Pedea 10mg2ml solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Orphan Europe (UK

ATC code:

C01EB16

INN (International Name):

Ibuprofen

Dosage:

5mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Summary of Product characteristics

OBJECT 1
PEDEA 5 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 31-May-2018 | Orphan Europe
(UK) Limited
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 acco