DHACOCIN for injection 500mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Vancomycin Hydrochloride 512.571mg/vial equivalent to Vancomycin

Available from:

MYLAN PHARMACEUTICALS PTE. LTD.

ATC code:

J01XA01

Dosage:

500 mg

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Vancomycin Hydrochloride 512.571mg/vial equivalent to Vancomycin 500 mg

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Mylan Laboratories Limited - Specialty Formulation Facility

Authorization status:

ACTIVE

Authorization date:

2009-12-14

Summary of Product characteristics

DHACOCIN - Vancomycin Hydrochloride for Injection 500 mg/vial
300 x 290 mm
Ver. 7; Date: 18.03.2021
Mylan / Singapore
Pack Insert
--
1
Black
= For Position Only. Codes shall be assigned during commercial artwork
preparation.
FRONT SIDE
PRODUCT DESCRIPTION:
Vancomycin Hydrochloride for Injection is a white to off white
lyophilized plug or powder filled
in glass vial. May contain hydrochloric acid and/or sodium hydroxide
for pH adjustment. When
reconstituted with Sterile Water for Injection, USP, it forms a clear
solution. This product is oxygen
sensitive. Solutions of vancomycin hydrochloride reconstituted with
Sterile Water for Injection
contain no bacteriostat and are intended for use only as a single-dose
injection. When smaller doses
are required, the unused portion should be discarded. When
reconstituted with sterile water for
injection, further dilution is required before use.
COMPOSITION:
Each vial contains: Vancomycin Hydrochloride (lyophilized) equivalent
to Vancomycin 500 mg.
PHARMACOLOGY:
Vancomycin is a tricyclic glycopeptide antibiotic derived from
Amycolatopsis orientalis (formerly
Nocardia orientalis) and has the molecular formula C
66
H
75
C
l2
N
9
O
24
• HCl. The molecular weight is
1485.74; 500 mg of the base is equivalent to 0.34 mmol.
Vancomycin has bactericidal action against a variety of Gram-positive
bacteria. It is not active in-
vitro against gram-negative bacilli, mycobacteria or fungi. It exerts
its action by inhibiting cell wall
biosynthesis of susceptible bacteria. There is also evidence that
Vancomycin alters the permeability
of the cell membrane and selectively inhibits ribonucleic acid
synthesis. There is no cross-
resistance between Vancomycin and other antibiotics.
Microbiology - The bactericidal action of vancomycin results primarily
from inhibition of cell-wall
biosynthesis. In addition, vancomycin alters bacterial-cell-membrane
permeability and RNA
synthesis. There is no cross- resistance between vancomycin and other
antibiotics. Vancomycin is
not active in vitro against gram