Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Ibuprofen
Recordati Rare Diseases
C01EB16
ibuprofen
Cardiac therapy
Ductus Arteriosus, Patent
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Revision: 15
Authorised
2004-07-28
16 B. PACKAGE LEAFLET 17 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 ing Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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: - 1 st injection: 10 mg/kg, - 2 nd and 3 rd 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. 3 4.3 CONTRAINDICATIONS - Hy Pročitajte cijeli dokument