Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Clonmel Healthcare Ltd
125 Anhyd mg/5ml
Powder for Oral Suspension
1981-07-02
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonamp 125 mg / 5ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of suspension contains 125 mg of Ampicillin as Ampicillin Trihydrate. Excipients: For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension A white polyethylene bottle with a child-resistant cap containing an off-white powder giving a pink/red suspension on reconstitution. 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 20 Kg 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 20 Kg 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) 0.25 mg / 5ml Sucrose 2.59 g / 5ml IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/03/2007_ _CRN 2034999_ _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 re Przeczytaj cały dokument