BERINERT SC Human C1 esterase inhibitor 2000 IU powder for injection glass vial with diluent vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

C1 esterase inhibitor, Quantity: 2000 IU

Beschikbaar vanaf:

CSL Behring Australia Pty Ltd

farmaceutische vorm:

Injection, diluent for

Samenstelling:

Excipient Ingredients:

Toedieningsweg:

Subcutaneous

Eenheden in pakket:

1

Prescription-type:

Not Scheduled after consideration by Committee

therapeutische indicaties:

Berinert? SC for subcutaneous injection is indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in patients aged 8 years and older with C1 esterase inhibitor deficiency.

Product samenvatting:

Visual Identification: Clear solution; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2018-07-12

Bijsluiter

Berinert SC AU CMI 5.00
Page 1 of 7
BERINERT
®
SC
Human C1 esterase inhibitor
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Berinert
®
SC.
It does not contain all the
available information. If you
require further information
about this medicine or your
treatment generally, or if you
have any questions or are not
sure about something in this
leaflet, consult your doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Berinert
®
SC
will have for you against the
risks.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR. FOLLOW YOUR
DOCTOR’S ADVICE EVEN IF IT IS
DIFFERENT FROM WHAT THIS LEAFLET
SAYS.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
The information in this leaflet is
subject to change.
Please check with your doctor
whether there is any new
information about this medicine
that you should know since you
were last treated.
WHAT BERINERT
®
SC IS
USED FOR
Berinert
®
SC is administered
subcutaneously (under the skin).
When given subcutaneously on
a regular basis, Berinert
®
SC
should prevent or reduce the
number of hereditary
angioedema attacks in patients
aged 8 years and older.
Hereditary angioedema (HAE)
(oedema = swelling) is a
congenital disease of the
vascular system. It is a
non-allergic disease. HAE is
caused by deficiency, absence or
defective production 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.
IF YOU SHOULD EXPERIENCE AN
HAE ATTACK, FOLLOW THE
INSTRUCTIONS YOUR DOCTOR HAS
GIVEN YOU.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
BERINERT
®
SC HAS BEEN
PRESCRIBED FOR YOU.
HO

Productkenmerken

Berinert SC AU PI 5.00
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
BERINERT
®
SC
(HUMAN C1 ESTERASE INHIBITOR)
1
NAME OF THE MEDICINE
Human C1 esterase inhibitor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Berinert
®
SC is a highly purified, freeze-dried C1 esterase inhibitor
concentrate derived from
human plasma.
Berinert
®
SC is available in two presentations which contain 500 IU/mL of C1
esterase
inhibitor when reconstituted as directed (see TABLE 1).
TABLE 1: BERINERT
®
SC PRESENTATIONS
A
PRESENTATION
2000 IU
3000 IU
ACTIVE INGREDIENTS (IU/VIAL)
C1 esterase inhibitor
2000
3000
RECONSTITUTION VOLUME (ML)
4
5.6
CONCENTRATION
500 IU/ML
500 IU/ML
TOTAL PROTEIN CONTENT (MG/ML)
65
65
a
Nominal values.
The potency of C1 esterase inhibitor is expressed in International
Units (IU), which are
related to the current WHO Standard for C1 esterase inhibitor
products.
Berinert
®
SC contains up to 486 mg sodium per 100 mL of solution. For the full
list of
excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Berinert
®
SC is produced as a sterile, pyrogen-free, freeze-dried white powder
for
subcutaneous injection and supplied with Water for Injections (clear,
colourless) for
reconstitution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Berinert
®
SC for subcutaneous injection is indicated for prevention of recurrent
Hereditary
Angioedema (HAE) attacks in patients aged 8 years and older with C1
esterase inhibitor
deficiency.
Berinert SC AU PI 5.00
Page 2 of 17
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that prescribed doses of Berinert
®
SC should be expressed as International
Units written in full.
Berinert
®
SC is intended for self-administration by subcutaneous injection. The
patient or
carer should be trained on how to administer Berinert
®
SC. Refer to the _SELF ADMINISTRATION _
_AND HOME TREATMENT_ section under ADMINISTRATION.
DOSAGE
The recommended dose is 60 IU per kg body weight twice weekly (every 3
–
4 days).
RECONSTITUTION
Reconstitution and withdrawal must be carrie