Gammaplex 10%100 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human normal immunoglobulin

Available from:

BPL Bioproducts Laboratory GmbH

ATC code:

J06BA; J06BA02

INN (International Name):

Human normal immunoglobulin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

Authorization status:

Not marketed

Authorization date:

2018-07-06

Summary of Product characteristics

Health Products Regulatory Authority
13 June 2019
CRN008ZGQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gammaplex 10%100 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg).
One ml contains 100 mg human normal immunoglobulin (purity of at least
98% IgG).
Each vial of 50 ml contains 5 g of human normal immunoglobulin.
Each vial of 100 ml contains 10 g of human normal immunoglobulin. Each
vial of 200 ml contains 20 g of human normal
immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1 ……… 63%
IgG2 ……… 31%
IgG3 ……… 5%
IgG4 ……… 1%
The maximum IgA content is <20 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear or slightly opalescent and colourless or pale
yellow (see section 6.6).
The pH of the solution is 4.9 – 5.2, the osmolality is not less than
240 mOsmol/kg and typically 280 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, 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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
He