LG-OCTAPLAS %v/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HUMAN PLASMA PROTEIN

Available from:

Octapharma Limited

ATC code:

B05AA

INN (International Name):

HUMAN PLASMA PROTEIN

Dosage:

%v/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Blood substitutes and plasma protein fractions

Authorization status:

Authorised

Authorization date:

2001-03-09

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LG-OCTAPLAS, 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 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 LG-octaplas
is and what it is used for
2.
What you need to know before you use LG-octaplas
3.
How to use LG-octaplas
4.
Possible side effects
5.
How to store LG-octaplas
6.
Contents of the pack and other information
1.
WHAT LG-OCTAPLAS IS AND WHAT IT IS USED FOR
LG-octaplas 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).
LG-octaplas helps in case of complex deficiencies of coagulation
factors which can be caused by
severe failure of the liver or massive transfusion. LG-octaplas 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.
LG-octaplas 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 LG-OCTAPL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LG-octaplas, 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).
LG-octaplas is
supplied in seperate 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 LG-octaplas/kg body weight is a
generally accepted starting dose.
This should increase the patient's plasma coagulation factor levels by
approximately
25%.
It is important to monitor the response,
both clinically and with measurement of e.g.
activated partial thromboplastin
time (aPTT), prothrombin time (PT), and/or specific coagulation factor
assays.
Dosage