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Aqumeldi® is an innovative formulation and the first and only paediatric-licensed enalapril ODT for heart failure — because children are not just small adults1-3:

  • Aqumeldi® - dedicated paediatric clinical studies in HF establishing its safety profile over a duration of 1 year4,5
  • Aqumeldi® is an innovative paediatric formulation — a mini ODT that rapidly disperses in the mouth1,4
  • Aqumeldi® is readily available in a low dose strength (0.25 mg) — enabling accurate titration and dose adjustments1,4

Paediatric medication should be in an age-appropriate formulation, accepted by children with convenient administration.

  • HCPs, parents and caregivers are often required to manipulate an adult medicine to obtain an appropriate dose for a child6
  • Patient acceptability is likely to have a significant impact on patient adherence and consequently on the safety and efficacy of the medicine.5
  • The World Health Orgnisation has proposed a shift from liquid administration to small-size solid drug formulation administration for children7
  • Mini ODTs have been designed specifically for paediatric patients to aid accurate dose administration, removing the need to manipulate adult formulations1,8,9

Use the links below to explore

References

  1. Bajcetic, M., et al. (2019). Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow up safety study. Contemporary Clinical Trials Communications. Vol15:100393.
  2. Klassen, T.P., et al. (2008). Children are not just small adults: the urgent need for high quality trial evidence in children. PLOS Medicine. Vol 5(8):e172.
  3. British National Formulary for Children (BNFC). Enalapril maleate. Available from:https://bnfc.nice.org.uk/drugs/enalapril-maleate/  
  4. Aqumeldi Summary of Product Characteristics, (January 2024) 
  5. Data on file.
  6. Batchelor, H. K., Marriott, J. F. (2015). Formulations for children: problems and solutions. British Journal of Clinical Pharmacology. Vol 79(3):405–418.
  7. Klingmann, V., et al. (2015). Acceptability of Uncoated Mini-Tablets in Neonates – A Randomized Controlled Trial. The Journal of Pediatrics. Vol.167(4):893-896.e2.
  8. Thabet, Y., et al. (2018). Flexible and precise dosing of enalapril maleate for all paediatric age groups utilizing orodispersible minitablets. International Journal of Pharmaceutics. Vol 541(1–2): 136–42.
  9. CORDIS | European Commission. (2023) LENA Final Report Summary. Available at: https://cordis.europa.eu/project/id/602295/reporting.

UK-ENA-24-0040 | January 2025

Adverse Event Reporting Information

UK: Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard

Republic of Ireland: Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie.

Adverse events should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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