Since ibuprofen was shown in vitro to displace bilirubin from its binding site to albumin, the risk of bilirubin encephalopathy in premature newborn infants may be increased (see section 5.2). Therefore, ibuprofen should not be used in infants with marked elevated bilirubin concentration. – Highlighted revised text was – unconjugated hyperbilirubinaemia.
As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection. Pedea must therefore be used cautiously in the presence of an infection (see also section 4.3). – Added text
In preterm newborn infants less than 27 weeks of gestational age, the closure rate of the ductus arteriosus (33 to 50%) was shown to be low at the recommended dose regimen (see section 5.1). – Highlighted text added.
This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
The concomitant use of Pedea with the following medicinal products is not recommended: - Added text
4.8 Undesirable effects
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. – Added text
6.3 Shelf life
To avoid any possible microbiological contamination, the product should be used immediately after first opening. – Added text
6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements. – Added text
7. MARKETING AUTHORISATION HOLDER
Orphan Europe SARL
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux - Address change
France
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/04/284/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 29 July 2004
Date of renewal: 29 July 2009 – Added text
10. DATE OF REVISION OF THE TEXT
29/07/2009 – added text
