Pedea

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Ibuprofen

Available from:

Recordati Rare Diseases

ATC code:

C01EB16

INN (International Name):

ibuprofen

Therapeutic group:

Cardiac therapy

Therapeutic area:

Ductus Arteriosus, Patent

Therapeutic indications:

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

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2004-07-28

Patient Information leaflet

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

Summary of Product characteristics

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