Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Xeolas Pharmaceuticals Limited, Hamilton Building, DCU, Glasnevin, Dublin 9, Ireland
Pedippi 2 mg/ml powder for oral suspension.
| Pharmaceutical Form |
|---|
|
Powder for Oral Suspension. Powder in Cap: White / off-white / slightly yellow powder. Powder in Bottle: White / off-white / slightly yellow powder. May contain dark specks due to sweetener. |
After constitution, each ml of suspension contains 2 mg of omeprazole. Each constituted bottle (90 ml) contains 180 mg of omeprazole.
Excipients with known effect: Each ml of suspension contains sodium methyl parahydroxybenzoate (E219) 2.3 mg, maltitol (E965) 272 mg, sodium benzoate (E211) 5 mg, sodium 17.2 mg and potassium 54.3 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Omeprazole |
Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing. |
| List of Excipients |
|---|
|
Sodium hydrogen carbonate (E500) |
Amber plastic (PET) bottle with powder fitted with a red Polypropylene (PP) closure cap containing powder, all enclosed in an aluminium foil pouch.
Each bottle contains 47 g of powder for oral suspension. Once constituted the bottle contains 90 ml of oral suspension, of which 75 ml is intended for dosing and administration.
Each pack also contains an opaque PP oral dosing syringe (5 ml, graduated at each 1ml and intermediate marks every 0.1ml) with white HDPE plunger, colourless, transparent LDPE bottle adaptor and grey PP replacement cap.
Pack: 1 or 2 bottles.
Not all pack sizes may be marketed
Xeolas Pharmaceuticals Limited, Hamilton Building, DCU, Glasnevin, Dublin 9, Ireland
PA1572/002/001
Date of first authorisation: 15th November 2019
| Drug | Countries | |
|---|---|---|
| PEDIPPI | Ireland, Netherlands, New Zealand |
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