FLETCHERS' PHOSPATE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
SODIUM ACID PHOSPHATE SODIUM PHOSPHATE
Available from:
Chemidex Pharma Limited
Dosage:
10%w/v, 8%
Pharmaceutical form:
Enema
Authorization date:
2008-03-28
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1161/007/001
Case No: 2046426
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0100/027/002.
CHEMIDEX PHARMA LIMITED
CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE, CRABTREE ROAD, EGHAM, SURREY TW20 8RB, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FLETCHERS' PHOSPHATE ENEMA
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 28/03/2008 until 22/06/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/03/2008_
_CRN 2046426_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fletchers’ Phosphate Enema
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains:
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Rectal solution.
A clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For evacuation of the colon in constipation, prior to surgical and diagnostic procedures and in obstetrics prior to
delivery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For rectal use only.
Adults: The usual dose is one enema as required.
Children (over 3 years): In proportion according to body weight.
Childre
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