Diflucan 2 mg/ml solution for infusion
Each ml contains 2 mg of fluconazole.
1 vial/ PVC bag with 100 ml solution for infusion contains 200 mg fluconazole.
Excipient(s) with known effect:
Each ml contains 9 mg sodium chloride (equivalent to 0.154 mmol sodium) (see section 4.4).
For the full list of excipients, see section 6.1.
Solution for infusion
Clear, colourless solution with no visible particles.
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 topical treatment are insufficient.
Diflucan is indicated in adults for the prophylaxis of:
• Relapse of crytopcoccal 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.
• 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, infants, toddlers, children and adolescents aged from 0 to 17 years old:
Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).
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.
Consideration should be given to official guidance on the appropriate use of antifungals.
Posology
The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.
Adults
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Indications
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Posology
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Duration of treatment
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Cryptococcosis
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- Treatment of cryptococcal meningitis
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Loading dose: 400 mg on Day 1
Subsequent dose: 200 mg to 400 mg daily
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Usually at least 6 to 8 weeks. In life threatening infections the daily dose can be increased to 800 mg
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- Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence.
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200 mg daily
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Indefinitely at a daily dose of 200 |
