LG-octaplas, Powder and solvent for solution for infusion

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Human plasma protein

Доступна з:

Octapharma (IP) SPRL

Код атс:

B05AA

ІПН (Міжнародна Ім'я):

Human plasma protein

Фармацевтична форма:

Powder and solvent for solution for infusion

Терапевтична области:

Blood substitutes and plasma protein fractions

Дата Авторизація:

2023-03-10

інформаційний буклет

_LG-octaplas PIL 20230213 _
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PACKAGE LEAFLET: INFORMATION FOR THE USER
LG-OCTAPLAS POWDER AND SOLVENT FOR 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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness 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-OCTAPLAS
DO NOT USE LG-OCTAPLAS:
-
if you ar

Характеристики продукта

Health Products Regulatory Authority
13 March 2023
CRN00CQV1
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
LG-octaplas powder and solvent for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
LG-octaplas is presented as a powder and solvent for solution for
infusion. One vial contains 9 - 14 g of ABO-blood group
specific human plasma proteins. After reconstitution with 190 ml of
solvent, the solution contains 45 - 70 mg/mL ABO-blood
group specific human plasma proteins. LG-octaplas 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
Powder and solvent for solution for infusion.
The powder is friable solid of almost white or slightly yellow colour.
The solvent is a clear and colourless liquid.
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