Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
bortezomib, Quantity: 2.5 mg
Juno Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol; nitrogen
Intravenous, Subcutaneous
1 x vial
(S4) Prescription Only Medicine
BORTEZOMIB JUNO 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 JUNO 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 JUNO is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. BORTEZOMIB JUNO 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 in a glass vial with rubber stopper and flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-10-02
Bortezomib Juno BORTEZOMIB JUNO 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 JUNO? Bortezomib Juno contains the active ingredient bortezomib. Bortezomib Juno is used to treat adults with multiple myeloma (cancer of the bone marrow). Bortezomib Juno 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 Juno? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB JUNO? 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 Juno? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Bortezomib Juno 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 JUNO? • 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 Juno? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BORTEZOMIB JUNO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using bortezomib. • Keep all doctor’s appointments and follow doctor’s instruction. You may need Les hele dokumentet
Australian Product Information Page | 1 BORTEZOMIB JUNO POWDER FOR INJECTION _(BORTEZOMIB)_ _ _ PRODUCT INFORMATION _ _ 1 NAME OF THE MEDICINE Bortezomib Juno contains bortezomib. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bortezomib Juno (bortezomib) is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Each single dose vial contains: • 1 mg of bortezomib as a sterile lyophilised powder. Inactive ingredients: 10 mg mannitol and nitrogen qs, or • 2.5 mg of bortezomib as a sterile lyophilised powder. Inactive ingredients: 25 mg mannitol and nitrogen qs, or • 3.5 mg of bortezomib as a sterile lyophilised powder. Inactive ingredients: 35 mg mannitol and nitrogen qs. Bortezomib is a modified dipeptidyl boronic acid. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine. The solubility of bortezomib, as the monomeric boronic acid, in water is: 3.3 – 3.8 mg/mL in a pH range of 2 – 6.5. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Bortezomib, 1mg, powder for injection. Bortezomib, 2.5 mg, powder for injection. Bortezomib, 3.5 mg, powder for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bortezomib Juno, 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 Juno, 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 Juno is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. Bortezomib Juno in combination with rituximab, Les hele dokumentet