ATGAM INJECTION 50 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HORSE GAMMA GLOBULIN

Available from:

PFIZER PRIVATE LIMITED

ATC code:

L04AA03

Dosage:

50 mg/ml

Pharmaceutical form:

INJECTION

Composition:

HORSE GAMMA GLOBULIN 50 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Pharmacia & Upjohn Company LLC

Authorization status:

ACTIVE

Authorization date:

1988-05-23

Patient Information leaflet

 
Page 1 of 12 

ATGAM
®

LYMPHOCYTE IMMUNE GLOBULIN, 
ANTI-THYMOCYTE GLOBULIN [EQUINE] STERILE SOLUTION 

FOR INTRAVENOUS USE ONLY 

DESCRIPTION 
ATGAM Sterile Solution contains lymphocyte immune
globulin, anti-thymocyte 
globulin
[equine]. It is the purified, concentrated, and sterile gamma
globulin, 
primarily monomeric IgG, from hyperimmune serum of horses immunized with
human 
thymus lymphocytes. Anti-thymocyte globulin
(equine) is a transparent to slightly 
opalescent aqueous protein
solution. It may appear colorless to faintly pink or brown 
and is nearly odorless. It may develop a
slight granular or flaky deposit during 
storage. (For information about in-line filters, see Infusion Instructions in
the 
POSOLOGY AND METHOD OF ADMINISTRATION.) 

Before release for clinical use, each lot of anti-thymocyte
globulin (equine) is tested 
to assure its ability to inhibit rosette formation between
human peripheral 
lymphocytes and sheep red blood cells _in vitro_. In each
lot, antibody activity against 
human red blood cells and platelets is also measured and determined to be within 
acceptable
limits. Only lots that test negative for antihuman serum protein antibody, 
antiglomerular basement membrane antibody and pyrogens are released. 

Each milliliter of anti-thymocyte globulin
(equine) contains 50 mg of horse gamma 
globulin stabilized in 0.3 molar glycine to a
pH of approximately 6.8. 

PHARMACOLOGICAL PROPERTIES 
PHARMACODYNAMIC PROPERTIES 
ATGAM Sterile Solution is
a lymphocyte-selective immunosuppressant as is 
demonstrated by its ability to
reduce the number of circulating, thymus-dependent 
lymphocytes that form rosettes with
sheep erythrocytes. This antilymphocytic effect is 
believed to reflect an alteration
of the function of the T lymphocytes, which are 
responsible
in part for cell-m

Summary of Product characteristics

ATGAM
®
LYMPHOCYTE IMMUNE GLOBULIN,
ANTI-THYMOCYTE GLOBULIN (EQUINE) STERILE SOLUTION
FOR INTRAVENOUS USE ONLY
DESCRIPTION
ATGAM sterile solution contains lymphocyte immune globulin,
anti-thymocyte globulin (equine). It
is the purified, concentrated, and sterile gamma globulin, primarily
monomeric IgG, from
hyperimmune serum of horses immunized with human thymus lymphocytes.
ATGAM is a transparent
to slightly opalescent aqueous protein solution. It may appear
colorless to faintly pink or brown and is
nearly odorless. It may develop a slight granular or flaky deposit
during storage. (For information
about in-line filters, see POSOLOGY AND METHOD OF ADMINISTRATION,
Administration.)
Before release for clinical use, each lot of ATGAM is tested to assure
its ability to inhibit rosette
formation between human peripheral lymphocytes and sheep red blood
cells
_in vitro_
. In each lot,
antibody activity against human red blood cells and platelets is also
measured and determined to be
within acceptable limits. Only lots that test negative for antihuman
serum protein antibody,
antiglomerular basement membrane antibody and pyrogens are released.
Each milliliter of ATGAM contains 50 mg of horse gamma globulin
stabilized in 0.3 molar glycine to
a pH of approximately 6.8.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
ATGAM sterile solution is a lymphocyte-selective immunosuppressant as
is demonstrated by its
ability to reduce the number of circulating, thymus-dependent
lymphocytes that form rosettes with
sheep erythrocytes. This antilymphocytic effect is believed to reflect
an alteration of the function of
the T lymphocytes, which are responsible in part for cell-mediated
immunity and are involved in
humoral immunity. In addition to its antilymphocytic activity, ATGAM
contains low concentrations
of antibodies against other formed elements of the blood. In rhesus
and cynomolgus monkeys,
ATGAM reduces lymphocytes in the thymus-dependent areas of the spleen
and lymph nodes. It also
decreases the circulating sheep-erythroc