THROMBOTROL-VF antithrombin III 1000IU powder for injection vial and diluent vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Antithrombin III, Quantity: 1000 IU

Dostupné z:

CSL Behring Australia Pty Ltd

Forma lieku:

Drug delivery system

Zloženie:

Excipient Ingredients:

Spôsob podávania:

Intravenous

Počet v balení:

Glass vial containing 1000 IU Antithrombin III supplied wtih 1 x 20 mL diluent vial

Typ predpisu:

Not scheduled. Not considered by committee

Terapeutické indikácie:

Thromboltrol-VF is indicated in patients with hereditary deficiency of ATIII under the following circumstances. a) Prophylactic administration for the prevention of thrombosis and pulmonary embolism in surgery, pregnancy and childbirth (see PRECAUTIONS: Use in Pregnancy). b) Therapeutic administration in thrombosis or pulmonary embolism.

Prehľad produktov:

Visual Identification: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

1999-04-08

Príbalový leták

Thrombotrol-VF AU CMI 9.00
Page 1 of 4
THROMBOTROL
®
-VF
Antithrombin III Concentrate (Human).
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Thrombotrol
®
-VF. It does not
contain all the available
information.
It does not take the place of
talking to your doctor.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you having
Thrombotrol
®
-VF against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT HAVING THIS MEDICINE,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may
need to read it again.
WHAT
THROMBOTROL
®
-VF IS
USED FOR
This medicine is used to prevent
blood clots in people who have
an inherited deficiency of
antithrombin III in the following
circumstances:
•
before surgery
•
during pregnancy
•
during childbirth.
It can also be used to treat blood
clots in these patients.
This medicine belongs to a
group of medicines called
antithrombotic agents. It works
by increasing antithrombin III
levels and thereby preventing
the formation of blood clots.
Some people have an inherited
deficiency of antithrombin III
and these people may be at risk
of spontaneous thrombosis
(blood clots) or pulmonary
embolism (blood clot which
stops blood circulating through
the lungs). The risk of these
conditions increases with age
and in association with surgery,
pregnancy and childbirth.
Thrombotrol
®
-VF contains a
concentrated form of
antithrombin III which is a
protein normally present in the
blood and prevents the
formation of blood clots.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
BEFORE YOU ARE GIVEN
THROMBOTROL
®
-VF
WHEN YOU MUST NOT
HAVE IT
DO NOT HAVE THROMBOTROL
®
-VF
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
antithrombin III
•
any of the ingredients listed
at the end of this leaflet
•
any other similar medicines.
Some of the symptoms of an
allergic reaction may include:
•
shortness

Súhrn charakteristických

Thrombotrol-VF AU PI 10.00
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
THROMBOTROL
®
-VF (
ANTITHROMBIN III CONCENTRATE (HUMAN)
)
1
NAME OF THE MEDICINE
Antithrombin III Concentrate (Human).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thrombotrol
®
-VF is a sterile, freeze-dried preparation of purified human
antithrombin III
(ATIII).
Thrombotrol
®
-VF is manufactured from human plasma collected by Australian Red
Cross
Lifeblood. Each vial of Thrombotrol
®
-VF contains 1000 International Units (IU) of ATIII.
The potency assignment has been determined with a standard calibrated
against a
World Health Organisation (WHO) Antithrombin III reference
preparation.
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 (Water for Injections): clear, colourless
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Thrombotrol
®
-VF is indicated in patients with
hereditary deficiency of ATIII under the
following circumstances:
a)
Prophylactic administration for the prevention of thrombosis and
pulmonary embolism in
surgery, pregnancy and childbirth (see section 4.6 Fertility,
Pregnancy and Lactation; Use
in Pregnancy).
b)
Therapeutic administration in thrombosis or pulmonary embolism.
Thrombotrol-VF AU PI 10.00
Page 2 of 11
4.2
D
OSE AND METHOD OF ADMINISTRATION
Each vial of Thrombotrol
®
-VF nominally contains 1000 IU of ATIII.
An individual patient’s dose should be determined using the
pre-treatment and desired plasma
ATIII levels, according to the following formula:
Dose required (IU)
=
[desired - pre-treatment ATIII level*] x weight (kg)
2.2
*expressed as % normal level based on functional ATIII assay.
The above formula is based on an expected incremental
_in vivo_
recovery above baseline
levels for ATIII of 2.2% per IU per kg administered. Thus, if a 70 kg
individual has a
pre-treatment ATIII level of 57%, in order to increase plasma ATIII to
120%, the initial
Thrombotrol
®
-VF dose required would be [(120 - 57