Teicoplanin 400 mg powder and solvent for solution for injection/infusion or oral solution

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

TEICOPLANIN

זמין מ:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

קוד ATC:

J01XA02

INN (שם בינלאומי):

TEICOPLANIN 400 mg

טופס פרצבטיות:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION ORAL SOLUTION

הרכב:

TEICOPLANIN 400 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIBACTERIALS FOR SYSTEMIC USE

מצב אישור:

Authorised

תאריך אישור:

2018-03-26

עלון מידע

PIL_Teicoplanin_MT_
1
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 ‘
_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 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’
•
if you have had a flushi

מאפייני מוצר

SmPC_Teicoplanin_MT_
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg teicoplanin equivalent to not less than
200,000 IU.
After reconstitution, the solution contains 200 mg teicoplanin in 3.0
ml.
Each vial contains 400 mg teicoplanin equivalent to not less than
400,000 IU.
After reconstitution, the solution contains 400 mg teicoplanin in 3.0
ml.
Excipient with known effect: this medicine contains less than 1 mmol
sodium (23 mg) per vial and is
essentially ‘sodium-free’
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 powder
Solvent: clear, colorless solution
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 res