DOXORUBICIN

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

DOXORUBICIN HYDROCHLORIDE

Предлага се от:

Accord Healthcare Limited

АТС код:

L01DB01

INN (Международно Name):

DOXORUBICIN HYDROCHLORIDE

дозиране:

2 Mg/Ml

Лекарствена форма:

Concentrate for Soln for Inf

Вид предписание :

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

Терапевтична област:

doxorubicin

Статус Оторизация:

Marketed

Дата Оторизация:

2010-07-09

Листовка

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 further questions, please 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 symptoms 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 the immune system
•
leukaemi

Данни за продукта

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.
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