| Product Name: | Ketorolac Tromethamine Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 300mg/10mL |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml, 2ml Single dose vial |
| Route of Administration: | For I.M. /I.V. use |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Analgesic, Anti-Inflammatory, NSAIDs |
| Indication: | Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Ketorolac Tromethamine Injection USP 300mg/10mL
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ketorolac Tromethamine Injection USP 300mg/10mL
Each ml contains:
Ketorolac Tromethamine USP…………..300mg
Alcohol USP……………..10 %v/v
Sodium Chloride BP…………………………4.35mg
Water for Injection BP…………………….q. s
THERAPEUTIC INDICATION:
Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
CAUTION & WARNING:
CAUTION:
- Not indicated for long-term use.
- Not recommended in pregnant mothers.
- Do not use the injection if the contents are not clear or show any visible particulate matter.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Discard the unused portion.
Dosage: As directed by the Physician.