البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Abbott Laboratories Ireland Ltd
250mg/5ml %v/v
Granules for Oral Suspension
1998-06-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid 250mg/5ml Granules for Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution as directed, each 5ml of suspension contains 250mg Clarithromycin. Excipients: also contain 2.42g of sucrose per 5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white, free-flowing granules with an odour of fruit. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid Suspension is indicated for the treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections. Upper respiratory tract infections. Skin and skin structure infections. Acute otitis media. Klacid 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 Suspension has bactericidal activity against several bacterial strains. These organisms include _Haemophilus_ _influenzae, Streptococcus pneumoniae, Streptococcus اقرأ الوثيقة كاملة