Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Clonmel Healthcare Ltd
500 Anhyd Milligrams
Capsules Hard
1981-07-02
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonamp 500 mg Hard Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains ampicillin trihydrate equivalent to 500 mg ampicillin. Excipients: _For full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Hard, Capsule. (Capsule) Size ‘0’ hard gelatin capsules with a red body and a grey cap marked ‘CLON AMP 500’ containing an off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For treatment of infections due to organisms sensitive to ampicillin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 20Kg b.w.: 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 under 20Kg b.w.: 50 to 100mg/Kg per day in divided doses. Route of administration Oral. 4.3 CONTRAINDICATIONS Ampicillin is penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients. Amaranth (E123) 0.271 mg Tartrazine (E102) 0.128 mg Brilliant Black (E151) 0.014 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/05/2010_ _CRN 2082962_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE (i) Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective. (ii) Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin. (iii) The dosage should be reduced Lees het volledige document