STERETS PRE-INJECTION SWABS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
ISOPROPANOL
Available from:
Medlock Medical Ltd
Pharmaceutical form:
Impregnated Dressing
Authorization date:
2006-06-23
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)
PA1175/009/001
Case No: 2043167
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MEDLOCK MEDICAL LTD
TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
STERETS PRE-INJECTION SWABS %V/V 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 23/04/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/12/2008_
_CRN 2043167_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterets Pre-Injection Swabs 70% v/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each swab is impregnated with an aqueous solution of Isopropyl Alcohol 70% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated dressing.
Impregnated dressing in a colourless to pale straw solution presented in a disposable sachet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For pre-injection site cleansing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
To be used as directed by a physician.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the act
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