Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
itraconazole, Quantity: 100 mg
Janssen-Cilag Pty Ltd
Capsule, hard
Excipient Ingredients: macrogol 20000; titanium dioxide; Gelatin; hypromellose; indigo carmine; erythrosine; maize starch; sucrose
Oral
4 capsules, 60 capsules, 15 capsules, 6 capsules, 28 capsules
(S4) Prescription Only Medicine
Sporanox is indicated for use in adults for the treatment of: Superficial dermatomycoses not responding to topical treatment. Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. Pityriasis versicolor not responding to any other treatment. Vulvovaginal candidiasis not responding to topical treatment. Oral candidiasis in immunocompromised patients. Onychomycosis caused by dermatophytes. Systemic mycoses: -Systemic aspergillosis, histoplasmosis, sporotrichosis. -Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. -Treatment of oropharyngeal and/or oesophageal candidiasis when fist line systemic antifungal therapy is inappropriate or has proven ineffective. -Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology,
Visual Identification: Cream-coloured, coated sugar spheres filled into capsules with an opaque blue cap and pink transparent body.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-02-02
SPORANOX® CAPSULES 1 SPORANOX ® CAPSULES _Itraconazole _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPORANOX capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPORANOX capsules against the benefits this medicine is expected to have for you. If you have any concerns about taking SPORANOX capsules, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT SPORANOX CAPSULES ARE USED FOR SPORANOX capsules are used to treat certain fungal infections which include the following: • persistent infections of the nails, skin, hands, feet or groin; • persistent candida (yeast) infections of the vagina; • eye infections which have not responded to other treatment or which may be affecting vision; • candida (yeast) infections of the mouth or throat in patients with lower resistance to disease; • generalised infections. SPORANOX works by killing or stopping the growth of the fungus that causes the infection. Your doctor may have prescribed SPORANOX capsules for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE SPORANOX CAPSULES _WHEN YOU MUST NOT TAKE IT _ Do not take SPORANOX capsules if: • you are pregnant or may become pregnant. If there is any chance of you becoming pregnant, talk to your doctor about the need for highly effective contraception. Once you have finished taking SPORANOX, you should continue using highly effective contraception until you have had your next period. Tell your doctor immediately if you do become pregnant while taking SPORANOX. • you have a condition called heart failure (also called congestive heart failure or CHF), SPORANOX could make it worse. If your doctor decides that you need to take SPORANOX even if you have this condition, be sur Lue koko asiakirja
16.220321 Page 1 of 28 SPORANOX(220617)API AUSTRALIAN PRODUCT INFORMATION SPORANOX (ITRACONAZOLE) CAPSULES 1. NAME OF THE MEDICINE Itraconazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg of itraconazole. Excipients with known effect: sucrose For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Capsule Blue opaque cap and pink transparent body containing beads. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPORANOX is indicated for use in adults for the treatment of: • Superficial dermatomycoses not responding to topical treatment. • Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. • Pityriasis versicolor not responding to any other treatment. • Vulvovaginal candidiasis not responding to topical treatment. • Oral candidiasis in immunocompromised patients. • Onychomycosis caused by dermatophytes. • Systemic mycoses, only in the following fungal infections: ־ Systemic aspergillosis, histoplasmosis, lymphocutaneous/cutaneous sporotrichosis. ־ Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. ־ Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. ־ Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity. 16.220321 Page 2 of 28 SPORANOX(220617)API 4.2 DOSE AND METHOD OF ADMINISTRATION It is essential that SPORANOX capsules are taken immediately after a meal for maximal absorption. The capsules must be swallowed whole. Treatment schedules are as follows: _SUPERFICIAL DERMATOMYCOSES: _ • Tinea corporis, tinea cruris: 1 capsule (100 mg) daily for 2 weeks. • Tinea pedis, tinea manus: Lue koko asiakirja