Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMIQUIMOD
iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch
IMIQUIMOD
2 gm; 12 Sachets
Ensign Laboratories Pty Limited
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ALDARA ® CREAM 5% W/W Imiquimod (5% w/w) WHAT IS IN THIS LEAFLET 1. What Aldara® Cream 5% w/w is used for 2. How Aldara® Cream 5% w/w works 3. Before you use Aldara® Cream 5% w/w 4. How to use Aldara® Cream 5% w/w 5. While you are using it 6. Side effects 7. Storage and disposal of Aldara® Cream 5% w/w 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ALDARA® CREAM 5% W/W IS USED FOR Aldara® Cream 5% w/w is used to treat genital/perianal warts, actinic keratoses on the face and scalp and superficial basal cell carcinoma. • External genital/perianal warts (condyloma acuminate) are warts that appear on the surface of the penis or vulva (external female sexual organ) and around the anus (back passage). • Actinic keratosis is thickened, scaly patches of skin caused by too much sun exposure. • Superficial basal cell carcinoma (sBCC) is a common slow- growing form of skin cancer. Your doctor may prescribe Aldara® Cream 5% w/w for another purpose. If you are not sure why you are using this medicine, ask your doctor. HOW ALDARA® CREAM 5% W/W WORKS Aldara® Cream 5% w/w contains an 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 Aldara® Cream 5% w/w works is unknown, it is believed to be due to its effects on the immune system. BEFORE YOU USE ALDARA® CREAM 5% W/W _-When you must not use it _ Do not use this medicine: • if you are allergic to imiquimod or to any of the ingredients listed at the end of this leaflet. • on skin where there are open sores or wounds. Do not start using Aldara® Cream 5% w/w until after the area has healed. • on warts inside the vagina or inside the anus or inside the urethra (where you pass urine). The use of Aldara® Cream 5% w/w has not been studied. • on areas that are sunburnt. • if the packa Διαβάστε το πλήρες έγγραφο
ALDARA® CREAM 5% W/W PRODUCT DESCRIPTION White to faintly yellow cream with a uniform appearance. COMPOSITION Each sachet contains 12.5mg of Imiquimod in 250mg cream (5%w/w). Each pump contains 1000mg of Imiquimod in 2g crem (5%w/w) Excipients: Isostearic Acid, Cetyl Alcohol, Stearyl Alcohol, White Soft Paraffin, Polysorbate 60, Sorbitan Stearate, Glycerol, Xanthan Gum, Purified Water, Benzyl Alcohol, Methyl Hydroxybenzoate and Propyl Hydroxybenzoate. PHARMACODYNAMICS Imiquimod is an immune response modifier. It has no direct antiviral activity in cell culture. A mechanism of action study in 22 patients with genital/perianal warts shows that imiquimod induces cytokines including interferon-α at the treatment site. In addition, HPV E7 and L1mRNA as well as HPV DNA are significantly decreased following treatment. However, the clinical relevance of these findings is unknown. PHARMACOKINETICS Percutaneous absorption of [ 14 C] imiquimod was minimal in a study involving 6 healthy subjects treated with a single topical application (5mg) of [ 14 C] imiquimod cream formulation. No radioactivity was detected in the serum (lower limit of quantitation: 1ng/mL) and <0.9% of the radiolabelled dose was excreted in the urine and faeces following topical application. CLINICAL STUDIES In a double-blind, placebo-controlled clinical trial, Aldara® Cream 5% w/w applied three times a week for treatment of genital and perianal warts had wart clearance rates that were statistically significantly greater than the placebo control. The percentage of patients achieving total clearance was 77% for females and 40% for males. The percentage of patients achieving partial wart area (>50%) reduction was 91% for female and 74% for male. The median baseline wart area was 69mm 2 (range 8 to 5525 mm 2 ). Visible wart changes occurred as early as 4 weeks and some patients required 16 weeks. The median time to total wart clearance was 10 weeks. In another study, Aldara® Cream 5% w/w applied daily, 59% of the males and 84% of the females achieved t Διαβάστε το πλήρες έγγραφο