Octagam 2.5g/50ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Normal immunoglobulin human

Available from:

Octapharma Ltd

ATC code:

J06BA02

INN (International Name):

Normal immunoglobulin human

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 14050100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAGAM 50 MG/ML, 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 50 MG/ML IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAGAM 50 MG/ML
3. HOW TO USE OCTAGAM 50 MG/ML
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OCTAGAM 50 MG/ML
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT OCTAGAM 50 MG/ML IS AND WHAT IT IS USED FOR
WHAT OCTAGAM 50 MG/ML IS:
Octagam 50 mg/ml 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 50 mg/ml 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 50 mg/ml has a broad spectrum of antibodies against various
infectious
agents.
WHAT OCTAGAM 50 MG/ML IS USED FOR:
Octagam 50 mg/ml 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.
Page 1 of 9
PACKAGE LEAFLET: Octagam 50 mg/ml, solution for infusion
Octagam 50 mg/ml is used as replacement therapy. There are 3 groups of
replacement
therapy:
-
Patients with inborn deficiency of antibodies (primary
immunodeficiency
syndromes: conge

Summary of Product characteristics

OBJECT 1
OCTAGAM 5%
Summary of Product Characteristics Updated 26-Jun-2017 | Octapharma
Limited
1. Name of the medicinal product
OCTAGAM
50 mg/ml solution for infusion
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One ml contains :
Human normal immunoglobulin* 50 mg
* corresponding to the total protein content of which at least 95% is
human Immunoglobulin G
Distribution of IgG subclasses:
IgG
1
ca. 60%
IgG2
ca. 32%
IgG3
ca. 7%
IgG4
ca. 1%
Maximum IgA content: 200 micrograms/ml
Each vial of 20 ml contains 1g of human normal immunoglobulin.
Each bottle of 50 ml contains 2.5g of human normal immunoglobulin.
Each bottle of 100 ml contains 5g of human normal immunoglobulin.
Each bottle of 200 ml contains 10g of human normal immunoglobulin.
Each bottle of 500 ml contains 25g 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 5.1 – 6.0, 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 p