Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Methotrexate 100 mg/mL
Sandoz New Zealand Limited
Methotrexate 100 mg/mL
100 mg/mL
Concentrate for injection
Active: Methotrexate 100 mg/mL Excipient: Sodium hydroxide Water for injection
Vial, glass, 500mg/5mL vial, 1 x 5 mL, 5 mL
Prescription
Prescription
Fermion Oy
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 medicine 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 carcinoma. Calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. Psoriasis chemotherapy. 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 the diagnosis has been definitely established, as by biopsy and/or after dermatological consultation.
Package - Contents - Shelf Life: Vial, glass, 500mg/5mL vial, 1 x 5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 1000mg/10mL vial, 1 x 10 mL - 10 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 5000mg/50mL vial, 1 x 50 mL - 50 mL - 24 months from date of manufacture stored at or below 25°C protect from light
2004-07-26
Methotrexate Ebewe® CMI v1.0 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 or 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 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 for females and 3 months for males after stopping treatment. • Discuss wi Baca dokumen lengkapnya
240229-Methotrexate Ebewe-ds-v1.0 Page 1 of 25 NEW ZEALAND DATA SHEET METHOTREXATE EBEWE INJECTION CONCENTRATE (METHOTREXATE BP) WARNINGS METHOTREXATE EBEWE (METHOTREXATE 100 MG/ML) IS RECOMMENDED FOR INTRAVENOUS ADMINISTRATION ONLY. METHOTREXATE MUST BE USED ONLY BY DOCTORS EXPERIENCED IN ANTIMETABOLITE CHEMOTHERAPY OR IN THE CASE OF NON-ONCOLOGICAL CONDITIONS, BY A SPECIALIST DOCTOR. BECAUSE OF THE POSSIBILITY OF FATAL OR SEVERE TOXIC REACTIONS, THE PATIENT SHOULD BE FULLY INFORMED BY THE DOCTOR 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 USE SHOULD BE RESTRICTED TO SEVERE, RECALCITRANT, DISABLING DISEASE THAT IS NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY, AND 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 drugs 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 _Pneumocystis _ _jirovecii Baca dokumen lengkapnya