Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
imiquimod, Quantity: 12.5 mg
Strides Pharma Science Pty Ltd
Imiquimod
Cream
Excipient Ingredients: benzyl alcohol; purified water; methyl hydroxybenzoate; isostearic acid; xanthan gum; glycerol; white soft paraffin; polysorbate 60; stearyl alcohol; propyl hydroxybenzoate; sorbitan monostearate; cetyl alcohol
Topical
6 and 12 sachets per carton
Medicine Registered
(S4) Prescription Only Medicine
? treatment of solar (actinic) keratosis on the face and scalp (see Precautions), and ,? primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and ,? treatment of external genital and perianal warts/condyloma acuminata in adults (see Precautions).
Visual Identification: A white to off white, oil in water vanishing cream; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-07-19
ALDIQ _imiquimod_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALDIQ. 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 using ALDIQ against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALDIQ IS USED FOR ALDIQ is used to treat: • Solar keratosis (SK) on the face and Superficial Basal Cell Carcinoma (sBCC) Solar keratoses are thickened, scaly patches of skin caused by too much sun exposure. Solar keratosis is also known as actinic keratosis. Basal cell carcinoma is a type of skin cancer. • Genital/perianal warts External genital/perianal warts (condyloma acuminata) are warts that appear on the surface of the penis or vulva (external female sexual organ) and around the anus. ALDIQ is not recommended for use in patients under the age of 18 years as there have been no studies of its effects in this age group. ALDIQ cream contains the active ingredient imiquimod. Imiquimod is an immune response modifier. It activates immune cells in the body. The immune cells then proceed to kill and remove the virus-infected or cancer cells. Although the exact way that ALDIQ works is unknown, it is believed to be due to its effects on the immune system. 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 USING IT _WHEN YOU MUST NOT USE IT_ DO NOT USE ALDIQ IF YOU HAVE AN ALLERGY TO: • any medicine containing imiquimod • any of the ingredients listed 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 Leggi il documento completo
AUSTRALIAN PRODUCT INFORMATION ALDIQ _imiquimod cream _ 1 NAME OF THE MEDICINE Imiquimod 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 250 mg sachet of ALDIQ contains 12.5 mg of imiquimod as the active ingredient. Excipients of known effect: hydroxybenzoates. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM ALDIQ is a white to off-white, oil in water vanishing cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALDIQ 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) 4.2 DOSE AND METHOD OF ADMINISTRATION Before applying ALDIQ, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly. ALDIQ 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 to 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 to 10 hour 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 superficial basal cell carcinoma (sBCC) the histological clearance following imiquimod therapy was statistically (p < 0.001) higher (91%) in patients with moderate to severe local skin reactions compared to those patients who experienced no or mild skin reactions (54%). Similarly, there was a significant association between the intensity o Leggi il documento completo