TEICOPLANIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TEICOPLANIN

Available from:

Generics (UK) Limited

ATC code:

J01XA02

INN (International Name):

TEICOPLANIN

Dosage:

200 Milligram

Pharmaceutical form:

Pdr for Soln Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

teicoplanin

Authorization status:

Not Marketed

Authorization date:

2017-11-10

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEICOPLANIN 100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL
SOLUTION
TEICOPLANIN 200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL
SOLUTION
TEICOPLANIN 400 MG POWDER 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 Teicoplanin is and what it is used for
2.
What you need to know before you are given Teicoplanin
3.
How Teicoplanin is given
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 FOR
Teicoplanin contains the active substance teicoplanin, which is an
antibiotic. 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 the
_Clostridium difficile_ bacteria in the gut. For
this, the solution is taken by mouth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TEICOPLANIN
YOU MUST NOT BE GIVEN TEICOPLANIN if you are allergic to teicoplanin
or any of th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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
Teicoplanin 200 mg Powder 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 solution will contain 200 mg teicoplanin in
3.0 mL.
Excipient(s) with known effect
Each 200 mg vial contains approximately 11.6 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion or oral solution.
White to off-white lyophilised powder or cake.
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 patient factors such as age and
renal function.
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