País: Israel
Língua: inglês
Origem: Ministry of Health
CLARITHROMYCIN
ABBOTT MEDICAL LABORATORIES LTD, ISRAEL
J01FA09
GRANULES FOR RECONSTITUTION
CLARITHROMYCIN 125 MG / 5 ML
PER OS
Required
ABBVIE S.R.L., ITALY
CLARITHROMYCIN
CLARITHROMYCIN
Bronchitis, Pharyngitis, Tonsilitis pneumonia skin infections due to susceptible microorganisms. Treatment of Mycobacterium avium complex in patients with AIDS. Treatment of Otitis Media.
2014-09-30
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 Leia o documento completo