Levviax
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-02-2008
Karatteristiċi tal-prodott
(SPC)
15-02-2008
Rapport ta 'Valutazzjoni Pubblika
(PAR)
15-02-2008
Ingredjent attiv:
telithromycin
Disponibbli minn:
Aventis Pharma S.A.
Kodiċi ATC:
J01FA15
INN (Isem Internazzjonali):
telithromycin
Grupp terapewtiku:
Antibacterials for systemic use,
Żona terapewtika:
Community-Acquired Infections; Pharyngitis; Bronchitis, Chronic; Pneumonia; Tonsillitis; Sinusitis
Indikazzjonijiet terapewtiċi:
When prescribing Levviax 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).Levviax 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 sinusitisIn patients of 12 years and older:- Tonsillitis/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 (see sections 4.4 and 5.1).
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2001-07-09
Fuljett ta 'informazzjoni
Medicinal Product no longer authorised
21
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVVIAX 400 MG FILM-COATED TABLETS
Telithromycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Levviax is and what it is used for
2.
Before you take_ _Levviax.
3.
How to take_ _Levviax.
4.
Possible side effects
5.
How to store Levviax
6.
Further Information
1.
WHAT LEVVIAX IS AND WHAT IT IS USED FOR
Levviax belongs to one of a group of medicines called ketolides, a new
class of antibiotics related to
macrolides. Antibiotics stop the growth of bacteria which cause
infections.
Levviax is used in adults and adolescents of 12 years and older to
treat infections due to bacteria
against which the medicine is active. In adolescents of 12 years and
older, Levviax can be used to
treat: infections of the throat. In adults, Levviax can be used to
treat infections of the throat, infections
of the sinuses, chest infections in patients with long standing
breathing difficulties and pneumonia.
2.
BEFORE YOU TAKE LEVVIAX
DO NOT TAKE LEVVIAX:
-
if you suffer from myasthenia gravis, a rare disease which causes
muscle weakness.
-
if you are allergic (hypersensitive) to telithromycin, to any of the
macrolide antibiotics or to any of
the other ingredients of Levviax. If in doubt, talk to your doctor or
pharmacist.
if you have had a hepatitis and/or jaundice while taking Levviax in
the past.
-
if you are taking certain medicinal products to control the blood
level of cholesterol or other lipids.
-
if you or someone in your family are known to ha
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Karatteristiċi tal-prodott
Medicinal Product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Levviax 400 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of telithromycin.
For a 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 Levviax, 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).
Levviax 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
The recommended dose is 800 mg once a day i.e. two 400 mg tablets once
a day. The tablets should be
swallowed whole with a sufficient amount of water. The tablets may be
taken with or without food.
Consideration may be given to taking Levviax at bedtime, to reduce the
potential impact of visual
disturbances and loss of consciousness (see section 4.4).
_In patients of 18 years and older, according to the indication, the
treatment regimen will be: _
-
Comm
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