48
6.2 Shelf Life and Storage
6.3 Preparation and Handling
6.4 Indication, Dosing, and Administration
Berinert
®
is stable for the period indicated by the expira-
tion date on the carton and vial label (up to 30 months).
Berinert
®
should be stored in its original carton until ready
to use, and the carton should be kept closed to protect
Berinert
®
from light. Berinert
®
should not be stored above
25°C and should not be frozen.
Please refer to the chapter 9.2
Summary of Product
Characteristics
for instructions on reconstituting Berinert
®
.
In Europe, Berinert
®
is indicated for the treatment and pre-
procedure prevention of acute angioedema attacks in
adult and pediatric patients with HAE.
For treatment of acute attacks, the recommended dose of
Berinert
®
is 20 IU/kg body weight administered by intra-
venous injection. For pre-procedure prevention, dosing
recommendations are 1,000 IU Berinert
®
for adult patients
and 15 to 30 IU/kg body weight Berinert
®
for pediatric
patients, less than 6 hours prior to a medical, dental, or
surgical procedure.
It is recommended that Berinert
®
be administered by slow
intravenous injection at a rate of 4 mL/minute. Thus, the
infusion takes about 1 minute for every 10 kg (approxi-
mately 22 lbs) of body weight.
Berinert
®
should not be mixed with other medicinal pro-
ducts and should be administered by a separate infusion
line.
Berinert
®
does not contain any preservatives.
Berinert
®
should not be refrigerated after reconstitution.
Once Berinert
®
is reconstituted, it can be kept in the vial at
room temperature for up to 8 hours before use. Partially
used vials should be discarded in accordance with local
require-ments.
Because Berinert
®
contains no preservatives, partial
vials should be used within 8 hours or discarded. Any un-
used product or waste material should be discarded in ac-
cordance with local requirements.
For self-administration with Berinert
®
, the patient is to be
provided with instructions and training for intravenous
injection outside of a clinical setting. The training pro-
gram should cover the aspects of drug storage, reconsti-
tution of lyophilized C1-INH preparation, management
of treatment-associated side effects, keeping of an HAE
diary, and documentation of dose, drug name, and batch
number. Instructions for self-infusion usually include filling
of the syringe under sterile conditions, disinfection of the
injection site, and performing the infusion by peripheral
venous puncture technique.
90
The general recommendations for storage, dosing, and
rate of administration of Berinert
®
also apply for self-
administration.
