SCANDONEST Solution for Injection 2% w/v /1: Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
MEPIVACAINE HYDROCHLORIDE EPINEPHRINE
Available from:
Septodont
Dosage:
2% w/v /1: Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
1999-05-27
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)
PA0196/016/001
Case No: 2059595
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SEPTODONT
58 RUE DU PONT DE CRÉTEIL, 94 107 SAINT MAUR-DES-FOSSÉS, CEDEX, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SCANDONEST 2% W/V/1:100,000 SPECIAL, SOLUTION FOR INJECTION
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 27/05/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/05/2010_
_CRN 2059595_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scandonest 2% w/v / 1:100,000 Special, Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients - contains Potassium Metabisulphite (E224) 1.2mg (per 1ml)
Also contains Sodium (<1mmol/ml)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local anaesthetic for dental use, where a vasoconstrictor effect is desirable.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Administration:
Local injection (block or infiltration)
To minimise the likelihood of intravascular
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