been observed, but there is currently no data with fibrinogen.

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Haemocomplettan^® P is supported by >27 years of post-marketing safety data.

• Low risk of adverse drug reactions (1 case per 6,200 standard doses of 4 g)
• Low risk of developing thromboembolic events (1 case per 23,300 standard doses of 4 g)
• No confirmed case of viral transmission due to Haemocomplettan^® P

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