Diflucan 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluconazole

Available from:

Pfizer Healthcare Ireland

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:

1989-08-22

Patient Information leaflet

Page 1 of 9
2023-0089584
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUCAN
® 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Diflucan is and what it is used for
2.
What you need to know before you take Diflucan
3.
How to take Diflucan
4.
Possible side effects
5.
How to store Diflucan
6.
Contents of the pack and other information
1.
WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan is one of a group of medicines called “antifungals”. The
active substance is fluconazole.
Diflucan 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 Diflucan 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 t

Summary of Product characteristics

Health Products Regulatory Authority
26 March 2024
CRN00F50Z
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
1 vial 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.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution with no visible particles
4 CLINICAL PARTICULARS
4.1 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 4.4).

Invasive candidiasis.

Mucosal candidiasis including oropharyngeal, oesophageal candidiasis,
candiduria and chronic mucocutaneous
candidiasis.

Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical treatment are insufficient.
Diflucan 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
Hematopoietic Stem Cell Transplantation (see section
5.1)).
Diflucan is indicated in term newborn infants, infants, toddlers,
children and adolescents aged from 0 to 17 years old:
Diflucan is used for the treatment of mucosal candidiasis
(oropharyngeal, oesophageal), invasive candidiasis, cryptococcal
meningitis and the prophylaxis of candidal infections in
immunocompromised patients. Diflucan can be used as maintenance
therapy to prevent relapse of cryptococcal m