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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.
Themeasures 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 adminis-
tered 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.
4.5 Interaction with other medicinal products and other
forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data that indicate no increased
risk from the use of Berinert in pregnant women. Berinert is a
physiological component of human plasma. Therefore, no studies
on reproduction and developmental toxicity have been performed
in animals and no adverse effects on fertility, pre- and postnatal
development are expected in humans. Therefore, Berinert should
be given to a pregnant woman only if clearly needed.
Breastfeeding
It is unknown whether Berinert is excreted in human milk,
but due to its high molecular weight, the transfer of Berinert
into breast milk seems unlikely. However, breastfeeding is
questionable in women suffering from hereditary angioedema.
A decision must be made whether to discontinue breastfeeding
or to discontinue the Berinert therapy taking into account the
benefit of breastfeeding for the child and the benefit of therapy
for the woman.
Fertility
Berinert is a physiological component of human plasma.
Therefore, no studies on reproduction and developmental toxicity
have been performed in animals and no adverse effects on
fertility, pre- and postnatal development are expected in humans.
4.7 Effects on ability to drive and use machines
Berinert has no or negligible influence on the ability to drive
and use machines.
4.8 Undesirable effects
The following adverse reactions are based on post marketing
experience as well as scientific literature.
Organ class
Very common Common Uncommon
Rare
Very rare
Vascular disorders
Development of thrombosis*
General disorders
and administration
site conditions
Rise in temperature,
reactions at the injection side
Immune system
disorders
Allergic 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.
