País: Tanzania
Idioma: inglés
Fuente: Tanzania Medicinces & Medical Devices Authority
vancomycin Hydrochloride
VHB MEDI SCIENCES LIMITED, INDIA
Other antibacterial drugs
vancomycin Hydrochloride
1000 mg
Powder for solution for injection
,
Physical description: White almost white or tan to brown, free flowing powder; Local technical representative: GENERICS & SPECIALITIES LIMITED
Registered/Compliant
2021-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT VANSAFE-CP 1g (Vancomycin Hydrochloride for Injection USP) ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION AND DISTRIBUTION CATEGORY ATC Classification: J01X01, Anti-bacterial Agent Distribution category: Prescription only drug 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains: Vancomycin Hydrochloride USP Equivalent to Vancomycin……………….1g 3. PHARMACEUTICAL FORM DOSAGE FORM: DRY Powder for Injection DESCRIPTION: White to almost white or tan to brown free flowing powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillinallergic patients, or in those who have failed to respond to other medicines, including the penicillins or cephalosporins, and for infections caused by vancomycin -susceptible organisms that are resistant to other antimicrobial medicines. Vancomycin is indicated as an initial therapy when methicillin-resistant staphylococci are suspected. However, when the susceptibility data is available, therapy should be adjusted accordingly. Vancomycin is effective in the treatment of Staphylococcal endocarditis. Effectiveness has also been documented in other infections due to staphylococci, including septicaemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, is recommended that the antibiotics be used as adjuncts to appropriate surgical measures. Vancomycin is reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., Enterococcus faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocar Leer el documento completo