Ketoprofen, tulathromycin (Draxxin Plus &)
Ketoprofen, tulathromycin
Zoetis South Africa (Pty) Ltd
Registration
- Applicant
- Zoetis South Africa (Pty) Ltd
- Registrations
- 1
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Draxxin plus 100 mg/ml & 120 mg/ml EACH 1,0 ml SOLUTION CONTAINS KETOPROFEN 120,0 mg TULATHROMYCIN 100,0 mg | 100 mg/ml 120 mg/ml | 21/0521/17.1.4/05 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Tulathromycin
Consolidated Schedules 06 July 2026, line 8307
S3: Ketoprofen
- except when intended for application to the skin; (S1)
- except when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, subject to a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2)
- except when intended for the emergency treatment of acute gout attacks or for the treatment of post- traumatic conditions, subject to a maximum dose of 75 milligrams of ketoprofen per day and a maximum treatment period of 5 days; (S2)
- except in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S2)
Consolidated Schedules 06 July 2026, lines 3836 to 3858
S2: Ketoprofen
- when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours;
- when intended for the emergency treatment of acute gout attacks or for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days;
- in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S3)
- except when intended for application to the skin. (S1)
Consolidated Schedules 06 July 2026, lines 2191 to 2220
S1: Ketoprofen
- when intended for application to the skin; (S3)
- except when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2)
- except when intended for the emergency treatment of acute gout attacks; (S2)
- except when intended for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days; (S2)
- except in the form of lozenges indicated and intended for the relief of pain associated with sore throats in patients 18 years and older subject to- (i) a maximum of 12,5 milligrams per lozenge; (ii) a maximum of 5 lozenges in any 24 hour period; (iii) a maximum treatment period of 3 days; and (iv) a maximum pack size of 15 lozenges. (S2)
Consolidated Schedules 06 July 2026, lines 596 to 624
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.