Berinert 500IU Powder and solvent for solution for injection /infusion

Pajjiż: Malta

Lingwa: Ingliż

Sors: Malta Medicines Authority

Ingredjent attiv:

C, ESTERASE INHIBITOR, HUMAN

Disponibbli minn:

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

Kodiċi ATC:

B06AC01

INN (Isem Internazzjonali):

C1-ESTERASE INHIBITOR, HUMAN 500 IU

Għamla farmaċewtika:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Kompożizzjoni:

C1-ESTERASE INHIBITOR, HUMAN 500 IU

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

OTHER HEMATOLOGICAL AGENTS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2017-01-10

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BERINERT 500 IU
Powder and solvent for solution for injection / infusion.
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 or
infusion into a vein.
Berinert is made from human plasma (this is the liquid part of the
blood). It contains the human
protein 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

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Berinert
500
500IU
Powder and solvent for solution for injection / infusion.
Berinert 1500
1500 IU
Powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human C1-esterase inhibitor (from human plasma)
Berinert 500 contains 500 IU per injection vial.
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 500 contains 50 IU/ml human C1-esterase inhibitor after
reconstitution with 10 ml
water for injections.
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 500 IU solution is 6.5
mg/ml.
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
Berinert 500:
Powder and solvent for solution for injection / infusion.
Berinert 1500:
Powder and solvent for solution for injection.
White Powder.
Clear, colourless Solvent.
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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 angioedem