ATryn

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Antithrombin alfa

Saatavilla:

Laboratoire Francais du Fractionnement et des Biotechnologies

ATC-koodi:

B01AB02

INN (Kansainvälinen yleisnimi):

antithrombin alfa

Terapeuttinen ryhmä:

Antithrombotic agents

Terapeuttinen alue:

Antithrombin III Deficiency

Käyttöaiheet:

ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2006-07-28

Pakkausseloste

18
B. PACKAGE LEAFLET
Medicinal product no longer authorised
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATRYN 1750 IU POWDER FOR SOLUTION FOR INFUSION
antithrombin alfa (rDNA)
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ATryn is and what it is used for
2.
What you need to know before you use ATryn
3.
How to use ATryn
4.
Possible side effects
5.
How to store ATryn
6.
Contents of the pack and other information
1.
WHAT ATRYN IS AND WHAT IT IS USED FOR
ATryn contains antithrombin alfa which is similar to the naturally
occurring human antithrombin. In the
body, antithrombin blocks thrombin, a substance that plays a central
role in the process of blood clotting.
If you have an inborn deficiency of antithrombin, your blood level of
antithrombin is lower than normal.
This may result in a higher tendency to form clots in your blood
vessels. This may be in the vessels of your
legs (deep vein thrombosis) or in other vessels of your body
(thromboembolism). Around major surgical
procedures this tendency to clot is even more increased. Therefore, it
is important that your antithrombin
blood level be maintained at sufficient levels in these situations.
This medicine is used in patients who have ‘congenital antithrombin
deficiency’ (inherited low levels of the
protein antithrombin). It is used when the patients are having
surgery, to prevent problems due to the
formation of blood clots in the vessels. It is normally given in
association with heparin or l

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
ATryn 1750 IU powder for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains nominally 1750 IU* antithrombin alfa**.
After reconstitution, 1 ml of solution contains 175 IU antithrombin
alfa.
The specific activity of ATryn is approximately 7 IU/mg protein.
* potency (IU) determined using European Pharmacopoeial chromogenic
assay.
** recombinant human antithrombin produced in the milk of transgenic
goats by recombinant DNA
technology (rDNA).
Excipient with known effect
This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for infusion
The powder is white to off-white.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATryn is indicated for the prophylaxis of venous thromboembolism in
surgery of adult patients with
congenital antithrombin deficiency. It is normally given in
association with heparin or low molecular weight
heparin.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of patients
with congenital antithrombin deficiency.
Posology
Due
to
differences
in
pharmacokinetics
of antithrombin
alfa
and
plasma-derived
antithrombin,
treatment
s h o u l d
f o l l o w
t h e
s p e c i f i c
dose
r e c o m m e n d a t i o n s
d e s c r i b e d
b e l o w .
I n
t h e
t r e a t m e n t
o f
c o n g e n i t a l
antithrombin deficiency, the dose and duration of treatment should be
individualised for each patient taking
into account the family history with regard to thromboembolic events,
the actual clinical risk factors, and the
labor