GAMMAGARD SD FOR INJECTION

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

IMMUNOGLOBULIN G

Dostupné s:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC kód:

J06BA02

Dávkování:

48-56 mg/ml

Léková forma:

INJECTION, POWDER, FOR SOLUTION

Složení:

IMMUNOGLOBULIN G 48-56 mg/ml

Podání:

INTRAVENOUS

Druh předpisu:

Prescription Only

Výrobce:

Baxalta US Inc. (Intermediate)

Stav Autorizace:

ACTIVE

Datum autorizace:

1995-12-13

Informace pro uživatele

GAMMAGARD S/D 
IMMUNE GLOBULIN INTRAVENOUS 
(HUMAN) 
IGA LESS THAN 2.2 ΜG/ML IN A 5% SOLUTION  

DESCRIPTION 
GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a
solvent/detergent 
treated, sterile, freeze-dried preparation of highly purified
immunoglobulin G (IgG) derived from 
large pools of human plasma.  The product is manufactured by the
Cohn-Oncley cold ethanol 
fractionation process followed by ultrafiltration and ion exchange
chromatography. 
Source 
material for fractionation may be obtained from another U.S.
licensed 
manufacturer.The manufacturing  process  includes  treatment
with an organic solvent/detergent 
mixture,
1,2
 composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80.
3
    The 
GAMMAGARD S/D manufacturing process provides a significant viral
reduction in _in vitro_ 
studies.
3
  These studies, summarized in Table 1, demonstrate virus clearance
during 
GAMMAGARD S/D manufacturing using infectious human immunodeficiency
virus, Type 1 
(HIV-1); as the relevant virus for HIV-1 and HIV-2, bovine viral
diarrhea virus (BVD); a model 
virus for enveloped RNA viruses such as hepatitis C virus (HCV),
pseudorabies virus (PRV), a 
generic model virus for enveloped DNA viruses such as hepatitis B
virus (HBV); hepatitis A 
virus (HAV) and ; and mice minute virus (MMV), a model for small
non-enveloped DNA 
viruses such as human parvovirus B19 (B19V).
3 
 These reductions are achieved through a 
combination of process chemistry, partitioning and/or
inactivation during cold ethanol 
fractionation and the solvent/detergent treatment.
3 

TABLE 1 
_IN VITRO_ VIRUS CLEARANCE DURING GAMMAGARD S/D 
MANUFACTURING

Process Step Evaluated 
Virus Clearance (log
10
) 
Enveloped Viruses 
Non-Enveloped 
Viruses 
BVD HIV-1  PRV  HAV MMV 
Step 1 
Processing of Cryo-Poor Plasma to 
Fraction I+II+III Precipitate 
0.6* 5.6 1.0* 0.5* NT 
Step 2-3 
Processing of Resuspended 
Suspension A Precipitate to 
S

Charakteristika produktu

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
7.0 pt
NA
CODE ITF 2/5
3069
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
Black
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
LE-07-49040
VERSION: 2
PROFILE: 0400381_1_PIL_Drwg
LE0400381
355 x 600 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
06MAR2020
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
PANTONE 293 C
Swatch
Swatch
Black
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GAMMAGARD S/D
IMMUNE GLOBULIN INTRAVENOUS
(HUMAN)
IGA LESS THAN 2.2 ΜG/ML IN A 5% SOLUTION
DESCRIPTION
GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a
solvent/detergent treated, sterile, freeze-dried preparation of highly
purified
immunoglobulin G (IgG) derived from large pools of human plasma. The
product is manufactured by the Cohn-Oncley cold ethanol fractionation
process followed by ultrafiltration and ion exchange chromatography
steps. The distribution of IgG subclasses present in this product is
similar to that
in normal plasma. The Fc portion is maintained intact. When
reconstituted with the total volume of diluent (Sterile Water for
Injection, USP) supplied,
and reconstituted to 5% solution, the product contains approximately
50 mg/mL of protein, of which at least 90% is gamma globulin.
GAMMAGARD
S/D contains trace amounts of IgA (≤ 2.2 µg/mL in a 5% solution)
and IgM is present in trace amounts. GAMMAGARD S/D contains all of the
IgG
antibody activities which are present in the donor population.
The product, after reconstituted to 5% solution, contains a
physiological concentration of sodium chloride (approximately 8.5
mg/mL) and has a pH of
6.8 ± 0.4. Stabilizing agents and additional components are present
in the following maximum amounts for a 5% solution: 3 mg/mL Albumin
(Human),
22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol
(PEG), 1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100
µg/mL
polysorbate 80. GAMMAGARD S/D contains no preservative.
To prepare a 10%