Pedea 5 mg Solution

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.

PEDEA should not be administered to your baby:

• if they are hypersensitive (allergic) to ibuprofen or to any of the other ingredients of PEDEA (listed in section 6)
• if they have a life-threatening infection which has not been treated
• if they are bleeding, especially if the bleeding is inside the skull or in the intestines
• if they have decreased blood cells called platelets (thrombocytopenia) or other problems with their blood clotting
• if they have kidney problems
• if they have other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained
• if they have certain problems with their intestines (a condition called necrotising enterocolitis)

Warnings and precautions

Before PEDEA is given to your baby, 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.

PEDEA should not be used prophylactically.

PEDEA may cause problems with your baby’s respiratory system. If the blood oxygen levels of your baby decreases after receiving PEDEA, the healthcare professional will monitor the blood pressure in your baby’s lungs.

PEDEA will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professionals. 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 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.

The calculated amount will be given by infusion in a vein over a period of 15 minutes.

If 48 hours after this first course of treatment, the ductus arteriosus is not closed, or it reopens, your baby’s doctor may decide to give a second course of treatment. If the condition is unchanged after the second course of therapy, surgery may be necessary.

If your baby receive more PEDEA than they should

Since a healthcare provider will administer PEDEA, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If your baby is administered more PEDEA than they should, speak to your baby’s doctor about the risks and any actions that need to be taken. The symptoms of overdose can include drowsiness, loss of consciousness, coma, convulsions, gastrointestinal problems, slow heart rate, low blood pressure, breathing problems or stopped breathing, blood in the urine, inability of kidneys to work properly, excess acid in the blood, and low levels of potassium in the blood.

PEDEA may cause side effects. Not all side effects reported for PEDEA are included in this leaflet. Should the general health of your baby worsen of if your baby experience any untoward effects while receiving PEDEA, please consult your baby’s healthcare provider for advice.

The following side effects have been reported with PEDEA:

Frequent side effects:

• 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)
• bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia)
• bleeding in the lungs (pulmonary haemorrhage)
• perforation or bleeding of the intestine which could be fatal, injury of the intestinal tissue (necrotising enterocolitis), stomach ulcers, nausea, vomiting, diarrhoea, wind (flatulence), constipation, indigestion (dyspepsia), abdominal pain, tarry black stools due to intestinal bleeding (melena), vomiting blood (hematemesis), sore in the mouth (ulcerative stomatitis), exacerbation of inflammation of the bowel (colitis and Crohn’s disease), inflammation of the stomach (gastritis)
• reduced volume of urine passed (oliguria), blood in urine (haematuria), fluid retention
• increase in blood pressure in the lungs

Less frequent side effects:

• acute failure of the kidney’s functions
• below normal oxygen content in arterial blood (hypoxaemia)

Frequency unknown:

• high blood pressure (hypertension), heart failure
• perforation of the stomach
• a red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, upper extremities, and mucous membranes accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis); treatment with PEDEA should be stopped if your baby develops these symptoms, seek medical attention immediately (see also section 2)

If you notice any side effects not mentioned in this leaflet, please inform your baby’s doctor or your pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the MedSafety APP (Medsafety SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PEDEA.

Store all medicines out of reach of children.

Store at or below 25 °C.

Do not use after the expiry date stated on the label or carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).