PEDEA ibuprofen 10 mg/2 mL solution for intravenous infusion 2 mL glass ampoule

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

ibuprofen, Quantity: 5 mg/mL

Verfügbar ab:

Recordati Rare Diseases Australia Pty Ltd

INN (Internationale Bezeichnung):

Ibuprofen

Darreichungsform:

Injection, solution

Zusammensetzung:

Excipient Ingredients: trometamol; sodium hydroxide; sodium chloride; hydrochloric acid; water for injections

Verabreichungsweg:

Intravenous Infusion

Einheiten im Paket:

Pack of 4 ampoules

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

PEDEA is indicated for the treatment of haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

Produktbesonderheiten:

Visual Identification: Colourless to slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2017-03-14

Gebrauchsinformation

Pedea AU CMI 2.0
1
PEDEA
®
_Ibuprofen 5 mg/mL solution for injection _
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
Pedea.
It does not contain all of the
available information. It does
not take the place of talking to
your baby
’s do
ctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of your baby
taking Pedea against the benefits
he/she expects it will have for
your baby.
IF YOU HAVE ANY CONCERNS
ABOUT YOUR BABY TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read this again.
WHAT PEDEA IS
USED FOR
Pedea is used in premature
babies to close the patent
ductus arteriosus.
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 a 'ductus arteriosus' near
the heart which allows the
baby's blood to bypass its lungs
and circulate to the rest of its
body.
When the baby is born and
starts using its lungs the ductus
arteriosus normally closes up.
However, in some cases this
does not happen.
The doctor has prescribed
Pedea for your baby because
your baby has a ductus
arteriosus which has not closed
properly. Pedea can help close
this blood vessel.
If the ductus arteriosus remains
open, blood intended for the
body may be returned to the
lungs, overloading the lung's
blood vessels, making the
lungs and heart work harder to
pump blood to the rest of the
body. This can lead to failure
to gain weight, shortness of
breath, a fast heart rate,
frequent chest infections, and
sometimes heart failure.
Pedea belongs to a group of
medicines called Non-Steroidal
Anti-Inflammatory Drugs
(NSAIDs). These medicines
can be used to treat swelling,
redness, pain and fever.
Pedea works by stopping the
production of prostaglandin, a
naturally occurring chemical in
the body which keeps the
ductus arteriosus open.
The reduction of these levels
by Pedea is essential for the
treatment of PDA.
ASK YOUR DOCTOR IF YOU HAVE

Fachinformation

PEDEA PI Ver 2.4
1
AUSTRALIAN PRODUCT INFORMATION - PEDEA (IBUPROFEN)
1.
NAME OF THE MEDICINE
Ibuprofen
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
PEDEA is a 5 mg/ml solution for intravenous infusion in a 2 mL vial
containing ibuprofen as
the active ingredient.
Ibuprofen is a white to almost white crystalline powder, insoluble in
water, freely soluble in
organic solvents (acetone, methanol and methylene chloride). It
dissolves in alkali hydroxides
and carbonates.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
PEDEA 5 mg/ml solution for intravenous infusion is a colourless to
slightly yellow solution.
Each ml contains 5 mg of ibuprofen. PEDEA 5 mg/ml, solution for
intravenous infusion
is
dispensed in 2 ml colourless One-Point-Cut (OPC) type I glass ampoules
and is supplied in
packs of 4 x 2 ml ampoules.
4.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PEDEA is indicated for the treatment of haemodynamically significant
patent
_ductus arteriosus _
in preterm newborn infants less than 34 weeks of gestational age.
DOSE 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.
A course of therapy is defined as three intravenous infusions of PEDEA
given at 24-hour
intervals. The first infusion should be given after the first 6 hours
of life.
The ibuprofen dose is adjusted to the body weight as follows:
•
1
st
infusion: 10mg/kg,
•
2
nd
and 3
rd
infusions: 5mg/kg.
PEDEA PI Ver 2.4
2
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 infusion 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.
ADMINISTRATION:
For intravenous use only.
Chlorhexidine should n