Anbinex Powder For Injection 500 I.U.

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Human Antithrombin

Dostępny od:

GRIFOLS ASIA PACIFIC PTE. LTD.

Kod ATC:

B01AB02

Dawkowanie:

500 I.U. per 10ml

Forma farmaceutyczna:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Skład:

Human Antithrombin 500 I.U. per 10ml

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

INSTITUTO GRIFOLS, S.A. (manufacturer for lyophilisate)

Status autoryzacji:

ACTIVE

Data autoryzacji:

2009-08-06

Ulotka dla pacjenta

Human antithrombin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human antithrombin. 
Anbinex
®
 is presented as a lyophilised powder containing nominally 500 I.U. or 1000 I.U. human 
plasma-derived antithrombin per vial.
The product contains approximately 500 I.U./10 ml or 1000 I.U./20 ml human plasma-derived 
antithrombin when reconstituted with 10 ml or 20 ml of water for injections.
The  potency  (I.U.)  is  determined  using  the  European  Pharmacopoeial  chromogenic  assay.  The 
specific activity of Anbinex
®
 is at least 5 I.U./mg protein.
For a full list of excipients, see section "List of excipients".
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
Vial containing a white, hygroscopic, friable solid or powder and a syringe pre-filled with water 
for injections.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
-  Patients with congenital deficiency:
a)  Prophylaxis  of  deep  vein  thrombosis  and  thromboembolism  in  clinical  risk  situations 
(especially during surgery or during the peri-partum period), in association with heparin 
if indicated.
b)  Prevention of progression of deep vein thrombosis and thromboembolism in association 
with heparin as indicated.
POSOLOGY AND METHOD OF ADMINISTRATION 
Treatment should be initiated under the supervision of a physician experienced in the treatment 
of patients with deficiency of antithrombin.
Posology
In congenital deficiency, dosage should be individualised for each patient taking into account 
the family history with regard to thromboembolic events, the actual clinical risk factors, and the 
laboratory assessment.
The  number  of  units  of  antithrombin  administered  is  expressed  in  International  Units  (I.U.), 
which are related to the current WHO standard for antithrombin. Anti

Charakterystyka produktu

Human antithrombin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human antithrombin.
Anbinex
®
is presented as a lyophilised powder containing nominally 500 I.U. or
1000 I.U. human
plasma-derived antithrombin per vial.
The product contains approximately 500 I.U./10 ml or 1000 I.U./20 ml
human plasma-derived
antithrombin when reconstituted with 10 ml or 20 ml of water for
injections.
The potency (I.U.) is determined using the European Pharmacopoeial
chromogenic assay. The
specific activity of Anbinex
®
is at least 5 I.U./mg protein.
For a full list of excipients, see section "List of excipients".
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
Vial containing a white, hygroscopic, friable solid or powder and a
syringe pre-filled with water
for injections.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
-
Patients with congenital deficiency:
a)
Prophylaxis of deep vein thrombosis and thromboembolism in clinical
risk situations
(especially during surgery or during the peri-partum period), in
association with heparin
if indicated.
b)
Prevention of progression of deep vein thrombosis and thromboembolism
in association
with heparin as indicated.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment
of patients with deficiency of antithrombin.
Posology
In congenital deficiency, dosage should be individualised for each
patient taking into account
the family history with regard to thromboembolic events, the actual
clinical risk factors, and the
laboratory assessment.
The number of units of antithrombin administered is expressed in
International Units (I.U.),
which are related to the current WHO standard for antithrombin.
Antithrombin activity plasma
is expressed either as a percentage (relative to normal human plasma)
or in International Units
(relative to the International Standard for antithrombin in plasma).
One International Unit (I.U.) of antithrombin activity is equivalent
to that quantity of antithrombin
in one ml of normal