KLACID PAEDIATRIC SUSPENSION 125 MG5 ML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

CLARITHROMYCIN

Verfügbar ab:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC-Code:

J01FA09

Darreichungsform:

GRANULES FOR RECONSTITUTION

Zusammensetzung:

CLARITHROMYCIN 125 MG / 5 ML

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

ABBVIE S.R.L., ITALY

Therapiegruppe:

CLARITHROMYCIN

Therapiebereich:

CLARITHROMYCIN

Anwendungsgebiete:

Bronchitis, Pharyngitis, Tonsilitis pneumonia skin infections due to susceptible microorganisms. Treatment of Mycobacterium avium complex in patients with AIDS. Treatment of Otitis Media.

Berechtigungsdatum:

2014-09-30

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
KLACID PAEDIATRIC SUSPENSION 125MG/ 5ML
1.
NAME OF THE MEDICINAL PRODUCT
Klacid Paediatric Suspension 125mg/ 5ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the granules for suspension contains 125 mg of
clarithromycin.
Excipient: Sucrose 550 mg/mlFor the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
White to off - white granules for reconstitution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Klacid
Paediatric
Suspension
is
indicated
for
the
treatment
of
Bronchitis,
Pharyngitis,
Tonsilitis
pneumonia,
skin
infections
due
to
susceptible
microorganisms.
Treatment
of
Mycobacterium avium complex in patients with AIDS. Treatment of otitis
media.
Klacid Paediatric Suspension is usually active against the following
organisms _in vitro_:
GRAM-POSITIVE BACTERIA: _Staphylococcus aureus_ (methicillin
susceptible); _Streptococcus _
_pyogenes_ (Group A beta-haemolytic streptococci); alpha-haemolytic
streptococci (viridans
group); _Streptococcus (Diplococcus) pneumoniae_; _Streptococcus
agalactiae_; _Listeria _
_monocytogenes_.
GRAM-NEGATIVE BACTERIA: _Haemophilus_ _influenzae_, _Haemophilus_
_parainfluenzae_, _Moraxella_
(_Branhamella_) _catarrhalis_, _Neisseria_ _gonorrhoeae_; _Legionella_
_pneumophila_, _Bordetella_
_pertussis_, _Helicobacter_ _pylori_; _Campylobacter_ _jejuni_.
MYCOPLASMA: _Mycoplasma_ _pneumoniae_; _Ureaplasma_ _urealyticum_.
OTHER ORGANISMS: _Chlamydia_ _trachomatis_; _Mycobacterium_ _avium_;
_Mycobacterium_ _leprae_;
_Chlamydia_ _pneumoniae_.
ANAEROBES: Macrolide-susceptible _Bacteroides_ _fragilis_;
_Clostridium_ _perfringens_;
_Peptococcus_ species; _Peptostreptococcus_ species;
_Propionibacterium_ _acnes_.
Klacid Paediatric Suspension has bactericidal activity against several
bacterial strains. These
organisms include _H. influenzae, Streptococcus pneumoniae,
Streptococcus pyogenes, _
_Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis,
Neisseria gonorrhoeae, _
_Helicobacter pylori and Campylobacter _species_._
The