Teicoplanin 400mg Powder and Solvent for Solution for injection/infusion or oral solution

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

teicoplanin

Available from:

Noridem Enterprises Ltd

ATC code:

J01XA02

INN (International Name):

teicoplanin

Dosage:

400,000 IU

Pharmaceutical form:

Powder and solvent for solution for injection/infusion or oral solution

Administration route:

intravenous or intramuscular route

Units in package:

Pack Size: Bt x 1 vial x 400 mg + 1 ampoule x 3 ml solvent

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

DEMO S.A.

Therapeutic group:

Glycopeptide antibacterials

Therapeutic indications:

It is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1): • complicated skin and soft tissue infections, • bone and joint infections, • hospital acquired pneumonia, • community acquired pneumonia, • complicated urinary tract infections, • infective endocarditis, • peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) • bacteraemia that occurs in association with any of the indications listed above.

Authorization status:

Authorised

Authorization date:

2015-04-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TEICOPLANIN 200 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION 
TEICOPLANIN 400 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION 

TEICOPLANIN 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or nurse. 

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 
are the same as yours. 

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

WHAT IS IN THIS LEAFLET: 
1. What Teicoplanin is and what it is used for 
2. What you need to know before you are given Teicoplanin 
3. How to use Teicoplanin  
4. Possible side effects  
5. How to store Teicoplanin 
6. Contents of the pack and other information 

1. 
WHAT TEICOPLANIN IS AND WHAT IT IS USED  

Teicoplanin is an antibiotic.  
It contains a medicine called ‘teicoplanin’.  
It works by killing the bacteria that cause infections in your body. 
Teicoplanin is used in adults and children (including newborn babies) to treat bacterial infections of: 
- 
the skin and underneath the skin 
– sometimes called ‘soft tissue’ 
- 
the bones and joints 
- 
the lung 
- 
the urinary tract 
- 
the heart 
– sometimes called ‘endocarditis’ 
- 
the abdominal wall 
– peritonitis 
- 
the blood, when caused by any of the conditions listed above 

Teicoplanin 
can be used to treat some infections caused by �

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Teicoplanin 400 mg Powder and Solvent for Solution for
injection/infusion or oral 
solution 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial contains 400 mg teicoplanin equivalent to
not less than 400,000 IU. 
After reconstitution, the solutions will contain 400 mg teicoplanin
in 3.0 mL.  

Excipient with known effect: The content of sodium per vial is
0.41 mmol. 

For the full list of excipients, see section 6.1.  

3 PHARMACEUTICAL 
FORM 
Powder and solvent for solution for injection/infusion or
oral solution 

Powder:  White to off white powder. 

Solvent: clear, colourless liquid. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Teicoplanin is indicated in adults and in children from birth for
the parenteral 
treatment of the following infections (see sections 4.2, 4.4 and
5.1):  
•

complicated skin and soft tissue infections,  
•

bone and joint infections,  
•

hospital acquired pneumonia,  
•

community acquired pneumonia,  
•

complicated urinary tract infections,  
•

infective endocarditis,  
•

peritonitis associated with
continuous ambulatory peritoneal dialysis (CAPD) 
•

bacteraemia that occurs in association with any of
the indications listed above. 

Teicoplanin is also indicated as an alternative oral treatment
for _Clostridium_ _difficile_ 
infection-   associated diarrhoea and colitis. 

Where appropriate, teicoplanin should be administered in
combination with other 
antibacterial agents. 

Consideration should be given to official guidance on the
appropriate use of 
antibacterial agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology  
The dose and duration of treatment should be
adjusted according to the underlying 
type and severity of infection and clinical response of the
patient, and