octaplasLG solution for infusion

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

HUMAN PLASMA PROTEIN

Beszerezhető a:

Octapharma (IP) Limited

ATC-kód:

B05AA

INN (nemzetközi neve):

HUMAN PLASMA PROTEIN

Gyógyszerészeti forma:

SOLUTION FOR INFUSION

Összetétel:

HUMAN PLASMA PROTEIN 45-70 mg/ml

Recept típusa:

POM

Terápiás terület:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Engedélyezési státusz:

Authorised

Betegtájékoztató

_ _
_ _
_1/8 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAPLASLG, SOLUTION FOR INFUSION
ABO-blood group specific human plasma proteins
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.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If you get any side effectstalk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What octaplasLG
is and what it is used for
2.
What you need to know before you use octaplasLG
3.
How to use octaplasLG
4.
Possible side effects
5.
How to store octaplasLG
6.
Contents of the pack and other information
1.
WHAT OCTAPLASLG IS AND WHAT IT IS USED FOR
octaplasLG is human plasma pooled and treated for virus inactivation.
Human plasma is the fluid
part of human blood that carries the cells. It contains human plasma
proteins which are important to
maintain normal clotting characteristics and is used the same way as
normal fresh-frozen plasma
(FFP).
octaplasLG
helps in case of complex deficiencies of coagulation factors which can
be caused by
severe failure of the liver or massive transfusion. octaplasLG
may also be given in emergency
situations when a coagulation factor concentrate (such as Factor V or
Factor XI) is not available or
a necessary laboratory diagnosis is not possible.
It may also be given to rapidly reverse the effects of oral
anticoagulants (coumarin or indanedione
type), when vitamin K is insufficient due to impaired liver function
or in emergency situations.
octaplasLG can be given to patients who undergo plasma exchange in
order to restore the
balance of the coagulation factors.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAPLASLG
DO NOT USE OCTAPLASLG:
-
if you are allergic (hypersensitive) to human plasma proteins or any
of the other

Termékjellemzők

_Page 1 of 10 _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
octaplasLG, solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A 200 ml bag contains 9 - 14 g of ABO-blood group specific human
plasma proteins (45 - 70
mg/mL). octaplasLG is supplied in separate presentations according to
the following blood
groups:
Blood group A
Blood group B
Blood group AB
Blood group O
For details about important coagulation factors and inhibitors, see
section 5.1 and table 2.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The frozen solution is (slightly) yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Complex deficiencies of coagulation factors such as coagulopathy due
to severe hepatic
failure or massive transfusion.

Substitution therapy in coagulation factor deficiencies, when a
specific coagulation factor
concentrate (e.g. factor V or factor XI) is not available for use or
in emergency situations
when a precise laboratory diagnosis is not possible.

Rapid reversal of the effects of oral anticoagulants (coumarin or
indanedione type), when
a prothrombin complex concentrate is not available for use or
administration of vitamin K
is insufficient due to impaired liver function or in emergency
situations.

Potentially
dangerous
haemorrhages
during
fibrinolytic
therapy,
using
e.g.
tissue
plasminogen activators, in patients who fail to respond to
conventional measures.

Therapeutic
plasma
exchange
procedures,
including
those
in
thrombotic
thrombocytopenic purpura (TTP).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The dosage depends upon the clinical situation and underlying
disorder, but 12-15 ml
octaplasLG/kg body weight is a generally accepted starting dose. This
should increase the
patient's plasma coagulation factor levels by approximately 25%.
_Page 2 of 10 _
_ _
It is important to monitor the response, both clinically and with
measurement of e.g. activated
partial thromboplastin time (aPTT), prothrombin