Ketorolac tromethamine
Sold as Sabax ketorolac, Kelopt, Acuvail, Oflaect, Bedoral
5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid
Drag to rotate. Structure from PubChem CID 3826.
Background
Registration
- Applicants
- 5
- Registrations
- 8
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock Ingram Critical Care (Pty) Ltd | Sabax ketorolac | 30, 60 | 430178, 430179 | Not determined | None |
| Gen-eye (Pty) Ltd | Kelopt | Not stated | 451033 | Not determined | None |
| Abbvie (Pty) Ltd | Acuvail | 4,5 mg/ml | 470336 | Not determined | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Oflaect | 15, 30, 60 | 540286, 540287, 540288 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) LtdCancelled | Bedoral | 30 mg | A400147 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sabax ketorolac 30 EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 30,0 mg | 30 | 43017843/2.7/0178 | Registered | Not determined | None |
| Sabax ketorolac 60 EACH 2,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 60,0 mg | 60 | 43017943/2.7/0179 | Registered | Not determined | None |
| Kelopt EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 5,0 mg | Not listed | 45103345/15.4/1033 | Registered | Not determined | None |
| Acuvail Each 1,0 ml Solution contains: Ketorolac Tromethamine 4,5 mg | 4,5 mg/mlEye drops, solution | 47033647/15.4/0336Approved 21 April 2024 | Registered | Not determined | PIPIL |
| Oflaect 15 injection EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 15,0 mg | 15Injection | 54028654/2.7/0286 | Registrered | Not determined | None |
| Oflaect 30 injection EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 30,0 mg | 30Injection | 54028754/2.7/0287 | Registrered | Not determined | None |
| Oflaect 60 injection EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 60,0 mg | 60Injection | 54028854/2.7/0288 | Registrered | Not determined | None |
| Bedoral 30 EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETHAMINE 30,0 mg | 30 mgSolution for injection | A400147A40/2.7/0147Approved 18 September 2023 | Cancelled | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.