Endoxan

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Cyclophosphamide monohydrate 2138mg equivalent to Cyclophosphamide anhydrous 2000 mg;  

Saatavilla:

Baxter Healthcare Ltd

INN (Kansainvälinen yleisnimi):

Cyclophosphamide monohydrate 2138 mg (=Cyclophosphamide anhydrous 2000 mg)

Annos:

2000 mg

Lääkemuoto:

Powder for injection

Koostumus:

Active: Cyclophosphamide monohydrate 2138mg equivalent to Cyclophosphamide anhydrous 2000 mg  

Kpl paketissa:

Vial, glass, 1x2000mg, 2000 mg

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Baxter Oncology GmbH

Käyttöaiheet:

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.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Vial, glass, 1x2000mg - 2000 mg - 36 months from date of manufacture stored at or below 25°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1996-02-09

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
ENDOXAN Data Sheet 1 August 2018
Page 1 of 22
Baxter Healthcare Ltd
1 ENDOXAN
ENDOXAN 1000mg powder for injection
ENDOXAN 2000mg powder for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyclophosphamide monohydrate 1069mg (equivalent to cyclophosphamide
anhydrous 1000mg) per
vial.
Cyclophosphamide monohydrate 2138mg (equivalent to cyclophosphamide
anhydrous 2000mg) per
vial.
3 PHARMACEUTICAL FORM
Powder for injection.
The white crystalline monohydrate is soluble in water (> 4% w/v).
Cyclophosphamide monohydrate
liquefies when its water of crystallisation is lost.
4 CLINICAL PARTICULARS
4.1
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 Iymphoproliferative
disorders _
Malignant lymphomas including Hodgkins (stages III and IV, Peter's
Staging System*) and non‐
Hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides
(advanced disease).
* Modified as the International Staging Classification for Hodgkin's
Disease in 'Report of the committee on the
Staging of Hodgkin's Disease'. Can