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DIFLUCAN Solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Diflucan 2 mg/ml solution for infusion.

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 ...

Pharmaceutical form

Solution for infusion. Clear, colourless solution with no visible particles.

Therapeutic indications

Diflucan is indicated in the following fungal infections (see section 5.1). Diflucan is indicated in adults for the treatment of: Cryptococcal meningitis (see section 4.4). Coccidioidomycosis (see section ...

Posology and method of administration

Posology The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests ...

Contraindications

Hypersensitivity to the active substance to related azole substances, or to any of the excipients listed in section 6.1. Coadministration of terfenadine is contraindicated in patients receiving Diflucan ...

Special warnings and precautions for use

Tinea capitis Fluconazole has been studied for treatment of tinea capitis in children. It was shown not to be superior to griseofulvin and the overall success rate was less than 20%. Therefore, Diflucan ...

Interaction with other medicinal products and other forms of interaction

Concomitant use of the following other medicinal products is contraindicated Cisapride There have been reports of cardiac events including torsades de pointes in patients to whom fluconazole and cisapride ...

Fertility, pregnancy and lactation

Pregnancy An observational study has suggested an increased risk of spontaneous abortion in women treated with fluconazole during the first trimester. There have been reports of multiple congenital abnormalities ...

Effects on ability to drive and use machines

No studies have been performed on the effects of Diflucan on the ability to drive or use machines. Patients should be warned about the potential for dizziness or seizures (see section 4.8) while taking ...

Undesirable effects

The most frequently (>1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline ...

Overdose

There have been reports of overdose with Diflucan. Hallucination and paranoid behaviour have been concomitantly reported. In the event of overdose, symptomatic treatment (with supportive measures and gastric ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives ATC code: J02AC01 Mechanism of action Fluconazole is a triazole antifungal agent. Its primary mode of action is the inhibition ...

Pharmacokinetic properties

The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral route. Absorption After oral administration fluconazole is well absorbed, and plasma levels ...

Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the human exposure indicating little relevance to clinical use. Carcinogenesis Fluconazole showed no ...

List of excipients

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

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life Glass vials: 5 years. Plasticised PVC bags: 12 months. Once opened the product should be used immediately. Any unused infusion should be discarded. From a microbiological point of view, the ...

Special precautions for storage

Glass vials: Do not freeze. Plasticised PVC bags: Store below 30°C. Do not freeze. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

Fluconazole intravenous infusion is compatible with the following administration fluids: Dextrose 5% and 20% Ringers solution Hartmanns solution Potassium chloride in dextrose Sodium bicarbonate 4.2% and ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 00057/0315

Date of first authorization / renewal of the authorization

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

Date of revision of the text

04/2018

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