Tromax 100 mg/10 ml 100 mg/10ml

Страна: Иордания

Язык: английский

Источник: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Активный ингредиент:

Rituximab 100 mg/10ml

Доступна с:

شركة ام اس فارما - MS Pharma

код АТС:

L01XC02

ИНН (Международная Имя):

Rituximab 100 mg/10ml

дозировка:

100 mg/10ml

Штук в упаковке:

2 Vial X 10ml

Производитель:

Mabxience S.A.U (الأرجنتين)

тонкая брошюра

TROMAX
®
Rituximab
420x300 mm
Color: Black
TROMAX
®
Rituximab
12/2018
DESCRIPTION:
_ACTIVE SUBSTANCES: RITUXIMAB _
_EXCIPIENTS:_ Sodium chloride, Sodium Citrate Dihydrate, polysorbate
80, hydrochloric acid, sodium
hydroxide and water for injection.
TROMAX
®
(Rituximab) is a chimeric mouse/human monoclonal antibody that binds
specifically to the
Transmembrane antigen CD20. This antigen is located on pre-B- and
mature B-lymphocytes, But not
on hemopoietic stem cells, pro-B-cells, normal plasma cells or other
Normal tissue.
The antigen is expressed on >95% of all cells of B-cell non-Hodgkin's
Lymphomas (NHLs).
Following antibody binding, CD20 is not internalized or shed from the
cell membrane into the environ-
ment. CD20 does not circulate in the plasma as a free Antigen and thus
does not compete for antibody
binding. Studies conducted to date have shown no connection between
the intensity of CD20 expres-
sion on malignant cells and Therapeutic response.
Rituximab binds to the CD20 antigen on B-Iymphocytes and causes B-cell
lysis. Possible Mechanisms
of cell lysis include complement-dependent cytotoxicity (CDC) and
antibody dependent Cellular cytotox-
icity (ADCC) and induction of apoptosis.
PROPERTIES:
The mean
C
max following the fourth infusion of 375 mg/m
2
is 486 µg/ml (range 77.5 to 996.6 µg/ml).
Following the intravenous administration of 500 and 1,000 mg doses of
Rituximab on two occasions two
weeks apart, mean
C
max values were 183 µg/ml (range 81.8 to 279 µg/ml) and 370 µg/ml
(range 212
to 637 µg/ml), respectively.
Distribution: The mean steady-state distribution volume was 4.6L
(range 1.7 to 7.51L).
Elimination: Like all proteins, Rituximab is broken down in the liver.
The estimated mean Terminal
elimination half-life of Rituximab is 20.8 to 24 days (range 6.1 to 52
days).
Tumour mass has an influence on specific clearance.
INDICATIONS:
TROMAX
®
INDICATED FOR THE:
NON-HODGKIN'S LYMPHOMA
Monotherapy in patients with CD20-positive follicular non-Hodgkin's
lymphoma (stage III-IV) who have
relaps