RITUZENA rituximab (rch) 100 mg/ 10 mL concentrate solution for intravenous infusion

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

rituximab, Quantity: 100 mg

Предлага се от:

Celltrion Healthcare Australia Pty Ltd

Лекарствена форма:

Injection, concentrated

Композиция:

Excipient Ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate

Начин на приложение:

Intravenous Infusion

Броя в опаковка:

2

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Non-Hodgkin?s Lymphoma RITUZENA is indicated for treatment of patients with: -CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin?s lymphoma; - CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma; - CD20 positive, diffuse large B-cell non-Hodgkin?s lymphoma, in combination with chemotherapy.,Chronic Lymphocytic Leukaemia RITUZENA is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.,Rheumatoid Arthritis RITUZENA (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy. RITUZENA has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,Granulomatosis with polyangiitis (Wegener?s) (GPA) and Microscopic pol

Каталог на резюме:

Visual Identification: Clear to opalescent, colourless to pale yellow liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

2019-03-01

Данни за продукта

1
Ver 02-0521 AUST R 311691, 311692
Celltrion Healthcare Australia Pty Ltd
PRODUCT INFORMATION
Rituximab 500 mg/100 mg Concentrate Solution for Intravenous Infusion
AUSTRALIAN PRODUCT INFORMATION
RITUZENA

RITUXIMAB (RCH)
1
NAME OF THE MEDICINE
Rituzena
®
rituximab (rch) Concentrate for solution for intravenous (IV)
infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Rituzena contains the active ingredient rituximab (rch).
Rituzena is supplied at a concentration of 10 mg/mL in either 100 mg
(10 mL) or 500
mg (50 mL) single-use glass vials.
EXCIPIENTS
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rituzena concentrate for solution for IV infusion is a sterile, clear,
colourless, preservative-free,
concentrated solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_NON-HODGKIN’S LYMPHOMA_
Rituzena is indicated for treatment of patients with:
•
CD20
positive,
previously
untreated,
Stage
III/IV
follicular,
B-cell
non-Hodgkin’s
lymphoma,
•
CD20
positive,
relapsed
or
refractory
low
grade
or
follicular,
B-cell
non-Hodgkin's
lymphoma,
•
CD20
positive,
diffuse
large
B-cell
non-Hodgkin’s
lymphoma,
in
combination
with
chemotherapy.
WARNING
USE OF RITUZENA MAY BE ASSOCIATED WITH AN INCREASED RISK OF
PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY (PML), AN OPPORTUNISTIC VIRAL INFECTION OF THE
BRAIN THAT USUALLY
LEADS TO DEATH OR SEVERE DISABILITY. PATIENTS MUST BE MONITORED FOR
ANY NEW OR WORSENING
NEUROLOGICAL SYMPTOMS OR SIGNS SUGGESTIVE OF PML. IF SUCH SYMPTOMS
OCCUR, FURTHER
ADMINISTRATION OF RITUZENA SHOULD BE IMMEDIATELY SUSPENDED UNTIL A
DIAGNOSIS OF
PML
HAS
BEEN
EXCLUDED.
TO
ESTABLISH
OR
EXCLUDE
A
DIAGNOSIS
OF
PML
EVALUATION
INCLUDING MRI SCAN, CSF TESTING FOR JC VIRAL DNA AND REPEAT
NEUROLOGICAL ASSESSMENTS,
SHOULD BE
CONSIDERED.
IF
A DIAGNOSIS
OF
PML
IS
CONFIRMED
RITUZENA
MUST
BE
PERMANENTLY DISCONTINUED (SEE SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS
FOR USE).
2
Ver 02-0521 AUST R 311691, 311692
Celltrion Healthcare Australia Pty Lt