Fluconazole 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluconazole

Available from:

B. Braun Melsungen AG

ATC code:

J02AC; J02AC01

INN (International Name):

Fluconazole

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Triazole derivatives; fluconazole

Authorization status:

Marketed

Authorization date:

2008-11-28

Patient Information leaflet

Page 1 of 9
030810.0MM0720A24
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 2 MG/ML SOLUTION FOR INFUSION
fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor or pharmacist.
●
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effect not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Fluconazole is and what it is used for
2.
What you need to know before you are given Fluconazole
3.
How Fluconazole is given
4.
Possible side effects
5.
How to store Fluconazole
6.
Contents of the pack and other information
1.
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole is one of a group of medicines called ‘antifungals’.
The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi and may also
be used to stop you from getting
candidal infection. The most common cause of fungal infections is a
yeast called
_Candida_
.
_Adults _
You might be given this medicine by your doctor to treat the following
types of fungal infections:
●
Cryptococcal meningitis - a fungal infection in the brain
●
Coccidioidomycosis – a disease of the bronchopulmonary system
●
Infections caused by
_Candida_
and found in the blood stream, body organs (e.g. heart, lungs) or
urinary
tract
●
Mucosal thrush – infection affecting the lining of the mouth, throat
and denture sore mouth
You might also be given Fluconazole to:
●
stop cryptococcal meningitis from coming back
●
stop mucosal thrush from coming back
●
stop you from getting an infection caused by
_Candida_
(if your immune system is weak and not working
properly)
_Children and adolescents (0 to 17 years old) _
You might be given this medicine by your doctor to treat the following
types of fungal infections:
●
Mucosal thrush – infection affecting the lining of the mouth, throa

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2024
CRN00F52G
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 ml solution for infusion contains 100 mg of fluconazole.
Each 100 ml solution for infusion contains 200 mg of fluconazole.
Each 200 ml solution for infusion contains 400 mg of fluconazole.
Each ml contains 2mg of Fluconazole
Excipients with known effect:
Each ml also contains 0.15 mmol (3.5 mg) sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless aqueous solution
pH: 4.0 – 8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections (see
section 5.1).
Fluconazole is indicated in adults for the treatment of:

Cryptococcal meningitis (see section 4.4)

Coccidioidomycosis (see section 4.4).

Invasive candidiasis.

Mucosal candidiasis (including oropharyngeal candidiasis, oesophageal
candidiasis, candiduria and chronic
mucocutaneous candidiasis),

Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical treatment are insufficient.
Fluconazole is indicated in adults for the prophylaxis of:

Relapse of cryptococcal meningitis in patients with high risk of
recurrence.

Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high risk of
experiencing relapse.

Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as patients with haematological
malignancies receiving chemotherapy or patients receiving
Haematopoietic Stem Cell Transplantation (see section
5.1).
Fluconazole is indicated in term newborn infants, infants, toddlers,
children and adolescents aged from 0 to 17 years old:
Fluconazole is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal), invasive candidiasis, cryptococcal
meningitis and the prophylaxis of candidal infections in