Pedea - patient leaflet, side effects, dosage

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);

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.

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.

• 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 Efc^rapufl Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 ^paHUHÍI Česká republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francie

Lietuva Recordati AB. Tel: + 46 8 545 80 230 Svedija Luxembourg/Lu­xemburg Recordati Tél/Tel: +32 2 46101 36 Belgique/Belgien Magyarorszag Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franciaorszag

Danmark Recordati AB. Tlf : +46 8 545 80 230 Sverige	Malta Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza
Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0	Nederland Recordati Tel: +32 2 46101 36 Belgie
Eesti Recordati AB. Tel: + 46 8 545 80 230 Rootsi	Norge Recordati AB. Tlf : +46 8 545 80 230 Sverige
ElláSa Recordati Rare Diseases Tql: +33 (0)1 47 73 64 58 Fallía	Österreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland
España Recordati Rare Diseases Spain S.L.U. Tel: + 34 91 659 28 90	Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francja
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United Kingdom

Recordati Rare Diseases UK Ltd.

Tel: +44 (0)1491 414333

This leaflet was last approved in

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

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.