Drug Description
Active substance: C1-esterase inhibitor, humanBerinert contains 500 units C1-esterase inhibitor per injection vial. 1 U is equivalent to the C1-esterase inhibitor activity in 1 ml of fresh citrated plasma of healthy donors, 1 U is equivalent to 6 Levy-Lepow units.The product contains 50 U/ml C1-esterase inhibitor after reconstitution with 10 ml water for injections.The total protein content of the reconstituted solution is 6.5 mg/ml.Excipients recognized to have a known effect:Sodium up to 486 mg (approximately 21 mmol) per 100 ml solution
Presentation
Powder (white lyophilisate) and solvent for solution for injection / infusion.
Indications
Hereditary angioedema type I and II (HAE)Treatment of acute episodes
Adult Dosage
Treatment should be initiated under the supervision of a physician experienced in the treatment of C1-esterase inhibitor deficiency.Posology20 units per kilogram body weight (20 U/kg b.w.)Dosage for neonates, infants and childrenThe dose for children is 20 units per kilogram body weight (20 U/kg b.w.).Method of administrationBerinert is to be reconstituted according to section 6.6. The reconstituted solution is to be administered by slow i.v. injection or infusion.
Contra Indications
Known hypersensitivity to any of the components of the product.
Special Precautions
In patients with known tendency towards allergies, antihistamines and corticosteroids should be administered prophylactically.If allergic or anaphylactic-type reactions occur, the administration of Berinert has to be stopped immediately (e.g. discontinue injection/infusion) and an appropriate treatment has to be initiated. Therapeutic measures depend on the kind and severity of the undesirable effect. The current medical standards for shock treatment are to be observed.Patients with laryngeal oedema require particularly careful monitoring with emergency treatment in stand-by.Unlicenced use or treatment of Capillary Leak Syndrome (CLS) with Berinert (see also section "4.8 Undesirable effects") is not advised.Berinert contains up to 486 mg sodium (approximately 21 mmol) per 100 ml solution. To be taken into consideration by patients on a controlled sodium diet.Virus safetyStandard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).Appropriate vaccination (hepatitis A and B) should be generally considered for patients in regular/repeated receipt of human plasma-derived products.It is strongly recommended that every time Berinert is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Interactions
No interaction studies have been performed.
Adverse Reactions
The following adverse reactions are based on post marketing experience as well as scientific literature. The following standard categories of frequency are used:Very common: 1/10Common: 1/100 and < 1/10Uncommon: 1/1,000 and < 1/100Rare: 1/10,000 and < 1/1,000Very rare: < 1/10,000 (including reported single cases)Undesired reactions with Berinert are rare.Organ ClassVery commonCommonUncommonRareVery RareVascular disordersDevelopment of thrombosis*General disorders and administration site conditionsRise in temperature, reactions at the injection sideImmune system disordersAllergic or anaphylactic-type reactions (e.g. tachycardia, hyper- or hypotension, flushing, hives, dyspnoea, headache, dizziness, nausea)Shock* In treatment attempts with high doses of Berinert for prophylaxis or therapy of Capillary Leak Syndrome (CLS) before, during or after cardiac surgery under extracorporal circulation (unlicensed indication and dose), in single cases with fatal outcome.
Manufacturer
CSL Behring UK Limited
Updated
23 April 2009
