Prescribing information

Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Berinert® 500 IU powder and solvent for solution for injection/infusion, containing human C1-esterase inhibitor 500 IU/vial (50 IU/ml when reconstituted). Berinert® 1500 IU powder and solvent for solution for injection, containing human C1-esterase inhibitor 1500 IU/vial (500 IU/ml when reconstituted). Indications: Hereditary angioedema type I and II (HAE). Treatment and pre-procedure prevention of acute episodes. Dosage and Administration: Treatment should be initiated under the supervision of a physician experienced in the treatment of C1-esterase deficiency. Berinert 500 IU: Slow IV injection/infusion (4ml/minute) only. Berinert 1500 IU: Slow IV injection only. Dose: Treatment of acute angioedema attacks: Adults and Children: 20 IU/kg b.w.; Pre-procedure prevention of angioedema attacks: Adults- 1000IU, Children- 15-30 IU/kg b.w. to be given less than 6 hours prior to a medical, dental or surgical procedure. Dose should be selected taking into account clinical circumstances (e.g. type of procedure and disease severity) Contraindications: Known hypersensitivity to any of the components of the product. Warnings & Special Precautions: In patients with known tendency towards allergies, antihistamines and corticosteroids give prophylactically. Stop administration immediately if allergic or anaphylactic-type reactions occur and initiate appropriate treatment. Observe current medical standards for shock treatment. Patients with laryngeal oedema require particularly careful monitoring with emergency treatment in stand-by. Unlicensed use or treatment of Capillary Leak Syndrome (CLS) is not advised. Contains up to 486 mg sodium (approximately 21 mmol) per 100 ml solution.

Home treatment and self-administration: Home treatment or self-administration can be done at the decision of the treating physician, with appropriate training and review. Virus safety: Standard measures used to prevent infections resulting from medicinal products prepared from human blood or plasma are considered effective for enveloped viruses such as HIV, HBV, HCV and the non-enveloped viruses HAV and parvovirus B19. See SmPC for further details. Pregnancy and Lactation: Limited safety data in human pregnancy. Therefore, use during pregnancy only if clearly indicated. It is unknown whether Berinert is excreted in human breast milk. Undesirable effects: Undesirable reactions with Berinert are rare but include a rise in temperature, injection site reactions, allergic or anaphylactic reactions (e.g. tachycardia, flushing, hyper- and hypo-tension, hives, dyspnoea, headache, dizziness and nausea). Thrombosis has also occurred rarely in attempts to use high doses of Berinert in Capillary Leak Syndrome, with fatal outcome. See SmPC for further details. Legal Category: POM. Basic NHS Price: 500 IU: £467.50, 1500 IU: £1,402.50 Marketing Authorisation Number: Berinert 500 IU: PL 15036 / 0030, Berinert 1500 IU: PL 15036 / 0035 Further information is available from: CSL Behring UK Limited, Haywards Heath, West Sussex, RH16 1AH. Date text last revised: 13 June 2017

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to CSL Behring UK on 01444 447 405.