国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
carmustine, Quantity: 100 mg
Accord Healthcare Pty Ltd
Diluent, not applicable
Excipient Ingredients: ethanol absolute
Intravenous
1 powder for injection vial and 1 diluent vial
(S4) Prescription Only Medicine
CARMUSTINE ACCORD is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. Malignant Glioma,2. Multiple Myeloma - in combination with prednisone.,3. Hodgkin?s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. Non-Hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.
Visual Identification: clear, colourless liquid; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2021-05-21
Carmustine Accord - version 1 1 CARMUSTINE ACCORD 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 CARMUSTINE ACCORD? Carmustine Accord contains the active ingredient carmustine. Carmustine Accord is used to treat malignant glioma (a type of brain cancer) and multiple myeloma (a cancer of the blood). It may also be used to treat other types of cancers called Hodgkin's Disease and Non-Hodgkin's lymphomas. For more information, see Section 1. Why am I using Carmustine Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CARMUSTINE ACCORD? Do not use if you have ever had an allergic reaction to carmustine 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 Carmustine Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Carmustine Accord 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 CARMUSTINE ACCORD? Carmustine Accord is an injection and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Carmustine Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CARMUSTINE ACCORD? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Carmustine Accord. • Be sure to keep all your doctor's appointments so your progress can be checked. • Keep follow up appointments with your doctor. It is important to have your follow-up doses of Carmustine Accord at the appropriate times to get the best effects from your treatments. DRIVING OR USING MACHINES • Carmustine Accord may cause nausea, dizziness or tiredness in some people. If y 完全なドキュメントを読む
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION CARMUSTINE ACCORD (CARMUSTINE) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Carmustine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lyophilised powder vial contains 100 mg carmustine. After reconstitution and dilution (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION ), 1 mL of solution contains 3.3 mg carmustine. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Carmustine Accord is presented in a composite pack that includes a powder for injection amber glass vial containing a pale yellow lyophilised powder and a clear colourless liquid diluent of sterile absolute ethanol. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Carmustine Accord is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. Malignant Glioma. 2. Multiple Myeloma - in combination with prednisone. 3. Hodgkin’s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. Non-Hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Carmustine Accord is administered by slow intravenous infusion. CARMUSTINE ACCORD SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. The recommended dose of Carmustine Accord as single agent in previously untreated in patients is 200 mg/m 2 intravenously every 6 weeks. This may be given as a single dose or divided into daily injections such as 100 mg/m 2 on successive days. When Carmustine Accord is used in combination with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted, the doses should be adjusted accordingly. A repeat course of Carmustine Accord should not be given until circulating blood elemen 完全なドキュメントを読む