Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
NRIM Limited
1000 Milligram
Pdr/Conc/Soln for Infus
2011-09-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancomycin 1000mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg vancomycin (as vancomycin hydrochloride) equivalent to 1,000,000 IU). 3 PHARMACEUTICAL FORM Powder for Concentrate for Solution for Infusion A white to cream coloured porous cake After reconstitution a solution is obtained with a pH of approximately 3. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous vancomycin is indicated in the following severe infections caused by gram-positive bacteria susceptible to vancomycin which cannot be treated or failed to respond or are resistant to other antibiotics such as penicillins and cephalosporins (see section 5.1). - endocarditis - infections of the bones (osteomyelitis) - pneumonia - soft tissue infections Where appropriate, vancomycin should be co-administered with other antibacterial agents. This particularly applies to the treatment of endocarditis. Vancomycin may be used for the perioperative prophylaxis against bacterial endocarditis, in patients at high risk of developing bacterial endocarditis when they undergo major surgical procedures (e.g., cardiac and vascular procedures, etc) and are unable to receive a suitable beta-lactam antibacterial agent. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Parenterally vancomycin shall only be administered as slow intravenous infusion (not more than 10 mg/min – over at least 60 min) which is sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg). Patients requiring fluid restriction can receive a solution of 500 mg / 50 ml or 1000 mg / 100 Read the complete document