Source: Health Products Regulatory Authority (ZA) Publisher: Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181, South Africa
CETAWAY SOLUTION 0,5 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear and colourless oral solution, essentially free from particles, with a wild strawberry-like smell and flavour. |
Each 1 ml solution contains 0,5 mg levocetirizine dihydrochloride.
Contains preservative sodium benzoate 0,4% m/v.
Contains maltitol liquid 400 mg/ml.
Contains sweeteners glycerol 230 mg/ml and saccharin sodium 2 mg/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose. |
| List of Excipients |
|---|
|
Maltitol liquid (E965) |
CETAWAY SOLUTION is packed in brown Type III glass bottles containing 60 ml, 100 ml, 150 ml or 200 ml solution and closed with a white polypropylene childproof screw cap.
The bottle is labelled and packed in a cardboard box with or without a calibrated oral syringe for dosing. The main graduation per 1 ml is marked on the syringe by bold line and number. Additional graduation per 0,5 ml is marked by a thin line.
Not all pack sizes are necessarily marketed.
Abex Pharmaceutica (Pty) Ltd, Suite C, Rubenstein Ridge, 617 Rubenstein Drive, Moreleta Park, 0181, South Africa
47/5.7.1/0953.952
23 August 2022
| Drug | Countries | |
|---|---|---|
| CETAWAY | South Africa |
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