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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
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