MABTHERA rituximab 500mg/50mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rituximab, Quantity: 10 mg/mL

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; sodium chloride; water for injections; sodium hydroxide; hydrochloric acid; citric acid; sodium citrate dihydrate

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Non-Hodgkin's Lymphoma: MABTHERA 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: MABTHERA is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy. Rheumatoid Arthritis: MABTHERA (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. MABTHERA has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate. Granulomatosis with polyangiitis (Wegener's ) (GPA) and Microscopic poly

Product summary:

Visual Identification: Clear to opalescent, colourless to pale yellow liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1998-10-06

Patient Information leaflet

MABTHERA
® INTRAVENOUS
INFUSION
_FOR THE TREATMENT OF RHEUMATOID ARTHRITIS & GRANULOMATOSIS WITH
POLYANGIITIS AND MICROSCOPIC_
_POLYANGIITIS_
PRONOUNCED (MAB-THIR-RA)
_contains the active ingredient rituximab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MabThera
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
MabThera 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 MABTHERA IS
USED FOR
MabThera 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.
MabThera 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.
MabThera 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 MabThera reduces the
ability of B lymphocytes to cause
inflammation.
In RA MabThera can also slow down
the damage to your joints and
improve your ability to do your
normal daily activities.
Your doctor may have prescribed
MabThera for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY MABTHERA HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
MABTHERA
_WHEN YOU MUST NOT BE GIVEN_
_MABTHERA_
DO NOT USE MABTHERA:
•
IF YOU HAVE HAD AN ALLERGIC
REACTION TO RITUXIMAB OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET
•
IF Y

Summary of Product characteristics

MabThera IV 20211216
1
AUSTRALIAN PRODUCT INFORMATION
MABTHERA
® (RITUXIMAB)
1.
NAME OF THE MEDICINE
Rituximab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MabThera 100mg vial contains 10mL of rituximab 10mg/mL solution equal
to 100mg
rituximab per vial.
MabThera 500mg vial contains 50mL of rituximab 10mg/mL solution equal
to 500mg
rituximab per vial.
Excipients with known effect
_MabThera 100mg _
Each 10mL vial contains 2.3 mmol (52.6 mg) sodium.
_MabThera 500mg _
Each 50mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1. List of excipients
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-HODGKIN’S LYMPHOMA
MabThera 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 MABTHERA 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 MABTHERA 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
MABTHERA MUST BE PERMANENTLY
DISCONTINUED (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE).
MabThera IV 20211216
2
CHRONIC LYMPHOCYTIC LEUKAEMIA
MabThera is indicated for the treatment of patients with CD20 positive
chronic lymphocytic
leukaemia (CLL) in combination with chemothera