DIFLUCAN SOLUTION FOR INFUSION 2 MG/ML (100MG/50ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
FLUCONAZOLE
Available from:
Pfizer Limited
Dosage:
2 mg/ml Mg/Ml
Pharmaceutical form:
Solution for Infusion
Authorization date:
1989-08-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0019/044/007
Case No: 2035051
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PFIZER LIMITED
RAMSGATE ROAD, SANDWICH, KENT CT13 9NJ, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DIFLUCAN SOLUTION FOR INFUSION 2 MG/ML (100MG/50ML)
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 10/05/2007 until 21/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/05/2007_
_CRN 2035051_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan Solution for Infusion 2 mg/ml (100mg/50ml)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains 2 mg fluconazole (100mg/50ml).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, sterile, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once
these results become available, anti-infective therapy should be adjusted accordingly.
Diflucan is indicated for:
1.
Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis.
2.
Mucosal
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