Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
rituximab, Quantity: 1400 mg
Roche Products Pty Ltd
Rituximab
Injection
Excipient Ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections
Subcutaneous
1 vial
(S4) Prescription Only Medicine
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.
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
Registered
2014-05-28
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 Read the complete document
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 Read the complete document