TRANSIPEG IN SACHET
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
14-05-2024
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
MACROGOL 3350
Fáanlegur frá:
Bayer Limited
Skammtar:
2.95 Grams
Lyfjaform:
Powder for Oral Solution
Leyfisdagur:
2008-10-17
Vara einkenni
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1410/055/001
Case No: 2043660
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0021/080/001.
BAYER LIMITED
THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TRANSIPEG 2.95G POWDER FOR ORAL SOLUTION IN SACHET.
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 17/10/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/10/2008_
_CRN 2043660_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transipeg 2.95g powder for oral solution in sachet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 2.95g of Macrogol 3350.
Excipients: Transipeg 2.95 g contains 145 mg of sodium and 20 mg of potassium per sachet as well as aspartame
(E951) and sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The posology is from 1 to 4 sachets
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