Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Itraconazole 100mg;
Viatris Limited
Itraconazole 100 mg
100 mg
Capsule
Active: Itraconazole 100mg Excipient: Capsugel red G60CSA00150 Colloidal silicon dioxide Ethanol Gelatin Hypromellose Iron oxide red Methylene chloride Opacode white S-1-7078 Purified water Sorbitan stearate Sugar spheres Titanium dioxide
Blister pack, PVC/PVDC-aluminium, 4 capsules
Prescription
Prescription
Mylan Laboratories Limited
Itraconazole capsules are indicated for the treatment of: · vulvovaginal candidiasis. · pityriasis versicolor, · dermatomycosis - including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, · fungal keratitis, · oral candidiasis, · onychomycosis caused by dermatophytes and/or yeasts. · systemic mycoses, only in the following fungal infections: - systemic aspergillosis - histoplasmosis, - histoplasmosis, maintenance therapy only in AIDS patients - sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous) - paraconccidioidomycosis, - chromomycosis, - blastomycosis
Package - Contents - Shelf Life: Blister pack, PVC/PVDC-aluminium - 4 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 6 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 7 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 8 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 15 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 18 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 30 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 50 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 60 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 84 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 100 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 140 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 150 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 280 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 300 capsules - 36 months from date of manufacture stored at or below 25°C
2004-06-04
Page 1 of 6 NEW ZEALAND CONSUMER MEDICINE INFORMATION ITRAZOLE _ITRACONAZOLE CAPSULE 100 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Itrazole. 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 Itrazole against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ITRAZOLE IS USED FOR Itrazole is 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; • generalised infections. Itrazole contains the active ingredient itraconazole_._ It belongs to a group of medicines called azoles. It works by killing or stopping the growth of the fungus that causes the infection. Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Itrazole. Finger and toenails may take several months to completely clear up. This is because your skin or nail will only look normal after new skin or nail has grown, even though the medicine has killed the fungus that caused 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. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE ITRAZOLE WHEN YOU MUST NOT TAKE IT: DO NOT TAKE ITRAZOLE IF YOU HAVE AN ALLERGY TO: • any medicine containing itraconazole • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezi Citiți documentul complet
Page 1 of 29 NEW ZEALAND DATA SHEET ITRAZOLE 1. PRODUCT NAME Itrazole 100 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg of itraconazole. Excipient with known effect: Sugar Allergen Declaration: Sugar For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule: Size 00, hard gelatin capsule with a red opaque cap and red opaque body printed axially with “MYLAN” over “IE 100” in white ink on cap and body, and containing white to off-white coloured pellets. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Itrazole capsule is indicated for the treatment of: • vulvovaginal candidiasis. • pityriasis versicolor, • dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, • fungal keratitis, • oral candidiasis, • onychomycosis caused by dermatophytes and/or yeasts, • systemic mycoses, only in the following fungal infections: o systemic aspergillosis and candidiasis, o histoplasmosis, o histoplasmosis, maintenance therapy only in AIDS patients o sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o paracoccidioidomycosis, o chromomycosis, o blastomycosis. Page 2 of 29 _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ Treatment schedules are as follows: INDICATION DOSE DURATION Vulvovaginal candidiasis 200 mg twice daily or 200 mg once daily 1 day 3 days Pityriasis versicolor 100 mg twice daily 200 mg once daily 5-7 days Dermatomycosis 100 mg once daily or 200 mg once daily 15 days or 7 days Dermatomycosis in highly keratinised regions as in plantar tinea pedis and palmar tinea manus 200 mg twice daily or 100 mg once daily 7 days or 30 days Oral candidiasis 100 mg once daily 15 days Fungal keratitis 200 mg once daily 21 days The duration of treatment should be adjusted to clinical response. ONYCHOMYCOSIS _Pulse treatment (see table below): _ A pulse treatment consists of two capsules (200 mg) twice daily for one week. Two pulse treatments are recommended for fingernail infect Citiți documentul complet