Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Cyclophosphamide monohydrate 53.5mg equivalent to 50 mg cyclophosphamide
Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)
Cyclophosphamide monohydrate 53.5 mg
50 mg
Film coated tablet
Active: Cyclophosphamide monohydrate 53.5mg equivalent to 50 mg cyclophosphamide Excipient: Croscarmellose sodium Isopropyl alcohol Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 21F240000 Purified water
Bottle, plastic, 40ml, 50 tablet pack, 50 tablets
Prescription
Prescription
Orion Corporation
Cyclophosphamide is a cytotoxic drug for the treatment of malignant disease in adults and children. As a single agent, it has successfully produced an objective remission in a wide range of malignant conditions. Cyclophosphamide is also frequently used in combination with other cytotoxic drugs, radiotherapy or surgery
Package - Contents - Shelf Life: Blister pack, Al/PA/Al/PVC - 50 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
1985-08-15
1 CYCLONEX CYCLOPHOSPHAMIDE TABLETS 50 MG NEW ZEALAND DATA SHEET 1 PRODUCT NAME CYCLONEX 50 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg cyclophosphamide EXCIPIENT(S) WITH KNOWN EFFECT: sugars as lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet Brown to pinkish round convex film coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cyclophosphamide is a cytotoxic drug for the treatment of malignant disease in adults and children. As a single agent, it has successfully produced an objective remission in a wide range of malignant conditions. Cyclophosphamide is also frequently used in combination with other cytotoxic drugs, radiotherapy or surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION Cyclonex Tablets are for oral use. Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Cyclophosphamide should only be administered where there are facilities for regular monitoring of clinical, biochemical and haematological parameters before, during, and after administration and under the direction of a specialist oncology service. 2 CYCLONEX CYCLOPHOSPHAMIDE TABLETS 50 MG DOSE Dosage must be individualized. Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient's general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring). The dosage regimen used for most indications is 100 – 300 mg daily as a single or divided dose. This treatment should be continued until a clear remission or improvement is seen or be interrupted when the extent of leucopenia becomes unacceptable. In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary. Activation of cyclophosphamide requires hepatic metabolism; therefore, oral and in read_full_document