Epirubicin Hydrochloride 2mg/ml Solution for Injection or Infusion (5ml)

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

EPIRUBICIN HYDROCHLORIDE

Disponível em:

Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

Código ATC:

L01DB03

DCI (Denominação Comum Internacional):

EPIRUBICIN HYDROCHLORIDE 2 mg/ml

Forma farmacêutica:

SOLUTION FOR INFUSION OR INJECTION

Composição:

EPIRUBICIN HYDROCHLORIDE 2 mg/ml

Tipo de prescrição:

POM

Área terapêutica:

ANTINEOPLASTIC AGENTS

Status de autorização:

Withdrawn

Data de autorização:

2011-03-21

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER 

EPIRUBICIN HYDROCHLORIDE 2 MG/ ML SOLUTION FOR INJECTION OR INFUSION 

(EPIRUBICIN 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, please 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 EPIRUBICIN IS AND WHAT IT IS USED FOR 
2.  BEFORE YOU USE EPIRUBICIN  
3.  HOW TO USE EPIRUBICIN  
4.  POSSIBLE SIDE EFFECTS   
5.  HOW TO STORE EPIRUBICIN  
6.  FURTHER INFORMATION 

1.   WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR 

Epirubicin belongs to the therapeutic group of antineoplastic agents
(medicine against 
cancer). It is used either alone or in combination with
other anti-cancer medicines. 

Epirubicin is used in the treatment of: 
• Breast 
cancer 
• Stomach 
cancer 
_ _
Epirubicin is also used intravesically to treat early
(superficial) urinary bladder cancer 
and help prevent recurrence of bladder cancer after surgery.” 

Epirubicin is often used concomitantly with other cancer fighting
medicinal products 
(in so-called polychemotherapy schedules). 

2.  BEFORE YOU USE EPIRUBICIN  

DO NOT USE EPIRUBICIN 
  if you are _ALLERGIC_ (hypersensitivity) to epirubicin or
any of the other ingredients of 

Epirubicin or to any other similar medicine (belonging to a group of
medicines called 

anthracyclines [e.g. doxorubicin and daunorubicin] or
anthracenediones)  
  if you have fewer blood cells than normal caused by previous
treatment with other 

antitumour drugs or by previous radiotherapy. Your doctor will check
this. 

Características técnicas

PACKAGE LEAFLET: INFORMATION FOR THE USER 

EPIRUBICIN HYDROCHLORIDE 2 MG/ ML SOLUTION FOR INJECTION OR INFUSION 

(EPIRUBICIN 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, please 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 EPIRUBICIN IS AND WHAT IT IS USED FOR 
2.  BEFORE YOU USE EPIRUBICIN  
3.  HOW TO USE EPIRUBICIN  
4.  POSSIBLE SIDE EFFECTS   
5.  HOW TO STORE EPIRUBICIN  
6.  FURTHER INFORMATION 

1.   WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR 

Epirubicin belongs to the therapeutic group of antineoplastic agents
(medicine against 
cancer). It is used either alone or in combination with
other anti-cancer medicines. 

Epirubicin is used in the treatment of: 
• Breast 
cancer 
• Stomach 
cancer 
_ _
Epirubicin is also used intravesically to treat early
(superficial) urinary bladder cancer 
and help prevent recurrence of bladder cancer after surgery.” 

Epirubicin is often used concomitantly with other cancer fighting
medicinal products 
(in so-called polychemotherapy schedules). 

2.  BEFORE YOU USE EPIRUBICIN  

DO NOT USE EPIRUBICIN 
  if you are _ALLERGIC_ (hypersensitivity) to epirubicin or
any of the other ingredients of 

Epirubicin or to any other similar medicine (belonging to a group of
medicines called 

anthracyclines [e.g. doxorubicin and daunorubicin] or
anthracenediones)  
  if you have fewer blood cells than normal caused by previous
treatment with other 

antitumour drugs or by previous radiotherapy. Your doctor will check
this.