Immunate 250 Iu/500 Iu/1000 Iu Solution

IMMUNATE is presented as powder and solvent for solution for injection containing nominally 250 IU (500 IU / 1000 IU) human coagulation factor VIII per vial. The product contains approximately 50 IU/ml (250 IU pack size) or 100 IU/ml (500 IU and 1000 IU pack size) of human coagulation factor VIII and at least 25 U/ml (250 IU pack size) or 50 U/ml (500 IU and 1000 IU pack size) of von Willebrand factor when reconstituted with 5 ml (250 IU and 500 IU pack size) or 10 ml (1000 IU pack size) of Sterilised Water for Injection.

Therapeutic indications:

• Treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency or acquired factor VIII deficiency (haemophilia A, haemophilia A with factor VIII inhibitor, acquired factor VIII deficiency due to spontaneous development of factor VIII inhibitor).
• Treatment of bleeding in patients with Von Willebrand's disease with factor VIII deficiency.

Contraindications:

• Hypersensitivity to the active substance or to any of the excipients.

Warnings:

As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician.

In the case of shock, the current medical standards for shock treatment should be observed. As the quantity of sodium in the maximum daily dose may exceed 200 mg, it may be harmful to people on a low sodium diet.

The formation of neutralising antibodies (inhibitors) to Factor VIII is a known complication in the management of individuals with haemophilia A. The product should be used with caution in children less than 6 years of age, who have limited exposure to factor VIII products, as there is limited clinical data available for this patient group.

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.

Method of administration:

IMMUNATE should be administered slowly via the intravenous route. The rate of administration should be determined, at a rate that ensures the comfort of the patient up to a maximum of 2 ml per minute. IMMUNATE is to be reconstituted only immediately before administration. The solution should then be used immediately (preparation does not contain preservatives).

The undesirable effects reported in the listings hereafter are based on reports from clinical trials and on post-marketing experience for IMMUNATE. Their frequency has been evaluated by using the following criteria: very common (>1/10), common (>1/100, 1/1,000, 1/10,000, <1/1,000) and very rare (<1/10,000).

Immune system disorder:

• Allergic reaction

Post Marketing Experience:

The incidence rate is <1/10,000, i.e. very rare, for all the Adverse Events reported below.

• Antibodies (Inhibitors) to Factor VIII
• Haemolysis in blood group A, B or AB patients
• Angioedema
• Urticaria (Generalised)
• Hives
• Headache
• Restlessness
• Tingling
• Tachycardia
• Flushing
• Hypotension
• Wheezing
• Nausea
• Vomiting
• Burning and stinging at the infusion site
• Chills
• Lethargy
• Tightness of the chest
• Fever
• Therapeutic response decreased

Store at 2 °C to 8 °C. Do not freeze. Store in the original package to protect from light. During the shelf life the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. Record the period of storage at room temperature below the expiration date indicated on the product package. At the end of this period the product should not be put back in the refrigerator but should be used or discarded. IMMUNATE should be administered at room temperature. Stability studies support the stability of the reconstituted product for 3 hours. Nevertheless, from a microbiological viewpoint, the product should be used immediately after reconstitution.