国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Vancomycin
Flynn Pharma Limited
J01XA; J01XA01
Vancomycin
1 gram(s)
Powder for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Glycopeptide antibacterials; vancomycin
Not marketed
2010-06-11
PACKAGE LEAFLET: INFORMATION FOR THE USER VANCOCIN 500 MG & 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION AND POWDER FOR ORAL SOLUTION Vancomycin hydrochloride The name of your medicine is Vancocin 500 mg & 1 g Powder for Concentrate for Solution for Infusion and Powder for Oral Solution, which will be referred to as Vancocin throughout the rest of this document. 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. WHAT IS IN THIS LEAFLET : 1. What Vancocin is and what it is used for 2. What you need to know before you are given Vancocin 3. How you are given Vancocin 4. Possible side effects 5. How to store Vancocin 6. Contents of the pack and other information 1. WHAT VANCOCIN IS AND WHAT IT IS USED FOR Vancocin contains the active ingredient vancomycin. Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections. Vancocin powder is made into a solution for infusion or oral solution. Vancocin 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 bone 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. Vancocin 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 完全なドキュメントを読む
Health Products Regulatory Authority 23 June 2022 CRN00CYCS Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancocin 1 g powder for concentrate for solution for infusion and powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 g vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin. When reconstituted with 20 mL water for injections, the concentrate for solution contains vancomycin 50 mg/mL. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion and powder for oral solution. An off-white lyophilised plug, when reconstituted in water, it forms a clear solution. 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 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 achieve targeted therapeutic concentrations. Renal function must be taken into consideration for subsequent doses and interval of administra 完全なドキュメントを読む