PEDEA 5 mg /Ml Injectable Solution

Зміст інструкції

1. Pedea 5 mg/ml injectable solution
   1. WHAT IS PEDEA AND WHAT IS IT USED FOR
   2. BEFORE PEDEA IS GIVEN TO YOUR CHILD
   3. HOW TO USE PEDEA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PEDEA
   6. OTHER INFORMATION

Pedea 5 mg/ml injectable solution

Ibuprofen

Read this leaflet carefully before the medicine is administered to your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as those of your child.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

• 1. What Pedea is and what it is used for
• 2. Before Pedea is administered to your child
• 3. How to use Pedea
• 4. Possible side effects
• 5. How to store Pedea
• 6. Further information

1. WHAT IS PEDEA AND WHAT IS IT USED FOR

When in the mother's womb, the fetus does not need to use its lungs. The fetus has a blood
vessel near the heart called the ductus arteriosus, which allows blood to bypass pulmonary
circulation and circulate throughout the rest of the body.
At birth, the newborn begins to use its lungs and, as a rule, the ductus arteriosus closes. In some cases,
however, this does not happen. The medical term for this condition is “patent ductus arteriosus”, that is, an
open ductus arteriosus. This condition, which can cause heart problems in the baby, is much
more common in premature infants than in full-term infants.
Pedea, administered to your baby, can facilitate the closure of the ductus arteriosus.
The active ingredient contained in Pedea is ibuprofen. Pedea closes the ductus arteriosus by inhibiting
the production of prostaglandin, a chemical substance naturally produced by the body that
keeps the ductus arteriosus open.

2. BEFORE PEDEA IS GIVEN TO YOUR CHILD

Pedea will be administered to your child exclusively by a qualified healthcare professional in a
specialized neonatal intensive care unit.

Do not use Pedea

• if your child is allergic (hypersensitive) to ibuprofen or any of the excipients of Pedea;
• if your child has a life-threatening infection that has not been treated;
• if your child has ongoing bleeding, particularly intracranial (inside the skull) and intestinal bleeding;
• if your child has a reduced number of blood cells called platelets (thrombocytopenia) or other blood clotting problems;
• if your child has kidney problems;
• if your child has other heart problems in which the ductus arteriosus must remain open to maintain adequate blood circulation;
• if your child has or is suspected to have certain intestinal problems (a disease called necrotizing enterocolitis).

Take particular care with Pedea

• Before treatment with Pedea, your child will undergo a heart examination to ensure that the ductus arteriosus is open.
• Pedea should not be administered within the first 6 hours of life.
• If you suspect that your child has a liver disease, whose signs and symptoms include yellowish discoloration of the skin and eyes.
• If your child has an infection for which they are being treated, the doctor will administer Pedea only after carefully assessing the child's condition.
• Pedea must be administered with caution by the healthcare professional to avoid damage to the skin and surrounding tissues.
• Since ibuprofen can reduce the ability of blood to clot, the child should be monitored for any signs of prolonged bleeding.
• Intestinal and kidney bleeding may occur in the child; for this reason, tests on stool and urine may be carried out to determine the possible presence of blood.
• Pedea may reduce the amount of urine eliminated by the child. If this occurs to a significant extent, the child's treatment may be interrupted until the urine volume returns to normal.
• The effectiveness of Pedea may be lower in very premature infants with a gestational age of less than 27 weeks.
• Serious skin reactions have been reported in association with treatment with Pedea. Stop taking Pedea and consult your doctor immediately if rash, mucosal lesions, blisters or other signs of allergy occur, as they may be the first signs of a very serious skin reaction. See section 4.

Use of Pedea with other medicines
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those without a prescription.
Some medicines, if administered together with Pedea, may cause undesirable effects. These are
described below:

• the child may have problems with urination, for which diuretics have been prescribed. Ibuprofen may reduce the effect of these medicines;
• anticoagulants (medicines that prevent blood clotting) may be given to the child. Ibuprofen may increase the anticoagulant effect of these products;
• nitric oxide may be given to the child to improve blood oxygenation. Ibuprofen may increase the risk of bleeding;

corticosteroids may be given to the child to prevent inflammation.
Ibuprofen may increase the risk of blood loss in the stomach and intestines.

• aminoglycosides (a family of antibiotics) may be given to your child to treat infections. Ibuprofen may increase their concentration in the blood and thus increase the risk of toxicity to the kidneys and ear.

Important information about some excipients of Pedea
This medicine contains less than 1 mmol of sodium (15 mg) per 2 ml; this means that it is
essentially sodium-free.

3. HOW TO USE PEDEA

Pedea must be administered to newborns exclusively by a qualified healthcare professional in a
specialized neonatal intensive care unit.
A therapeutic cycle is defined as three intravenous doses of Pedea administered at intervals of 24
hours. The dose to be administered will be calculated based on the newborn's weight. It is 10 mg/kg for the first
administration and 5 mg/kg for the second and third.
This calculated amount will be administered by infusion into a vein over 15 minutes.
If, after this first cycle of treatment, the ductus arteriosus does not close or reopens, the doctor may
decide to administer a second cycle of treatment to the newborn.
If after the second cycle of treatment the ductus arteriosus is still not closed, surgery may 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 the frequent complications that occur in
premature infants and from complications induced by the disease.
The frequency of the possible side effects listed below is defined using the following
convention:
very common (affects more than 1 in 10 users)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
very rare (affects less than 1 in 10,000 users)
not known (frequency cannot be estimated based on available data)
Very common:

• Reduction in the number of platelets in the blood (thrombocytopenia),
• Reduction in white blood cells called neutrophils (neutropenia),
• Increased level of creatinine in the blood,
• Reduction in the level of sodium in the blood,
• Breathing problems (bronchopulmonary dysplasia)

Common:

• Bleeding inside the skull (intraventricular hemorrhage) and brain injury (periventricular leukomalacia),
• Pulmonary hemorrhage,
• Intestinal perforation and damage to the intestinal tissue (necrotizing enterocolitis),
• Reduced urine volume, blood in the urine, fluid retention

Uncommon:

• Acute kidney failure
• Intestinal bleeding
• Oxygen content in arterial blood below normal (hypoxemia)

Not known:

• Perforation of the stomach
• A widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Pedea if you develop these symptoms and contact your doctor immediately. See also section 2.

If any of these side effects get worse, or if you notice any side effects not listed in this

5. HOW TO STORE PEDEA

Keep out of the reach and sight of children
Do not use Pedea after the expiry date which is stated on the package and on the label after Exp. The date
of expiry refers to the last day of the month.
This medicine does not require any particular storage conditions.
After opening, Pedea must be administered immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment .

6. OTHER INFORMATION

What Pedea contains

• The active ingredient is ibuprofen. Each ml contains 5 mg of ibuprofen. Each vial of 2 ml contains 10 mg of ibuprofen.
• The excipients are: trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.

Description of the appearance of Pedea and contents of the pack
Pedea 5 mg/ml injectable solution is a clear solution, from colourless to slightly yellow.
Pedea 5 mg/ml injectable solution is available in packs of four vials of 2 ml.

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 further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

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Recordati
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Recordati Rare Diseases
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Recordati Rare Diseases
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Recordati AB.
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Recordati Rare Diseases
Tel: +33 1 47 73 64 58
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Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0

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Recordati
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Recordati Rare Diseases Spain S.L.U.
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Recordati Rare Diseases
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Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173

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Recordati AB.
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United Kingdom (Northern Ireland)
Recordati Rare Diseases UK Ltd.
Tel: +44 (0)1491 414333
More detailed information on this medicinal product is available on the website of the European
Medicines Agency (EMA): http://www.emea.europa.eu/.
The following information is intended exclusively for physicians or healthcare professionals:
As with all parenteral products, visually inspect the vials of Pedea before use,
to exclude the presence of particulate matter and to verify the integrity of the container. The vials
are for single use only; discard any unused residual solution.

Dosage and 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 therapeutic cycle is defined as three doses of Pedea to be administered intravenously at
intervals of 24 hours.
Determine the dose of ibuprofen 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 in
case of re-opening of the same, a second cycle of 3 doses can be administered, as illustrated in
the preceding text.
If no changes are observed even after the second cycle of therapy, surgical closure of the patent
ductus arteriosus may be necessary.
In case of manifest anuria or oliguria after the first or second dose, the
third dose should not be administered until urine volume has returned to normal.
Method of administration:
Pedea must be administered by short infusion lasting 15 minutes, preferably
undiluted. An infusion pump can be used to facilitate administration.
If necessary, adjust the injection volume with a solution for injection of sodium chloride
9 mg/ml (0.9%) or glucose 50 mg/ml (5%). Discard any unused residual solution.
In premature infants, the total volume of solution injected must take into account the total
daily volume of fluids administered. A maximum volume of 80 ml/kg/day should generally be
administered on the first day of life; this volume should then be gradually increased
over the following 1-2 weeks (approximately 20 ml/kg of birth weight/day) up to a maximum volume of
180 ml/kg of birth weight/day.

Incompatibilities
Chlorhexidine is incompatible with the Pedea solution and therefore should not be used
to disinfect the vial. A solution of 60% ethanol or 70% isopropyl alcohol is therefore recommended for
asepsis of the vial before use.
When disinfecting the vial with an antiseptic, the vial must be completely dry before
being opened to avoid any contact with the Pedea solution.
This medicinal product must not be mixed with other products except for the solution for injection
of sodium chloride 9 mg/ml (0.9%) or glucose solution 50 mg/ml (5%).
To avoid significant changes in pH due to the presence of acidic medicines that may remain
in the infusion line, flush the line before and after the administration of Pedea with 1.5 - 2 ml
of solution for injection of sodium chloride 9 mg/ml (0.9%) or glucose solution 50 mg/ml (5%).