Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
methotrexate, Quantity: 500 mg
Sandoz Pty Ltd
Injection, concentrated
Excipient Ingredients: water for injections; sodium hydroxide
Intravenous
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 and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). Methotrexate is now most commonly used for the maintenance of drug induced remissions.,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 sarcoma. Calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,Psoriasis Chemotherapy (See WARNINGS box and Section 4.4 Special warnings and precautions for use):,Methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. However, due to the high risk associated with its use, methotrexate should be used after diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.
Visual Identification: Clear yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-07-18
Methotrexate Ebewe 1 METHOTREXATE EBEWE® 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. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING METHOTREXATE EBEWE? Methotrexate Ebewe contains the active ingredient methotrexate. Methotrexate Ebewe is used to treat certain types of cancers and severe psoriasis when the condition does not improve with other medicines. For more information, see Section 1. Why am I using Methotrexate Ebewe? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE METHOTREXATE EBEWE? Do not use if you have ever had an allergic reaction to Methotrexate Ebewe 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 Methotrexate Ebewe? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Methotrexate Ebewe 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 METHOTREXATE EBEWE? • The dose of medicine given to you will depend on the condition being treated, your medical condition, your age, your size and how well your kidneys and liver are working. More instructions can be found in Section 4. How do I use Methotrexate Ebewe? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING METHOTREXATE EBEWE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Methotrexate Ebewe. • You and your partner must use a reliable method of contraception (birth control pills or condom) during treatment with Methotrexate Ebewe and for at least 6 months after you stop treatment. • Discuss with your doctor how much water or fl Citiți documentul complet
220708-Methotrexate EBEWE-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION METHOTREXATE EBEWE ® (METHOTREXATE) CONCENTRATED INJECTION VIAL WARNINGS METHOTREXATE EBEWE (METHOTREXATE 100 MG/ML) IS RECOMMENDED FOR INTRAVENOUS ADMINISTRATION ONLY. Methotrexate must be used only by physicians experienced in antimetabolite 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 his constant supervision. 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, but only when the diagnosis has been established by biopsy and / or after appropriate 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 gastrointestinal 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 methotrexate with other medicines with hepatotoxic potential or 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 Citiți documentul complet