TARGOCID 400 Milligram Pdr+Solv for Soln for Inj

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TEICOPLANIN

Available from:

Ennogen Healthcare Ltd

ATC code:

J01AA02

INN (International Name):

TEICOPLANIN

Dosage:

400 Milligram

Pharmaceutical form:

Pdr+Solv for Soln for Inj

Prescription type:

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

Therapeutic area:

Tetracyclines

Authorization status:

Authorised

Authorization date:

2014-10-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGOCID®
200 MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION / INFUSION OR ORAL SOLUTION
TARGOCID®
400 MG 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 PRECAUTIO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targocid 400mg 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 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 PA0540/021/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/021/002
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.
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.
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