国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUCONAZOLE
MEDISPEC (M) SDN.BHD
FLUCONAZOLE
1x1 Capsules; 10 x (1x1) Capsules
Square Phamarceuticals Ltd.
FLUGAL CAPSULE Fluconazole (150 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Flugal _ _ is used for 2. How Flugal _ _ works 3. Before you use Flugal 4. How to use Flugal 5. While you are using it 6. Side effects 7. Storage and Disposal of Flugal _ _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FLUGAL_ _IS USED FOR Flugal 150 _ _ is used to treat and prevent certain fungal and yeast infections including those with cancer (due to weak immune system). HOW FLUGAL_ _WORKS Flugal contains fluconazole as active ingredient, an antifungal agent, which works by preventing the growth of the fungal and yeast organisms causing your infection. _ _ BEFORE YOU USE FLUGAL_ _ _When you must not use it _ Do not use Flugal if you _: _ • have allergies to fluconazole or related azole antibiotics or any other ingredients in this medication (listed in Product Description). _ _ • are taking cisapride (medicine to treat heartburn) _ _ • are taking pimozide (medicine to control involuntary movements) _ _ • are taking halofantrine (medicine used for treating malaria) _ _ • are taking terfenadine (medicine for allergy) (not to be taken together with fluconazole in multiple doses of 400 mg per day or higher) _ _ _ _ - _Before you start to use it _ Inform your doctor if you have such conditions: - AIDS - kidney or liver impairment, or - suffer from any heart disease or taking medicine which may affect the heart. _Pregnancy and lactation _ _ _ Flugal may cause harm to your unborn baby. You should not take _ _ Flugal while you are pregnant unless your doctor has told you to. Inform your doctor if you are pregnant or planning to become pregnant. If you are a woman of child-bearing potential, avoid becoming pregnant during treatment. Use effective contraception during treatment and for 1 week after treatment. Flugal is secreted into human breast milk, hence its use in nursing mothers is not recommended. However, breast- feeding may be maintain 阅读完整的文件
FLUGAL FLUCONAZOLE EP 1. NAME OF THE MEDICINAL PRODUCT: _FLUGAL_ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _FLUGAL_ 3. PHARMACEUTICAL FORM Capsule PRODUCT DESCRIPTION: A hard gelatin capsule (Size#2) filled with white powder having a blue color cap and creamish color body imprinted “Square” on both parts. ROUTE OF ADMINISTRATION : Oral 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. _ FLUGAL_ can be used as maintenance therapy to prevent relapse of cryptococca l disease in patients with AIDS. 2. Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infection. These include infections of the peritoneum. endocardium, eye and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated. 3. Mucosal candidiasis , these include oropharyngeal , esophageal , 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. Prevention of relapse of oropharyngeal candidiasis in patients with AIDS. 4. Genital candidiasis, vaginal candidiasis, acute or recurrent, and prophylaxis to reduce the incidence of recurrent vaginal candidiasis (3 or more episodes a year), candidal balanitis. 5. Prevention of fungal infections in patients with malignancy who are predispose d to such infections as a result of cytotoxic chemotherap y or radiotherapy. 6. Dermatomycosis including tinea ped 阅读完整的文件