Berinert 1500 IU Powder and solvent for solution for injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

C1 Esterase Inhibitor (Human)

Disponible des:

CSL Behring GmbH

Codi ATC:

B06AC01

Designació comuna internacional (DCI):

C1 Esterase Inhibitor (Human)

Dosis:

1500 international unit(s)

formulario farmacéutico:

Powder and solvent for solution for injection

Área terapéutica:

c1-inhibitor, plasma derived

Estat d'Autorització:

Not marketed

Data d'autorització:

2021-08-27

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
BERINERT 1500
1500 IU
Powder and solvent for solution for injection.
Human C1-esterase inhibitor
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Berinert is and what it is used for
2.
What you need to know before you use Berinert
3.
How to use Berinert
4.
Possible side effects
5.
How to store Berinert
6.
Contents of the pack and other information
1.
WHAT BERINERT IS AND WHAT IT IS USED FOR
_WHAT IS BERINERT? _
Berinert is presented as powder and solvent. The made up solution is
to be given by injection into
a vein.
Berinert is made from human plasma (this is the liquid part of the
blood). It contains the protein
human C1-esterase inhibitor as active ingredient.
_WHAT IS BERINERT USED FOR? _
Berinert is used for the treatment and pre-procedure prevention of the
hereditary angioedema type
I and II (HAE, oedema = swelling). HAE is a congenital disease of the
vascular system. It is a
non-allergic disease. HAE is caused by deficiency, absence or
defective synthesis of C1-esterase
inhibitor, an important protein. The illness is characterised by the
following symptoms:
- swelling of the hands and feet that occurs suddenly,
- facial swelling with tension sensation that occurs suddenly
- eyelid swelling, lip swelling, possibly laryngeal (voice-box)
swelling with difficulty in
breathing,
- tongue swelling,
- colic pain in abdominal region
Generally, all parts of the body can be affected.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BERINERT
The following sectio

Fitxa tècnica

Health Products Regulatory Authority
01 February 2022
CRN00CJFD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Berinert 1500 IU Powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human C1-esterase inhibitor (from human plasma)
Berinert 1500 contains 1500 IU per injection vial.
The potency of human C1-esterase inhibitor is expressed in
International Units (IU), which are related to the current WHO
Standard for C1-esterase inhibitor products.
Berinert 1500 contains 500 IU/ml human C1-esterase inhibitor after
reconstitution with 3 ml water for injections.
The total protein content of the reconstituted 1500 IU solution is 65
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 and solvent for solution for injection.
White Powder.
Clear, colourless Solvent.
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:
Health Products Regulatory Authority
01 February 2022
CRN00CJFD
Page 2 of 8
15 to 30 IU per kilogram body 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