Topotecan 1mg/ ml concentrate for solution for infusion (x1ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TOPOTECAN

Available from:

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

ATC code:

L01XX17

INN (International Name):

TOPOTECAN 1 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

TOPOTECAN 1 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-09-26

Patient Information leaflet

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Page 1 of 8 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

TOPOTECAN 1 MG/ ML CONCENTRATE FOR SOLUTION FOR INFUSION 
topotecan 

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 nurse.  
  If you get any side effects, talk to your doctor or nurse. This
includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET: 

1.  WHAT TOPOTECAN IS AND WHAT IT IS USED FOR  
2.   WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN  
3.   HOW TO USE TOPOTECAN 
4.   POSSIBLE SIDE EFFECTS  
5.  HOW TO STORE TOPOTECAN  
6.   CONTENTS OF THE PACK AND OTHER INFORMATION 

1.  WHAT TOPOTECAN IS AND WHAT IT IS USED FOR 

Topotecan helps to destroy tumours. A doctor or a nurse will give you
the medicine as an 
infusion into a vein (a drip) in hospital. 

TOPOTECAN IS USED TO TREAT: 
- 
OVARIAN CANCER OR SMALL CELL LUNG CANCER that has come back after
chemotherapy 
- 
ADVANCED CERVICAL CANCER if surgery or radiotherapy treatment
is not possible.  When 
treating cervical cancer, Topotecan is combined with another
drug called _cisplatin_. 

Your doctor will decide with you whether topotecan therapy is better
than further treatment 
with your initial chemotherapy. 

2.  WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN 

DO NOT USE TOPOTECAN: 
  IF YOU ARE ALLERGIC  (_hypersensitive_) to topotecan or
any of the other ingredients of this 
medicine ( listed in section 6); 
  IF YOU ARE BREAST FEEDING. 
  IF YOUR BLOOD CELLS COUNT IS TOO LOW. Your doctor will tell
you, based on the results of your 
last blood test. 
→TELL YOUR DOCTOR if you think any of these could apply to you. 

WARNINGS AND PRECAUTIONS 
Talk to your doctor or nurse

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 
1 
NAME OF THE MEDICINAL PRODUCT 
Topotecan 1 mg/ ml concentrate for solution for infusion 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of concentrate contains 1 mg topotecan (as hydrochloride).

One vial of 1 ml of concentrate contains 1 mg topotecan (as
hydrochloride). 
One vial of 4 ml of concentrate contains 4 mg topotecan (as
hydrochloride). 

For the full list of excipients, see section 6.1. 
3 PHARMACEUTICAL 
FORM 
Concentrate for solution for infusion.  

A clear yellow to yellow green colour solution, free from visible
particles. 

pH = 2.0-2.6. 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Topotecan monotherapy is indicated for the treatment of: 
• 
patients with metastatic carcinoma of the ovary after failure
of first line or 
subsequent therapy. 
• 
patients with relapsed small cell lung cancer (SCLC) for
whom re-treatment with the 
first-line  

regimen is not considered appropriate (see section 5.1). 

Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the 
cervix recurrent after radiotherapy and for patients with Stage IVB
disease. Patients with 
prior exposure to cisplatin require a sustained treatment free
interval to justify treatment 
with the combination (see section 5.1). 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Method of administration 

The use of topotecan should be confined to units specialised in the
administration of 
cytotoxic chemotherapy and should only be administered under the
supervision of a 
physician experienced in the use of chemotherapy (see section 6.6). 

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Topotecan must be further diluted before use (see section 6.6). 

The diluted solution should be clear, colourless to light yellow
colour, free from visible 
particles. 

Posology 

When used in combination with cisplatin, the full prescribing
information for cisplatin 
should be consulted. 

Prior to admini