Berinert 2000 IU Powder and solvent for solution for injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

C1 Esterase Inhibitor (Human)

Disponível em:

CSL Behring GmbH

Código ATC:

B06AC01

DCI (Denominação Comum Internacional):

C1 Esterase Inhibitor (Human)

Dosagem:

2000 international unit(s)

Forma farmacêutica:

Powder and solvent for solution for injection

Área terapêutica:

c1-inhibitor, plasma derived

Status de autorização:

Not marketed

Data de autorização:

2021-08-27

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
BERINERT 2000
2000 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
under the skin.
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 prevention of recurrent hereditary angioedema
(HAE) attacks in
adolescent and adult patients. 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 sections contain

Características técnicas

Health Products Regulatory Authority
01 February 2022
CRN00CJFD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Berinert 2000 IU Powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human C1-esterase inhibitor (from human plasma)
subcutaneous (s.c.)
Berinert 2000 contains 2000 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 2000 contains 500 IU/ml human C1-esterase inhibitor after
reconstitution with 4 ml water for injections.
The total protein content of the reconstituted 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
Berinert for subcutaneous injection is indicated for prevention of
recurrent Hereditary Angioedema (HAE) attacks in adolescent
and adult patients with C1-esterase inhibitor deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Berinert is intended for self-administration by subcutaneous
injection. The patient or care giver should be trained on how to
administer Berinert as needed.
Posology
The recommended dose of Berinert s.c. is 60 IU/kg body weight twice
weekly (every 3-4 days)
PAEDIATRIC POPULATION
Posology in adolescents is the same as in adults.
Method of administration
Subcutaneous injection only
For instructions on reconstitution of the medicinal product before
administration see section 6.6.
The suggested site for the subcutaneous injection of Berinert is the
abdominal area. In the clinical trials, Berinert was injected
into a single site.
The reconstituted preparation should be administered by subcutaneous
injection at a rate tolerated by the patient.
Health Products Regulatory Autho