Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Generics (UK) Limited
500 mg Milligram
Capsule
1988-05-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ampicillin Capsules BP 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Ampicillin Trihydrate, equivalent to 500mg of Ampicillin (anhydrous). For excipients, see 6.1 3 PHARMACEUTICAL FORM Hard capsule Red/dark grey size 0+ capsules marked 'AN 500' and 'G', containing white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections due to organisms sensitive to ampicillin. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity to penicillins or ampicillin. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective. Patients with infectious mononucleosis are particularly prone to develop rashes with ampicillin. Adults: The usual dose is 250mg every six hours. For treatment of severe infections the dosage may be increased at the discretion of the physician. Children: Over 10 years old As for adults. up to 10 years old This strength is unsuitable for the appropriate dosage. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 11/08/2005_ _CRN 2013198_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None have been reported. 4.6 PREGNANCY AND LACTATION Anti-infectives should not be used during pregnancy or lactation unless considered essential by the physician. The drug has been shown to cross the placenta and is excreted in breast milk. Studies in animals and experience of human use to date have shown no evidence of teratogenic effects. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Прочитать полный документ