Bupivacaine

Sold as Bupivacaine HCL spinal ( ) fresenius, Pharma-q bupivacaine spinal with dextrose ( ), Pharma-q bupivacaine, Bupican, Bupivacaine HCL spinal with dextrose adco, Macaine viaflex, Bupivacaine viaflex adco, Macaine HCL, Macaine HCL spinal, Bupivacaine HCL ( ) fresenius, * adcane, Regibloc spinal m/v

S4Read from the PI-PIL document and verified

C₁₈H₂₈N₂O288.40 g/mol

1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide

Drag to rotate. Structure from PubChem CID 2474.

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Registration

Applicants: 5
Registrations: 12
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Fresenius Kabi Manufacturing SA (Pty) Ltd	Bupivacaine HCL spinal ( ) fresenius, Bupivacaine HCL ( ) fresenius	1 ml, 10 ml	290558, W0335	S4	PI PIL
Pharma-q Holdings (Pty) Ltd	Pharma-q bupivacaine spinal with dextrose ( ), Pharma-q bupivacaine	20 mg/4ml, 50 mg/10 ml	310006, 310007	Not determined	None
Biotech Laboratories (Pty) LtdCancelled	Bupican	Not stated	450127	Not determined	None
Adcock Ingram Critical Care (Pty) LtdCertificate held by Adcock Ingram Critical Care (Pty) Ltd.	Bupivacaine HCL spinal with dextrose adco, Macaine viaflex, Bupivacaine viaflex adco, Macaine HCL, Macaine HCL spinal, * adcane	0,1 %, 0,5 %, 1 mL, 5 mg/mL	510547, A400182, A400214, J0113, U0055, Z0063	S4	PI PIL
Bodene (Pty) Ltd Trading As IntramedCancelled	Regibloc spinal m/v	0,75%	Z0095	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Bupivacaine HCL 0,5% spinal (4ml) fresenius EACH 4 ml SOLUTION CONTAINS BUPIVACAINE HYDROCHLORIDE 20,0 mg	1 mlSolution for injection.	29055829/4/0558Approved 25 May 2023	Registered	S4	PI PIL
Pharma-q bupivacaine spinal with dextrose injection (20 mg/4ml) EACH 4 ml SOLUTION CONTAINS BUPIVACAINE HYDROCHLORIDE 20 mg	20 mg/4mlInjection	31000631/4/0006	Registered	Not determined	None
Pharma-q bupivacaine injection 50 mg/10 ML EACH 10 ml SOLUTION CONTAINS BUPIVACAINE HYDROCHLORIDE 50 mg	50 mg/10 mlInjection	31000731/4/0007	Registered	Not determined	None
Bupican EACH 1,0 ml SOLUTION CONTAINS BUPIVACAINE HYDROCHLORIDE 5,0 mg	Not listed	45012745/4/0127	Cancelled	Not determined	None
Bupivacaine HCL 0,5 % spinal injection with dextrose adco EACH 4,0 ML CONTAINS: BUPIVACAINE HYDROCHLORIDE 20,0 mg	5 mg/mLSpinal injection	51054751/4/0547Approved 29 September 2025	Registered	S4	PI PIL
Macaine viaflex 0,1 % EACH 1000,0 ml SOLUTION CONTAINS BUPIVACAINE HYDROCHLORIDE 1,0 g	0,1 %	A400182A40/4/0182	Registered	Not determined	None
Bupivacaine 0,1 % viaflex adco EACH 1000,0 ml SOLUTION CONTAINS :BUPIVACAINE HYDROCHLORIDE 1,0 g	0,1 %	A400214A40/4/0214	Registered	Not determined	None
Macaine HCL 0,5 % injection EACH 1 ml SOLUTION CONTAINS: BUPIVACAINE HYDROCHLORIDE 5 mg	1 mLInjection	J0113J/4/113Approved 27 October 2025	Registered	S4	PI PIL
Macaine HCL 0,5 % spinal injection EACH 1 ml SOLUTION CONTAINS :BUPIVACAINE HYDROCHLORIDE 5 mg	0,5 %Injection	U0055U/4/55	Registered	Not determined	None
Bupivacaine HCL 0,5% (10ml) fresenius EACH 10 ml INJECTION CONTAINS BUPIVACAINE HYDROCHLORIDE 50 mg	10 mlSolution for injection.	W0335W/4/335Approved 17 September 2022	Registered	S4	PI PIL
* adcane EACH 10 ml SULUTION CONTAINS: BUPIVACAINE HYDROCHLORIDE 10 mg	Not listed	Z0063Z/4/63	Registered	Not determined	None
Regibloc spinal 0,75% m/v injection EACH 2 ml AMPOULE CONTAINS BUPIVACAINE HYDROCHLORIDE 15 mg	0,75%Injection	Z0095Z/4/95	Cancelled	Not determined	None

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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

Schedule verified from official documents

Schedule Verification

Bupivacaine HCL 0,5% spinal (4ml) fresenius, Fresenius Kabi Manufacturing SA (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsBupivacaine HCL 0,5% spinal (4ml) fresenius, Fresenius Kabi Manufacturing SA (Pty) Ltd Patient information leaflet (PIL)For patients and carersBupivacaine HCL 0,5% spinal (4ml) fresenius, Fresenius Kabi Manufacturing SA (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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