Letter to health care professionals on the risk of accidental overdose during administration of the drug Perfalgan 10 mg/ml (intravenous paracetamol)


The company PharmaSwiss d.o.o., marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml, in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED) has sent a letter to physicians regarding the risk of medication errors and the consequential accidental overdose in newborns and infants during the administration of the medicinal product Perfalgan 10 mg/ml. The letter also informs physicians of the risk of accidental overdose in all patients with body weight ≤50 kg and reminds of the currently valid dosage recommendations.

The letter gives recommendations for avoiding unintentional overdose, with the general conditions for dosage based on the patient's body weight. The strength of the drug Perfalgan 10 mg/ml is 10 milligrams of paracetamol per 1 millilitre of solution. Errors occur in dosage of the drug if the drug dose to be administered is calculated in milligrams, when the drug is administered in millilitres. The result of this error is the administration of a dose 10 times higher than the recommended dose of paracetamol. In order to avoid errors in dosage in newborns and infants, and the confusion between milligrams (mg) and millilitres (ml), it is recommended that the intended volume for administration be specified in millilitres (ml).

Due to the above, new and more carefully explained recommendations for the dosage and administration of the medicinal product Perfalgan 10 mg/ml will be included in the Summary of Product Characteristics and the Instructions for Use as soon as possible.

The Letter to Health Care Professionals may be viewed here (in Croatian).

HALMED has not yet received a single report of any adverse reactions, medication errors or overdoses for the drug Perfalgan 10 mg/ml. HALMED will continue to monitor the safety of use of this drug and the public will be informed of any new information in a timely manner.

We hereby remind all health care professionals that they are obliged to report every adverse reaction to medicinal products to HALMED (in Croatian). Patients developing an adverse reaction may also report the same directly to HALMED, with the recommendation that they consult their doctor or pharmacists regarding any adverse reactions they observe for consultations on the continuation of therapy.