About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Pedea?
Pedea is a solution for injection that contains the active substance ibuprofen.
- What is Pedea used for?
Pedea is used to treat ‘patent ductus arteriosus’ in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age). Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby’s lungs before birth) fails to close after birth. This causes heart and lung problems in the baby.
Because the number of babies born with patent ductus arteriosus is low, the disease is considered ‘rare’, and Pedea was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 February 2001.
The medicine can only be obtained with a prescription.
- How is Pedea used?
Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).
Pedea 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 Pedea may be given. If the condition is unchanged after the second course of therapy, surgery may be necessary.
Pedea should not be used before there is proof that the baby has patent ductus arteriosus.
- How does Pedea work?
The active substance in Pedea, ibuprofen, has been used since the 1960s as a painkiller and an anti-inflammatory medicine. It works by reducing the level of chemical messengers called prostaglandins within cells. As prostaglandins are also involved in keeping the ductus arteriosus open after birth, Pedea is thought to work by reducing the levels of prostaglandins, allowing this blood vessel to close.
- How has Pedea been studied?
Because ibuprofen has been in use for a long time, the company presented information from the published literature. It also presented the results of studies, including one study looking at different doses of Pedea in 40 newborn premature babies. The main measure of effectiveness was the number of babies whose ductus arteriosus closed without the need for surgery.
A further study compared the effects of Pedea and placebo (a dummy treatment) in 131 newborns who were treated before there was proof that they had patent ductus arteriosus.
- What benefit has Pedea shown during the studies?
In the study looking at the treatment of patent ductus arteriosus, the approved dose of Pedea led to a closure rate of 75% in babies born 11 to 13 weeks premature (six out of eight) and 33% in babies born 14 to 16 weeks premature (two out of six).
In study looking at the use of Pedea before there was proof that the babies had patent ductus arteriosus, Pedea seemed to be more effective than placebo at preventing surgery. However, the study had to be stopped early because of side effects (kidney and lung problems).
- What is the risk associated with Pedea?
The cause of any side effects seen in babies receiving Pedea is difficult to assess because they may be related to the patent ductus arteriosus or to Pedea itself. The most common side effects seen in babies receiving the medicine (seen in more than 1 baby in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely), increased blood creatinine levels (a marker of kidney problems) and decreased blood sodium levels. For the full list of all side effects reported with Pedea, see the Package Leaflet.
Pedea should not be used in babies who may be hypersensitive (allergic) to ibuprofen or any of the other ingredients. It must not be used in babies who have a life-threatening infection, bleeding, blood clotting problems or kidney problems. It must also not be used in babies with congenital heart disease where an open ductus arteriosus is needed for the blood to flow, or in babies with necrotising enterocolitis (a severe bacterial infection causing patches of dead tissue in the gut).
- Why has Pedea been approved?
The Committee for Medicinal Products for Human Use (CHMP) accepted that the information presented by the company showed that Pedea is effective in treating patent ductus arteriosus. The Committee decided that Pedea’s benefits are greater than its risks for the treatment of patent ductus arteriosus in preterm (less that 34 weeks gestational age) newborn infants. The Committee recommended that Pedea be given marketing authorisation.
- Other information about Pedea
The European Commission granted a marketing authorisation valid throughout the European Union to Orphan Europe SARL on 29 July 2004. The marketing authorisation was renewed on 29 July 2009.
This EPAR was last updated on 18/08/2009 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
24/07/2009 Pedea -EMEA/H/C/000549 -R/0006
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Cardiac therapy
Therapeutic indication
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Pedea : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 18/08/2009 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Pedea : EPAR - Scientific Discussion | (English only) | 21/10/2005 | |
| Pedea : EPAR - Procedural steps taken before authorisation | (English only) | 21/10/2005 |
Authorised
This medicine is approved for use in the European Union
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