GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Vancomycin Hydrochloride for Injection USP 250mg (VANCOTAJ)
B. Vancomycin Hydrochloride for Injection USP 500mg (VANCOTAJ)
C. Vancomycin Hydrochloride for Injection USP 750mg (VANCOTAJ)
D. Vancomycin Hydrochloride for Injection USP 1g (VANCOTAJ)
E. Vancomycin Hydrochloride for Injection USP 1.25g (VANCOTAJ)
F. Vancomycin Hydrochloride for Injection USP 1.5g (VANCOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Vancomycin Hydrochloride for Injection USP 250mg
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..250mg
b. Sterile Water for Injection USP………….10ml

B. Vancomycin Hydrochloride for Injection USP 500mg
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..500mg
b. Sterile Water for Injection USP………….10ml


C. Vancomycin Hydrochloride for Injection USP 750mg
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..750mg
b. Sterile Water for Injection USP………….10ml

D. Vancomycin Hydrochloride for Injection USP 1g
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..1000mg
b. Sterile Water for Injection USP………….10ml

E. Vancomycin Hydrochloride for Injection USP 1.25g
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..1.25g
b. Sterile Water for Injection USP………….10ml

F. Vancomycin Hydrochloride for Injection USP 1.5g
a. Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to
Vancomycin…………………..1.5g
b. Sterile Water for Injection USP………….10ml

THERAPEUTIC INDICATIONS:

Vancomycin injection is used alone or in combination with other medications to treat certain serious infections such as endocarditis (infection of the heart lining and valves), peritonitis (inflammation of the lining of the abdomen), and infections of the lungs, skin, blood, and bones.

DIRECTION OF USE:

For Intravenous use.
Reconstitute contents with Sterile Water for Injection USP.

Preparation for Intravenous Administration:
Suspend container from eyelet support.
Remove protector from outlet port at bottom of container.
Attach administration set.
Refer to complete directions accompanying set.
Use sterile equipment.

After reconstitution, may be stored in the refrigerator for 96 hours without significance loss of potency. After reconstitution must be further diluted.
Read package insert for detailed dose, precautions and directions before use.

CAUTION & WARNING:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
Do not use later than the date of expiry.
Discard unused portion.
Must be further diluted before use.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Prior to the reconstitution Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the physician.

Vancomycin Hydrochloride for Injection USP 500mg Technical Specification:

Product Name:Vancomycin Hydrochloride for Injection USP
Brand Name:VANCOTAJ
Strength:250mg (250,000 IU per vial) (1,000 IU per mg of Vancomycin),
500mg (500,000 IU per vial) (1,000 IU per mg of Vancomycin),
750mg (750,000 IU per vial) (1,000 IU per mg of Vancomycin),
1g (1000,000 IU per vial) (1,000 IU per mg of Vancomycin),
1.25g (1250,000 IU per vial) (1,000 IU per mg of Vancomycin),
1.5g (1500,000 IU per vial) (1,000 IU per mg of Vancomycin)
Dosage Form:Lyophilized Powder for Injection (Sterile, Nonpyrogenic and Preservative free)
CHROMATOGRAPHICALLY PURIFIED
Packing:Single Dose Vial + WFI Tray
Route of Administration:For I.V. Infusion use after dilution
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibiotics, Anti-bacterial
Indication: Vancomycin injection is used alone or in combination with other medications to treat certain serious bacterial  infections in hospitalized patients such as endocarditis (infection of the heart lining and valves), peritonitis (inflammation of the lining of the abdomen), and infections of the lungs, skin, blood, and bones.
Storage:Prior to the reconstitution Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vancomycin Hydrochloride for Injection USP 500mg (VANCOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vancomycin Hydrochloride for Injection USP 500mg
    a. Each vial contains:
    Vancomycin Hydrochloride USP
    Equivalent to
    Vancomycin…………………..500mg
    b. Sterile Water for Injection USP………….10ml

THERAPEUTIC INDICATIONS:

Vancomycin injection is used alone or in combination with other medications to treat certain serious infections such as endocarditis (infection of the heart lining and valves), peritonitis (inflammation of the lining of the abdomen), and infections of the lungs, skin, blood, and bones.

DIRECTION OF USE:

For Intravenous use.
Reconstitute contents with Sterile Water for Injection USP

Preparation for Intravenous Administration:
Suspend container from eyelet support.
Remove protector from outlet port at bottom of container.
Attach administration set.
Refer to complete directions accompanying set.
Use sterile equipment.

After reconstitution, may be stored in the refrigerator for 96 hours without significance loss of potency. After reconstitution must be further diluted.
Read package insert for detailed dose, precautions and directions before use.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Discard unused portion.
Do not use later than the date of expiry.
Must be further diluted before use.
KEEP OUT OF REACH AND SIGHT OF CHILDREN. 

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Prior to the reconstitution Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Keep all medicines out of reach of children.

Dosage: As directed by the physician.