Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Didanosine
Bristol-Myers Squibb Australia Pty Ltd
Medicine Registered
VIDEX ® EC _didanosine_ CONSUMER PRODUCT INFORMATION WHAT IS IN THIS LEAFLET Read this leaflet carefully before taking VIDEX EC capsules. This leaflet answers some common questions about VIDEX EC. It does not contain all the available information. Some of the information contained in this leaflet may not apply to you. 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 taking VIDEX EC against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Always follow the instructions that your doctor or pharmacist give you about VIDEX EC capsules. Keep this leaflet with the medicine. You may need to read it again. WHAT VIDEX EC IS USED FOR VIDEX is a trade name (manufacturer's name) for the medicine, didanosine. VIDEX belongs to a group of medicines called nucleoside (NUKE-lee-O-side) analogues. You may also know didanosine as "ddI". VIDEX is used to treat adults and children infected with the Human Immunodeficiency Virus (HIV). VIDEX EC capsules are a different presentation of VIDEX. EC stands for 'enteric coated'. The didanosine in the capsules has a special coating which prevents acid in the stomach from destroying it. The enteric coat protects the beads of didanosine in the stomach, and then release the didanosine in the small intestine where there is no acid, and the didanosine can be absorbed. WHAT IS HIV HIV is a virus that kills important cells in the immune system over time (eg. CD4 cells). When enough of the immune cells have been killed by HIV, the body can become prone to certain types of infections. Some infections are the cause of "AIDS- defining" illnesses. This is when someone is said to have developed the Acquired Immunodeficiency Syndrome or AIDS. AIDS is a serious condition and can lead to death. HOW VIDEX EC WORKS When HIV infects cells in the immune system it takes over part of the cell's internal workings and u Lestu allt skjalið
Version 5.0 PRODUCT INFORMATION VIDEX AND VIDEX EC (DIDANOSINE) NAME OF THE MEDICINE Didanosine DESCRIPTION Didanosine is a synthetic, purine nucleoside analogue active against the Human Immuno- deficiency Virus (HIV). The chemical name for didanosine is 2', 3'-dideoxyinosine; it is also called ddI. It has the following structural formula: Didanosine is a white, crystalline, non-hygroscopic powder with the molecular formula C 10 H 12 N 4 O 3 and a molecular weight of 236.2 daltons. The aqueous solubility of didanosine at 25 o C and pH of approximately 6 is 27.3mg/mL. CAS Registry Number: 69655-05-6 Videx Paediatric Powder for Oral Solution contains only didanosine. Videx EC capsules contain didanosine, sodium starch glycollate, carmellose sodium, methacrylic acid copolymer, diethyl phthalate, talc, sodium hydroxide, gelatin, titanium dioxide, silicon dioxide and sodium lauryl sulfate. The capsules are imprinted with Tan Ink SW-8010 ARTG No 4409 (125 mg capsules), Tekprint SB-4020 Green Ink ARTG No 2652 (200mg capsules), Tekprint SB-6018 Blue Ink ARTG No 2653 (250mg capsules), and Opacode S-1-15034 Red ARTG No 2861 (400mg capsules). PHARMACOLOGY Pharmacokinetics Didanosine is rapidly degraded at acidic pH. The paediatric powder must be administered with a buffering agent. Adult Absorption Information Peak plasma concentrations and area under the plasma concentration versus time curves were proportional to dose over the range of 0.4-16.5mg/kg IV and 0.8-10.2mg/kg PO. Plasma Version 5.0 2 concentrations in excess of 2400 ng/mL (10 M) were achieved at in Lestu allt skjalið