Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
methotrexate, Quantity: 100 mg/mL
Accord Healthcare Pty Ltd
Methotrexate
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections
Intramuscular, Intravenous, Intrathecal, Intraarterial
1 vial
(S4) Prescription Only Medicine
Antineoplastic chemotherapy - Methotrexate has a broad spectrum of antineoplastic activity. It is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. Methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. It may also be used in the treatment of Burkitt's lymphoma, advanced stages (III and IV, Peters' Staging System) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. High dose therapy - In high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. Calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. Psoriasis chemotherapy (see WARNING box) - Methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. However, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.
Visual Identification: A yellow to orange clear solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-10-10
Methotrexate Accord – version 5.0 1 METHOTREXATE 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 BEING GIVEN METHOTREXATE ACCORD? Methotrexate Accord contains the active ingredient methotrexate. Methotrexate Accord belongs to a group of medicines known as antineoplastic or cytotoxic agents. Methotrexate Accord is used to treat some types of cancers. It may also be used in severe psoriasis when these conditions do not improve with other medicines. For more information, see Section 1. Why am I using Methotrexate Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN METHOTREXATE ACCORD? Do not use if you have ever had an allergic reaction to methotrexate 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 am given Methotrexate Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines and methotrexate may interfere with each other and may affect how well each medicine works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN METHOTREXATE ACCORD? Methotrexate Accord will be given to you by a doctor or a nurse as an injection into a muscle, a vein, an artery or into the spine. More instructions can be found in Section 4. How will I be given Methotrexate Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN METHOTREXATE ACCORD? THINGS YOU SHOULD DO • Be sure to keep all your doctor's appointments • Use an effective method of birth control while you are being treated with methotrexate or for at least 6 months after stopping treatment • If you or your partner becomes pregnant while you are being treated with methotrexate, or for up to 6 months Læs hele dokumentet
Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION METHOTREXATE ACCORD (METHOTREXATE) SOLUTION FOR INJECTION WARNING Methotrexate must only be used by physicians experienced in anti-metabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Because of the possibility of fatal or severe toxic reactions the patient should be fully informed by the physician of the risks involved and should be under constant supervision of the physician. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy and only when the diagnosis has been established, by biopsy and/or after consultation. 1. Methotrexate may produce marked depression of the bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. 2. Methotrexate may be hepatotoxic particularly at high dosage or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis have been reported. Since changes may occur without previous signs of gastro-intestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. Special caution is indicated in the presence of pre-existing liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential (including alcohol) should be avoided. 3. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted. 4. Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy. 5. USE IN PREGNANCY Category D. This category specifies drugs, which have caused an Læs hele dokumentet