Doxorubicin 50mg/25ml concentrate for solution for infusion vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Doxorubicin hydrochloride

Disponível em:

Accord-UK Ltd

Código ATC:

L01DB01

DCI (Denominação Comum Internacional):

Doxorubicin hydrochloride

Dosagem:

2mg/1ml

Forma farmacêutica:

Solution for injection

Via de administração:

Intravenous; Intravesical

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 08010200; GTIN: 5060149312575

Folheto informativo - Bula

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

Características técnicas

OBJECT 1
DOXORUBICIN 2 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 02-Jun-2016 | Accord
Healthcare Limited
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.
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 the risk of often lethal CARDIOMYOPATHY, the risks and benefits
of the