MABTHERA SC rituximab (rch) 1400 mg/11.7 mL solution for injection vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

rituximab, Quantity: 1400 mg

Dostępny od:

Roche Products Pty Ltd

INN (International Nazwa):

Rituximab

Forma farmaceutyczna:

Injection

Skład:

Excipient Ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections

Droga podania:

Subcutaneous

Sztuk w opakowaniu:

1 vial

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

MABTHERA SC 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, - CD 20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.

Podsumowanie produktu:

Visual Identification: Clear to opalescent, colourless to yellowish solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

2014-05-28

Ulotka dla pacjenta

MABTHERA
®
SC
SUBCUTANEOUS INJECTION
_FOR THE TREATMENT OF NON-HODGKIN'S LYMPHOMA (1400 MG STRENGTH) AND
CHRONIC LYMPHOCYTIC_
_LEUKAEMIA (1600 MG STRENGTH)_
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 SC for
subcutaneous (under the skin)
injection. 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 SC 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 SC IS
USED FOR
MabThera SC contains the active
ingredient rituximab.
MabThera SC belongs to a group of
medicines known as anti-cancer
agents. There are many different
classes of anti-cancer agents.
MabThera SC belongs to a class
called monoclonal antibodies.
Monoclonal antibodies are proteins
which specifically recognise and bind
to other unique proteins in the body.
MabThera SC is used to treat non-
Hodgkin's lymphoma and chronic
lymphocytic leukaemia. MabThera
SC in chronic lymphocytic leukaemia
was approved building on data from
both the intravenous form of
MabThera and MabThera SC in non-
Hodgkin's lymphoma.
MabThera SC works by binding to a
protein on the surface of certain
white blood cells known as B
lymphocytes. During the process of
binding to the protein, the abnormal
growth of the B lymphocytes is
stopped.
It is the abnormally growing B
lymphocytes that are responsible for
certain types of non-Hodgkin's
lymphoma and chronic lymphocytic
leukaemia.
MabThera SC may be used on its
own or together with chemotherapy.
If your doctor thinks it is appropriate
for your circumstances you may
continue to receive MabThera SC
after the initial course of treatment.
Your doctor may have prescribed
MabThera SC f

Charakterystyka produktu

MabThera SC 2020211216
1
AUSTRALIAN PRODUCT INFORMATION
MABTHERA
® SC (RITUXIMAB)
1.
NAME OF THE MEDICINE
rituximab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MabThera SC 1400mg
Each mL contains 120 mg of rituximab. Each vial contain
S
1400 mg/11.7 mL rituximab.
MabThera SC 1600mg
Each mL contains 120 mg of rituximab. Each vial contains 1600 mg/ 13.4
mL rituximab.
Excipients with known effect
MabThera SC contains less than 1mmol sodium per dose, i.e. essentially
sodium free.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to opalescent, colourless to yellowish liquid.
Target pH 5.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-HODGKIN’S LYMPHOMA
MabThera SC 1400mg 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 SC 2020211216
2
CHRONIC LYMPHOCYTIC LEUKAEMIA
MabThera SC 1600 mg is indicated for the treatment of patients with
CD20 positive chronic
lymphocytic leukaemia (CLL) in combination with c