Mannitol
Sold as Adco-mannitol (25%m/v), Mannitol fresenius m/v irrigation, Sabax osmitrol in viaflex, Sabax osmitrol, Sabax osmitrol (mannitol), Mannitol m/v fresenius, Mannitol fresenius
(2R,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexol
Drag to rotate. Structure from PubChem CID 6251.
Background
Registration
- Applicants
- 3
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limitedCancelled | Adco-mannitol (25%m/v) | 250 mg/ml 20 ml | 280654 | Not determined | None |
| Fresenius Kabi Manufacturing SA (Pty) Ltd | Mannitol fresenius m/v irrigation, Mannitol m/v fresenius, Mannitol fresenius | 5 %, 20%, 50 ml | 310163, L0228, W0190 | S3 | PIPIL |
| Adcock Ingram Critical Care (Pty) Ltd | Sabax osmitrol in viaflex, Sabax osmitrol, Sabax osmitrol (mannitol) | 5 %, 20% | D0211, F0594, H1652 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adco-mannitol 250 mg/ml (25%m/v) 20 ML EACH 1,0 ml SOLUTION CONTAINS MANNITOL 250,0 mg | 250 mg/ml 20 ml | 28065428/18.1/0654 | Cancelled | Not determined | None |
| Mannitol fresenius 5 % m/v irrigation solution EACH 1000 ml SOLUTION CONTAINS MANNITOL 50,0 g | 5 %Solution | 31016331/34/0163 | Registered | Not determined | None |
| Sabax osmitrol 20% in viaflex EACH 100 ml CONTAINS: MANNITOL 20 g | 20% | D0211D/18.1/211 | Registered | Not determined | None |
| Sabax osmitrol 20% 1000 ML MANNITOL A 200 G | 20% | F0594 | Old Medicine | Not determined | None |
| Sabax osmitrol (mannitol) 5 % EACH 1000 ml CONTAINS :MANNITOL A 50 g | 5 % | H1652 | Old Medicine | Not determined | None |
| Mannitol 20% m/v fresenius EACH 500 ml SOLUTION CONTAINS MANNITOL 100 g | 20% | L0228L/18.1/228 | Registered | Not determined | None |
| Mannitol 25% injection fresenius EACH 50,0 ml SOLUTION CONTAINS MANNITOL 12,5 g | 50 mlSolution for injection. | W0190W/18.1/190Approved 7 April 2022 | Registered | S3 | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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
Schedule Verification
Mannitol 25% injection fresenius, Fresenius Kabi Manufacturing SA (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.