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Administration of Berinert
®
to patients with C1-INH de-
ficiency replaces the missing or malfunctioning protein in
patients to treat the fundamental cause of HAE symptoms.
For more on the pharmacology and mechanism of action
of C1-INH, see chapter 7.
4.0 Berinert
®
Product Description
Chapter 4 Highlights
•
Berinert
®
is a purified, pasteurized, virus
filtered (nanofiltred), lyophilized concentrate
of human C1-INH.
•
Berinert
®
treats the fundamental cause of
HAE symptoms by replacing the missing
or malfunctioning C1-INH.
•
Berinert
®
has a quick onset of action (short
time to maximum plasma concentration is
observed) that is consistent with the rapid
onset of clinical efficacy in patients suffering
from HAE attacks and a long half-life.
•
The risk of recurrent angioedema symptoms
is minimal after treatment with Berinert
®
.
Redosing is generally not needed; 99% of
attacks are treated effectively with a single
dose of Berinert
®
.
•
Berinert
®
is contraindicated in individuals
who have had an anaphylactic or severe
systemic reaction to C1-INH preparations.
•
In more than half a million treatments
worldwide, no proven case of infection
due to
Human immunodeficiency virus
types 1 or 2 (HIV-1/2),
Hepatitis A virus
(HAV),
Hepatitis B virus
(HBV),
Hepatitis C virus
(HCV), or
Parvovirus B19
(B19V) has been
reported with the use of Berinert
®
.
4.1 Pharmacology: Replacing the C1-INH Protein
Berinert
®
is a purified, pasteurized, virus filtered (nanofiltred),
lyophilized concentrate of human C1-INH to be reconstituted
for intra-venous administration for:
•
Hereditary angioedema type I and II (HAE)
•
Treatment and pre-procedure prevention of acute
episodes.
Product Description
