Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
imiquimod
Arrow Pharma Pty Ltd
Imiquimod
Registered
APO-IMIQUIMOD CREAM _Contains the active ingredient imiquimod_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about imiquimod. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Imiquimod. It contains the active ingredient imiquimod. It is used to treat: • Solar keratosis on the face and scalp. Solar keratosis is thickened, scaly patches of skin caused by too much sun exposure. It is also known as actinic keratosis. • Superficial basal cell carcinoma (a type of skin cancer). • External genital/perianal warts (condyloma acuminate). They appear on the surface of the penis or vulva (external female sexual organ) and around the anus. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Imiquimod is an immune response modifier. It activates immune cells in the body. The immune cells then proceed to kill and remove the virus- infect Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION APO-IMIQUIMOD (IMIQUIMOD) CREAM 1 NAME OF THE MEDICINE Imiquimod. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Imiquimod 50 mg/g (5% w/w) cream. Each 250 mg single-use sachet contains 12.5 mg imiquimod, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Methyl hydroxybenzoate, propyl hydroxybenzoate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White, soft cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Imiquimod 50 mg/g (5%) cream is indicated for: • Treatment of solar (actinic) keratosis on the face and scalp (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE); • Primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate; • Treatment of external genital and perianal warts/condyloma acuminata in adults (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 2 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Imiquimod cream is intended for topical administration. Imiquimod cream is provided in single use sachets. A new sachet should be opened for each treatment, and cream from a previously opened sachet should not be used. Before applying imiquimod cream, the patient should wash the treatment area with mild soap and water, and allow the area to dry thoroughly. Imiquimod cream is to be applied to the affected area prior to normal sleeping hours and should be left on the skin for approximately 8 hours (6-10 hours). The cream should be rubbed in until it is no longer visible. Following the treatment period the cream should be removed by washing the treated area with mild soap and water. During the 6-10 hours treatment period showering or bathing should be avoided. Hand washing before and after cream application is recommended. Local skin reactions (erythema) at the treatment area are common. These reactions may be due to the pharmacological response of the body’s immune system to imiquimod. In clinical studies in patients with sBCC the histologic Прочетете целия документ