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1. NAME OF THE MEDICINAL PRODUCT
Berinert
®
500 IU
Powder and solvent for solution for injection/infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: C1-esterase inhibitor, human
Berinert contains 500 IU C1-esterase inhibitor per injection vial.
The potency of C1-esterase inhibitor is expressed in International
Units (IU), which are related to the current WHO Standard for
C1-esterase inhibitor products.
The product contains 50 IU/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 with known effect:
Sodium up to 486 mg (approximately 21 mmol) per 100 ml
solution.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder (white lyophilisate) and solvent for solution for injection /
infusion.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hereditary angioedema type I and II (HAE).
Treatment and pre-procedure prevention of acute episodes.
4.2 Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the treatment of C1-esterase inhibitor deficiency.
Posology
Adults
Treatment of acute angioedema attacks:
20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks:
1000 IU less than 6 hours prior to a medical, dental, or surgical
procedure.
Paediatric Population
Treatment of acute angioedema attacks:
20 IU per kilogram body weight (20 IU/kg b.w.).
Pre-procedure prevention of angioedema attacks:
15 to 30 IU per kilogrambody weight (15-30 IU/kg b.w.) less than
6 hours prior to a medical, dental, or surgical procedure. Dose
should be selected taking into account clinical circumstances
(e.g. type of procedure and disease severity).
Method of administration
Berinert is to be reconstituted according to section 6.6. The
reconstituted solution is to be administered by slow i.v. injection
or infusion (4 ml/minute).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
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 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.
Home-treatment and self-administration
There are limited data on the use of this medicinal product in
home- 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.
Product Information
9.2 EU Summary of Product Characteristics
