Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
Noridem Enterprises Limited
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
2011-06-03
PACKAGE LEAFLET: INFORMATION FOR THE USER VANCOMYCIN 500 MG & 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION AND ORAL SOLUTION VANCOMYCIN HYDROCHLORIDE 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 nurse. • 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. THE NAME OF YOUR MEDICINE IS ONE OF THE FOLLOWING: - Vancomycin 500 mg Powder for concentrate for solution for infusion and oral solution - Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution _In the rest of this leaflet your medicine is called Vancomycin. _ _ _ 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 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. Vancomycin powder is made into a solution for infusion or 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 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. Vancomycin can be gi Přečtěte si celý dokument
Health Products Regulatory Authority 15 December 2023 CRN00DYLT Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin. When reconstituted with 20 mL of water for injections, the resulting concentrate for solution for infusion contains 50 mg/mL vancomycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion and oral solution. A white to pinkish powder. 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 acute bacterial meningitis 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 _Clostridioides 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 adm Přečtěte si celý dokument