FLUCOMEL Capsule 150 Milligram

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

FLUCONAZOLE

Disponibil de la:

Kellpharm Limited

Dozare:

150 Milligram

Forma farmaceutică:

Capsule

Data de autorizare:

2005-10-21

Caracteristicilor produsului

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucomel 150 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150mg fluconazole.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Size 1 hard capsule with a white 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.
Dermatomycoses includ