Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE DISODIUM PHOSPHATE DODECAHYDRATE
Laboratorios Casen-Fleet S.L.U.
SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE DISODIUM PHOSPHATE DODECAHYDRATE
21.4/9.4 Grams
Rectal Solution
Product not subject to medical prescription
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fleet Ready-to use 21.4g/9.4g Enema 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 118ml dose delivers the equivalent of 21.4 g (18.1% w/v) Sodium Dihydrogen Phosphate Dihydrate and 9.4 g (8.0% w/v) Disodium Phosphate Dodecahydrate. Contains 4.4 g Sodium per 118ml delivered dose. Excipients: contains 70mg benzalkonium chloride per 118ml delivered dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal Solution (Enema) Clear, colourless, odourless solution, free from precipitate and turbidity. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • For use in the relief of occasional constipation. • For use where bowel cleansing is required, such as before and after lower bowel surgery, delivery and post partum, before proctoscopy, sigmoidoscopy and before radiological examinations of the lower bowel. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and Children over 12 years old: 1 bottle (118ml delivered dose) no more than once daily or as directed by a physician (see section 4.4). Elderly patients: 1 bottle (118ml delivered dose) no more than once daily or as directed by a physician. Fleet Ready to Use enema should be used with caution in the elderly (see section 4.4). Children aged 3 years to less than 12 years: As directed by a physician (see section 4.4 and 4.9). Fleet Ready-to-Use Enema is contraindicated in children under 3 years of age (see section 4.3). Renal impairment. Do not administer to patients with clinically significant impairment of renal function (see section 4.3). The product should be used with caution in patients with impaired renal function, when the clinical benefit is expected to outweigh the risk of hyperphosphataemia (see section 4.4). Hepatic Aqra d-dokument sħiħ