Spanish Agency for Medicines and Health Products has withdrawn a new drug that was dependent on the Ministry of Health. After removing a batch for cholesterol that was sold in Spain, he ordered the withdrawal of an allergen medicine, specifically a batch JEXT 150 micrograms. It contains self-injectable devices containing adrenaline in different doses. They are used as an emergency treatment for severe allergic reactions (anaphylaxis).
One unit was found to have a defect in its closing system, which is a level two error. All units were removed from affected batches and returned to the laboratory via the normal channels. K3240 is the affected batch, expiring on 10/31/2023. The following trade name is JEXT 150micrograms SOLUTION for INJECTION in PRE-FILLED Pen, 1 pre-filled pen 0.15 ml (NR 73186, Cn: 677267).
Aemps explains that JEXT can be used to treat anaphylactic shock, which is a sudden, severe allergic reaction caused by insect bites or stings. The prospectus states that anaphylactic reactions can be triggered by a few minutes after exposure. These symptoms include itchy skin, rash, hot flushes, swelling of the lips and throat, tongue, lips, hands and feet, hoarseness, difficulty breathing, nausea, vomiting, abdominal cramps, and sometimes loss of consciousness.
For allergic-type emergencies, 300 micrograms of Epinephrine are recommended for injection into the outer leg for children and adults weighing over 30 kg. Half is recommended for minors.