Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMIQUIMOD
iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch
IMIQUIMOD
1Units Units
3M HEALTH CARE LTD
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ALDARA ® CREAM 5% Imiquimod (5% w/w) WHAT IS IN THIS LEAFLET 1. What Aldara Cream 5% is used for 2. How Aldara Cream 5% works 3. Before you use Aldara Cream 5% 4. How to use Aldara Cream 5% 5. While you are using it 6. Side effects 7. Storage and disposal of Aldara Cream 5% 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ALDARA CREAM 5% IS USED FOR Aldara Cream 5% 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% for another purpose. If you are not sure why you are using this medicine, ask your doctor. HOW ALDARA CREAM 5% WORKS Aldara Cream 5% 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% works is unknown, it is believed to be due to its effects on the immune system. BEFORE YOU USE ALDARA CREAM 5% _-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% 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% has not been studied. • on areas that are sunburnt. • if the packaging is torn or shows signs of tampering or after the “use by” date shown on the box Aqra d-dokument sħiħ
ALD A RA ® C REA M Name of The Drug Imiquimod Description Imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4 -amine. It is a odourless, white t o o ff-whit e cryst alline solid. Imiquimod has a molecular formula of C 14H16N4 and a molecular weight of 240. 3. It’s structural formula is Aldara ® is the brand name for imiqui mod. Each gram of the 5% cream contains 50mg of imiquimod in an off-white oil-in-wate r vanish ing cream base consist ing of isostearic a cid, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbat e 60, sorbit an monostearate, glycerol, xanthan gum, purified wat er, benzyl alcohol, methyl-hydroxybenzoate and propyl-hydroxy-benzoate. Pharmacolog y Pharmacodynamics: Imiquimod is an immune response modifier. It has no direct antiviral activity in cell culture. A mechanism of action study in 22 patien ts wit h genital/peria nal warts shows that imiquimod induces cytokines including interferon-α at the treatment site. In ad dition, HPV E7 and L1mRNA as well as HPV DNA are significantly decreased f ollowing tre atment. Ho wever, the clinica l relevance of these f indings is unknown. Pharmacokinetics Percutaneous absorptio n of [ 14C] imiquimod was minimal in a study involving 6 healthy subjects tre ated with a s ingle t opical applicat ion (5mg) of [ 14C] imiquimo d cream formulation. No radioactivity was det ected in the serum (lower limit of qua ntitation: 1ng/mL) and 50%) reduction was 91% for female and 74% for male. The median baseline wart area was 69mm 2 (rang e 8 to 5525 mm 2). Visible w art changes occurred as early as 4 weeks and some patients required 16 weeks. The median time to total wart clearance was 10 weeks. In anoth er st udy, Aldara 5% cream applied daily, 59% of the males and 84% of the females achieved total clearance o f their genital/perianal warts. A low percent age (6-23%) of the pat ients wh o achieved total clearan ce of their warts experienced a recur rence of their warts during the 12 week follow-up period. In two studies, some patients achieved t o Aqra d-dokument sħiħ