What Pedea contains
- The active substance is ibuprofen. Each ml contains 5 mg ibuprofen. Each 2 ml ampoule contains 10 mg ibuprofen.
- The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
What Pedea looks like and contents of the pack
Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution. Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.
Marketing Authorisation Holder and Manufacturer
Orphan Europe S.A.R.L.
Immeuble ?Le Wilson?
70 avenue du Général de Gaulle
F- 92800 Puteaux,
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiqueBelgiëBelgien Orphan Europe Benelux Koning Albert I laan 48 bus 3 B-1780 Wemmel BelgiqueBelgiëBelgien TélTel32 2 461 01 36 LuxembourgLuxemburg Orphan Europe Benelux Koning Albert I laan 48 bus 3 B-1780 Wemmel BelgiqueBelgiëBelgien TélTel32 2 461 01 36
Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Te. 49 6074 914090 Magyarország Orphan Europe GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Németország Tel 49 06074 914090
eská republika Orphan Europe GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Nmecko Tel 49 06074 914090 Malta Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux France Tel 33 1 47 73 64 58
Danmark Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Sverige Tel 46 8 545 80 230 Nederland Orphan Europe Benelux Koning Albert I laan 48 bus 3 B-1780 Wemmel BelgiqueBelgiëBelgien TélTel32 2 461 01 36
Deutschland Orphan Europe GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Tel 49 06074 914090 Norge Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Sverige Tel 46 8 545 80 230
Eesti Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Rootsi Tlf 46 8 545 80 230 Österreich Orphan Europe GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Deutschland Tel 49 6074 914090
Polska Orphan Europe GmbH Max-Planck Str. 6 D - 63128 Dietzenbach Niemcy Tel 49 6074 914090 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux 33 1 47 73 64 58
España Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho n1 E 08010 Barcelona Tel 34 93 244 09 30 Portugal Orphan Europe, S.L. Gran via de les Cortes Catalanes, 649 Despacho n1 E 08010 Barcelona - Espanha Tel 34 93 244 09 30
France Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux Tél. 33 1 47 73 64 58 România Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Germania Tel 49 6074 914090
Slovenija Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemija Tel 49 6074 914090 Ireland Orphan Europe UK Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT, UK United Kingdom Tel 44 1491 414333
Ísland Orphan Europe Nordic AB Banérgatan 37 S-11522 Stockholm Svíjóð Tel 46 8 545 80 230 Slovenská republika Orphan Europe Germany GmbH Max-Planck Str. 6 D-63128 Dietzenbach Nemecko Tel 49 6074 914090
Italia Orphan Europe Italy Srl Via Cellini 11 I-20090 Segrate Milano Tel 39 02 26 95 01 39 SuomiFinland Orphan Europe Nordic AB Banérgatan 37 S-11522 Stockholm Ruotsi Tel 46 8 545 80 230
Sverige Orphan Europe Nordic AB Banérgatan 37 S-11522 Stockholm Tel 46 8 545 80 230 Orphan Europe SARL Immeuble Le Wilson 70 avenue du Général de Gaulle F 92800 Puteaux 33 1 47 73 64 58
Latvija Orphan Europe Nordic AB Banérgatan 37 S-11522 Stockholm Zviedrija Tel 46 8 545 80 230 United Kingdom Orphan Europe UK Ltd. Isis House, 43 Station road Henley-on-Thames Oxfordshire RG9 1AT, UK Tel 44 1491 414333
Lietuva
Orphan Europe Nordic AB
Banérgatan 37
S-11522 Stockholm
?vedija
Tel: + 46 8 545 80 230
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
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.
Posology and method of administration (see also section 3)
For intravenous use only. Treatment with Pedea can 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 doses of Pedea given at 24-hour intervals. The ibuprofen dose is adjusted to the body weight as follows:
- 1 st injection: 10 mg/kg,
- 2 nd and 3 rd injections: 5 mg/kg.
If the ductus arteriosus 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 PDA may then be necessary.
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.
Method of administration:
Pedea should be administered as a short infusion over 15 minutes, preferably undiluted. To facilitate the administration an infusion pump may be used.
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 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.
Incompatibilities
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.
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.