País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage.; ; Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400 U/g, micropulverised, plus 10% overage.
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Nystatin 25 mg/g (=100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage.)
100000 U/mL
Topical cream
Active: Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400U/g, micropulverised, plus 10% overage. Excipient: Aluminium hydroxide gel Perfume Promulgen D Propylene glycol Purified water Simeticone Sorbitol Titanium dioxide Water White soft paraffin Active: Nystatin 25 mg/g equivalent to 100,000 U/g based on potency of 4400 U/g, micropulverised, plus 10% overage. Excipient: Aluminium hydroxide gel Promulgen D Propylene glycol Purified water Simeticone Sorbitol Titanium dioxide Water White soft paraffin
Tube, 1 x 15 g, 15 g
Pharmacy only
Pharmacy only
Patheon Capua SpA
The treatment of candidal infections of the skin.
Package - Contents - Shelf Life: Tube, - 15 g - 24 months from date of manufacture stored at or below 25°C
1972-05-05
NEW ZEALAND DATA SHEET 1. MYCOSTATIN (TOPICAL CREAM, 100000 U/ML) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mycostatin (Nystatin), 100,000 units/g: 15 g. 3. PHARMACEUTICAL FORM Topical cream 15g. 4. CLINICALT PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nystatin topical preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida species. This preparation is not indicated for systemic use. 4.2 DOSE AND METHOD OF ADMINISTRATION Apply liberally to affected areas twice daily or as indicated until healing is complete. 4.3 CONTRAINDICATIONS Known sensitivity to nystatin or other components. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken. Nystatin topical preparations should not be used for the treatment of systemic or ophthalmic infections. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens. INFORMATION FOR THE PATIENT Patients using these medications should receive the following information and instructions: 1. The patient should be instructed to use the medication as directed (including the replacement of missed doses). The medication is not for any disorder other than that for which it was prescribed. 2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue the medication until the prescribed course of treatment is completed. 3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly. LABORATORY TEST If there is a lack of therapeutic response, KOH smears, cultures or other diagnostic methods should be repeated. CARCINOGENESIS AND MUTAGENESIS No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. 4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FO Leia o documento completo