Vancomycin Hydrochloride for Injection USP 1.25g (VANCOTAJ)

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Vancomycin Hydrochloride Injection USP 1.5g
a) Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………………1500mg
b) Sterile Water for Injection USP………….10ml

B) Vancomycin Hydrochloride Injection USP 1.25g
a) Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………………1250mg
b) Sterile Water for Injection USP………………10ml

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

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

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

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

THERAPEUTIC INDICATIONS:

Vancomycin Injection is an antibiotic used in the treatment of severe bacterial infections in hospitalized patients.
***Severe bacterial infections.

DIRECTION OF USE:

For Intravenous use only.
Reconstitute the solution with 10ml Sterile Water for Injection USP
Preparation for IV 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.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNINGS: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, rarely cardiac arrest.

STORAGE & DOSAGE:

Storage: Prior to the reconstitution, Store at 20°C to 25°C (68°F to 77°F).
After reconstitution, this vial maybe stored in a refrigerator for 96 hours.
CHROMATOGRAPHICALLY PURIFIED.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read package insert for precautions and directions before use.
Dosage: As directed by Physician.

Vancomycin Hydrochloride for Injection USP 1.25g  Technical Specification:

Product Name:Vancomycin Hydrochloride for Injection, USP 1.25g
Brand Name:VANCOTAJ
Strength:1500mg, 1250mg, 1000mg, 750mg, 500mg, 250mg
Dosage Form:Dry Powder for Injection (Sterile) *Preservative-free
Packing:Single Dose Vial + WFI in a Tray
Route of Administration:For I.V. use only *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:Anti-bacterial & Anti-biotics
Indication: Vancomycin Injection is an antibiotic used in the treatment of severe bacterial infections in hospitalized patients.
***Severe bacterial infections.
Storage:Prior to the reconstitution, Store at 20°C to 25°C (68°F to 77°F)
After reconstitution, this vial maybe stored in a refrigerator for 96 hours.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Vancomycin Hydrochloride for Injection USP 1.25g

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vancomycin Hydrochloride Injection USP 1.25g
    Each vial contains:
    Vancomycin Hydrochloride USP
    Equivalent to Vancomycin……………………1250mg
    Sterile Water for Injection USP………….10ml

THERAPEUTIC INDICATION:

Vancomycin Injection is an antibiotic used in the treatment of severe bacterial infections in hospitalized patients.

***Severe bacterial infections.

DIRECTION OF USE:

For Intravenous use only.
Reconstitute the solution with 10ml Sterile Water for Injection USP

Preparation for IV 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.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.

FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE

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

Warnings: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, rarely cardiac arrest.

STORAGE & DOSAGE:

Storage: Prior to the reconstitution, Store at 20°C to 25°C (68°F to 77°F)
After reconstitution, this vial maybe stored in a refrigerator for 96 hours.

CHROMATOGRAPHICALLY PURIFIED.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

Read package insert for precautions and directions before use.

Dosage: As directed by Physician.