Berinert 2000IU Powder and solvent for solution for injection

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

C, ESTERASE INHIBITOR, HUMAN

Saadav alates:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC kood:

B06AC01

INN (Rahvusvaheline Nimetus):

C1-ESTERASE INHIBITOR, HUMAN 2000 IU

Ravimvorm:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Koostis:

C1-ESTERASE INHIBITOR, HUMAN 2000 IU

Retsepti tüüp:

POM

Terapeutiline ala:

OTHER HEMATOLOGICAL AGENTS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-01-10

Infovoldik

Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
BERINERT
®
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.
Page
2
of
9
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BERINERT
The foll

Toote omadused

Page
1
of
11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Berinert
2000
2000 IU
Powder and solvent for solution for injection
Berinert 3000
3000 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.
Berinert 3000 contains 3000 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.
Berinert 3000 contains 500 IU/ml human C1-esterase inhibitor after
reconstitution with 5.6 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
Berinert 2000
Powder and solvent for solution for injection
Berinert 3000
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
Page
2
of
11
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 s