国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
bortezomib, Quantity: 3.5 mg
Baxter Healthcare Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol; nitrogen
Intravenous, Subcutaneous
1 vial
(S4) Prescription Only Medicine
Bortezomib Baxter, 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 Baxter, 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 Baxter is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,Bortezomib Baxter in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.
Visual Identification: White to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2022-08-04
Bortezomib Baxter 1 BORTEZOMIB BAXTER CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BORTEZOMIB BAXTER? Bortezomib Baxter contains the active ingredient bortezomib. Bortezomib Baxter 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 Baxter 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. For more information, see Section 1. Why am I using Bortezomib Baxter? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB BAXTER? Do not use if you have ever had an allergic reaction to bortezomib or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Bortezomib Baxter? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Bortezomib Baxter and affect how it works. Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BORTEZOMIB BAXTER? Overall treatment with Bortezomib Baxter must be done under the supervision of a doctor. Your treatment with Bortezomib Baxter may be given by a healthcare professional (eg doctor or nurse) experienced in the administration 完全なドキュメントを読む
Version 3.0 1 AUSTRALIAN PRODUCT INFORMATION – BORTEZOMIB BAXTER (BORTEZOMIB) 1. NAME OF THE MEDICINE Bortezomib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bortezomib Baxter (bortezomib) 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 sterile lyophilised powder. It also contains 35 mg mannitol. For a full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for injection. White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bortezomib Baxter, 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 Baxter, 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 Baxter is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. Bortezomib Baxter in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma. 4.2 DOSE AND METHOD OF ADMINISTRATION Bortezomib Baxter 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. Version 3.0 2 BORTEZOMIB BAXTER IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH. RECOMMENDED DOSAGE: _PREVIOUSLY UNTREATED MULTIPLE MYELOMA - TRANSPLANT ELIGIBLE _ 1. _Bortezomib Baxter plus thalidomide-dexamethasone_ During the induction stage, B 完全なドキュメントを読む