Pedea

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 

Pedea 5 mg/ml solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each ml of the solution contains 5 mg ibuprofen. 

Each ampoule of 2 ml contains 10 mg ibuprofen. 

 

Excipients: each ml contains 7.5 mg of sodium. 

 

For a full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Solution for injection. 

Clear, colourless to slightly yellow solution. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less 

than 34 weeks of gestational age.  

 

4.2 Posology and method of administration 
 

Treatment with Pedea should only be carried out in a neonatal intensive care unit under the 

supervision of an experienced neonatologist. 

 

Posology 

A course of therapy is defined as three intravenous injections of Pedea given at 24-hour intervals. The 

first injection should be given after the first 6 hours of life. 

The ibuprofen dose is adjusted to the body weight as follows: 

-  1st injection: 10 mg/kg, 

-  2nd and 3rd injections: 5 mg/kg. 

 

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. 

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 patent ductus 

arteriosus may then be necessary. 

 

Method of administration 

For intravenous use only. 

Pedea should be administered as a short infusion over 15 minutes, preferably undiluted. 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 should take into account the total daily fluid volume 

administered. 

 



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4.3 Contraindications 
 

- Hypersensitivity to the active substance or to any of the excipients; 
- Life-threatening infection; 
- Active bleeding, especially intracranial or gastrointestinal haemorrhage; 
- Thrombocytopenia or coagulation defects; 
- Significant impairment of renal function; 
- Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory 

pulmonary or systemic blood flow (e.g. pulmonary atresia, severe tetralogy of Fallot, severe 

coarctation of the aorta); 

- Known or suspected necrotising enterocolitis; 
 

4.4 Special warnings and precautions for use 
 

Before administration of Pedea an adequate echocardiographic examination should be performed in 

order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary 

hypertension and ductal-dependent congenital heart disease. 

 

Since prophylactic use in the first 3 days of life (starting within 6 hours of birth) in preterm newborn 

infants less than 28 weeks of gestational age was associated with increased pulmonary and renal 

adverse events, Pedea should not be used prophylactically at any gestational age (see sections 4.8 and 

5.1). In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within 

one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy. 

If hypoxaemia occurs during or following Pedea infusion, close attention should be paid to pulmonary 

pressure. 

 

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. 

 

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). 

 

Pedea should be administered carefully to avoid extravasation and potential resultant irritation to 

tissues. 

 

As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of 

bleeding. 

 

As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels 

is recommended during co-administration with ibuprofen. 

 

Careful monitoring of both renal and gastrointestinal function is recommended. 

 

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). 

 

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: 

- diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of 
nephrotoxicity of NSAIDs in dehydrated patients. 



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- anticoagulants: ibuprofen may increase the effect of anticoagulants and enhance the risk of 
bleeding. 

- corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding. 
- nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory 

increase the risk of bleeding. 

- other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the 
increased risk of adverse reactions. 

- aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their co-
administration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4). 

 

4.6 Pregnancy and lactation 
 

Not relevant 

 

4.7 Effects on ability to drive and use machines 
 

Not relevant 

 

4.8 Undesirable effects 

 

Data are currently available on approximately 1,000 preterm newborn from both the literature 

concerning ibuprofen and clinical trials with Pedea. Causality of adverse events reported in the 

preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of 

the patent ductus arteriosus as well as to direct effects of ibuprofen. 

 

Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are 

defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100). 

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 

 

Blood and lymphatic system disorders Very common: Thrombocytopenia, Neutropenia 

Nervous system disorders Common: Intraventricular haemorrhage, 

Periventricular leukomalacia 

Respiratory, thoracic and mediastinal 

disorders 

Very common: Bronchopulmonary dysplasia*  

Common: Pulmonary haemorrhage  

Uncommon: Hypoxemia*  

Gastrointestinal disorders Common: Necrotizing enterocolitis, Intestinal 

perforation 

Uncommon: Gastrointestinal haemorrhage 

Unknown: Gastric perforation 

Renal and urinary disorders Common: Oliguria, Fluid retention, Haematuria 

Uncommon: Acute renal failure 

Investigations Very Common: Blood creatinine increased, Blood 

sodium decreased 

* see below 

 

In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational 

age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/81 (16%) 

for indomethacin versus 23/94 (24%) for ibuprofen. 

 

In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe 

hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of 

gestational age. This occurred within one hour of the first infusion and was reversed within 30 minutes 

after the inhalation of nitric oxide. There have also been post-marketing reports of pulmonary 

hypertension where Pedea was administered to premature neonates in the therapeutic setting. 

 

Reporting of suspected adverse reactions 



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Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

No case of overdose has been reported with intravenous ibuprofen in preterm newborn infants. 

 

However, overdose has been described in infants and children administered oral ibuprofen: CNS 

depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal 

function, haematuria have been observed. 

Massive overdose (up to more than 1000 mg/kg) has been reported to induce coma, metabolic 

acidosis, and transient renal failure. All patients recovered with conventional treatment. Only one 

recorded death has been published: after an overdose of 469 mg/kg, a 16-month old child developed 

an apnoeic episode with seizures and a fatal aspiration pneumonia. 

 

The management of ibuprofen overdose is primarily supportive. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 
 

Pharmacotherapeutic group: other cardiac preparations, ATC code: C01 EB16 

 

Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity. Ibuprofen 

is a racemic mixture of S(+) and R(-) enantiomers. In vivo and in vitro studies indicate that the S(+) 

isomer is responsible for the clinical activity. Ibuprofen is a non selective inhibitor of cyclo-

oxygenase, leading to reduced synthesis of prostaglandins. 

Since prostaglandins are involved in the persistence of the ductus arteriosus after birth, this effect is 

believed to be the main mechanism of action of ibuprofen in this indication. 

 

In a dose-response study of Pedea in 40 preterm newborn infants, the ductus arteriosus closure rate 

associated to the 10-5-5 mg/kg dose regimen was 75% (6/8) in neonates of 27-29 weeks’ gestation and 

33% (2/6) in neonates of 24-26 weeks’ gestation. 

 

Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm 

newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal 

failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary 

haemorrhage, as compared to curative use. Conversely, a lower incidence of neonatal grade III-IV 

intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea. 

 

5.2 Pharmacokinetic properties 
 

Distribution 

Although a great variability is observed in the premature population, peak plasma concentrations are 

measured around 35-40 mg/l after the initial loading dose of 10 mg/kg as well as after the last 

maintenance dose, whatever gestational and postnatal age. Residual concentrations are around 10-

15 mg/l 24 hours after the last dose of 5 mg/kg. 

Plasma concentrations of the S-enantiomer are much higher than those of the R-enantiomer, which 

reflects a rapid chiral inversion of the R- to the S-form in a proportion similar to adults (about 60%). 

 

The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies). 

The central volume of distribution may depend on the status of the ductus and decrease as the ductus 

closes. 

 



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In vitro studies suggest that, similarly to other NSAIDs, ibuprofen is highly bound to plasma albumin, 

although this seems to be significantly lower (95 %) compared with adult plasma (99 %). Ibuprofen 

competes with bilirubin for albumin binding in newborn infant serum and, as a consequence, the free 

fraction of bilirubin may be increased at high ibuprofen concentrations. 

 

Elimination 

Elimination rate is markedly lower than in older children and adults, with an elimination half-life 

estimated at approximately 30 hours (16–43). The clearance of both enantiomers increases with 

gestational age, at least in the range of 24 to 28 weeks. 

 

PK-PD relationship 

In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and 

their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. Low levels were sustained up to 

72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were 

observed at 72 hours after only 1 dose of ibuprofen. 

 

5.3 Preclinical safety data 
 

There are no preclinical data considered relevant to clinical safety beyond data included in other 

sections of this Summary of Product Characteristics. With the exception of an acute toxicity study, no 

further studies have been carried out in juvenile animals with Pedea. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Trometamol, 

sodium chloride, 

sodium hydroxide (for pH adjustment), 

hydrochloric acid 25% (for pH adjustment), 

water for injections. 

 

6.2 Incompatibilities 
 

This medicinal product must not be mixed with other medicinal products except those mentioned in 

section 6.6. 

 

Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics. 

A rinse of the infusion line must be performed between each product administration (see section 6.6). 

 

6.3 Shelf life 
 

4 years. 

To avoid any possible microbiological contamination, the product should be used immediately after 

first opening. 

 

6.4 Special precautions for storage 
 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 
 

2 ml solution in a colourless type 1 glass ampoule. 

Pedea is supplied in packs of 4 x 2 ml ampoules. 

 

6.6 Special precautions for disposal and other handling 



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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.  

 

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. 

 

The required volume to be given to the infant should be determined according to body weight, and 

should be injected intravenously as a short infusion over 15 minutes, preferably undiluted. 

 

Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to 

adjust injection volume. 

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. 

 

Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion 

line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml 

(5%), solution for injection. 

 

After first opening of an ampoule, any unused portions must be discarded. 

 

Any unused product or waste material should be disposed of in accordance with local requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Recordati Rare Diseases 

Immeuble “Le Wilson” 

70, avenue du Général de Gaulle 

F-92800 Puteaux 

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 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

 

Detailed information on this product is available on the web site of the European medicines Agency 

(EMEA) http://www.emea.europa.eu 

  



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ANNEX II 

 

A. MANUFACTURER  RESPONSIBLE FOR BATCH 
RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Recordati Rare Diseases  

Immeuble “Le Wilson”  

70, avenue du Général de Gaulle 

F- 92800 Puteaux,  

France 

 

or 

 

Recordati Rare Diseases 

Eco River Parc 

30, rue des Peupliers 

F-92000 Nanterre 

France 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 
 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 

 Periodic Safety Update Reports 
 

The marketing authorisation holder shall submit periodic safety update reports for this product 

in accordance with the requirements set out in the list of Union reference dates (EURD list) 

provided for under Article 107c(7) of Directive 2001/83/EC and published on the European 

medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 Risk Management Plan (RMP) 
 

Not applicable.  



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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



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A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON TEXT 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Pedea 5 mg/ml solution for injection 

Ibuprofen 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml contains 5 mg ibuprofen 

Each ampoule of 2 ml contains 10 mg ibuprofen 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for 

injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

4 x 2 ml ampoules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Intravenous use as short infusion 

Read the package leaflet before use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 

 

Keep out of the reach and sight of children 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

From a microbiological point of view, the product should be used immediately 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

After first opening of an ampoule any unused portions must be discarded. 

Any unused product or waste material should be disposed of in accordance with local requirements. 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Recordati Rare Diseases  

Immeuble “Le Wilson”  

70 avenue du Général de Gaulle 

F- 92800 Puteaux  

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/04/284/001 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription 

 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  

 

  



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

GLASS AMPOULE LABEL  

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Pedea 5 mg/ml solution for injection 

Ibuprofen 

IV use 

 

 

2. METHOD OF ADMINISTRATION 

 

See leaflet 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

10 mg / 2 ml 

 

 

6. OTHER 

 

  



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B. PACKAGE LEAFLET 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 

 

Pedea 5mg/ml solution for injection 

Ibuprofen 

 

Read all of this leaflet carefully before this medicine is administered to your baby. 
- Keep this leaflet. You may need to read it again. 
- If you have further questions, please ask your doctor or your pharmacist. 
- This medicine has been prescribed for your baby. Do not pass it on to others. It may harm 

them, even if their symptoms are the same as your baby’s. 

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 
please tell your doctor or your pharmacist. 

 

In this leaflet:  

1. What Pedea is and what it is used for 

2. Before Pedea is administered to your baby 

3. How Pedea is used 

4. Possible side effects 

5. How to store Pedea 

6. Further information 

 

 

 

1. WHAT PEDEA IS AND WHAT IT IS USED FOR 
 

While a baby is inside its mother’s womb it does not need to use its lungs. An unborn baby has a blood 

vessel called the ductus arteriosus near the heart which allows the baby’s blood to bypass the lungs and 

circulate to the rest of the body. 

When the baby is born and starts using its lungs the ductus arteriosus normally closes. However, in 

some cases this does not happen. The medical term for this condition is ‘patent ductus arteriosus’, i.e. 

an open ductus arteriosus. This can cause heart problems in your baby. This condition is much more 

frequent in premature newborn than in full-term newborn infants. 

Pedea, when given to your baby, can help to close the ductus arteriosus. 

 

The active substance in Pedea is ibuprofen. Pedea closes the ductus arteriosus by inhibiting the 

production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus 

arteriosus open. 

 

 

2. BEFORE PEDEA IS ADMINISTERED TO YOUR BABY 
 

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care 

professionals. 

 

Do not use Pedea 
- if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea; 
- if your baby has a life-threatening infection which has not been treated; 
- if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines; 
- if your baby has a decrease of blood cells called platelets (thrombocytopenia) or other problems 

with their blood clotting; 

- if your baby has kidney problems; 
- if your baby has other problems with their heart which require the ductus arteriosus to remain open 

so that adequate circulation of the blood is maintained; 

- if your baby has or is suspected to have certain problems with their intestines (a condition called 
necrotising enterocolitis); 

 



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Take special care with Pedea 

- Before treatment with Pedea, your baby’s heart will be examined to confirm that the ductus 
arteriosus is open. 

- Pedea should not be given in the first 6 hours of life. 
- If your baby is suspected of having liver disease, signs and symptoms of which include yellowing 

of the skin and eyes. 

- If your baby is already suffering from an infection that is being treated, the doctor will treat your 
baby with Pedea only after careful consideration of your baby’s condition. 

- Pedea should be carefully administered to your baby by the healthcare professional, to avoid 
damage to the skin and surrounding tissues. 

- Ibuprofen may reduce the ability of your baby’s blood to clot. Your baby should therefore be 
watched for signs of prolonged bleeding. 

- Your baby may develop some bleeding from the intestines and the kidneys. To detect this, your 
baby’s stools and urine may be tested to determine if there is any blood present in them. 

- Pedea may reduce the amount of urine your baby passes. If this is significant, your baby’s 
treatment may be stopped until the volume of urine returns to normal. 

- Pedea may be less effective in very premature babies less than 27 weeks of gestational age. 
 

Using other medicines 

Please tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, 

including medicines obtained without a prescription. 

 

Certain medicines, if given together with Pedea, may cause side effects. These are detailed below: 

 

-  your baby may have problems passing urine and may have been prescribed diuretics. Ibuprofen 

may reduce the effect of these medicines. 

 

-  your baby may be given anticoagulants (medicine preventing blood clotting). Ibuprofen may 

increase the anti-clotting effect of this product. 

 

-  your baby may be given nitric oxide to improve blood oxygenation. Ibuprofen may increase the 

risk of bleeding. 

 

-  your baby may be given corticosteroids to prevent inflammation. Ibuprofen may increase the 

risk of bleeding in the stomach and intestines. 

 

-  your baby may be given aminosides (one family of antibiotics) to treat infection. Ibuprofen may 

increase blood concentrations and thus increase the risk of toxicity on kidney and ear 

 

Important information about some of the ingredients of Pedea 

This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodium-

free’. 

 

 

3. HOW PEDEA IS USED 
 

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare 

professional. 

 

A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals. The 

dose to be administered will be calculated from the weight of your baby. It is 10 mg/kg for the first 

administration and 5 mg/kg for the second and the third administrations. 

 

This calculated amount will be given by infusion in a vein over a period of 15 minutes. 

If after this first course of treatment, the ductus arteriosus is not closed or re-opens, your baby’s doctor 

may decide to give a second course of treatment. 

 



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If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be 

proposed. 

 

 

4. POSSIBLE SIDE EFFECTS 

 

Like all medicines, Pedea can cause side effects, although not everybody gets them. However, it is 

difficult to distinguish them from frequent complications occurring in premature babies and 

complications due to the disease. 

 

The frequency of possible side effects listed below is defined using the following convention: 

very common (affects more than 1 user in 10) 

common (affects 1 to 10 users in 100) 

uncommon (affects 1 to 10 users in 1,000) 

very rare (affects less than 1 user in 10,000) 

not known (frequency cannot be estimated from the available data) 

 

Very common:  

- Decrease in the number of platelets in the blood (thrombocytopenia), 
- Decrease in white blood cells called neutrophils (neutropenia), 
- Increase in creatinine level in the blood, 
- Decrease in sodium level in the blood, 
- Breathing problems (bronchopulmonary dysplasia), 
 

Common:  

- Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular 
leukomalacia), 

- Bleeding in the lung, 
- Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), 
- Reduced volume of urine passed, blood in the urine, fluid retention 
 

Uncommon:  

- Acute failure of the kidney’s functions 
- Bleeding in the intestine 
- Below normal oxygen content in the arterial blood (hypoxemia) 
 

Not known: 

- Perforation of the stomach 
 

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 

your baby’s doctor or your pharmacist. 

 

 

5. HOW TO STORE PEDEA 
 

Keep out of reach and sight of children. 

 

Do not use Pedea after the expiry date which is stated on the carton and label after EXP. The expiry date 

refers to the last day of that month. 

 

This medicinal product does not require any special storage conditions. 

 

After opening, Pedea should be administered immediately. 

 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 

dispose of medicines no longer required. These measures will help to protect the environment. 

 



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6. FURTHER INFORMATION 
 

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  

Recordati Rare Diseases 

Immeuble “Le Wilson”  

70, avenue du Général de Gaulle 

F- 92800 Puteaux  

France 
 

Manufacturer 

 

Recordati Rare Diseases 

Immeuble “Le Wilson” 

70, avenue du Général de Gaulle 

F-92800 Puteaux 

France 

 

or 

 
Recordati Rare Diseases 

Eco River Parc 

30, rue des Peupliers 

F-92000 Nanterre 

France 
 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

Belgique/België/Belgien 
Recordati 

Tél/Tel: +32 2 46101 36 

Lietuva 
Recordati AB. 

Tel: + 46 8 545 80 230  

Švedija 

 

България 

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This leaflet was last approved in  

 

Detailed information on this medicine is available on the European medicines Agency website: 

http://emea.europa.eu 

 

 

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: 

- 1st injection: 10 mg/kg, 

- 2nd and 3rd 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. 

 



22 

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. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET