INTRAGAM P immunoglobulin-normal (human) 30g/500mL for intravenous use injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

normal immunoglobulin, Quantity: 60 mg/mL

Disponible des:

CSL Behring Australia Pty Ltd

Designació comuna internacional (DCI):

normal immunoglobulin

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: maltose; human immunoglobulin A; water for injections

Vía de administración:

Intravenous

Unidades en paquete:

500mL x 1

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Intragam P is indicated in replacement Immunoglobulin G (IgG) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. INDICATIONS AS AT 21 JULY 2000: Replacement IgG therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. Immunomodulatory therapy in: idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; Kawasaki disease. INDICATIONS AS AT 25 FEBRUARY 2003: For replacement immunoglobulin G (IgG) therapy in: Primary immunodeficiency; Myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; Congenital acquired immune deficiency syndrome with recurrent infections. For immunomodulatory therapy in: Idiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; Allogeneic bone marrow transplantation; Kawasaki disease, and; Guillain-Barre Syndrome (GBS).

Resumen del producto:

Visual Identification: A clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

1999-05-28

Fitxa tècnica

Intragam P AU PI 15.00
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
INTRAGAM
® P
(HUMAN NORMAL IMMUNOGLOBULIN)
1
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Intragam
®
P is a sterile, preservative free solution for intravenous infusion
containing 6 g of
human protein and 10 g of maltose in each 100 mL. The solution has a
pH of 4.25. Isotonicity
is achieved by the addition of maltose. At least 98% of the protein
has the electrophoretic
mobility of immunoglobulin G (IgG). At least 90% of the protein is IgG
monomer and dimer.
Based on three preclinical and four clinical batches, the distribution
of IgG subclasses present
in Intragam
®
P is, on the average, 61% IgG
1
, 36% IgG
2
, 3% IgG
3
and 1% IgG
4
. Intragam
®
P
contains only trace amounts of IgA (nominally <0.025 mg/mL).
Intragam
®
P is manufactured from human plasma collected by the Australian Red
Cross
Blood Service.
Excipient of known effect: maltose.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Intragam
®
P is indicated for replacement IgG therapy in:
•
Primary Immunodeficiency Diseases (PID)
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Intragam
®
P is indicated for immunomodulatory therapy in:
•
Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at
high risk of bleeding
or prior to surgery to correct the platelet count
•
Kawasaki disease
•
Guillain-Barré Syndrome (GBS).
Comprehensive evidence-based guidelines describing appropriate
clinical use of intravenous
immunoglobulin in ITP have been published and should be followed
wherever possible to
avoid the inappropriate utilisation of this blood product
1, 2
.
Intragam P AU PI 15.00
Page 2 of 13
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_REPLACEMENT THERAPY _
The optimal dose and frequency of administration of Intragam
®
P must be determined for
each patient
_._
Freedom from recurrent bacterial infections is usually achieved with a
serum
IgG level above