Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70, avenue du Général de Gaulle, F-92800 Puteaux, France
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
A course of therapy is defined as three intravenous injections of Pedea given at 24-hour intervals. The first injection should be given after the first 6 hours of life.
The ibuprofen dose is adjusted to the body weight as follows:
If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.
If the ductus arteriosus/em> does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.
If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
For intravenous use only.
Pedea should be administered as a short infusion over 15 minutes, preferably undiluted. If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Any unused portion of the solution should be discarded.
The total volume of solution injected should take into account the total daily fluid volume administered.
No case of overdose has been reported with intravenous ibuprofen in preterm newborn infants.
However, overdose has been described in infants and children administered oral ibuprofen: CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Massive overdose (up to more than 1000 mg/kg) has been reported to induce coma, metabolic acidosis, and transient renal failure. All patients recovered with conventional treatment. Only one recorded death has been published: after an overdose of 469 mg/kg, a 16-month old child developed an apnoeic episode with seizures and a fatal aspiration pneumonia.
The management of ibuprofen overdose is primarily supportive.
4 years.
To avoid any possible microbiological contamination, the product should be used immediately after first opening.
This medicinal product does not require any special storage conditions.
2 ml solution in a colourless type 1 glass ampoule.
Pedea is supplied in packs of 4 × 2 ml ampoules.
As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.
Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution. Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.
The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered. A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day.
Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
After first opening of an ampoule, any unused portions must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
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