TRUXIMA rituximab (rch) 500 mg/ 50 mL concentrate solution for intravenous infusion

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

rituximab, Quantity: 500 mg

可用日期:

Celltrion Healthcare Australia Pty Ltd

药物剂型:

Injection, concentrated

组成:

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

给药途径:

Intravenous Infusion

每包单位数:

1

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Non-Hodgkin?s Lymphoma Truxima 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 Truxima is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.,Rheumatoid Arthritis Truxima (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. Truxima 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 polyangiitis (MPA) Truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener?s granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with rituximab have not been established.

產品總結:

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

授权状态:

Registered

授权日期:

2018-04-16

资料单张

Celltrion Healthcare Australia
CONSUMER MEDICINE INFORMATION
Rituximab 500 mg/100 mg Concentrate Solution for Intravenous Infusion
TRUXIMA
®
INTRAVENOUS INFUSION
_FOR THE TREATMENT OF RHEUMATOID ARTHRITIS & GRANULOMATOSIS WITH
POLYANGIITIS AND _
_MICROSCOPIC POLYANGIITIS, NON-HODGKIN'S LYMPHOMA AND CHRONIC
LYMPHOCYTIC _
_LEUKAEMIA _
_contains the active ingredient rituximab (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Truxima
®
intravenous
infusion. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
Truxima
®
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TRUXIMA
® IS
USED FOR
Truxima
®
contains the active
ingredient rituximab, which is a
monoclonal antibody. Monoclonal
antibodies are proteins which
specifically recognise and bind to
other unique proteins in the body.
Truxima
®
is used to treat rheumatoid
arthritis (RA), Granulomatosis with
polyangiitis (Wegener's) (GPA) and
Microscopic polyangiitis (MPA).
RA is an inflammatory disease of the
joints. GPA and MPA are
inflammatory diseases of the blood
vessels.
Truxima
®
works by binding to a
protein on the surface of certain
white blood cells known as B
lymphocytes. B lymphocytes play a
role in the inflammation observed in
RA, GPA and MPA. By binding to
the protein Truxima
®
reduces the
ability of B lymphocytes to cause
inflammation.
In RA Truxima
®
can also slow down
the damage to your joints and
improve your ability to do your
normal daily activities.
Your doctor may have prescribed
Truxima
®
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY TRUXIMA
® HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
TRU

产品特点

1
Ver 06-0521 AUST R 285815, 285816
Celltrion Healthcare Australia Pty Ltd
PRODUCT INFORMATION
Rituximab 500 mg/100 mg Concentrate Solution for Intravenous Infusion
AUSTRALIAN PRODUCT INFORMATION
TRUXIMA

RITUXIMAB (RCH)
1
NAME OF THE MEDICINE
Truxima
®
rituximab (rch) Concentrate for solution for intravenous (IV)
infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Truxima
®
contains the active ingredient rituximab (rch).
Truxima
®
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
Truxima
®
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_
Truxima
®
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 TRUXIMA
® 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 TRUXIMA
® 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
TRUXIMA
®
MUST
BE
PERMANENTLY DISCONTINUED (SEE SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS
FOR USE).
2
Ver 06-0521 AUST R 285815, 285816
Celltrion Healthcare Aust