Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
ASPELONE 15 mg per 5 ml liquid.
| Pharmaceutical Form |
|---|
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Liquid. ASPELONE is a clear, pinkish-red liquid, free from foreign particles with a sweet raspberry odour. |
Each 5 ml liquid of ASPELONE contains prednisolone sodium phosphate equivalent to 15 mg prednisolone base.
Preservatives:
Sodium methyl parahydroxybenzoate 0,21% m/v
Sodium propyl parahydroxybenzoate 0,022% m/v
Contains sugar: Sorbitol liquid (70%) 2,5 g/5 ml, glycerol 0,5 g/5ml.
Contains sweetener: Saccharin sodium 7,5 mg/5 ml.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Prednisolone |
Prednisolone is a glucocorticoid which has anti-inflammatory activity. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. |
| List of Excipients |
|---|
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Colour raspberry red (C.I.14720) |
100 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a leaflet.
50 ml is packed in a round amber glass bottle sealed with a white, tamper evident, expanded polyethylene lined polypropylene screw cap. The bottle is placed in a cardboard unit carton with a leaflet.
Not all pack sizes may be marketed.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
41/21.5.1/0189
Date of first authorization: 19 March 2010
| Drug | Countries | |
|---|---|---|
| ASPELONE | South Africa |
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