CYCLOPHOSPHAMIDE INTAS cyclophosphamide (as monohydrate) 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyclophosphamide, Quantity: 500 mg (Equivalent: cyclophosphamide monohydrate, Qty mg)

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient?s general and haematologic status. It is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide.,The clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. Careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk.,Antineoplastic properties Patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.,The following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide:,Frequently responsive myeloproliferative and lymphoproliferative disorders: Malignant lymphomas including Hodgkins (stages III and IV, Peter?s Staging System*) and non-Hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease).,Stage I: Disease limited to one anatomic region (Stage I) or two contiguous anatomic regions (Stage I2) on the same side of the diaphragm.,* Modified as the International Staging Classification for Hodgkin?s Disease in ?Report of the committee on the Staging of Hodgkin?s Disease?. Cancer Res 26:1310, 1966.,Stage II: Disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm.,Stage III: Disease on both sides of the diaphragm, but not extending beyond the involvement of lymph nodes, spleen, and/or Waldeyer?s ring.,Stage IV: Involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or Waldeyer?s ring.,All stages are subclassified as A or B to indicate the absence or presence, respectively, of systemic symptoms.,Frequently responsive solid malignancies: Neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma.,Infrequently responsive malignancies: Carcinoma of the breast; malignant neoplasms of the lung.,Immunosuppressive properties,Cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (ie Wegener?s granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. Cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

Product summary:

Visual Identification: White lyophilised powder or cake; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-03-07