VANCONEX LYOPHILIZED POWDER FOR INJECTION 500MGVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Vancomycin Hydrochloride 512.59 mg/vial eqv Vancomycin

Available from:

HETERO SINGAPORE PTE. LTD.

ATC code:

J01XA01

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Vancomycin Hydrochloride 512.59 mg/vial eqv Vancomycin 500 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Aspiro Pharma Limited

Authorization status:

ACTIVE

Authorization date:

2020-09-24

Summary of Product characteristics

VANCONEX
VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP 1 G/VIAL
1.4.3 PACKAGE INSERT (PI)
Enclosed in the following pages.
19
VANCONEX
Vancomycin for Injection USP 500 mg/Vial & 1 g/Vial
Lyophilised powder
VANCONEX (Vancomycin for Injection USP 500 mg/Vial)
Each vial contains Vancomycin Hydrochloride USP
equivalent to Vancomycin 500 mg.
VANCONEX (Vancomycin for Injection USP 1 g/Vial)
Each vial contains Vancomycin Hydrochloride USP
equivalent to Vancomycin 1 g.
DESCRIPTION
Vancomycin Hydrochloride
for Injection is a lyophilized
powder, for preparing intravenous (IV) infusions, in vials
containing the equivalent of 500 mg or 1 g vancomycin base.
500 mg of the base is equivalent to 0.34 mmol, and 1 g of the
base is equivalent to 0.67 mmol. When reconstituted with
Sterile Water for Injection to a concentration of 50 mg/mL, the
pH of the solution is between 2.5 and 4.5. Vancomycin
Hydrochloride for Injection should be administered
intravenously in diluted solution. After reconstitution further
dilution is required before use.
Vancomycin Hydrochloride is a chromatographically purified
tricyclic glycopeptide antibiotic derived from _Amycolatopsis _
_orientalis _ (formerly _ Nocardia orientalis_) and has the
molecular formula C H Cl N O .HCl. The molecular weight
66
75
2
9
24
is 1485.71; 500 mg of the base is equivalent to 0.34 mmol,
and 1 g of the base is equivalent to 0.67 mmol.
Vancomycin Hydrochloride has the following structural
formula:
Vancomycin Hydrochloride is a white to tan lyophilized
powder. When reconstituted with Sterile Water for Injection,
USP, it forms a clear, light to dark tan solution. May contain
hydrochloric acid and/or sodium hydroxide for pH
adjustment. This product is oxygen sensitive.
Each vial contains Vancomycin Hydrochloride USP is
equivalent to Vancomycin 500 mg
Each vial contains Vancomycin Hydrochloride USP is
equivalent to Vancomycin 1 g.
INDICATIONS
Vancomycin is indicated for the treatment of serious or
severe infections caused by susceptible strains of
methicillin-resistant (beta-lacta