Targocid 200mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TEICOPLANIN

Available from:

Sanofi Malta Limited

ATC code:

J01XA02

INN (International Name):

TEICOPLANIN

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

TEICOPLANIN 200 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-12-21

Patient Information leaflet

1
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGOCID 100 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
OR ORAL SOLUTION
TARGOCID 200 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
OR ORAL SOLUTION
TARGOCID 400 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
OR ORAL SOLUTION
teicoplanin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
-
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 Targocid is and what it is used for
2.
What you need to know before you are given Targocid
3.
How to use Targocid
4.
Possible side effects
5.
How to store Targocid
6.
Contents of the pack and other information
1.
WHAT TARGOCID IS AND WHAT IT IS USED FOR
Targocid is an antibiotic. It contains a medicine called
‘teicoplanin’. It works by killing the bacteria
that cause infections in your body.
Targocid 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
Targocid can be used to treat some infections caused by
‘_Clostridium difficile_’ bacteria in the gut. For
this, the solution is taken by mouth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TARGOCID
DO NOT USE TARGOCID IF:

you are allergic to

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Targocid 200 mg powder and solvent for solution for injection/infusion
or oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg teicoplanin equivalent to not less than
200,000 IU
After reconstitution, the solutions will contain 200 mg teicoplanin in
3.0 mL
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 for solution for injection/infusion or oral solution: spongy
ivory coloured homogeneous mass
Solvent: clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Targocid 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. _ _
Targocid 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 p