The National Directorate of Pharmacy and Drugs of the Ministry of Health (MINSA) published Resolution No. 113, dated October 5, in Official Gazette No. 30643 of October 27, 2026, on Lactated Ringer's solution, also known as Hartmann's solution, one of the most widely used intravenous fluids in hospitals and clinics.

The recitals explain the reason: since March 2002, the National Pharmacovigilance Center has received 49 reports of suspected adverse reactions associated with this solution, 48.98 % of them in patients aged 2 to 12. Most involved skin disorders, such as hives and itching, and in 89.80 % of cases the infusion had to be stopped.

Article one orders marketing authorization holders and manufacturers to include in the monograph an expanded list of contraindications, among them hyperkalemia, severe kidney failure and uncompensated heart failure. It adds a ban on administering ceftriaxone together with the solution to newborns up to 28 days old, even through separate lines, because of the risk of fatal precipitates. It also adds warnings on air embolism in pressurized infusions and on interactions with diuretics, lithium and digoxin. Article two adds requirements for variants containing magnesium, and article three requires a label warning about serious hypersensitivity reactions.

For laboratories and distributors, the measure means reviewing inserts, monographs and labeling for all batches intended for the Panamanian market. Article four extends it to products already registered, those in registration or renewal, and every new application, so it could affect pending files. For hospitals and public buyers, the new warnings could be reflected in administration protocols and in the specifications of future purchases.

The change is not immediate in the market. Although the resolution takes effect upon publication under article six, article five grants eight (8) months from publication in the Official Gazette to comply with the measures, which puts the deadline at the end of June 2027. Nexo Capital will follow the application of these provisions in sanitary registrations.

Research assisted by Sentinel, with editorial verification of official sources. Discover Legislat.ai