Octagam 10% 5g/50ml solution for infusion bottles

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Normal immunoglobulin human

Verfügbar ab:

Octapharma Ltd

INN (Internationale Bezeichnung):

Normal immunoglobulin human

Dosierung:

100mg/1ml

Darreichungsform:

Solution for infusion

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Caution - AMP level prescribing advised

Produktbesonderheiten:

BNF: 14050100; GTIN: 5060237670174

Gebrauchsinformation

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 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 immunodeficiencies)
-
P

Fachinformation

OBJECT 1
OCTAGAM 10%
Summary of Product Characteristics Updated 09-May-2018 | Octapharma
Limited
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.
• 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
• K