Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Pfizer Limited
J02AC01
FLUCONAZOLE
10 Mg/Ml
Powder for Oral Suspension
Product subject to prescription which may be renewed (B)
Triazole derivatives
Authorised
1991-11-12
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 ----------------------------------------------------------------------------- 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 Preberite celoten dokument
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 Preberite celoten dokument