GENERIC NAME OF MEDICINAL PRODUCT:

A. Vancomycin Hydrochloride for Injection IP 250mg (VANCOTAJ)
B. Vancomycin Hydrochloride for Injection IP 500mg (VANCOTAJ)
C. Vancomycin Hydrochloride for Injection IP 1000mg (VANCOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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


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

C. Vancomycin HCl for Injection IP 1000mg
a. Each vial contains:
Sterile Vancomycin Hydrochloride IP
Equivalent to
Vancomycin…………………..1000mg
b. Sterile Water for Injection IP………………10ml

THERAPEUTIC INDICATION:

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 I.V. Infusion use after dilution.
Use immediately after the preparation, if the solution is clear.
Refer package insert for detailed dose, direction for use and administration.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
Reconstituted solution should be use immediately after preparation.
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.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Prior to reconstitution, Store below 25°C.
Protect from light.
After reconstitution, the reconstituted solution must be stored in the refrigerator (2°C to 8°C).
DOSAGE: As directed by Physician.

Vancomycin Hydrochloride for Injection IP 250mg Technical Specification:

Product Name:Vancomycin Hydrochloride for Injection IP
Brand Name:VANCOTAJ
Strength:250mg500mg,  1000mg
Dosage Form:Lyophilized Powder for Injection
Chromatographically purified
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For I.V. Infusion use after dilution
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antibiotics, Anti-bacterial
Indication: 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.
Storage:Prior to reconstitution, Store below 25°C. Protect from light.
After reconstitution, the reconstituted solution must be stored in the refrigerator (2°C to 8°C).

GENERIC NAME OF MEDICINAL PRODUCT:

  • Vancomycin Hydrochloride for Injection IP 250mg (VANCOTAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATION:

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 I.V. Infusion use after dilution.
Use immediately after the preparation, if the solution is clear.
Refer package insert for detailed dose, direction for use and administration.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial.
Reconstituted solution should be use immediately after preparation.
Must be further diluted before use.
Do not use later than the date of expiry.
Discard unused portion.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Prior to reconstitution, Store below 25°C.
Protect from light.
After reconstitution, the reconstituted solution must be stored in the refrigerator (2°C to 8°C).

DOSAGE: As directed by the Physician.