| Product Name: | Omeprazole for Injection |
| Brand Name: | PRiLOSID |
| Strength: | 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), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Proton-pump inhibitor |
| Indication: | Omeprazole Injection is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux oesophagitis. |
| Storage: | Store below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
Omeprazole for Injection (40mg) (PRiLOSID)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Omeprazole for Injection (40mg)
Composition:
Each vial contains:
Omeprazole Sodium BP
Equivalent to Omeprazole………40mg
Sterile Water for Injection BP…………10ml
THERAPEUTIC INDICATIONS:
Omeprazole Injection is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.
DIRECTION OF USE:
For IV use only after reconstitution.
Reconstitution: To Reconstitute, add 10mL of Sterile Water for Injection BP to make a solution containing 4mg/mL of Omeprazole(approximately).
The reconstituted solution should be used immediately after preparation.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
It should not be allowed to freeze.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Warning: If any particle is visible after dissolving the contents do not use it & return for a replacement.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.