CLONAMP Powder for Oral Suspension 125 Anhyd mg/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
AMPICILLIN TRIHYDRATE
Available from:
Clonmel Healthcare Ltd
Dosage:
125 Anhyd mg/5ml
Pharmaceutical form:
Powder for Oral Suspension
Authorization date:
1981-07-02
Summary of Product characteristics
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
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