Human medicines European public assessment report (EPAR): Ibuprofen Gen.Orph, ibuprofen, Date of authorisation: 16/02/2024, Status: Authorised
Treatment with Ibuprofen Gen.Orph should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).
Ibuprofen Gen.Orph is given as three injections into a vein at 24-hour intervals. Each injection lasts 15 minutes. The first injection is given when the baby is at least six hours old. If the ductus arteriosus has not closed by 48 hours after the final injection, or if it re-opens, a second course of three doses of Ibuprofen Gen.Orph may be given. If the condition is unchanged after the second course of therapy, surgery may be necessary.
Ibuprofen Gen.Orph should not be used before there is proof that the baby has patent ductus arteriosus.
For more information about using Ibuprofen Gen.Orph, see the package leaflet or contact your doctor or pharmacist.
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