देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
VANCOMYCIN AS HYDROCHLORIDE
GENMEDIX , ISRAEL
A07AA09
LYOPHILIZED POWDER FOR CONCENTRATED SOLUTION
VANCOMYCIN AS HYDROCHLORIDE 500 MG/VIAL
I.V, ORAL
Required
VIATRIS SANTE, FRANCE
VANCOMYCIN
VANCOMYCIN
Vancomycin hydrochloride is indicated for the treatment of severe or serious infections due to susceptible strains of methicillin - resistant (beta-Iactam-resistant) staphylococci. It is also indicated for administration to penicillin-allergic patients as well patients who have failed to respond to or who cannot receive other drugs including cephalosporins or penicillins and for infections due to vancomycin-susceptible organisms that are resistant to other antimicrobial drugs.Vancomycin hydrochloride is indicated for first-line therapy when methicillin-resistant staphylococci are suspected but when susceptibility data become available appropriate therapy should be instituted. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis as well as in other infections due to staphylococci including lower respiratory tract infections septicemia skin and skin - stucture infection and bone infections. Antibiotic therapy is as an adjunct to appropriate surgical measures when staphylococcal infections are purulent and localized. For endocarditis due to Streptococcus viridans or Streptococcus bovis vancomycin hydrochloride has been shown to be effective in combination with an aminoglycoside. Vancomycin hydrochloride has been shown to be effective only in combination with an aminoglycoside for endocarditis due to enterococci (eg Enterococcus fecalis). Vancomycin hydrochloride has been shown to be effective for the treatment of diphtheroid endocareditis. In early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis or diptheroids vancomycin hydrochloride has been administered successfully in combination with either rifampin an aminoglycoside or combined with both drugs. Bacteriologic cultures of specimens should be obtained for isolation and identification of causative organisms and determination of susceptibilities to vancomycin hydrochloride. Oral Therapy Vancomycin hydrochloride injection may be given orally for the treatment of antibiotic-associated Pseudomembrannous colitis due to Staphylococcus enterocolitis and Clostridium difficile. Vancomycin hydrochloride is not effective orally when administered for other types of infection.
2021-10-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ךיראת /2017 3 / 8 םושירה רפסמו תילגנאב רישכתה םש 30297 - 63 - 123 – VANCOMYCIN MYLAN 500 MG 30298 - 64 - 123 – VANCOMYCIN MYLAN 1 G םושירה לעב םש : GENMEDIX ! דבלב תורמחהה טורפל דעוימ הז ספוט ה תושקובמה תורמחה ןולעב קרפ טסקט שדח טסקט יחכונ 4.1 THERAPEUTIC INDICATIONS … Oral THERAPY administration: Vancomycin hydrochloride injection may be given orally for the treatment of antibiotic- associated Pseudomembrannous colitis due to Staphylococcus enterocolitis and Clostridium difficile. Vancomycin hydrochloride is not effective orally when administered for other types of infection. Vancomycin is ineffective in these diseases if given parenterally … Oral Therapy Vancomycin hydrochloride injection may be given orally for the treatment of antibiotic-associated Pseudomembrannous colitis due to Staphylococcus enterocolitis and Clostridium difficile. Vancomycin hydrochloride is not effective orally when administered for other types of infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ... Nephrotoxicity:Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of oral vancomycin must be used with cautionand, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. The risk is greater in patients with renal failure asimpairment. It should be noted that the possibilitytotal systemic and renal clearances of developing toxic effects is much highervancomycin are reduced in the … Nephrotoxicity: vancomycin must be used with caution in patients with renal failure as the possibility of developing toxic effects is much higher in the presence of prolonged high blood concentrations. In the treatment of these patients and in t पूरा दस्तावेज़ पढ़ें
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vancomycin Viatris 500 mg Vancomycin Viatris 1000 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vancomycin 500 mg lyophilized powder for concentrated solution. Each vial contains 500 mg vancomycin (as hydrochloride), equivalent to 500,000 IU. When reconstituted with 10 ml of water for injections, the solution contains 50mg/ml vancomycin. Vancomycin 1000 mg lyophilized powder for concentrated solution. Each vial contains 1 g vancomycin (as hydrochloride), equivalent to 1,000,000 IU. When reconstituted with 20 ml of water for injections, the solution contains 50mg/ml vancomycin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilized powder for concentrated solution for intravenous infusion or for oral solution. White or almost white freeze dried powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS INTRAVENOUS INFUSION Vancomycin hydrochloride is indicated for the treatment of severe or serious infections due to susceptible strains of methicillin - resistant (beta-Iactam-resistant) staphylococci. It is also indicated for administration to penicillin-allergic patients as well patients who have failed to respond to or who cannot receive other drugs including cephalosporins or penicillins and for infections due to vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride is indicated for first-line therapy when methicillin-resistant staphylococci are suspected but when susceptibility data become available appropriate therapy should be instituted. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis as well as in other infections due to staphylococci including lower respiratory tract infections septicemia skin and skin - structure infection and bone infections. Antibiotic therapy is as an adjunct to appropriate surgical measures when staphylococcal infections are purulent and localized. Page 2 of 15 For endocarditis due to पूरा दस्तावेज़ पढ़ें