Basic Information
Qaialdo
Regulatory Information
EMEA/H/C/005535
May 26, 2023
1
February 20, 2025
Company Information
Ireland
3rd Floor, Ulysses House Foley Street Dublin 1, D01 W2T2
NOVA LABORATORIES IRELAND LIMITED
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).
Overview Summary
Qaialdo is a medicine used to manage refractory oedema (swelling due to fluid build-up that does not respond to standard treatments) associated with any of the following conditions: - congestive heart failure (when the heart does not pump blood as well as it should and fluid builds up around the heart and in the legs); - hepatic cirrhosis (liver scarring) with ascites (fluid build-up in the belly) and oedema (fluid build-up in the legs, feet and ankles); - malignant ascites (ascites caused by cancer cells spreading to the organs in the belly); - nephrotic syndrome (a group of symptoms associated with kidney damage, such as the presence of protein in the urine or oedema); - essential hypertension (high blood pressure without a known cause). It can also be used to diagnose and treat primary aldosteronism, a condition in which the body produces too much of the hormone aldosterone, which also results in oedema. Qaialdo is a ‘hybrid medicine’. This means that the medicine is similar to a ‘reference medicine’ containing the same active substance, but Qaialdo is available as a liquid to be taken by mouth while the reference medicine is available as tablets. The reference medicine for Qaialdo is Aldactone. Qaialdo contains the active substance spironolactone.