Finished Products
페데아 주
Pedea® Inj.
Classification
Agent for Patent Ductus Arteriosus (PDA)

Indication/Usage 

 

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. 

 

 

Dosage/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:
- 1st injection: 10 mg/kg,
- 2nd and 3rd 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

 

 

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