国家: 马耳他
语言: 英文
来源: Medicines Authority
POLYMYXIN B, SULFATE, NYSTATIN, NEOMYCIN SULFATE
Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France
G01AA51
POLYMYXIN B SULFATE 35000 IU NYSTATIN 100000 IU NEOMYCIN SULFATE 35000 IU
VAGINAL CAPSULE
POLYMYXIN B SULFATE 35000 IU NYSTATIN 100000 IU NEOMYCIN SULFATE 35000 IU
POM
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
Authorised
2007-01-02
Page 1 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. PACKAGE LEAFLET : INFORMATION FOR THE USER POLYGYNAX ® , VAGINAL CAPSULE NEOMYCIN SULFATE, POLYMYXIN SULFATE, NYSTATIN WHAT IS IN THIS LEAFLET? 1. What POLYGYNAX, vaginal capsule is and what it is used for? 2. What you need to know before you use POLYGYNAX, vaginal capsule? 3. How to use POLYGYNAX, vaginal capsule? 4. Possible side effects. 5. How to store POLYGYNAX, vaginal capsule? 6. Contents of the pack and other information. 1. WHAT POLYGYNAX, VAGINAL CAPSULE IS AND WHAT IT IS USED FOR? WHAT POLYGYNAX, VAGINAL CAPSULE IS? Pharmacotherapeutic group: ANTIINFECTIVES and ANTISEPTICS IN GYNECOLOGICAL USE (G. genitourinary system and sex hormones), ATC code: G01AA51. This medicine is a local anti-infectious. POLYGYNAX, vaginal capsule combines 3 active substances: • Two antibiotics: • Neomycin which belongs to the aminoside family. • Polymyxin B which belongs to the polypeptide family. They fight infections due to bacteria. • An antifungal: nystatin which belongs to the polyene family. It allows the destruction of some microscopic fungus or to block their growth. WHAT IT IS USED FOR? This medicine is i ndicated in the local treatment of vaginal infections sensitive to active substances contained in this medicine (neomycin, polymyxin B and nystatin). This medicine is intended for adults only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POLYGYNAX, VAGINAL CAPSULE? DO NOT USE POLYGYNAX, VAGINAL CAPSULE: • if you are allergic (hypersensitive) to one of the active substan 阅读完整的文件
1/5 APPENDIX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT POLYGYNAX, VAGINAL CAPSULE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Neomycin sulfate ......................................................................................................................... 35 000 I.U. Polymyxin B sulfate ..................................................................................................................... 35 000 I.U. Nystatin ..................................................................................................................................... 100 000 I.U. For one vaginal capsule Excipient with known effect: Hydrogenated soybean oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal capsule. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Local treatment of vaginitis due to sensitive germs (bacterial vaginitis, vulvo-vaginitis due to _Candida albicans _ and _Candida _non-_albicans_, mixed vaginitis) and treatment of bacterial vaginosis. The official recommendations concerning appropriate use of antibacterial products must be taken into consideration. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY FOR ADULTS ONLY One vaginal capsule in the evening for 12 days. METHOD OF ADMINISTRATION Introduce one capsule deep in the vagina, preferably in lying down position. Practical advices: • The treatment should be associated with hygiene recommendations (wear cotton underwear, avoid vaginal douches, using an internal tampon during the treatment…) and elimination of contributing factors, as much as possible. • Treating the partner must be discussed on a case by case basis. • Do not stop the treatment during menstruation periods. • Treatment is compatible with latex and polyisoprene male condoms (see section 4.5). 4.3. CONTRAINDICATIONS This medicinal product is contraindicated in the following situations: • Hypersensitivity to the active substances or to any excipients listed in section 6.1 (or group sensitivity), • In case 阅读完整的文件