Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
VANCOMYCIN
Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia
J01XA01
VANCOMYCIN 50 mg/ml
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
VANCOMYCIN 50 mg/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-08-09
PAGE 1 OF 10 PACKAGE LEAFLET: INFORMATION FOR THE USER VANCOMYCIN APTAPHARMA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION VANCOMYCIN APTAPHARMA 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 further questions, ask your doctor or hospital pharmacist or nurse. - 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 AptaPharma is and what it is used for 2. What you need to know before you use Vancomycin AptaPharma 3. How to use Vancomycin AptaPharma 4. Possible side effects 5. How to store Vancomycin AptaPharma 6. Contents of the pack and other information 1. WHAT VANCOMYCIN APTAPHARMA 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 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 the bones and joints • An infection of the lungs called "pneumonia" • An infection of the lungs called "pneumonia" acquired in hospital, including ventilator-associated 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 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. Vancomycin powder is made into a solution for infusion or oral solution. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN APTAPHARMA DO NOT U Citiți documentul complet
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 19 1. NAME OF THE MEDICINAL PRODUCT Vancomycin AptaPharma 500 mg powder for concentrate for solution for infusion Vancomycin AptaPharma 1000 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vancomycin AptaPharma 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin. When reconstituted with 10 ml water for injections, the concentrate for solution contains vancomycin 50 mg/ml. Vancomycin AptaPharma 1000 mg powder for concentrate for solution for infusion 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white or pinkish sterile lyophilized porous cake. 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 Page 3 of 19 Where appropriate, vancomycin should be admini Citiți documentul complet