Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-10-2022
Summary of Product characteristics
(SPC)
13-10-2022
Active ingredient:
Teicoplanin
Available from:
Noridem Enterprises Limited
ATC code:
J01XA; J01XA02
INN (International Name):
Teicoplanin
Dosage:
400 milligram(s)
Pharmaceutical form:
Powder and solvent for solution for injection/infusion
Administration route:
For injection/infusion or oral solution
Units in package:
Bt x 1 vial x 400 mg + 1 ampoule x 3 ml solvent
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
DEMO S.A.,
Therapeutic group:
Glycopeptide antibacterials
Therapeutic area:
Glycopeptide antibacterials; teicoplanin
Therapeutic indications:
It is indicated in adults and in children from birth for the parenteral treatment of the following infections: 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; also indicated as an alternative oral treatment for Clostridium difficile infection- associated diarrhoea and colitis
Authorization status:
Marketed
Authorization date:
2015-05-22
Patient Information leaflet
PACKAGE 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.
•
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 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 ‘
_Clostridioides 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 TEICOPLANIN IF:
-
you are allergic to teicoplanin or any of the other ingredients of
this medicine, (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Teicoplanin if:
•
you are allergic to an antibiotic called ‘vancomycin’
•
you have had a flushing of your up
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
13 October 2022
CRN00D6JQ
Page 1 of 11
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.
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
_Clostridioides 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.
Measurement of serum concentrations
Teicoplanin trough serum concentrations should be monitored at steady
state after completion of the loading dose regimen in
order to ensure that a minimum trough serum concentration ha
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