BERINERT

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

C - 1 ESTERASE INHIBITOR HUMAN

Διαθέσιμο από:

CSL BEHRING LTD., ISRAEL

Φαρμακολογική κατηγορία (ATC):

B06AC01

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION FOR INJ/INF

Σύνθεση:

C - 1 ESTERASE INHIBITOR HUMAN 500 IU/VIAL

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

CSL BEHRING GmbH, GERMANY

Θεραπευτική ομάδα:

C1- INHIBITOR,PLASMA DERIVED

Θεραπευτική περιοχή:

C1- INHIBITOR,PLASMA DERIVED

Θεραπευτικές ενδείξεις:

Hereditary angioedema type I and II (HAE).Treatment and pre-procedure (prior to oral, dental, and upper respiratory tract procedures) prevention of acute episodes

Ημερομηνία της άδειας:

2015-12-31

Φύλλο οδηγιών χρήσης

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
’
REGULATIONS (PREPARATIONS) - 1986
This medicine can be sold with a physician's prescription only
BERINERT IS USUALLY INJECTED INTO A VEIN (INTRAVENOUSLY) BY THE
PHYSICIAN OR NURSE. YOU OR
YOUR CARER MIGHT ALSO ADMINISTER BERINERT AS AN INJECTION BUT ONLY
AFTER RECEIVING
ADEQUATE TRAINING. IF YOUR PHYSICIAN DECIDES THAT YOU ARE SUITABLE FOR
HOME-TREATMENT,
DETAILED INSTRUCTIONS WILL BE GIVEN TO YOU. YOU WILL BE REQUIRED TO
KEEP A DIARY IN ORDER TO
DOCUMENT EACH TREATMENT RECEIVED AT HOME AND TO BRING IT TO EACH OF
YOUR VISITS TO THE
PHYSICIAN. REGULAR REVIEW OF YOUR OR
YOUR CARER’S INJECTION TECHNIQUE WILL BE PERFORMED TO
ENSURE CONTINUED APPROPRIATE HANDLING.
BERINERT
®
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION / INFUSION
500 IU
The active ingredient and its quantity:
The vial with the powder contains:
C1 - Esterase Inhibitor Human 500 IU
For list of excipients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
your physician or
pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if you think that their illness is the same as
yours.
1. WHAT IS THE MEDICINE USED FOR?
•
Hereditary angioedema type I and II (HAE)
•
Treatment and pre-procedure (prior to oral, dental, and upper
respiratory tract procedures)
prevention of acute episodes.
Hereditary Angioedema is a congenital, non-allergic disease of the
vascular system.
Hereditary Angioedema is caused by deficiency, absence or defective
synthesis of C1-
esterase inhibitor which is an important protein.
The illness is characterized 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 breathing
difficulties
- tongue swel

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BERINERT
®
500 IU
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION / INFUSION.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: human C1-esterase inhibitor (from human plasma).
Berinert contains 500 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.
The total protein content of the reconstituted 500 IU 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 and solvent for solution for injection / infusion.
White Powder.
Clear, colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hereditary angioedema type I and II (HAE)
Treatment and pre-procedure (prior to oral, dental, and upper
respiratory tract procedures)
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 oral, dental, and upper respiratory
tract procedures.
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 kilogram body weight (15-30 IU/kg b.w.) less than 6
hours prior to oral,
dental, and upper respiratory tract procedures. 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 secti