Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
itraconazole, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Itraconazole
Capsule
Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
60 capsules, 28 capsules, 15 capsules, 4 capsules, 6 capsules
(S4) Prescription Only Medicine
ITRACAP 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 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.
Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-08-09
ITRACAP ITRACONAZOLE CAPSULE ITRACAP _Itraconazole_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ITRACAP Itraconazole 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 benefits and risks. Your doctor has weighed the risks of you taking ITRACAP against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ITRACAP IS USED FOR ITRACAP 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 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. ITRACAP works by killing or stopping the growth of fungus that causes the infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE ITRACAP _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ITRACAP IF YOU HAVE AN ALLERGY TO: • any medicine containing itraconazole • any of the ingredients listed at the end of this leaflet. See Product Description at the end of this leaflet. Some of the symptoms of an allergic reaction may include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin • add any other specific reactions listed in the PI. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR MAY BECOME PREGNANT. It may affect your developing baby if you take it during pregnancy. If there is any chance of you becoming pregnant, talk to your doctor about the ne Прочитайте повний документ
1 AUSTRALIAN PRODUCT INFORMATION ITRACAP (Itraconazole) capsules 1 NAME OF THE MEDICINE Itraconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ITRACAP capsules contain itraconazole 100 mg. EXCIPIENTS Each capsule contains sucrose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ITRACAP is available as white opaque capsules printed with ITR on the cap and 100 on the body. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ITRACAP 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. 2 4.2 D OSE AND METHOD OF ADMINISTRATION It is essential that ITRACAP 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: 1 capsule (100 mg) daily for 4 weeks _ _ _FUNGAL KERATITIS: Прочитайте повний документ