Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
Fresenius Kabi Limited
J01XA; J01XA01
VANCOMYCIN HYDROCHLORIDE
1000 milligram(s)
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Glycopeptide antibacterials; vancomycin
Not marketed
2011-09-16
palen-vancomycin-500mg-1000mg-Var13-Art31-sep2017-cleanpalen-vancomycin-500mg-1000mg-Var13-Art31-sep2017-clean 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VANCOMYCIN [NATIONAL COMPLETED NAME] 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION VANCOMYCIN [NATIONAL COMPLETED NAME] 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Vancomycin 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 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 Vancomycin [national completed name] is and what it is used for 2. What you need to know before you use Vancomycin [national completed name] 3. How to use Vancomycin [national completed name] 4. Possible side effects 5. How to store Vancomycin [national completed name] 6. Contents of the pack and other information 1. WHAT VANCOMYCIN [NATIONAL COMPLETED NAME] IS AND WHAT IT IS USED FOR Vancomycin [national completed name] is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin [national completed name] works by eliminating certain bacteria that cause infections. Vancomycin powder is made into a solution for infusion. 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 - Infection in central nervous system. - Infection in the Preberite celoten dokument
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. 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 weight can be used to facilitate rapid attainment of target trough serum vancomycin concentration. _Infants and children aged from one month to less than 12 years of age:_ The recommended dose is 10 t Preberite celoten dokument