FLUCONAZOLE Solution for Infusion 2 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
FLUCONAZOLE
Available from:
Teva UK Limited
Dosage:
2 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Authorization date:
2010-08-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0237/064/001
Case No: 2087402
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0585/015/001.
TEVA UK LIMITED
BRAMPTON ROAD, HAMPDEN PARK, EASTBOURNE, EAST SUSSEX BN22 9AG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FLUCONAZOLE 2 MG/ML SOLUTION FOR INFUSION
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 13/08/2010.
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 2087402_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 2mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole 2mg per ml.
Each 25ml vial contains 50mg fluconazole.
Each 50ml vial contains 100mg fluconazole.
Each 100ml vial contains 200mg fluconazole.
Also contains: sodium 3.8 mmol per 25ml vial, 7.6 mmol per 50 ml vial and 15.2 mmol per 100 ml vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
Fluconazole 2mg/ml Solution for Infusion is a clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy may be started before the res
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