Epirubicin Hydrochloride 2mg/ml Solution for Injection or Infusion (50ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EPIRUBICIN HYDROCHLORIDE

Available from:

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

ATC code:

L01DB03

INN (International Name):

EPIRUBICIN HYDROCHLORIDE 2 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

EPIRUBICIN HYDROCHLORIDE 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2011-03-21

Patient Information leaflet

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. 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Epirubicin hydrochloride 2 mg/ml Solution for Injection or
Infusion 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of solution for injection or infusion contains 2 mg of
epirubicin hydrochloride. 

Each vial of 5 ml contains 10 mg of epirubicin hydrochloride. 
Each vial of 25 ml contains 50 mg of epirubicin hydrochloride. 
Each vial of 50 ml contains 100 mg of epirubicin hydrochloride. 
Each vial of 100 ml contains 200 mg of epirubicin hydrochloride. 

Excipient (S): 
1 ml of solution for injection or infusion contains
3.5 mg sodium. 
- 1 vial of 5 ml solution contains 17.7 mg sodium. 
- 1 vial of 25 ml solution contains 88.5 mg sodium. 
- 1 vial of 50 ml solution contains 177.0 mg sodium. 
- 1vial of 100 ml solution contains 354.1  mg sodium. 

For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Solution for Injection or Infusion. 

A red solution 
4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Epirubicin is used in the treatment of a range of neoplastic
conditions including; 
•  
Carcinoma of the breast 
•  
Gastric cancer 

When administered intravesically, epirubicin has been shown to be
beneficial in the treatment of: 
•  
Papillary transitional cell carcinoma of the bladder 
• 
Carcinoma-in-situ of the bladder 
• 
Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following 
 transurethral 
resection. 

For intravesical use a positive benefit-risk ratio could only be
established in patients in whom live 
attenuated BCG is contra-indicated or inappropriate. 

Epirubicin hydrochloride 2 mg/ml can be used in polychemotherapy
schedules. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Epirubicin is for intravenous and intravesical use only. 

Intravenous administration: 

It is advisable to give the drug via the tubing of a freely running
I.V.