Octagam 10% Solution for Infusion 1mg/10ml (20ml vial)

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

IMMUNOGLOBULIN G, HUMAN

から入手可能:

Octapharma (IP) Limited

ATCコード:

J06BA02

INN（国際名）:

IMMUNOGLOBULIN G, HUMAN

医薬品形態:

SOLUTION FOR INFUSION

構図:

IMMUNOGLOBULIN G, HUMAN 100 mg I/ml

処方タイプ:

POM

治療領域:

IMMUNE SERA AND IMMUNOGLOBULINS

認証ステータス:

Authorised

承認日:

2009-08-25

情報リーフレット

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAGAM 10%, SOLUTION FOR INFUSION
Human Normal Immunoglobulin (IVIg)
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 or pharmacist.

This medicine has been prescribed for you. 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 of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Octagam 10% is and what it is used for
2.
What you need to know before you use Octagam 10%
3.
How to use Octagam 10%
4.
Possible side effects
5.
How to store Octagam 10%
6.
Contents of the pack and other information
1
WHAT OCTAGAM 10% IS AND WHAT IT IS USED FOR
WHAT OCTAGAM 10% IS
Octagam
10%
is
a
human
normal
immunoglobulin
(IgG)
solution
(i.e.
solution
of
human
antibodies) for intravenous administration (i.e. infusion into a
vein). Immunoglobulins are normal
constituents of the human body and support the immune defence of your
body. Octagam 10%
contains all IgG activities which are present in the normal
population. Adequate doses of this
medicinal product may restore abnormally low IgG levels to the normal
range.
Octagam 10% has a broad spectrum of antibodies against various
infectious agents.
WHAT OCTAGAM 10% IS USED FOR
Octagam 10% is used
* as replacement therapy in patients who do not have sufficient
amounts of own antibodies.
* in certain inflammatory diseases
* to prevent or treat infections after a bone marrow transplantation
Octagam 10% is used as replacement therapy. There are 3 groups of
replacement therapy:
-
Patients
with
inborn
deficiency
of
antibodies
(primary
immunodeficiency
syndromes:
congenital
agammaglobulinaemia
and
hypogammaglobulinaemia,
common
variable
immunodeficiency, severe combined immunod

製品の特徴

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM 10%,solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)* 100mg/ml
* corresponding to the total protein content of which at least 95% is
human Immunoglobulin
G
Distribution of IgG subclasses:
IgG
1
ca. 60%
IgG
2
ca. 32%
IgG
3
ca. 7%
IgG
4
ca. 1%
Maximum IgA content: 400 micrograms/ml
Each vial of 20 ml contains 2g of human normal immunoglobulin.
Each bottle of 50 ml contains 5g of human normal immunoglobulin.
Each bottle of 60 ml contains 6g of human normal immunoglobulin.
Each bottle of 100 ml contains 10g of human normal immunoglobulin.
Each bottle of 200 ml contains 20g of human normal immunoglobulin.
Produced from plasma of human donors.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
The liquid preparation is clear to slightly opalescent and colourless
to slightly yellow. The pH of the
liquid preparation is 4.5 – 5.0, the osmolality is ≥ 240
mosmol/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS (0-18
YEARS) IN: _

Primary immunodeficiency syndromes with impaired antibody production
(see Section 4.4).

Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic
lymphocytic leukaemia, in whom prophylactic antibiotics have failed.

Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma
patients who have failed to respond to pneumococcal immunisation.
Page 2 of 15

Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation
(HSCT).

Congenital AIDS with recurrent bacterial infections.
_IMMUNOMODULATION IN ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS)
IN: _

Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery
to correct the platelet count.

Guillain Barré syndrome

Kawasaki disease

Chronic inflammat