Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
methotrexate, Quantity: 2.5 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; sodium chloride; water for injections; hydrochloric acid
Intravenous, Intramuscular, Intraarterial, Intrathecal
5x5mg/2mL, 5x5mg/2mL(E)
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
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 o
Visual Identification: Yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-08
DBL™ METHOTREXATE INJECTION D B L ™ M e t h o t r e x a t e I n j e c t i o n 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 DBL METHOTREXATE INJECTION? DBL Methotrexate Injection contains the active ingredient methotrexate. DBL Methotrexate Injection is used to treat certain types of cancers, severe psoriasis or rheumatoid arthrtis when the condition does not improve with other medicines. For more information, see Section 1. Why am I using DBL Methotrexate Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DBL METHOTREXATE INJECTION? Do not use if you have ever had an allergic reaction to DBL Methotrexate Injection 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 DBL Methotrexate Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Methotrexate Injection 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 DBL METHOTREXATE INJECTION? • 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 DBL Methotrexate Injection? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DBL METHOTREXATE INJECTION? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using DBL Methotrexate. • You and your partner must use a reliable method of contraception (birth control pills or condom) Lees het volledige document
Version: pfpmetxi10422 supersedes: pfpmetxi11021 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION – DBL™ METHOTREXATE INJECTION (METHOTREXATE) WARNINGS Methotrexate must only be used by physicians experienced in anti-metabolite chemotherapy, or in the case of non-oncological conditions, by a specialist physician. Patients should be fully informed of the risk of fatal or severe toxic reactions involved with the administration of methotrexate and should be under constant supervision of the physician. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, 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 depression of the bone marrow, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia and bleeding. 2. At high or prolonged doses, methotrexate may be hepatotoxic. 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 liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential and 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 jirovecii_ pneumonia, may occur with methotrexate therapy. 5. USE IN PREGNANCY Category D. This category specifies drugs, which have c Lees het volledige document