Doxorubicin 2mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

Seacross Pharma (Europe) Limited

ATC code:

L01DB; L01DB01

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Anthracyclines and related substances; doxorubicin

Authorization status:

Not marketed

Authorization date:

2010-01-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN 2MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
REFERRED TO IN THIS LEAFLET AS DOXORUBICIN 2MG/ML
DOXORUBICIN HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Doxorubicin 2 mg/ml is and what it is used for
2.
Before you use Doxorubicin 2 mg/ml
3.
How to use Doxorubicin 2 mg/ml
4.
Possible side effects
5.
How to store Doxorubicin 2 mg/ml
6.
Further information
1.
WHAT DOXORUBICIN 2MG/ML IS AND WHAT IT IS USED FOR
Doxorubicin, the active ingredient in Doxorubicin 2 mg/ml, is a
medicine that kills cancer
cells. It is used to treat several types of cancer, e.g., breast
cancer, lung cancer, leukaemia
(cancer of the blood or bone marrow), tumours of the thyroid gland,
bladder and ovaries, and
paediatric malignancy. Doxorubicin 2 mg/ml is frequently used in
combination with other
anti-cancer treatments.
2.
BEFORE YOU USE DOXORUBICIN 2 MG/ML
DO NOT USE DOXORUBICIN 2 MG/ML
-
if you are hypersensitive (allergic) to doxorubicin or any of the
other ingredients of
Doxorubicin 2 mg/ml, or to other anthracyclines or anthracenediones
(anti-cancer
medicines)
-
if you are pregnant or breastfeeding
_ _
INTRAVENOUS MEDICATION MUST NOT BE USED IF:
-
you have decreased bone marrow function or if severe oral mucositis
(inflammation of
the mouth) has occurred during previous cytotoxic therapy
-
you have a generalised infection
-
you have severe hepatic impairment (liver damage)
-
you have severe arrhythmia (irregular heart beat), cardiac impairment
(problems with
your heart function) or yo

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2023
CRN00DDLJ
Page 1 of 7
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 should be started by or after consulation
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) 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 dose or in divided doses
on 2-3 consecutive days administered with 21 day’s intervals. The
lower dose should be given to pat