Ketek

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

telithromycin

Tilgængelig fra:

Aventis Pharma S.A.

ATC-kode:

J01FA15

INN (International Name):

telithromycin

Terapeutisk gruppe:

Antibacterials for systemic use,

Terapeutisk område:

Sinusitis; Tonsillitis; Bronchitis, Chronic; Pharyngitis; Community-Acquired Infections; Pneumonia, Bacterial

Terapeutiske indikationer:

When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.Ketek is indicated for the treatment of the following infections:In patients of 18 years and oldercommunity-acquired pneumonia, mild or moderate.when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:acute exacerbation of chronic bronchitis;acute sinusitis;In patients of 12 years and oldertonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.

Produkt oversigt:

Revision: 25

Autorisation status:

Withdrawn

Autorisation dato:

2001-07-09

Indlægsseddel

24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
KETEK 400 MG FILM-COATED TABLETS
Telithromycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Ketek is and what it is used for
2.
What you need to know before you take
_ _
Ketek
3.
How to take
_ _
Ketek
4.
Possible side effects
5.
How to store Ketek
6.
Contents of the pack and other information
1.
WHAT KETEK IS AND WHAT IT IS USED FOR
Ketek contains the active substance telithromycin.
Ketek is an antibiotic of the type macrolides. Antibiotics stop the
growth of bacteria which cause
infections.
Ketek is used to treat infections due to bacteria against which the
medicine is active.
-
In adults, Ketek is used to treat infections of the throat, infections
of the sinuses (hollow cavities
in the bones around the nose) and chest infections in patients with
long standing breathing
difficulties and lung infection (pneumonia).
-
In adolescents of 12 years and older, Ketek is used to treat
infections of the throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETEK
DO NOT TAKE KETEK:
-
if you are ALLERGIC to telithromycin, to any of the macrolide
antibiotics or to any of the other
ingredients of this medicine (listed in section 6). If in doubt, talk
to your doctor or pharmacist.
-
if you suffer from MYASTHENIA GRAVIS, a rare disease which causes
muscle weakness.
-
if you have had a liver disease (HEPATITIS and/or JAUNDICE) while
taking Ketek in the past.
-
if you are TAKING OTHER MEDICINES

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Ketek 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of telithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light orange, oblong, biconvex tablet, imprinted with ‘H3647’ on
one side and ‘400’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
When prescribing Ketek, consideration should be given to official
guidance on the appropriate use of
antibacterial agents and the local prevalence of resistance (see also
sections 4.4 and 5.1).
Ketek is indicated for the treatment of the following infections:
_In patients of 18 years and older: _
• Community-acquired pneumonia, mild or moderate (see section 4.4).
• When treating infections caused by known or suspected beta-lactam
and/or macrolide resistant
strains (according to history of patients or national and/or regional
resistance data) covered by
the antibacterial spectrum of telithromycin (see sections 4.4 and
5.1):
-
Acute exacerbation of chronic bronchitis,
-
Acute sinusitis
_In patients of 12 years and older: _
• Tonsillitis/pharyngitis caused by S
_treptococcus pyogenes_
, as an alternative when beta lactam
antibiotics are not appropriate in countries/regions with a
significant prevalence of macrolide
resistant
_S. pyogenes_
, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 800 mg once a day i.e. two 400 mg tablets once
a day.
_In patients of 18 years and older, according to the indication, the
treatment regimen will be: _
-
Community-acquired pneumonia: 800 mg once a day for 7 to 10 days,
-
Acute exacerbation of chronic bronchitis: 800 mg once a day for 5
days,
-
Acute sinusitis: 800 mg once a day for 5 days,
-
Tonsillitis/pharyngitis caused by
_Streptococcus pyogenes:_
800 mg once a day for 5 days.
_In patients of