Pedea

ibuprofen

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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 its 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.

Name Language First published Last updated
Pedea : EPAR - Summary for the public BG = bălgarski 18/08/2009  
Pedea : EPAR - Summary for the public ES = español 18/08/2009  
Pedea : EPAR - Summary for the public CS = čeština 18/08/2009  
Pedea : EPAR - Summary for the public DA = dansk 18/08/2009  
Pedea : EPAR - Summary for the public DE = Deutsch 18/08/2009  
Pedea : EPAR - Summary for the public ET = eesti keel 18/08/2009  
Pedea : EPAR - Summary for the public EL = elliniká 18/08/2009  
Pedea : EPAR - Summary for the public EN = English 18/08/2009  
Pedea : EPAR - Summary for the public FR = français 18/08/2009  
Pedea : EPAR - Summary for the public IT = italiano 18/08/2009  
Pedea : EPAR - Summary for the public LV = latviešu valoda 18/08/2009  
Pedea : EPAR - Summary for the public LT = lietuvių kalba 18/08/2009  
Pedea : EPAR - Summary for the public HU = magyar 18/08/2009  
Pedea : EPAR - Summary for the public MT = Malti 18/08/2009  
Pedea : EPAR - Summary for the public NL = Nederlands 18/08/2009  
Pedea : EPAR - Summary for the public PL = polski 18/08/2009  
Pedea : EPAR - Summary for the public PT = português 18/08/2009  
Pedea : EPAR - Summary for the public RO = română 18/08/2009  
Pedea : EPAR - Summary for the public SK = slovenčina 18/08/2009  
Pedea : EPAR - Summary for the public SL = slovenščina 18/08/2009  
Pedea : EPAR - Summary for the public FI = suomi 18/08/2009  
Pedea : EPAR - Summary for the public SV = svenska 18/08/2009  

This EPAR was last updated on 24/01/2014 .

Authorisation details

Product details

Product details for Pedea
NamePedea
Agency product numberEMEA/H/C/000549
Active substance

ibuprofen

International non-proprietary name (INN) or common name

ibuprofen

Therapeutic area Ductus Arteriosus, Patent
Anatomical therapeutic chemical (ATC) code C01EB16
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Pedea
Marketing-authorisation holder

Orphan Europe S.A.R.L.

Revision10
Date of issue of marketing authorisation valid throughout the European Union29/07/2004

Contact address:

Orphan Europe SARL
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France

Product information

Product information

19/12/2013  Pedea -EMEA/H/C/000549 -IG/392

Name Language First published Last updated
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014
Pedea : EPAR - Product Information SV = svenska 18/08/2009 24/01/2014

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.


Name Language First published Last updated
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  
Pedea : EPAR - All Authorised presentations SV = svenska 21/10/2005  

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 SV = svenska 18/08/2009 24/01/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Pedea : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
Pedea : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union

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