Daunorubicin

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL

Tilgjengelig fra:

Pfizer New Zealand Limited

INN (International Name):

Daunorubicin hydrochloride 2.14 mg/mL (equivalent to daunorubicin 2 mg/mL)

Dosering :

2 mg/mL

Legemiddelform:

Solution for injection

Sammensetning:

Active: Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL Excipient: Sodium chloride Water for injection

Enheter i pakken:

Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid, 1 dose unit

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Meiji Seika Kaisha Ltd

Indikasjoner:

Daunorubicin Injection is indicated for the treatment of the following: · Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid - 1 dose units - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisasjon dato:

2011-02-24

Preparatomtale

Version: pfddauni11121
Supersedes: pfddauni11120
Page 1 of 16
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Pfizer (Perth) Daunorubicin 2 mg/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
Each vial of Pfizer (Perth) Daunorubicin contains 2.14 mg/mL
daunorubicin hydrochloride
(equivalent to 2 mg/mL daunorubicin).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Pfizer (Perth) Daunorubicin is a sterile, red, isotonic, preservative
free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pfizer (Perth) Daunorubicin is indicated for the treatment of the
following:

Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually
reserved for use
in cases shown to be resistant to other drugs. However, combined
treatment with
daunorubicin, vincristine and a steroid has been used in the early
stages of this disease.

Acute myeloblastic leukaemia: Daunorubicin has been used in all
stages, alone or in
combination with other cytotoxic agents (e.g., cytarabine).

Disseminated solid tumours: Daunorubicin has been investigated for use
in these tumours
and
found
to
be
effective
in
some
cases
of
disseminated
neuroblastoma
and
rhabdomyosarcoma.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The dosage of each individual injection may vary from 0.5 to 3 mg/kg,
with the frequency of
repetition according to the dose:

0.5 to 1 mg/kg repeated at intervals of one or more days

2 mg/kg repeated at intervals of four or more days

2.5 or 3 mg/kg, if used, should only be given at seven to fourteen day
intervals.
Dosage must be adjusted to meet individual requirements of each
patient, on the basis of
clinical response and appearance or severity of toxicity. One
injection has sometimes sufficed;
Version: pfddauni11121
Supersedes: pfddauni11120
Page 2 of 16
commonly three to six injections have been necessary; occasionally up
to 10 injections in one
series have been used.
When second or subsequent injections are to be given the dos