RIASTAP human fibrinogen 1g powder for injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Fibrinogen, Quantity: 900 mg

Dostupno od:

CSL Behring Australia Pty Ltd

INN (International ime):

Fibrinogen

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients: sodium citrate; Albumin; arginine hydrochloride; sodium chloride

Administracija rute:

Intravenous Infusion, Intravenous

Jedinice u paketu:

1 g

Tip recepta:

Not scheduled. Not considered by committee

Terapijske indikacije:

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.

Proizvod sažetak:

Visual Identification: White powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Licence status A

Datum autorizacije:

2010-08-09

Uputa o lijeku

RiaSTAP
®
AU CMI 10.00
Page 1 of 6
RIASTAP
®
Human Fibrinogen
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
RiaSTAP
®
.
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 RiaSTAP
®
will
have for you against the possible
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 RIASTAP
®
IS
USED FOR
This medicine is used for the
treatment of acute bleeding in
people with an absence or low
level of human fibrinogen
(congenital lack of fibrinogen).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
RIASTAP
®
HAS BEEN
PRESCRIBED FOR YOU.
HOW RIASTAP
®
WORKS
This product is made from
human plasma (this is the liquid
part of the blood). It contains
human fibrinogen as the active
ingredient. Human fibrinogen is
a protein which is important for
blood clotting (coagulation). If
you have missing or
malfunctioning fibrinogen the
blood does not clot as quickly as
it should which results in an
increased tendency of bleeding.
The replacement of human
fibrinogen with RiaSTAP
®
will
repair the coagulation
mechanisms.
BEFORE YOU ARE GIVEN
RIASTAP
®
WHEN YOU MUST NOT
HAVE IT
DO NOT HAVE RIASTAP
®
IF YOU
ARE ALLERGIC TO:

human fibrinogen

any of the ingredients listed
at the end of this leaflet.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD BE GIVEN THIS
MEDICINE, TALK TO YOUR DOCTOR.
BEFORE YOU ARE GIVEN
IT
TELL YOUR DOCTOR IF YOU:

have had a

Svojstava lijeka

RiaSTAP
®
AU PI 10.00
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
RIASTAP
®
(HUMAN FIBRINOGEN)
1
NAME OF THE MEDICINE
Human fibrinogen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RiaSTAP
®
is a sterile, freeze-dried fibrinogen (coagulation factor I)
concentrate derived from
human plasma.
RiaSTAP
®
is presented as one vial of powder for injection containing 1 g of
human
fibrinogen and one vial of diluent containing 50 mL of Water for
Injections (WFI). The
reconstituted solution contains approximately 20 mg/mL of human
fibrinogen.
RiaSTAP
®
contains up to 164 mg (7.1 mmol) sodium per vial. For the full list of
excipients,
see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection
Powder: white
Diluent (WFI): clear, colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of acute bleeding episodes in patients with congenital
fibrinogen deficiency,
including afibrinogenaemia and hypofibrinogenaemia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of coagulation disorders.
DOSAGE
The dosage and duration of the substitution therapy depend on the
severity of the disorder,
location and extent of bleeding and the patient’s clinical
condition.
RiaSTAP
®
AU PI 10.00
Page 2 of 16
The (functional) fibrinogen level should be determined in order to
calculate individual dosage
and the amount and frequency of administration should be determined on
an individual
patient basis by regular measurement of plasma fibrinogen level and
continuous monitoring
of the clinical condition of the patient and other replacement
therapies used.
Only general dosage guidelines are given below. Normal plasma
fibrinogen level is in the
range of 2.0–4.5 g/L. The critical plasma fibrinogen level below
which haemorrhages may
occur is approximately 1.0 g/L.
Clinical data on the use of RiaSTAP
®
in patients undergoing surgical procedures are very
limited. In case of surgical intervention, precise mo