UFT Capsules Hard 100/224 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
TEGAFUR URACIL
Available from:
Merck Serono Limited
Dosage:
100/224 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2005-12-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0654/017/001
Case No: 2072309
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MERCK SERONO LIMITED
BEDFONT CROSS, STANWELL ROAD, FELTHAM, MIDDLESEX, TW14 8NX, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
UFT 100MG/224 MG HARD CAPSULES
the particulars of which are set out in 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 23/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/08/2010_
_CRN 2072309_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
UFT 100mg/224 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg tegafur and 224 mg uracil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
The capsules are white, opaque and imprinted with the code TC434.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
UFT is indicated for first-line treatment of metastatic colorectal cancer in combination with calcium folinate (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: the dose of UFT is 300 mg/m2/day tegafur and 672 mg/m2/day uracil combined with 90 mg/day oral calcium
folinate, given in
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