Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Nova Laboratories Ireland Limited, 3<sup>rd</sup> Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
Qaialdo 10 mg/ml oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. White to off white viscous oral suspension. |
Each ml of suspension contains 10 mg spironolactone.
Each bottle of 150 ml contains 1 500 mg of spironolactone.
Excipients with known effect: This medicine contains 0.75 mg sodium benzoate and 400 mg sucrose in each ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Spironolactone |
Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing potassium loss at the distal renal tubule. It has a gradual and prolonged action. |
| List of Excipients |
|---|
|
Sodium benzoate (E211) |
Amber type III glass bottle with tamper evident child-resistant closure (high density polyethyleneHDPE with expanded polyethylene liner) containing 150 ml of oral suspension.
Each pack contains one bottle, a low density polyethylene (LDPE) bottle adaptor and 2 dosing syringes (a 1 ml syringe graduated in 0.1 ml increments and a 5 ml syringe graduated in 0.1 ml increments).
Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
EU/1/23/1731/001
| Drug | Countries | |
|---|---|---|
| QAIALDO | Austria, Estonia, Croatia, Ireland, Italy, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
