| Product Name: | Esomeprazole Sodium for Injection |
| Brand Name: | Generic |
| Strength: | 20mg, 40mg |
| Dosage Form: | Lyophilized Dry Powder Injection (Sterile) *Preservative Free |
| Packing: | 1 Vial + 1 Ampule + WFI Tray |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Proton-pump inhibitor |
| Indication: | Esomeprazole is indicated for the treatment of acid-reflux disorders including healing and maintenance of erosive esophagitis, and symptomatic gastroesophageal reflux disease (GERD), peptic ulcer disease. |
| Storage: | Store in a cool & dry place. Protect from light. Below 25°C. Do not allow it to freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Esomeprazole Sodium for Injection (20mg)
- Esomeprazole Sodium for Injection (40mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Esomeprazole Sodium for Injection (20mg)
Composition:
a) Each vial contains:
Esomeprazole Sodium IP
Equivalent to Esomeprazole ………20mg
b) Sodium Chloride Injection IP…………10ml - Esomeprazole Sodium for Injection (40mg)
Composition:
a) Each vial contains:
Esomeprazole Sodium IP
Equivalent to Esomeprazole ………40mg
b) Sodium Chloride Injection IP…………10ml
THERAPEUTIC INDICATIONS:
Esomeprazole is indicated for the treatment of acid-reflux disorders including healing and maintenance of erosive esophagitis, symptomatic gastroesophageal reflux disease (GERD), and peptic ulcer disease.
DIRECTION OF USE:
To reconstitute add 5ml of sodium chloride injection IP 0.9%w/v as required. Use the reconstituted solution immediately.
CAUTION & SCHEDULE:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution & return for the replacement.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store in a cool & dry place. Protect from light. Below 25°C. Do not allow it to freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.