Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
bortezomib, Quantity: 3.5 mg
Sandoz Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol
Subcutaneous, Intravenous Bolus
1 vial
(S4) Prescription Only Medicine
BORTEZOMIB SANDOZ, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,BORTEZOMIB SANDOZ, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,BORTEZOMIB SANDOZ is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,BORTEZOMIB SANDOZ in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.
Visual Identification: BORTEZOMIB SANDOZ bortezomib is supplied in a 10 mL, type I, glass vial with a grey bromobutyl stopper and blue aluminum seal, within a capped transparent tray.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-10-30
BORTEZOMIB SANDOZ ® 1 BORTEZOMIB SANDOZ ® _bortezomib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bortezomib Sandoz. 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 receiving this medicine against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BORTEZOMIB SANDOZ IS USED FOR Bortezomib Sandoz belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. These medicines are used to kill cancer cells. Bortezomib Sandoz is used to treat adults with multiple myeloma (cancer of the bone marrow). It is prescribed for patients who have not been previously treated for multiple myeloma. It is also prescribed for patients who have received one or more prior treatments and whose cancer is still progressing. Bortezomib Sandoz is also used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in adults in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated. Your doctor may have prescribed Bortezomib Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BORTEZOMIB SANDOZ HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU ARE GIVEN BORTEZOMIB SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT USE BORTEZOMIB SANDOZ IF YOU ARE: • allergic (hypersensitive) to bortezomib or boron or mannitol. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itch Soma hati kamili
191030-bortezomib sandoz-pi Page 1 of 48 AUSTRALIAN PRODUCT INFORMATION BORTEZOMIB SANDOZ ® (BORTEZOMIB) 1. NAME OF THE MEDICINE Bortezomib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial contains 3.5 mg of bortezomib as a sterile lyophilised powder. _List of excipients with known effect:_ mannitol. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Bortezomib Sandoz is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Each single dose vial contains 3.5 mg of bortezomib as a white to off-white sterile lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Bortezomib Sandoz, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. Bortezomib Sandoz, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. Bortezomib Sandoz is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. Bortezomib Sandoz in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma. 4.2. D OSE AND METHOD OF ADMINISTRATION Bortezomib Sandoz may be administered: • Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus injection or • Subcutaneously (at a concentration of 2.5 mg/mL) Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. BORTEZOMIB SANDOZ IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH. 191030-bortezomib sandoz-pi Page 2 of 48 RECOMMENDED DOSAGE _PREVIOUSLY UNTREATED MULTIPLE MYEL Soma hati kamili