Pedea 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pedea 5 mg/ml injection solution

Ibuprofen

Read all of this leaflet carefully before administering this medicine to your baby, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your baby only and must not be given to other people, even if they have the same symptoms as your baby, since it could harm them.
• If your baby experiences any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Pedea is and what it is used for
2. What you need to know before administering Pedea to your baby
3. How to use Pedea
4. Possible adverse effects
5. How to store Pedea
6. Contents of the pack and other information

1. What Pedea is and what it is used for

While the baby is inside the mother's uterus, the lungs are not needed. Fetuses have a blood vessel called the ductus arteriosus near the heart that allows the baby's blood to bypass the lungs and flow to the rest of the body.

When the baby is born and begins to use the lungs, the ductus arteriosus normally closes.

However, in some cases, this does not happen. The medical term for this condition is ‘persistent ductus arteriosus’, meaning an open ductus arteriosus. This may cause heart problems in your baby. This condition is much more common in premature newborns than in those born at term.

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

The active substance of Pedea is ibuprofen. Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a chemical substance naturally produced in the body that keeps the ductus arteriosus open.

2. What you need to know before Pedea is administered to your baby

Pedea will only be administered to your baby in a neonatal intensive care unit by qualified healthcare professionals.

Do not use Pedea

• if your baby is allergic to ibuprofen or to any of the other components of this medicine (listed in section 6);

• if your baby has a life-threatening infection that has not been treated;

• if your baby has bleeding, especially if the bleeding is inside the skull or in the intestines;

• if your baby has a low number of blood cells called platelets (thrombocytopenia) or other blood clotting disorders;

• if your baby has kidney problems;

• if your baby has other heart problems requiring the ductus arteriosus to remain open for adequate blood circulation;

• if your baby has or is suspected to have certain intestinal problems (a condition called necrotizing enterocolitis).

Take special care with Pedea

• Before starting treatment with Pedea, a heart examination will be performed on your baby to confirm that the ductus arteriosus is open.
• Pedea must not be administered within the first 6 hours of life.
• If liver disease in your baby is suspected, signs and symptoms of which include yellowing of the skin and eyes.
• If your baby already has an infection being treated, the doctor will administer Pedea to your baby only after carefully evaluating your baby's condition.
• Healthcare staff must administer Pedea to your baby with caution to avoid damage to the skin and surrounding tissues.
• Ibuprofen may reduce your baby's blood's ability to clot. Therefore, your baby should be monitored for signs of prolonged bleeding.
• Your baby may develop some bleeding in the intestines and kidneys. To detect this, your baby's stools and urine may be tested for the presence of blood.
• Pedea may reduce the amount of urine produced by your baby. If this reduction is significant, treatment may be interrupted until urine output returns to normal levels.
• Pedea may be less effective in very premature babies less than 27 weeks gestational age.
• Serious skin reactions have been reported with Pedea treatment. Your doctor should stop treatment with Pedea immediately if any of the following adverse effects occur: skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) has been identified as a potential risk associated with ibuprofen. Your doctor should stop treatment with Pedea immediately if any of the following adverse effects occur: skin rash, fever, lymph node swelling, and increased eosinophil levels (a type of white blood cell).

Other medicines and Pedea

Inform your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including those obtained without a prescription.

Certain medicines, if administered together with Pedea, may cause adverse reactions. These are listed below:

• your baby may have difficulty passing urine and may have been prescribed diuretics. Ibuprofen could reduce the effect of these medicines.
• your baby may be receiving anticoagulants (medicines that prevent blood from clotting). Ibuprofen may enhance the anticoagulant effect of these products.
• your baby may be receiving nitric oxide to improve blood oxygenation. Ibuprofen could increase the risk of bleeding.
• your baby may be receiving corticosteroids to prevent inflammation. Ibuprofen could increase the risk of gastrointestinal bleeding.
• to treat an infection, your baby may be receiving aminoglycosides (a family of antibiotics). Ibuprofen may increase blood concentrations of these drugs, thereby increasing the risk of kidney and ear toxicity.

Important information about some of the components of Pedea

This medicine contains less than 1 mmol of sodium (15 mg) per 2 ml, i.e., essentially 'sodium-free'.

3. How to use Pedea

Pedea will only be administered to your baby by a qualified healthcare professional in a neonatal intensive care unit.

A treatment cycle is defined as three intravenous injections of Pedea given at 24-hour intervals. The dose to be administered will be calculated based on your baby's weight: 10 mg/kg for the first dose and 5 mg/kg for the second and third doses.

The calculated amount will be given as an intravenous infusion over a period of 15 minutes.

If, after this first treatment cycle, the ductus arteriosus remains open or reopens, your baby's doctor may decide to administer a second treatment cycle.

If the ductus arteriosus remains open after the second treatment cycle, surgery may then be considered.

If your baby is given more Pedea than they should receive:

If your baby is given more Pedea than they should, speak with your baby's doctor about the risks and necessary measures. Symptoms of overdose may include numbness, loss of consciousness, coma, seizures, gastrointestinal problems, low heart rate, low blood pressure, breathing difficulties or respiratory arrest, blood in the urine, inability of the kidneys to function properly, excess acid in the blood, and low potassium levels in the blood.

4. Possible adverse effects

Like all medicines, Pedea may cause adverse effects, although not everyone experiences them. However, it is difficult to distinguish these from common complications occurring in premature infants and complications due to the underlying disease.

The following lists the frequency of possible adverse effects using the following convention:

very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects less than 1 in 10,000 people)
frequency not known (cannot be estimated from available data)

Very common:

• Decrease in platelet count in the blood (thrombocytopenia)
• Decrease in the number of white blood cells called neutrophils (neutropenia)
• Increased blood creatinine levels
• Decreased blood sodium levels
• Breathing problems (bronchopulmonary dysplasia)

Common:

• Bleeding inside the skull (intraventricular hemorrhage) and brain injury (periventricular leukomalacia)
• Pulmonary hemorrhage
• Perforation of the intestines and intestinal tissue damage (necrotizing enterocolitis)
• Reduced urine output, blood in the urine, fluid retention

Uncommon:

• Acute kidney failure
• Intestinal bleeding
• Arterial blood oxygen levels below normal (hypoxemia)

Frequency not known:

• Stomach perforation
• Widespread red scaly rash with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue Pedea if you experience these symptoms and seek immediate medical attention. See also section 2.
• Drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil levels (a type of white blood cell).

If you consider any of the adverse effects experienced to be severe, or if you notice any adverse effects not listed in this leaflet, inform your baby’s doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pedea

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Once opened, Pedea should be administered immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pedea

• The active substance is ibuprofen. Each ml contains 5 mg of ibuprofen. Each 2 ml ampoule contains 10 mg of ibuprofen.
• The other components are trometamol, sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid 25% (to adjust pH), and water for injections.

Nature of the product and contents of the container

Pedea 5 mg/ml solution for injection is a clear, colourless to pale yellow solution.

Pedea 5 mg/ml solution for injection is available in packs of four 2 ml ampoules.

Marketing Authorisation Holder

Recordati Rare Diseases
Tour Hekla
52, avenue du Général de Gaulle
F-92800 Puteaux,
France

Manufacturer

Recordati Rare Diseases
Tour Hekla
52, avenue du Général de Gaulle
92800 Puteaux
France

or

Recordati Rare Diseases Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this summary:

Detailed information on this medicine is available on the European Medicines Agency website: https://ema.europa.eu.

This information is intended for healthcare professionals only:

As with all parenteral products, Pedea ampoules should be inspected visually for particulate matter and container integrity prior to use. The ampoules are for single use only; any unused portion should be discarded.

Dosage and method of administration (see also section 3)

For intravenous use only. Treatment with Pedea must only be performed in a neonatal intensive care unit under the supervision of an experienced neonatologist. A treatment cycle is defined as three intravenous doses of Pedea administered at 24-hour intervals.

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

• 1st injection: 10 mg/kg,
• 2nd and 3rd injection: 5 mg/kg.

If the ductus arteriosus has not closed within 48 hours after the last injection or if it reopens, a second cycle of three doses may be administered as described above.

If the condition persists after a second treatment cycle, surgical intervention for persistent patent ductus arteriosus may be necessary.

In the event of manifest anuria or oliguria occurring after the first or second dose, the next dose should be postponed 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 administration, an infusion pump may be used.

If necessary, the injection volume may be adjusted with 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 in preterm neonates should take into account the total daily volume of fluids administered. Typically, a maximum volume of 80 ml/kg/day should be respected on the first day of life; this volume should be gradually increased over the following 1–2 weeks (approximately 20 ml/kg of birth weight/day) up to a maximum of 180 ml/kg of birth weight/day.

Incompatibilities

Chlorhexidine must not be used to disinfect the ampoule neck, as it is incompatible with the Pedea solution. Therefore, to perform aseptic preparation of the ampoule prior to use, 60% ethanol or 70% isopropyl alcohol is recommended.

To avoid any interaction with the Pedea solution during disinfection of the ampoule neck with an antiseptic, the ampoule must be completely dry before opening.

This medicine must not be mixed with other medicinal products except with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.

To avoid any significant change in pH due to the presence of acidic medicinal products that might remain in the infusion line, the line should be flushed before and after administration of Pedea with 1.5 to 2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.