Ifosfamide 2g powder for concentrate for solution for injection vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ifosfamide

Commercializzato da:

Baxter Healthcare Ltd

Codice ATC:

L01AA06

INN (Nome Internazionale):

Ifosfamide

Dosaggio:

2gram

Forma farmaceutica:

Powder for solution for injection

Via di somministrazione:

Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 08010100; GTIN: 05413760208800

Scheda tecnica

OBJECT 1
IFOSFAMIDE INJECTION 2G
Summary of Product Characteristics Updated 24-Oct-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Ifosfamide Injection 2g
2. Qualitative and quantitative composition
Each vial contains 2g of ifosfamide.
When reconstituted as directed, each milliliter of concentrate
contains 80 mg Ifosfamide
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White powder.
4. Clinical particulars
4.1 Therapeutic indications
Ifosfamide is a cytotoxic drug for the treatment of malignant disease.
As a single agent it has successfully
produced objective remissions in a wide range of malignant conditions.
Ifosfamide is also frequently used
in combination with other cytotoxic drugs, radiotherapy and surgery.
Children and adolescents - see section 5.1-Paediatric population
4.2 Posology and method of administration
Ifosfamide should only be administered when 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 by physicians experienced
with this drug.
Dosage must be individualised. 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 combination with other agents of similar toxicity, a dose reduction
or extension of the therapy-free
intervals may be necessary.
Method of administration
A guide to the dosage regimens used for most indications is given
below:
a) 8 - 12 g/m² equally fractionated as single daily doses over 3 - 5
days every 2 - 4 weeks.
b) 5 - 6 g/m² (maximum 10 g) given as a 24 hour infusion every 3 –
4 weeks.
The frequency of dosage is determined by the degree of
myelosuppression and the time taken to recover
adequate bone marrow function. The usual number of courses given is 4,
but up to 7 (6 by 24 hour
infusion) courses have been gi