Rabeprazole Sodium for Injection BP 20mg
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Rabeprazole Sodium for Injection BP 20mg
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
THERAPEUTIC INDICATIONS:
Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which the backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 years of age and older.
DIRECTION OF USE:
For IV administration after reconstitution.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
Ampoules should not be given separately.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Ampoules should not be given separately.
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 30°C. Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Rabeprazole Sodium for Injection BP 20mg Technical Specification:
| Product Name: | Rabeprazole Sodium for Injection BP |
| Brand Name: | RABITAJ |
| Strength: | 20mg |
| 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: | Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 year of age and older. |
| Storage: | Store below 30°C. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Rabeprazole Sodium for Injection (20mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rabeprazole Sodium for Injection (20mg)
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
THERAPEUTIC INDICATIONS:
Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which the backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 years of age and older.
DIRECTION OF USE:
For IV administration after reconstitution.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
Ampoules should not be given separately.
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 30°C. Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
