AMOXYCILLIN SACHET SUGAR FREE
Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Súhrn charakteristických
(SPC)
03-05-2024
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Aktívna zložka:
AMOXICILLIN TRIHYDRATE
Dostupné z:
Athlone Laboratories Ltd
Dávkovanie:
125 Milligram
Forma lieku:
Powder for Oral Suspension
Dátum Autorizácia:
1993-10-21
Súhrn charakteristických
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxycillin Sachet Sugar Free 125mg Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of product contains 125 mg of amoxicillin as amoxicillin trihydrate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
A lemon coloured, dry, free flowing powder with a characteristic lemon flavour for reconstitution in water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxycillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacteria infections such
as:
Upper respiratory infections, otitis media, acute and chronic bronchitis, lobar and bronchopneumonia, cystitis,
urethritis, pyelonephritis, bacteriuria in pregnancy, gynaecological infections including puerperal sepsis and septic
abortion, gonorrhoea, peritonitit, intra - abdominal sepsis, septiceamia, bacterial endocarditis, typhoid and parathphoid
fever, skin and soft tissue infections, osteomyelitis.
Amoxycillin may be used for the prevention of bacteraemia associated with procedures such as dental extraction in
patients as risk of developing bacterial endocarditis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE: The absorption of Amoxycillin is virtually unimpaired by the presence of food.
STANDARD ADULT DOSE: 250mg three times daily by the oral route.
In cases of severe infection the dosage may be doubled.
CHILDREN: (Up to 10 years).
125mg three times daily by the oral route.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to traditional and semi-synthetic penicillins or cephalosporins.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other penicillins, side effects are rare and usually of a mild and transitory nature. Gastrointestinal side effects,
such as nausea, vom
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