METHOTREXATE INTAS methotrexate 50mg/2mL injection vial

Active ingredient:

methotrexate, Quantity: 50 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Methotrexate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; sodium hydroxide

Administration route:

Intraarterial, Intramuscular, Intravenous, Intrathecal

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: A yellow to orange clear solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-10-10