Gammaplex 5g/100ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Normal immunoglobulin human

Available from:

Bio Products Laboratory 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; GTIN: 5019943000041

Patient Information leaflet

VSL10
–
Keep this leaflet. You may need to read it again.
–
If
you
have
any
further
questions,
ask
your
doctor,
pharmacist or nurse.
–
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT GAMMAPLEX
® IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GAMMAPLEX
®
3. HOW TO USE GAMMAPLEX
®
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE GAMMAPLEX
®
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT GAMMAPLEX
® IS AND WHAT IT IS USED FOR
Gammaplex
®
is a solution containing the active substance
called human normal immunoglobulin (a protein in the body
used to fight infections) which is obtained from blood plasma
from
screened
donors.
These
donors
are
selected
from
carefully screened and healthy donors from the USA. The
product is given by injection into a vein (intravenous infusion).
It can be given in a hospital or for use at home and is only
available on a doctor’s prescription.
Gammaplex
®
is used to treat several illnesses. Your doctor
will advise you what you are receiving Gammaplex
®
for. This
medicine is used to replace antibodies which are missing from
your body in primary antibody deficiencies (lack of certain
proteins protective against infection that you may either have
been born with or may develop during life) such as:
–
agammaglobulinaemia (deficiency of gamma globulins in
the blood),
–
hypogammaglobulinaemia (low levels of immunoglobulin
G (IgG), with or without low IgA and/or IgM),
–
common variable immunodeficiency (failure of the immune
system to produce antibodies against infections),
–
severe
combined
immunodeficiency
(a
severe
genetic
disorder of the immune system making you susceptible to
infections),
–
Wiskott Aldrich syndrome (hereditary disorder with signs
of eczema, recur

Summary of Product characteristics

OBJECT 1
GAMMAPLEX, A STERILE LIQUID OF 5% W/V NORMAL
IMMUNOGLOBULIN
Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Gammaplex is a sterile liquid of 5 % w/v normal immunoglobulin.
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One mL contains: Human normal immunoglobulin 50 mg (purity of at least
95% IgG).
Each 2.5 g vial of 50 mL contains: 2.5 g of human normal
immunoglobulin.
Each 5 g vial of 100 mL contains: 5 g of human normal immunoglobulin.
Each 10 g vial of 200 mL contains: 10 g of human normal
immunoglobulin.
Each 20 g vial of 400 mL contains: 20 g of human normal
immunoglobulin.
Distribution of the IgG subclasses (approximate values):
IgG1
62 %
IgG2
31 %
IgG3
6 %
IgG4
1 %
The maximum IgA content is 10 micrograms per mL (typically ~4
micrograms per mL).
Produced from the plasma of human donors.
Excipients
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gammaplex is a colourless sterile liquid for intravenous
administration.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents 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 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
4.2 Posology and method of administration
Replac