Targocid 200mg Powder and Solvent for Solution for Injection/infusion or oral solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Teicoplanin

Tilgængelig fra:

IMED Healthcare Ltd.

ATC-kode:

J01XA; J01XA02

INN (International Name):

Teicoplanin

Dosering:

200 milligram(s)

Lægemiddelform:

Powder and solvent for solution for injection/infusion

Recept type:

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

Terapeutisk område:

Glycopeptide antibacterials; teicoplanin

Autorisation status:

Authorised

Autorisation dato:

2015-09-11

Indlægsseddel

PACKAGE LEAFET: INFORMATION FOR THE USER
TARGOCID® 200MG 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 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 Targocid
if:
• you are allergic to

Produktets egenskaber

Health Products Regulatory Authority
12 November 2019
CRN009G4L
Page 1 of 3
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
Targocid 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
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and Solvent for Solution for Injection/infusion or oral
solution
_Product imported from UK:_
Powder for solution for injection/infusion or oral solution: spongy
ivory coloured homogeneous mass
Solvent: clear, colourless liquid.
4 CLINICAL PARTICULARS
As per PA0540/021/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/021/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Powder for solution for injection/infusion or oral solution
Sodium chloride
Sodium hydroxide (for pH adjustment)
Solvent
Water for injections
6.2 INCOMPATIBILITIES
Teicoplanin and aminoglycoside are incompatible when mixed directly
and must not be mixed before injection.
If teicoplanin is administered in combination therapy with other
antibiotics, the preparation must be administered separately.
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
Health Products Regulatory Authority
12 November 2019
CRN009G4L
Page 2 of 3
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Shelf life of reconstituted solution:
Chemical and physical in-use stability of the reconstituted solution
prepared as recommended has been demonstrate