Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUCONAZOLE
PFIZER (MALAYSIA) SDN. BHD.
FLUCONAZOLE
28Capsule Capsules
Fareva Amboise
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DIFLUCAN ® CAPSULES Fluconazole (50 mg, 100 mg, 150 mg) Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DIFLUCAN ® CAPSULES Fluconazole (50 mg, 100 mg, 150 mg) 1 WHAT IS IN THIS LEAFLET 1. What DIFLUCAN is used for 2. How DIFLUCAN works 3. Before you use DIFLUCAN 4. How to use DIFLUCAN 5. While you are using it 6. Side Effects 7. Storage and Disposal of DIFLUCAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT DIFLUCAN IS USED FOR DIFLUCAN is used to treat infections caused by fungi and may also be used to prevent you from getting fungal infections. You might be given this medicine by your doctor to treat the following types of fungal infections: - cryptococcal meningitis (fungal infection in the brain); - infections caused by _Candida_ in the bloodstream, body organs (e.g., heart, lungs) or urinary tract; - mucosal thrush (infection affecting the lining of the mouth, throat and dentures); - genital thrush (infection of the vagina or penis); - skin infections (e.g., Athlete’s foot, ringworm, jock itch). You might also be given DIFLUCAN to prevent recurrence of: - fungal infection in the brain - mucosal thrush; - vaginal thrush; - infection caused by _Candida_ (if your immune system is weak and not working properly). HOW DIFLUCAN WORKS DIFLUCAN belongs to a group of medicines called “antifungals”. The active substance is fluconazole. It works by inhibiting the growth of fungi that cause infection. BEFORE YOU USE DIFLUCAN - _When you must not use it_ Do not take DIFLUCAN if you - are allergic (hypersensitive) to fluconazole or to other medicines you have taken to treat fungal infections or to any of the other ingredients of DIFLUCAN; - are taking astemizole, terfenadine (antihistamine medicines for allergies); - are taking cisapride (used for stomach upsets); - are taking pimozide (used for treating mental illness); - are taking quinidine (used for tre Preberite celoten dokument
1 DIFLUCAN Fluconazole 1. NAME OF THE MEDICINAL PRODUCT DIFLUCAN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DIFLUCAN contains as its active ingredient fluconazole 50 mg, 100 mg and 150 mg as capsules, and as 2 mg/ml in a saline solution for intravenous infusion. Fluconazole is a bis-triazole, having the following chemical name: 2-(2, 4-difluorophenyl)- 1, 3-bis (1H, 2, 4-triazol-1-yl)-2-propanol. It has a molecular weight of 306.3. 3. PHARMACEUTICAL FORM _Capsule (manufactured by France)_ Fluconazole capsule 50 mg is a turquoise and white, opaque No 4 capsules over-printed with the Pfizer logo and 'FLU 50' and containing white powder. Fluconazole capsule 100 mg is a white and blue, opaque No 2 capsules over-printed with the Pfizer logo and the code FLU-100 and containing a white powder. Fluconazole capsule 150 mg is a turquoise, opaque No 1 capsules over-printed with the Pfizer logo and 'FLU 150' and containing white powder. _Capsule (manufactured by Australia)_ Fluconazole capsule 50 mg is a blue and white, opaque No 4 capsules over-printed with the Pfizer logo and 'FLU 50' and containing white powder. Fluconazole capsule 150 mg is a blue, opaque No 1 capsules over-printed with the Pfizer logo and 'FLU 150' and containing white powder. _Solution for intravenous infusion_ Fluconazole solution for intravenous infusion is a clear, colourless solution conforming to parenteral standards, in clear, neutral glass vial. 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. 1. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g., pulmonary, cutaneous). Normal hosts and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 2 2. Systemic candidia Preberite celoten dokument