AERRANE (ISOFLURANE), INHALATION VAPOUR, LIQUID
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
ISOFLURANE
Available from:
Baxter Healthcare Limited
Dosage:
100 %v/v
Pharmaceutical form:
Inhalation Vapour Liquid
Authorization date:
1999-12-02
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0167/106/001
Case No: 2084267
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BAXTER HEALTHCARE LIMITED
CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AERRANE (ISOFLURANE), 100% V/V INHALATION VAPOUR, LIQUID
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 16/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/08/2010_
_CRN 2084267_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AErrane (isoflurane), 100% v/v inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 100% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of general anaesthesia in adults and children. Use of isoflurane in dental anaesthesia should
be restricted to hospitals or day care units only (see Contraindications, Section 4.3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In order to be able to accurately control the precise concentration of isoflurane, v
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