Fluconazole Villerton 2mg/ml Solution for Infusion

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

FLUCONAZOLE

Disponible depuis:

Villerton Invest S.A. Rue Edward Steichen 14, 2540, Luxembourg

Code ATC:

J02AC01

DCI (Dénomination commune internationale):

FLUCONAZOLE 2 mg/ml

forme pharmaceutique:

SOLUTION FOR INFUSION

Composition:

FLUCONAZOLE 2 mg/ml

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTIMYCOTICS FOR SYSTEMIC USE

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2019-04-11

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 2MG/ML SOLUTION FOR INFUSION
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 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, tell your doctor or nurse. This includes
any possible side effects not listed in
this leaflet. See section 4.
Your medicine is called
FLUCONAZOLE 2MG/ML SOLUTION FOR INFUSION
(referred to as
FLUCONAZOLE INFUSION
in
this leaflet).
1.
WHAT FLUCONAZOLE INFUSION IS AND WHAT IT IS USED FOR
Fluconazole Infusion is one of a group of medicines called antifungal
agents. The active substance is
fluconazole.
Fluconazole Infusion is used to treat infections caused by fungi and
may also be used to stop you from getting
candidal infections. 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 - infections affecting the lining of the mouth,
throat and denture sore mouth
You might also be given fluconazole Infusion 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 - infections affecting the lining of the mouth,
throat
WHAT IS

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 2mg/ml Solution for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 2mg fluconazole.
Each 50 ml infusion bag contains 100mg fluconazole.
Each 100 ml infusion bag contains 200mg fluconazole.
Each 200 ml infusion bag contains 400mg fluconazole
Excipients with known effect
Also contains 15 mmol sodium per 100 ml dose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion
Infusion bag containing a clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluconazole Infusion is indicated in the following fungal infections
(see section 5.1).
Fluconazole Infusion 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 topical
treatments are insufficient
Fluconazole Infusion is indicated in adults for the prophylaxis of:
•
Relapse of crytopcoccal 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 Infusion is indicated in term newborn infants, infants,
toddlers, children
and adolescents aged from 0 to 17 years old
:
Fluconazole Infusion is used for the treatment of mucosal candidiasis
(oropharyngeal,
oesophageal), invasive candidiasis, cryptococcal meningitis and the
prophylaxis of
candidal infections in immunocompromised patients. Fluconazole
Infusion can be
used as main