FLUCONAZOLE

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

FLUCONAZOLE

Saadav alates:

Claris Lifesciences (UK) Limited

ATC kood:

J02AC01

INN (Rahvusvaheline Nimetus):

FLUCONAZOLE

Annus:

2 Mg/Ml

Ravimvorm:

Solution for Infusion

Retsepti tüüp:

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

Terapeutiline ala:

fluconazole

Volitamisolek:

Not Marketed

Loa andmise kuupäev:

2011-12-16

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 2 MG/ML SOLUTION FOR INFUSION
Fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 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 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 trush 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 medicin

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 2mg/ml Solution for Infusion, non-PVC bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg of fluconazole.
Each 100 ml solution for infusion contains 200 mg fluconazole.
Excipient with known effect
Each 100 ml solution for infusion contains 15.4 mmol sodium (see
section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and colorless solution.
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,
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
Hematopoietic 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
immunocompromised patients. Fluconazole
can be used as maintenance therapy to prevent relapse of cryptococcal
meningitis in children with high risk of
reoccurrence (see section 4.4).
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