| Product Name: | Vancomycin Hydrochloride for Injection USP |
| Brand Name: | VANCOTAJ |
| Strength: | 250mg, 500mg,1g |
| 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 250mg
- Vancomycin Hydrochloride for Injection USP 500mg
- Vancomycin Hydrochloride for Injection USP 1g
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Vancomycin Hydrochloride Injection USP 250mg
Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………………250mg
Sterile Water for Injection USP………….10ml - Vancomycin Hydrochloride Injection USP 500mg
Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………………500mg
Sterile Water for Injection USP………….10ml - Vancomycin Hydrochloride Injection USP 1g
Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………………1g
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.