FLUCOMEL Capsule 50 Milligram

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

FLUCONAZOLE

Commercializzato da:

Kellpharm Limited

Dosaggio:

50 Milligram

Forma farmaceutica:

Capsule

Data dell'autorizzazione:

2005-10-21

Scheda tecnica

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucomel 50 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50mg fluconazole.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Flucomel Size 3 hard capsule with a pale blue cap and
a white body.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Therapy may be instituted
before the results of the cultures and other laboratory
studies are known; however, once 
these results become available anti-infective therapy should
be adjusted accordingly.
Flucomel is indicated for:
1.
Genital candidiasis. Vaginal candidiasis,
acute or recurrent. Candidal balanitis.
2.
Mucosal candidiasis. These include oropharyngeal, oesophageal,
non-invasive bronchopulmonary infections, 
candiduria, mucocutaneous and
chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and
patients with 
compromised immune function may be treated.
3.
Systemic candidiasis including candidaemia, disseminated
candidiasis and other forms of invasive candidal 
infection. These include infections of the peritoneum,
endocardium and pulmonary and urinary tracts. Candidal 
infections in patients with malignancy, in
intensive care units of those receiving
cytotoxic or immunosuppressive 
therapy, may be treated.
4.
Cryptococcosis, including cryptococcal meningitis and
infections of other sites (e.g. pulmonary cutaneous).
Normal hosts and patients with acquired immune deficiency
syndrome (AIDS), organ transplants or other causes of 
immunosuppression may be treated. Flucomel can be used
as maintenance therapy to prevent relapse of cryptococcal 
disease in patients with AIDS.
5.
Prevention of fungal infections in patients with malignancy who
are predisposed to such infections as a result of 
cytotoxic chemotherapy or radiotherapy, including
bone marrow transplant patients.
6.
Dermatomy