Teicoplanin 200mg Powder and Solvent for solution for injection/infusion or oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Teicoplanin

Available from:

Rowex Ltd

ATC code:

J01XA; J01XA02

INN (International Name):

Teicoplanin

Dosage:

200 milligram(s)

Pharmaceutical form:

Powder and solvent for solution for injection/infusion

Administration route:

intravenous, intramuscular or oral route

Units in package:

1 powder vial with 1 solvent ampoule - 5x1 powder vials with 5x1 solvent ampoules - 10x1 powder vials with 10x1 solvent ampoules

Prescription type:

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

Manufactured by:

Lek Pharmaceuticals d.d

Therapeutic group:

: glycopeptide antibacterials

Therapeutic area:

Glycopeptide antibacterials; teicoplanin

Therapeutic indications:

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:

Not marketed

Authorization date:

2015-10-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEICOPLANIN 100MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR
INFUSION OR ORAL SOLUTION
TEICOPLANIN 200MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR
INFUSION OR ORAL SOLUTION
TEICOPLANIN 400MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR
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 you will be given 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 FOR
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
‘_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
DO NOT USE

Summary of Product characteristics

Health Products Regulatory Authority
11 August 2020
CRN009WYD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teicoplanin 200mg 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
Excipient(s) with known effect: 24 mg (1.0 mmol) of sodium (as
chloride) per vial.
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: White to
light yellow powder.
Solvent: Clear liquid, practically free from particles.
The reconstituted solution is isotonic with plasma and has a pH of
7.2-7.8.
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.
Measu