Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Biotech Laboratories (Pty) Ltd, Ground floor, Block K West, Central Park, 400 16<sup>th</sup> road, Randjespark, Midrand 1685, South Africa
MILSIA 1% 20 mL emulsion for injection/infusion.
MILSIA 1% 50 mL emulsion for injection/infusion.
MILSIA 1% 100 mL emulsion for injection/infusion.
MILSIA 2% emulsion for injection/infusion.
| Pharmaceutical Form |
|---|
|
Emulsion for injection/infusion. A white milky emulsion, practically free from extraneous particulate contamination and large oil droplets. The pH of the solution is between 7,5 and 8,5. The osmolality is between 250 and 390 mOsmol/kg. |
MILSIA 1% 20 mL: Each vial contains 10 mg/mL propofol.
MILSIA 1% 50 mL: Each vial contains 10 mg/mL propofol.
MILSIA 1% 100 mL: Each bottle contains 10 mg/mL propofol.
MILSIA 2%: Each vial contains 20 mg/mL propofol.
Sugar free.
Excipient with known effect: Soybean oil, refined.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Propofol (2, 6-diisopropylphenol) is a short-acting general anaesthetic agent with a rapid onset of action of approximately 30 seconds. |
| List of Excipients |
|---|
|
Egg lecithin |
MILSIA is presented in clear colourless glass vials (20 mL, 50 mL) or bottle (100 mL) with a grey bromobutyl rubber stopper crimped with a silver coloured aluminium cap and light blue polypropylene flip-off cap. The vials/bottles are placed in a carton with a package insert and patient information leaflet.
MILSIA is available in the following pack sizes:
MILSIA 1% 20 mL: Carton containing 5 vials of 20 mL of emulsion for injection or infusion.
MILSIA 1% 50 mL: Carton containing 1 vial of 50 mL emulsion for injection or infusion.
MILSIA 1% 100 mL: Carton containing 1 bottle of 100 mL emulsion for injection or infusion.
MILSIA 2%: Carton containing 1 vial of 50 mL emulsion for injection or infusion.
Biotech Laboratories (Pty) Ltd, Ground floor, Block K West, Central Park, 400 16th road, Randjespark, Midrand 1685, South Africa
MILSIA 1% 20 mL: A45/2.1/0701
MILSIA 1% 50 mL: A45/2.1/0702
MILSIA 1% 100 mL: A45/2.1/0703
MILSIA 2%: A45/2.1/0704
30 September 2016
| Drug | Countries | |
|---|---|---|
| MILSIA | South Africa |
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