DIFLUCAN Solution for infusion Ref.[6842] Active ingredients: Fluconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Product name and form

Diflucan 2 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution with no visible particles.

Qualitative and quantitative composition

Each ml contains 2 mg of fluconazole.

1 vial/ PVC bag with 100 ml solution for infusion contains 200 mg fluconazole.

Excipient(s) with known effect: Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol sodium) (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluconazole

Fluconazole is a triazole antifungal agent. Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

List of Excipients

Sodium chloride
Water for injections
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Clear Type I glass infusion vial sealed closed with rubber stoppers and aluminium caps.

Plasticised PVC bag.

Pack sizes:

1 vial containing 25 ml solution for infusion
1, 48 vial(s) containing 50 ml solution for infusion
1, 40 vial(s) containing 100 ml solution for infusion
1 vial containing 200 ml solution for infusion
1, 5, 10, 20 plasticised PVC bag(s) containing 100 ml solution for infusion
1, 5, 10, 20 plasticised PVC bag(s) containing 200 ml solution for infusion

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0315

Date of first authorisation: 31 August 1989
Date of latest renewal: 16 December 2013

Drugs

Drug Countries
DIFLUCAN Austria, Australia, Canada, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa

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