Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Umsebe Healthcare, Unit 20, Sunclare Building, 3rd Floor, 21 Dreyer Street, Claremont, Cape Town, 7708, South Africa
MISYO 10 mg/ml concentrate for oral solution.
| Pharmaceutical Form |
|---|
|
Concentrate for oral solution. Clear blue solution. |
Each 1 ml of the concentrate for oral solution contains 10 mg of methadone hydrochloride.
Sugar free.
Excipients with known effects:
Each 1 ml of the concentrate for oral solution contains 300 mg of sorbitol, liquid noncrystallising (E420) (which is equivalent to 210 mg of sorbitol).
Each 1 ml of the concentrate for oral solution contains 3 mg sodium benzoate (E211) as preservative.
Each 1 ml of the concentrate for oral solution contains 0,478 mg (0,021 mmol) sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Methadone |
Methadone is a synthetic opioid analgesic similar to morphine although less sedative. It acts on the CNS system and smooth muscles via the peripheral nervous system. |
| List of Excipients |
|---|
|
Citric acid monohydrate (E330) |
Type III, brown glass bottle containing 100 ml concentrate for oral solution, sealed with a PP 28 screw cap with PE-liner or with a PP 28 screw cap child-resistant, tamper evident ring with embossing and PE-liner. One bottle is packed in to a cardboard carton.
Type III, brown glass bottle containing 1000 ml concentrate for oral solution, sealed with a PP 28 screw cap with PE-liner or with a PP 28 screw cap child-resistant, tamper evident ring with embossing and PE-liner. One bottle is packed in to a cardboard carton.
Not all pack sizes may be marketed.
Umsebe Healthcare, Unit 20, Sunclare Building, 3rd Floor, 21 Dreyer Street, Claremont, Cape Town, 7708, South Africa
55/2.9/0741
9 November 2021
| Drug | Countries | |
|---|---|---|
| MISYO | Austria, Spain, Poland, Romania, South Africa |
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