5 mg / ml solution for injection
Ibuprofen
| Read all of this leaflet carefully before your child starts taking this medicine. Save this information, you may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for your child. Do not give it to others. It may harm them, even if they show symptoms similar to your child’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 pharmacist. |
What Pedea is and what it is used for
As long as the baby remains in the womb, the baby does not need to use its lungs. An unborn baby has a blood vessel called the ductus arteriosus near the heart that allows the baby’s blood to pass past the lungs and circulate to the rest of the body.
When the baby is born and begins to use its lungs, the ductus arteriosus usually closes . However, this does not always happen. The medical term for this condition is open ductus arteriosus . This can cause heart problems in your baby. This condition is much more common in premature infants than in full-term infants.
Pedea, when given to your baby, can help close the ductus arteriosus .
The active substance in Pedea is ibuprofen . Pedea closes the ductus arteriosus by preventing the production of prostaglandin , a naturally occurring substance in the body that keeps the ductus arteriosus open.
Before Pedea is given to your child
Pedea should only be given to your child by a qualified healthcare professional in an intensive care unit for infant care.
Do not use Pedea
- If your child is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea;
- if your child has a life-threatening infection that has not been treated;
- if your baby is bleeding, especially if the bleeding is in the skull or intestines;
- if your child has a decrease in the number of blood cells called platelets ( thrombocytopenia ) or other problems with blood coagulation;
- if your child has kidney problems;
- if your child has other heart problems that require the ductus arteriosus to remain open so that adequate blood circulation is maintained;
- if your child has or is suspected of having special bowel problems (a condition called necrotizing enterocolitis).
Take special care with Pedea
- Before treatment with Pedea, the baby’s heart must be examined to confirm that the ductus arteriosus is open.
- Pedea should not be given during the first 6 hours after birth.
- If your child is suspected of having liver disease. Signs and symptoms of this include yellowing of the skin and eyes.
- If your child has an infection for which the child is being treated, the doctor will only treat your child with Pedea after careful consideration of your child’s condition.
- To avoid damage to the skin and surrounding tissue , healthcare professionals should carefully administer Pedea to the child.
- Ibuprofen may affect your baby’s blood ability to coagulate. Your child should therefore be monitored for the risk of bleeding.
- Your baby may develop some bleeding from the intestines and kidneys. To detect this, your baby’s feces and urine should be tested to determine if there is any blood present.
- Pedea can reduce the amount of urine your baby excretes. If this is significant , your child’s treatment may be stopped until the amount of urine returns to normal.
- Pedea may be less effective in very premature babies who have a gestational age of 27 weeks.
Using Pedea with other medicines:
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Some medicines, if given together with Pedea, can cause side effects. These are described below:
- your child may have problems with urinary excretion and may thus have been prescribed diuretics. Ibuprofen may reduce the effect of these medicines.
- your child may be given anticoagulants (medicines that inhibit blood clotting). Ibuprofen may increase the anticoagulant effect of this preparation.
- your child may receive nitric oxide to improve blood oxygenation. Ibuprofen may increase the risk of bleeding.
- Your child may be given cortisone to prevent inflammation . Ibuprofen may increase the risk of bleeding in the stomach and intestines.
- Your child may be given amino acids (a family of antibiotics ) to treat an infection . Ibuprofen may increase blood levels and increase the risk of side effects on the kidneys and ears.
Important information about some of the ingredients of Pedea
This medicine contains less than 1 mmol sodium (15 mg) per 2 ml, ie essentially ‘sodium-free’.
How Pedea is used
Pedea should only be given by qualified healthcare professionals to your child in an intensive care unit for infant care.
One treatment is defined as three intravenous injections of Pedea given at 24 hour intervals. The dose administered is calculated based on your child’s weight. First dose one is 10 mg / kg and second and third dose one is 5 mg / kg.
This calculated amount is given as an infusion into a vein over a 15-minute period.
If the ductus arteriosus does not close or reopens after the first treatment, your child’s doctor may decide to give you another treatment.
If the ductus arteriosus does not close after the second treatment, surgery may be suggested.
Possible side effects
Like all medicines, Pedea can cause side effects , although not everybody gets them. However, it is difficult to distinguish them from recurrent complications that occur in premature infants and complications caused by the disease.
The frequency of possible side effects listed below is defined according to the following system:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1000)
Very rare (affects less than 1 user in 10,000)
Has been reported (occurs in an unknown number of users)
Very common:
- Decreased platelet count ( thrombocytopenia ),
- Reduction of white blood cells, so-called neutrophils ( neutropenia )
- Elevated creatinine level in the blood,
- The decreased sodium level in the blood,
- Respiratory problems (bronchopulmonary dysplasia)
Usual:
- Intracranial hemorrhage ( intraventricular hemorrhage) and brain damage (periventricular leukomalacia)
- Bleeding in the lung
- Perforation of the intestine and damage to the intestinal tissue ( necrotizing enterocolitis),
- Decreased volume of excreted urine, blood in the urine, fluid retention
Uncommon:
- Acute deterioration of renal function
- Bleeding in the intestines
- The oxygen level in the arterial blood is below normal ( hypoxemia )
Has been reported:
- Holes in 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 doctor or pharmacist.
How to store Pedea
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Pedea should be used immediately after opening.
The medicine 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.
Other information
Content declaration
- The active substance is ibuprofen . Each ml contains 5 mg of ibuprofen . Each 2 ml ampoule contains 10 mg of ibuprofen .
- The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH correction ), hydrochloric acid 25% (for pH correction ) and water for injections.
What the medicine looks like and contents of the pack
Pedea 5 mg / ml solution for injection is a clear, colorless to slightly yellowish solution.
Pedea 5 mg / ml solution for injection is supplied in cartons of four 2 ml ampoules.
Marketing Authorisation Holder
Record Rare Diseases
Real Estate “Le Wilson”
70, avenue du Général de Gaulle
F- 92800 Puteaux
France
Manufacturer
Record Rare Diseases
Real Estate “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
or
Record 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 Authorization Holder.
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