País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
G & A Licensing Limited
500 Milligram
Film Coated Tablet
2010-01-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid Forte 500mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of Clarithromycin For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from _Italy A yellow ovaloid film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for treatment of infections due to susceptible organisms. Such infections include. 1. Lower respiratory tract infections (eg. bronchitis, pneumonia). 2. Upper respiratory tract infections (eg. pharyngitis, sinusitis). 3. Skin and soft tissue infections (eg. folliculitis, cellulitis, erysipelas). 4. Disseminated or localised mycobacterial infections due to _Mycobacterium avium _or _Mycobacterium intracellulare_. Localised infections due to _Mycobacterium chelonae_, _Mycobacterium fortuitum_, or _Mycobacterium kansasii_. 5. Clarithromycin is indicated for the prevention of disseminated _Mycobacterium avium _complex infection in HIV - infected patients with CD4 lymphocyte counts less than or equal to 100/mm 3 . 6. Clarithromycin in the presence of acid suppression is indicated for the eradication _of H. pylori_, resulting in decreased recurrence of duodenal ulcer. (See Further Information) As with other antibiotics, it is recommended that guidelines on the prevalence of local resistance, and associated medical practice regarding the prescription of antibiotics, be consulted before prescribing Klacid Forte. FURTHER INFORMATION: _H. pylori _is strongly associated with peptic ulcer disease. Ninety to 100% of patients with duodenal ulcers are infected with this agent. Eradication of _H. pylori _has been shown to markedly reduce the rate of duodenal ulcer recurrence, thereby reducing t Llegiu el document complet