BETADINE ANTISEPTIC TULLE
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
27-04-2024
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Ingrédients actifs:
POVIDONE-IODINE
Disponible depuis:
Medlock Medical Ltd
Dosage:
10 %w/w
forme pharmaceutique:
Impregnated Dressing
Date de l'autorisation:
2007-06-08
Résumé des caractéristiques du produit
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA1175/002/015
Case No: 2037610
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0696/002/005.
MEDLOCK MEDICAL LTD
TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BETADINE ANTISEPTIC TULLE 250 MG IMPREGNATED DRESSING
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 08/06/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2007_
_CRN 2037610_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Antiseptic Tulle 250 mg Impregnated Dressing
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dressing is impregnated with 2.5 g of gel containing 250 mg povidone iodine equivalent to 10% w/w.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated dressing.
10 x 10cm gauze dressing impregnated with a golden brown gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic dressing for the management of cutaneous traumatic lesions and ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use only.
Apply as required to the affected area,
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