DIFLUCAN 10 Mg/Ml Powder for Oral Suspension

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

FLUCONAZOLE

Disponible desde:

Pfizer Limited

Código ATC:

J02AC01

Designación común internacional (DCI):

FLUCONAZOLE

Dosis:

10 Mg/Ml

formulario farmacéutico:

Powder for Oral Suspension

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Triazole derivatives

Estado de Autorización:

Authorised

Fecha de autorización:

1991-11-12

Información para el usuario

SERVICE
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
MANUFACTURER
Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocé-sur-Cisse
France
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER
STATES OF THE EEA UNDER THE FOLLOWING NAMES:
Austria
Diflucan 10 mg/ml and 40 mg/ml
Trockensaft
Belgium, Denmark,
Finland, Iceland, Ireland,
Italy, Luxembourg,
Norway, Portugal,
Sweden, United Kingdom
Diflucan
France
Triflucan 50 mg/5 ml, poudre
pour suspension buvable
Triflucan 200 mg/5 ml, poudre
pour suspension buvable
Germany
Diflucan Trockensaft 10 mg/ml
Diflucan 40 mg/ml Pulver zur
Herstellung einer Suspension
zum Einnehmen
Hungary
Diflucan 10 mg/ml and
40 mg/ml por belsőleges
szuszpenzióhoz
Greece
Fungustatin
The Netherlands
Diflucan 10mg/ml, poeder voor
orale suspensie
Diflucan 40mg/ml, poeder voor
orale suspensie
Romania
Diflucan 10 mg/ml pulbere pentru
Slovakia
Diflucan P.O.S. 10 mg/ml and
Diflucan P.O.S. 40 mg/ml
Slovenia
Diflucan 10 mg/ml prašek za
peroralno suspenzijo
Diflucan 40 mg/ml prašek za
peroralno suspenzijo
Spain
Diflucan 10 mg/ml polvo para
suspensión oral
Diflucan 40 mg/ml polvo para
suspensión oral
THIS LEAFLET WAS LAST REVISED IN:
UK 04/2018
IE MM/YYYY
Ref: DF 20_0
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The following information is intended for healthcare
professionals or for patients (where the pharmacist does
not reconstitute this product):
INSTRUCTIONS TO MAKE UP THE SUSPENSION:
The reconstituted suspension will provide a white to off-
white orange-flavoured suspension after reconstitution.
10 MG/ML OR 40 MG/ML POWDER FOR ORAL SUSPENSION IN 60 ML
CAPACITY BOTTLE: 35 ML SUSPENSION AFTER RECONSTITUTION
1. Tap the bottle to release the powder.
2. Add a small quantity of still water and shake it vigorously.
Add water up to the level marked (
è
) on the bottle (this
corresponds in total to adding the required 2

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diflucan 10 mg/ml powder for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of reconstituted suspension contains 10 mg fluconazole.
Excipient(s) with known effect: 0.58 g sucrose per ml of reconstituted
suspension.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
White to off-white powder for oral suspension providing a white to
off-white orange-flavoured suspension after
reconstitution.
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.
Vaginal candidiasis, acute or recurrent; when local therapy is not
appropriate.
_Candidal balanitis_ when local therapy is not appropriate.
Dermatomycosis including_ tinea pedis, tinea corporis, tinea cruris,
tinea versicolor_ and dermal_ candida_
infections when systemic therapy is indicated.
_Tinea unguinium (onychomycosis)_ when other agents are not considered
appropriate
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.
To reduce the incidence of recurrent vaginal candidiasis (4 or more
episodes a year).
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, infan