Antithrombin III Baxalta 50 IU/ml, powder and solvent for solution for injection or infusion - 20ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ANTITHROMBIN III

Available from:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC code:

B01AB02

INN (International Name):

ANTITHROMBIN III 50 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

ANTITHROMBIN III 50 IU

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-01-27

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
ANTITHROMBIN III BAXALTA 50 IU/ML, POWDER AND SOLVENT FOR SOLUTION FOR
INFUSION
Human plasma-derived antithrombin III
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, pharmacist.
-
If you get any side effects, talk to your doctor, pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What ANTITHROMBIN III BAXALTA is and what it is used for
2.
What you need to know before you use ANTITHROMBIN III BAXALTA
3.
How to use ANTITHROMBIN III BAXALTA
4.
Possible side effects
5.
How to store ANTITHROMBIN III BAXALTA
6.
Contents of the pack and other information
1.
WHAT ANTITHROMBIN III BAXALTA IS AND WHAT IT IS USED FOR
ANTITHROMBIN III BAXALTA is presented as pale yellow to pale green
friable solid or powder and
solvent for solution for infusion.
ANTITHROMBIN III BAXALTA is available in pack sizes containing
-
500 IU antithrombin III and 10 ml solvent
-
1000 IU antithrombin III and 20 ml solvent
ANTITHROMBIN III BAXALTA belongs to a pharmacotherapeutic group called
antithrombotic agents.
ANTITHROMBIN III BAXALTA is used for treatment of congenital or
acquired antithrombin III
deficiency, which may be within the framework of a large variety of
clinical disorders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANTITHROMBIN III BAXALTA
DO NOT USE ANTITHROMBIN III BAXALTA
-
If you are hypersensitive (allergic) to antithrombin III or to any of
the other ingredients of
ANTITHROMBIN III BAXALTA.
-
If you have a known history of heparin induced thrombocytopenia (i.e.
a decrease of platelets).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using ANTITHROMBIN III
BAXALTA.
-
Please tell your doctor immediately if you experience first signs of
an allergic reaction (e.g. hives,
generalized urticaria, tightness of the chest, wheezing,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ANTITHROMBIN III BAXALTA 50 IU/ml, powder and solvent for solution for
injection
or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human plasma-derived antithrombin III
ANTITHROMBIN III BAXALTA is presented as lyophilised powder for
injection or
infusion containing nominally 50 IU
*
/ml human plasma-derived ANTITHROMBIN III per
vial.
*
The potency International Unit (IU) is determined using the European
Pharmacopoeial
chromogenic assay. The specific activity of ANTITHROMBIN III BAXALTA
is at least 3
IU AT/mg plasma protein.
500 IU/10 ml
This medicinal product contains approximately 50 IU/ml (500 IU/10 ml)
human plasma-
derived antithrombin III when reconstituted with 10 ml of sterilised
water for injections.
1000 IU/20 ml
This medicinal product contains approximately 50 IU/ml (1000 IU/20 ml)
human plasma-
derived antithrombin III when reconstituted with 20 ml of sterilised
water for injections.
Excipient with known effect
500 IU/10 ml
ANTITHROMBIN III BAXALTA contains 37.7 mg sodium per vial.
1000 IU/20 ml
ANTITHROMBIN III BAXALTA contains 75.5 mg sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection or infusion.
ANTITHROMBIN III BAXALTA is a lyophilised pale yellow to pale green,
friable solid
or a powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Antithrombin deficiency may be congenital or it may be acquired within
the framework of
a large variety of clinical disorders. An acquired deficiency of
antithrombin may be due
either to increased consumption or loss of protein, or to defective
synthesis of antithrombin.
The administration of ANTITHROMBIN III BAXALTA is indicated in
patients with a
plasma antithrombin activity below 70% of normal, for prophylaxis and
treatment of
thrombotic and thromboembolic disorders. Infusions of antithrombin may
be particularly
valuable in the following clinical situations:
-
surgical
procedures,
or
pregnancy
and
deli