Cyclophosphamide 500mg powder for solution for injection vials

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Cyclophosphamide monohydrate

Dostupno od:

Baxter Healthcare Ltd

ATC koda:

L01AA01

INN (International ime):

Cyclophosphamide monohydrate

Doziranje:

500mg

Farmaceutski oblik:

Powder for solution for injection

Administracija rute:

Intravenous; Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 08010100; GTIN: 05413760208886

Svojstava lijeka

OBJECT 1
CYCLOPHOSPHAMIDE INJECTION 500 MG
Summary of Product Characteristics Updated 29-Jun-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Cyclophosphamide Injection 500 mg.
2. Qualitative and quantitative composition
Each vial contains cyclophosphamide monohydrate equivalent to 500 mg
anhydrous cyclophosphamide.
When reconstituted for intravenous use, the solution for
administration contains 20 mg cyclophosphamide
per ml.
3. Pharmaceutical form
Powder for solution for injection.
A white crystalline powder contained in clear glass injection vials.
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 Posology and method of administration
Cyclophosphamide Injection is for intravenous or oral administration.
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.
POSOLOGY
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).
A guide to the dosage regimens used for most indications is given
below.
This treatment should be continued until a clear remission or
improvement is seen or be interrupted when
the extent of leucopenia becomes unacceptable.
Conventional:
80-300 mg/m
2
daily as a single i.v. dose or daily divided oral doses.
300-600 mg/m
2
as a sin