Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
bortezomib, Quantity: 3.5 mg
Teva Pharma Australia Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol; nitrogen
Intravenous, Subcutaneous
1
(S4) Prescription Only Medicine
Bortezomib, 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, 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 is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,Bortezomib 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: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2019-05-14
BORTEZOMIB-TEVA ® B o r t e z o m i b - T e v a ® v 2 . 0 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-TEVA? Bortezomib-Teva contains the active ingredient bortezomib. Bortezomib-Teva is used to treat adults with multiple myeloma (cancer of the bone marrow). It is also used to treat those not previously treated for mantle cell lymphoma (a type of cancer affecting the lymph nodes) in adults in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, For more information, see Section 1. Why am I using Bortezomib-Teva? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB-TEVA? Do not use if you have ever had an allergic reaction to Bortezomib-Teva 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-Teva? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Bortezomib-Teva and affect how it works. 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-TEVA? • Your doctor will decide what dose you will receive. The dose will be calculated from your height and weight, as well as factors such as kidney function, liver function and other medicines you are being given. • The doctor will determine the number of cycles of treatment also. More instructions can be found in Section 4. How do I use Bortezomib-Teva? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BORTEZOMIB-TEVA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Bortezomib-Teva. • Keep all doctor’s appointments and follow doctor’s instruction. You may need to take other Preberite celoten dokument
Bortezomib-Teva PI version 2.0 AUSTRALIAN PRODUCT INFORMATION – BORTEZOMIB-TEVA (BORTEZOMIB) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Bortezomib. 2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each vial contains 3.5 mg bortezomib as a powder for injection for intravenous or subcutaneous injection. The powder for injection is a white to off-white cake or powder. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Bortezomib, 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, 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 is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. Bortezomib 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 Note that 1.0 mg and 3.0 mg strengths can be available from other brand/s. Bortezomib-Teva 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-TEVA IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH. Bortezomib-Teva PI version 2.0 RECOMMENDED DOSAGE _PREVIOUSLY UNTREATED MULTIPLE MYELOMA – TRANSPLANT ELIGIBLE _ _1._ _ _ _Bortezomib-Teva plus thalidomide-dexamethasone _ During the induction stage, Bortezomib-Teva (borte Preberite celoten dokument