BERINERT IV human C1 esterase inhibitor 500 IU powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 10 mL

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

C1 esterase inhibitor,water for injections

Pharmaceutical form:

Injection, diluent for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

500 IU

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

BERINERT IV is indicated for the treatment of acute attacks in patients with hereditary angioedema (HAE).

Product summary:

Visual Identification: Clear, colourless fluid; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2010-02-05

Patient Information leaflet

Berinert IV AU CMI 8.00
Page 1 of 8
BERINERT
®
IV
Human C1 esterase inhibitor
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Berinert
®
IV.
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
®
IV
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
® IV IS
USED FOR
This medicine is used for the
treatment of attacks in people
with hereditary angioedema
(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 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.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
BERINERT
®
IV HAS BEEN
PRESCRIBED FOR YOU.
HOW BERINERT
® IV
WORKS
This product is made from
human plasma (this is the liquid
part of the blood). It contains the
human protein C1 esterase
inhibitor as the active
ingredient. It treats the HAE
attack by replacing the missing
or malfunctioning C1

Summary of Product characteristics

Berinert IV AU PI 10.00
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
BERINERT
® IV
(HUMAN C1 ESTERASE INHIBITOR)
1
NAME OF THE MEDICINE
Human C1 esterase inhibitor
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Berinert
®
IV is a highly purified, freeze-dried C1 esterase inhibitor
concentrate derived from
human plasma.
Berinert
®
IV is available in two presentations with different concentrations
(strengths) as
detailed in
TABLE 1
. When reconstituted,
the 500 IU presentation contains 500 IU of
C1 esterase inhibitor per vial at 50 IU/mL and the 1500 IU
presentation contains 1500 IU of
C1 esterase inhibitor per vial at 500 IU/mL.
TABLE 1: BERINERT
® IV PRESENTATIONS
A
PRESENTATION
500 IU
1500 IU
ACTIVE INGREDIENTS (IU/VIAL)
C1 esterase inhibitor
500
1500
RECONSTITUTION VOLUME (ML)
10
3
CONCENTRATION
50 IU/mL
500 IU/mL
TOTAL PROTEIN CONTENT (MG/ML)
6.5
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
®
IV 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
®
IV is produced as a sterile, pyrogen-free, freeze-dried white powder
for intravenous
injection and supplied with Water for Injections (clear, colourless)
for reconstitution.
Berinert IV AU PI 10.00
Page 2 of 19
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Berinert
®
IV is indicated for the treatment of acute attacks in patients with
hereditary
angioedema (HAE).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of C1 esterase inhibitor deficiency.
It is recommended that prescribed doses of Berinert
®
IV should be expressed as International
Units written in full.
Berinert
®
IV is administered intravenously by a doctor or nurse. If self
administration and
home treatment is considered appropriate, refer to the
_SELF ADMINISTRATION AND