Doxorubicin 2mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

Genepharm (Europe) Trading Ltd

ATC code:

L01DB; L01DB01

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Anthracyclines and related substances; doxorubicin

Authorization status:

Not marketed

Authorization date:

2009-11-13

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2018
CRN008L43
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin 2mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxorubicin hydrochloride
1ml contains 2 mg Doxorubicin hydrochloride.
Each 5ml vial contains 10 mg of Doxorubicin hydrochloride.
Each 10ml vial contains 20 mg of Doxorubicin hydrochloride.
Each 25ml vial contains 50 mg of Doxorubicin hydrochloride.
Each 50ml vial contains 100 mg of Doxorubicin hydrochloride.
Each 100ml vial contains 200 mg of Doxorubicin hydrochloride.
Excipients: The product contains sodium chloride (3.54 mg sodium per 1
ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Red concentrate for infusion. pH = 2.5 – 3.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer, sarcoma, small-cell carcinoma of the lung, Hodgkin
disease or
non-Hodgkin lymphoma, acute leukaemia, cancer of the thyroid, bladder,
ovaries,
Paediatric tumours, such as neuroblastoma.
Doxorubicin is frequently used in combination chemotherapy regimens
with other
cytotoxic drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Doxorubicin 2mg/ml Concentrate for Solution for
Infusion should be
started by or after consultation with a doctor with extensive
experience from
cytostatic treatment.
The concentrate is injected via the tubing of a freely-running
intravenous infusion
(Sodium chloride 0.9% intravenous infusion or Dextrose 5% intravenous
infusion)
Health Products Regulatory Authority
16 November 2018
CRN008L43
Page 2 of 11
over 2-15 minutes. This technique minimizes the risk of
thrombophlebitis or
perivenous extravasation which can lead to severe cellulitis and
vesication.
Intravenous administration: The dosage of doxorubicin depends on
dosage regimen,
general status and previous treatment of the patient.
Several dosage regimens exist: The recommended dose is 60-75 mg/m²
body surface
i.v. as a single do