Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
Fresenius Kabi Deutschland GmbH
J01XA; J01XA01
VANCOMYCIN HYDROCHLORIDE
1000 milligram(s)
Powder for concentrate for solution for infusion
Glycopeptide antibacterials; vancomycin
Not marketed
2011-09-16
UK-IE -PIL-Vancomycin-500mg-1000mg-psusa-V017-Jan-2021-Clean 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 ARE GIVEN 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. 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 Vancomycin infusion is and what it is used for 2. What you need to know before you are given Vancomycin infusion 3. How Vancomycin infusion is given 4. Possible side effects 5. How to store Vancomycin infusion 6. Contents of the pack and other information 1. WHAT VANCOMYCIN INFUSION IS AND WHAT IT IS USED FOR Vancomycin infusion is a medicine that belongs to a group of antibiotics called “glycopeptides”. Vancomycin infusionworks by eliminating certain bacteria that cause infections. Vancomycin powder is made into a solution for infusion or oral solution. Vancomycin is used in 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. Vancomycin can be given orally in all age groups for the treament of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the _Clostridioides _ _difficile_ bacterium. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VANCOMYCIN INFUSION YOU MUST NOT BE GIVEN VANCOMYCIN INFUSION: If you are allergic to vancomyci Přečtěte si celý dokument
Health Products Regulatory Authority 07 December 2021 CRN00C612 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 Each vial contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin. When reconstituted with 20 ml water for injections, the concentrate for solution contains vancomycin hydrochloride 50 mg/ml. 3 PHARMACEUTICAL FORM Powder for Concentrate for Solution for Infusion A white to cream coloured porous cake. After reconsititution a solution is obtained with a pH of approximately 3. 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. 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 administration. _Patients aged 12 years and older_ The recommended dose is 15 to 20 mg/kg of body weight every 8 to 12 h (not to exceed 2 g per dose). In seriously ill patients, a loading dose of 25–30 mg/kg of body w Přečtěte si celý dokument