FLUCONAZOLE Capsules Hard 150 Milligram
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
03-05-2024
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Viambatanisho vya kazi:
FLUCONAZOLE
Inapatikana kutoka:
Medimpex France SA
Kipimo:
150 Milligram
Dawa fomu:
Capsules Hard
Idhini ya tarehe:
2003-03-07
Tabia za bidhaa
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluconazole 150 mg Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150mg fluconazole
The capsules contain lactose.
For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Capsule upper part: medium blue, lower part: white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is indicated for the treatment of the following infections when caused by fungi that are known or are likely
to be fluconazole-susceptible:
o
Acute or recurrent vaginal candidiasis.
o
Mucous membrane candidiasis including oropharyngeal, oesophageal, mucocutaneous and non-invasive
bronchopulmonary candidiasis and candiduria in patients with immunosuppression.
o
Systemic candidiasis (candidaemia, disseminated deep candidiasis, peritonitis).
o
Prevention of Candida infections in neutropenic patients (eg. AIDS, bone marrow transplantation).
o
Treatment and maintenance treatment of cryptococcal meningitis in immunosuppressed patients.
o
Verified fungal skin infections caused either by dermatophytes or other species (_tinea_
_corporis/cruris/pedis/versicolor_) or Candida when local treatment has failed or is considered inappropriate.
Fluconazole should be used to treat _Tinea versicolor _only when the infection is resistant to first line therapy or
when the patient is immunosuppressed.
Consideration should be given to official guidance on the appropriate use of antifungal agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The daily dose depends on the type and severity of the fungal infection.
The treatment of infections requiring multiple dosing must be continued until clinical parameters or laboratory results
show that the active fungal infection has responded. An insufficient treatment period may lead to
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