Remsima Powder for Concentrate for Solution for Infusion

Pajjiż: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

Infliximab

Disponibbli minn:

CELLTRION HEALTHCARE MALAYSIA SDN. BHD.

INN (Isem Internazzjonali):

Infliximab

Unitajiet fil-pakkett:

100mg mg

Manifatturat minn:

CELLTRION,Inc.

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REMSIMA
®
Infliximab 100mg
Powder for Concentrate for Solution for Infusion
Pharmacotherapeutic group: tumor necrosis alpha
(TNFα) inhibitors
ATC code: L04AB02.
A biosimilar product of Remicade.
FOR INTRAVENOUS ADMINISTRATION
DESCRIPTION: Each vial of the REMSIMA contains 100 mg of infliximab.
REMSIMA Powder for
Concentrate for Solution for Infusion is to be reconstituted with 10
ml of Sterile Water for Injection
and further diluted in 0.9% sodium chloride solution for infusion.
Inactive Ingredients: sodium
dihydrogen
phosphate
monohydrate,
Disodium
hydrogen
phosphate
dihydrate,
sucrose
and
polysorbate
80.
ACTIONS: Infliximab is a chimeric human-murine monoclonal antibody
that binds with high affinity
to both soluble and transmembrane forms of tumor necrosis factor alpha
(TNFα), but not to
lymphotoxin α (TNFβ). Infliximab inhibits the functional activity of
TNFα in a wide variety of
in vitro
bioassays. Infliximab prevents disease in transgenic mice that develop
polyarthritis as a result of
constitutive expression of human TNFα and when administered after
disease onset, it allowed eroded
joints to heal.
In vivo
, infliximab rapidly forms stable complexes with human TNFα, a
process that
parallels the loss of TNFα bioactivity.
CLINICAL PHARMACOLOGY: PHARMACODYNAMIC PROPERTIES: Histologic
evaluation of colonic
biopsies, obtained before and 4 weeks after administration of the
Infliximab, revealed a substantial
reduction of detectable TNFα. Infliximab treatment of Crohn’s
disease patients was also associated
with a substantial reduction of the commonly elevated serum,
inflammatory marker C-reactive
protein (CRP). Total peripheral white blood cell counts were minimally
affected in Infliximab -treated
patients, although changes in lymphocytes, monocytes and neutrophils
reflected shifts toward
normal ranges. Peripheral blood mononuclear cells (PBMC) from
Infliximab -treated patients showed
WARNING
RISK OF INFECTIONS
TUBERCULOSIS
(FREQUENTLY
DISSEMINATED
OR
EXTRAPULMONARY
AT
CLINICAL
PRESENTATI