VANCOMYCIN HCl INJECTION 500 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

VANCOMYCIN HCl EQV VANCOMYCIN

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

J01XA01

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

VANCOMYCIN HCl EQV VANCOMYCIN 500 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BCWorld Pharm. Co., Ltd

Authorization status:

ACTIVE

Authorization date:

1995-03-16

Summary of Product characteristics

STERILE VANCOMYCIN HCL
Vancomycin HCl - lyophilized powder for injection
_INFORM YOUR DOCTORS OF UNDESIRABLE EFFECTS WHEN USING THE DRUG._
_READ CAREFULLY THE PACKAGE INSERT BEFORE USING THE DRUG. PLEASE ASK
YOUR DOCTORS IN CASE YOU NEED MORE INFORMATION._
_THIS DRUG IS BY DOCTORS’ PRESCRIPTION ONLY._
_THIS DRUG IS USED IN HOSPITALS ONLY._
COMPOSITION
ACTIVE INGREDIENT:
Each vial of Vancomycin HCl Injection 500 mg contains Vancomycin
Hydrochloride equivalent to 500mg of Vancomycin.
EXCIPIENT:
Not applicable
DOSAGE FORM
A white to pale colored lyophilized powder for injection contained in
a colorless and clear vial.
PACKAGING SIZE
Box of 5 vials x 500 mg Vancomycin
INDICATIONS
Vancomycin,
used
intravenously
is
indicated
in
the
therapy
of
severe,
potentially
life-threatening
infections due to susceptible gram-positive microorganisms which
cannot be treated with or failed to respond
to other effective, less toxic antimicrobial medicinal products, such
as penicillins and cephalosporins.
Vancomycin should be reserved for those cases where there is a
specific indication, to minimize the chance of
resistance emerging.
Vancomycin is useful in the treatment of the following severe
infections caused by susceptible microorganisms
(see section PHARMACODYNAMIC):
- endocarditis,
- infections of bones (osteomyelitis),
- pneumonia,
- soft-tissue infections.
Endocarditis caused by enterococci, _Streptococcus viridans_ or _S.
bovis_ should be treated with a combination of
vancomycin and an aminoglycoside.
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._
DOSAGE AND ADMINISTRATIONS
DOSAGE
_Vancomycin powder for solution for infusion must be administered
intravenously. Each do