Doxorubicin 2 mg/ml Concentrate for Solution for Infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

DOXORUBICIN HYDROCHLORIDE

Saadav alates:

Accord Healthcare Ireland Ltd.

ATC kood:

L01DB; L01DB01

INN (Rahvusvaheline Nimetus):

DOXORUBICIN HYDROCHLORIDE

Annus:

2 milligram(s)/millilitre

Ravimvorm:

Concentrate for solution for infusion

Terapeutiline ala:

Anthracyclines and related substances; doxorubicin

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2010-07-09

Infovoldik

NL/H/4562/001/II/034, Version 01, DEC 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXORUBICIN 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
doxorubicin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Doxorubicin concentrate for solution for infusion is and what
it is used for
2. What you need to know before you use Doxorubicin concentrate for
solution for infusion
3. How to use Doxorubicin concentrate for solution for infusion
4. Possible side effects
5. How to store Doxorubicin concentrate for solution for infusion
6. Contents of the pack and other information
1. WHAT DOXORUBICIN CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT
IT IS USED FOR
The name of your medicine is
“Doxorubicin 2 mg/ml Concentrate for Solution for Infusion” but in
the rest
of the leaflet it will be called ‘Doxorubicin concentrate for
solution for infusion’.
Doxorubicin is one of a group of medicines called the anthracyclines.
These drugs are also known as cancer
drugs, chemotherapy, or "chemo". They are used in the treatment of
various cancers to slow or stop the
growth of cancer cells. A combination of different types of cancer
drugs will often be used to achieve better
results and minimize side effects.
Doxorubicin concentrate for solution for infusion
is used to treat the following forms of cancer:
•
breast cancer
•
cancer of the connective tissue, ligaments, bone, muscle (sarcoma)
•
cancer develops within the stomach or intestine
•
lung cancer
•
lymphomas, a cancer affecting

Toote omadused

Health Products Regulatory Authority
20 February 2024
CRN00F4MM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxorubicin 2 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg Doxorubicin hydrochloride.
Each 5 ml vial contains 10 mg of Doxorubicin hydrochloride.
Each 10 ml vial contains 20 mg of Doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg of Doxorubicin hydrochloride.
Each 50 ml vial contains 100 mg of Doxorubicin hydrochloride
Each 100 ml vial contains 200 mg of Doxorubicin hydrochloride.
EXCIPIENT(s) with known effect: Contains sodium 3.5 mg/ml (0.15 mmol)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The product is a clear, red solution, with a pH in the range of
2.5-3.5 and osmolality between 270 mOsm/kg to 320 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxorubicin is indicated in the following neoplastic conditions.
Examples include:

Small-cell lung cancer (SCLC)

Breast cancer

Advanced ovarian carcinoma

Intravesically for bladder cancer

Neoadjuvant and adjuvant therapy of osteosarcoma

Advanced soft-tissue sarcoma in adults

Ewing's sarcoma

Hodgkin's disease

Non-Hodgkin's lymphoma

Acute lymphatic leukaemia

Acute myeloblastic leukaemia

Advanced multiple myeloma

Advanced or recurrent endometrial carcinoma

Wilms' tumour

Advanced papillary/follicular thyroid cancer

Anaplastic thyroid cancer

Advanced neuroblastoma
Doxorubicin is frequently used in combination chemotherapy regimens
with other cytotoxic drugs.
Health Products Regulatory Authority
20 February 2024
CRN00F4MM
Page 2 of 15
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doxorubicin Injection should be administered only under the
supervision of a qualified physician with extensive experience in
cytotoxic treatment. Also, patients must be carefully and frequently
monitored during the treatment (see section 4.4)
Due to