Doxorubicin Hydrochloride (Hospira)

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Doxorubicin hydrochloride 10mg

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

Doxorubicin hydrochloride 10 mg

Dosis:

10 mg

formulario farmacéutico:

Powder for injection

Composición:

Active: Doxorubicin hydrochloride 10mg Excipient: Lactose monohydrate

Unidades en paquete:

Vial, 10 mg

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Microbiopharm Japan Co Ltd

indicaciones terapéuticas:

Doxorubicin has produced significant therapeutic responses in a number of solid tumours and haematologic malignancies, and is commonly used in the treatment of the following tumours: · carcinoma of the breast · carcinoma of the lung · carcinoma of the ovary · transitional bladder cell cancer · neuroblastoma · Wilms' tumour · soft tissue sarcomas · osteosarcoma · acute lymphocytic - lymphoblastic leukaemia · acute myelogenous leukaemia · non-Hodgkin's lymphoma · Hodgkin's disease Doxorubicin has also shown antitumour activity in the following adult and paediatric malignancies: · carcinoma of the thyroid · carcinoma of the endometrium · carcinoma of the head and neck · carcinoma of the stomach · primary hepatocellular carcinoma · non-seminomatous carcinoma of the testis · carcinoma of the prostate · Ewing's sarcoma · rhabdomyosarcoma · multiple myeloma · chronic leukaemias

Resumen del producto:

Package - Contents - Shelf Life: Vial, - 10 mg - 36 months from date of manufacture stored at or below 25°C

Data d'autorització:

1991-06-27

Fitxa tècnica

Version pfddoxoa10219
Page 1 of 16
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Doxorubicin hydrochloride Injection
Doxorubicin Hydrochloride (Hospira) for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Doxorubicin hydrochloride Injection is supplied in solution
form containing sodium
chloride.
Doxorubicin hydrochloride (Hospira) for Injection is supplied as a
freeze dried product
containing Lactose as an excipient.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL™ Doxorubicin hydrochloride Injection is a solution for injection
Doxorubicin Hydrochloride (Hospira) is a Powder for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxorubicin has produced significant therapeutic responses in a number
of solid tumours and
haematologic malignancies, and is commonly used in the treatment of
the following tumours:

carcinoma of the breast

carcinoma of the lung

carcinoma of the ovary

transitional cell bladder cancer

neuroblastoma

Wilm's tumour

soft tissue sarcomas

osteosarcoma
Version pfddoxoa10219
Page 2 of 16

acute lymphocytic - lymphoblastic leukaemia

acute myelogenous leukaemia

non-Hodgkin's lymphoma

Hodgkin's disease
Doxorubicin
has
also
shown
antitumour
activity
in
the
following
adult
and
paediatric
malignancies:

carcinoma of the thyroid

carcinoma of the endometrium

carcinoma of the head and neck

carcinoma of the stomach

primary hepatocellular carcinoma

non-seminomatous carcinoma of the testis

carcinoma of the prostate

Ewing's sarcoma

rhabdomyosarcoma

multiple myeloma

chronic leukaemias
4.2 DOSE AND METHOD OF ADMINISTRATION
Doxorubicin is a cytotoxic drug that is usually administered to cancer
patients by the
intravenous and, whenever appropriate, intravesical and intra-arterial
routes.
INTRAVENOUS (IV) ADMINISTRATION:
Dosage is usually calculated on the basis of body surface area (mg/m
2
). The doxorubicin
dose-schedule to be delivered may differ depending on the t