Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom
Entocort Enema.
| Pharmaceutical Form |
|---|
|
Dispersible tablet and solution for rectal suspension. Each Entocort enema consists of 2 components:
|
0.02 mg/ml budesonide (2 mg budesonide/100 ml).
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Budesonide |
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers. |
| List of Excipients |
|---|
|
Tablet: Lactose anhydrous Vehicle: Sodium chloride |
Entocort Enema 0.02 mg/ml consists of 2 components: A dispersible tablet and a vehicle.
The primary package for the tablets is an aluminium blister package consisting of polyamide 25 μm/Al ≥41 μm/polyvinylchloride 60 μm/A1 20 μm.
The primary package for the vehicle is a low density polyethylene (LDPE) bottle equipped with a high density polyethylene (HDPE) cap. Individually packaged nozzles (enema applicators) with non-return valves, both made of thermoplastic rubber.
Pack Size: each carton contains 7 tablets, 7 vehicle solutions, 7 nozzles (enema applicators), and 7 plastic bags to be used when giving the enema.
Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom
PL 36633/0007
4th June 2002
| Drug | Countries | |
|---|---|---|
| ENTOCORT | Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Malta, Mexico, Netherlands, New Zealand, Poland, Turkey, United Kingdom |
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