Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
IMIQUIMOD
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
IMIQUIMOD
3 Sachets
GLENMARK PHARMACEUTICALS LTD
1 IMIQUAD CREAM Imiquimod Cream USP 5% W/W _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Imiquimod cream is used for 2. How Imiquimod cream works 3. Before you use Imiquimod cream 4. How to use Imiquimod cream 5. While you are using it 6. Side Effects 7. Storage and Disposal of Imiquimod cream 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT IMIQUIMOD CREAM IS USED FOR Imiquimod cream may be used for three different conditions. Your doctor may prescribe Imiquimod cream for the treatment of: WARTS (CONDYLOMATA ACUMINATA) on the surface of the genitals (sexual organs) and around the anus (back passage). SUPERFICIAL BASAL CELL CARCINOMA- This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body. It usually occurs in middle- aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure. ACTINIC KERATOSIS- Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. Imiquimod cream should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Imiquimod cream is the most appropriate treatment for you. HOW IMIQUIMOD CREAM WORKS Imiquimod cream helps your body´s own immune system to produce natural substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts. BEFORE YOU USE IMIQUIMOD CREAM _-When you must not use it _ -If you are allergic to Imiquimod or any of the other ingredients of this medicine. _-Before you start to use it _ Talk to your doctor or pharmacist before using Imiquimod creams If you have previously used Imiquimod cream or other similar preparations tell your doctor be Lire le document complet
_For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory _ _ _ Imiquimod Cream USP 5% w/w IMIQUAD CREAM COMPOSITION Each 0.25 gm single use sachet contains: Imiquimod USP….12.5mg (5.00% w/w) Cream base……….q.s. Preservatives: Methyl Paraben 0.20% w/w Propyl Paraben 0.02% w/w Benzyl alcohol 2.00% w/w PRODUCT DESCRIPTION: White to off-white soft cream PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals: ATC Code: D06BB10. Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells. Imiquimod has no direct antiviral activity. In animal models imiquimod is effective against viral infections and acts as an anti-tumour agent principally by induction of alpha interferon and other cytokines. The induction of alpha interferon and other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated. Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study. PHARMACOKINETICS: External genital warts, superficial basal cell carcinoma and actinic keratosis: Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects. The small amount of drug which was absorbed into the systemic circulation was promptly excreted by both urinary and fecal routes at a mean ratio of approximately 3 to 1. No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical doses. Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [ C] imiquimod in urine and faeces. Minimal systemic absorption of imiquimod 5% cream across the skin of patients with actinic keratosis was observed with 3 times per week dosing for 16 weeks. The extent of percutaneous absorption did not change significantly between the first Lire le document complet