Berinert 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.
Unlicensed use or treatment of Capillary Leak Syndrome (CLS) with Berinert (see also Adverse Reactions) 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.
Home-treatment and self-administration: There are limited data on the use of this medicinal product in home-treatment or self-administration. Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse drug reactions, particularly hypersensitivity. The decision on the use of home-treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Virus safety: Standard 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, HCV and for the non-enveloped viruses HAV and parvovirus B19.
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.
Effects on ability to drive and use machines: Berinert has no or negligible influence on the ability to drive and use machines.