| Product Name: | Pantoprazole for Injection |
| Brand Name: | Pantotaj |
| 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: | Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or “heartburn” caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. |
| Storage: | Store below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
Pantoprazole for Injection (40mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Pantoprazole for Injection (40mg)
Composition:
Each vial contains:
Pantoprazole Sodium
(as lyophilized Pantoprazole Sodium)
Equivalent to Pantoprazole ………40mg
This pack contains:
Sodium Chloride Injection BP (0.9%w/v) …………10ml
THERAPEUTIC INDICATIONS:
Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or “heartburn” caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus.
DIRECTION OF USE:
Dissolve the contents in Sodium Chloride Injection BP (0.9%w/v). The reconstituted solution should be used immediately after the preparation.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
For IV use only after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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.