国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
Laboratórios Azevedos - Indústria Farmacêutica S.A
J01XA; J01XA01
VANCOMYCIN HYDROCHLORIDE
1000 milligram(s)
Powder for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Glycopeptide antibacterials; vancomycin
Marketed
2016-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER VANCOMYCIN 500 MG, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION VANCOMYCIN 1000 MG, POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Vancomycin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vancomycin is and what it is used for 2. What you need to know before you use Vancomycin 3. How to use Vancomycin 4. Possible side effects 5. How to store Vancomycin 6. Contents of the pack and other information 1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections. Vancomycin powder is made into a solution for infusion or an oral solution. Vancomycin is used in all age groups by infusion for the treatment of the following serious infections: Infections of the skin and tissues below the skin Infections of the bones and joints An infection of the lungs called "pneumonia". Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures Infection in the central nervous system. Infection in the blood linked to the infections listed above. Vancomycin can be given orally in adults and children for the treatment of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the _Clostridium difficile _ bacterium. 完全なドキュメントを読む
Health Products Regulatory Authority 24 June 2022 CRN00CZVQ Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancomycin 1000 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vancomycin 1000 mg, Powder for concentrate for solution for infusion Each vial contains 1000 mg of vancomycin (as vancomycin hydrochloride), equivalent to 1,000,000 IU vancomycin. One ml of reconstituted solution contains 50 mg of vancomycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Homogeneous solid, white to slightly brown. After reconstitution a solution is obtained with a pH between 2.5 – 4.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous administration Vancomycin is indicated in all age groups for the treatment of the following infections (see sections 4.2, 4.4 and 5.1): complicated skin and soft tissue infections (cSSTI) bone and joint infections community acquired pneumonia (CAP) hospital acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) infective endocarditis bacteraemia that occurs in association with, or is suspected to be associated with any of the above. Vancomycin is also indicated in all age groups for the perioperative antibacterial prophylaxis in patients that are at high risk of developing bacterial endocarditis when undergoing major surgical procedures. Oral administration Vancomycin is indicated in all age groups for the treatment of _Clostridium difficile_ infection (CDI) (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Where appropriate, vancomycin should be administered in combination with other antibacterial agents. Intravenous administration The initial dose should be based on total body weight. Subsequent dose adjustments should be based on serum concentrations to a 完全なドキュメントを読む