国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TESTOSTERONE
BREGO LIFE SCIENCES SDN. BHD
TESTOSTERONE
30Units Units; 7 Units Units
LABORATOIRES BESINS INTERNATIONAL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ANDROGEL 50MG, GEL OF TESTOSTERONE 1% ANDROGEL 25MG, GEL OF TESTOSTERONE 1% TESTOSTERONE GEL 1% 1 WHAT IS IN THIS LEAFLET? 1. What is Androgel used for 2. How Androgel works 3. Before you use Androgel 4. How to use Androgel 5. While you are using Androgel 6. Side effects 7. Storage and Disposal of Androgel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS ANDROGEL IS USED FOR Androgel is a colourless gel containing Testosterone 1% in a 5 g sachet. Testosterone is a male hormone produced naturally in the body. (Pharmacotherapeutic group: urogenital system and sex hormones). Androgel is prescribed for problemsrelating to testosterone deficiency in men over 18 years as hormone replacement therapy. HOW ANDROGEL WORKS Androgel is a topical daily testosterone replacement therapy (TRT) that can help bring your testosterone levels back to normal with daily morning use. This clear, odorless, and concentrated quick-drying gel is used to treat adult males who have low or no testosterone due to certain medical conditions. The testosterone in AndroGel is the same as the testosterone your body makes naturally. BEFORE YOU USE ANDROGEL _When you must not use it _ - Androgel is a transdermal product which is applied topically and should not be taken orally. - If you are suffering from prostate cancer or breast cancer. - If you are allergic to testosterone or to any of the ingredients of the gel _Pregnancy and lactation _ Pregnant women must avoid any contact with the Androgel application sites. This medicine may cause the development of unwanted male characteristics in the developing baby. In the event of contact, wash the area of contact as soon as possible with soap and water. If your partner becomes pregnant, you must follow the advice regarding avoiding transfer of the testosterone gel. _Before you start to use it _ Consult with your doctor or pharmacist before using Androgel. -Androgel is not used for the treatment of male st 阅读完整的文件
MOCKUP PACKAGE INSERT ANDROGEL, GEL IN SACHET 1. NAME OF THE MEDICINAL PRODUCT ANDROGEL 25 mg, gel in sachet ANDROGEL 50 mg, gel in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Testosterone …………………………….0.050 g for one 5 g sachet For excipients, see 6.1. 3. PHARMACEUTICAL FORM Gel in sachet. ANDROGEL is a transparent or slightly opalescent, colourless gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS al warnings and precautions for use). 4 . 2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adult and Elderly men The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the physician depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by this medicine. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (and up to one week). The f I . l e v e l d e r i s e d e h t e v o b a d e s i a r e r a s n o i t a r t n e c n o c e n o r e t s o t s e t a m s a l p e h t f i d e c u d e r e b y a m e s o d the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. _Paediatric population_ ANDROGEL is not indicated for use in children and has not been evaluated clinically in males under 18 years of age. _Use in women_ This medicine is not indicated for use in women. _Method of Administration_ Transdermal use The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms and abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin 阅读完整的文件