Indomethacin Agila

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Indometacin sodium trihydrate 1.061mg Equivalent to Indomethacin 1 mg

Disponible desde:

Viatris Limited

Designación común internacional (DCI):

Indometacin sodium trihydrate 1.061 mg (Equivalent to Indomethacin 1 mg)

Dosis:

1 mg

formulario farmacéutico:

Powder for injection

Composición:

Active: Indometacin sodium trihydrate 1.061mg Equivalent to Indomethacin 1 mg

tipo de receta:

Prescription

Fabricado por:

Sequent Scientific Limited

indicaciones terapéuticas:

Indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. Clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. Indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, 2 mL USP Type l tubular flint vial, rubber stopper, 3 vials/carton - 3 dose units - 18 months from date of manufacture stored at or below 25°C protect from light and moisture

Fecha de autorización:

2014-05-26

Información para el usuario

Page 1 of 2
NEW ZEALAND CONSUMER MEDICINE INFORMATION
INDOMETHACIN AGILA
_INDOMETHACIN SODIUM TRIHYDRATE POWDER FOR INJECTION 1 MG _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Indomethacin
Agila.
It does not contain all the available
information. It does not take the
place of talking to your baby’s
doctor.
All medicines have risks and
benefits. Your baby’s doctor has
weighed the risks of using
Indomethacin Agila against the
benefits they expect it will have for
your baby.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, TALK TO YOUR BABY’S
DOCTOR.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT INDOMETHACIN
AGILA IS USED FOR
Indomethacin Agila contains the
active ingredient indomethacin
sodium trihydrate.
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 the lungs
and circulate to the rest of the body.
When the baby is born and starts
using his/her lungs, the ductus
arteriosus spontaneously closes up.
However, in some cases this does
not happen. The medical term for
this condition is 'patent ductus
arteriosus', i.e. an open ductus
arteriosus. If the ductus arteriosus is
not closed it can cause problems for
your baby. Indomethacin Agila,
when given to your baby, can help
to close the ductus arteriosus.
It is not known exactly how
indomethacin works, but it is
believed that it closes a ductus
arteriosus by inhibiting the
production of prostaglandin, a
naturally occurring chemical in the
body which keeps the ductus
arteriosus open.
This medicine is used only in a
hospital under the supervision of a
specialist neonatologist.
BEFORE BEING GIVEN
INDOMETHACIN AGILA
_WHEN IT MUST NOT BE _
_USED _
INDOMETHACIN AGILA SHOULD NOT BE
GIVEN TO BABIES IF:

they have a suspected or
established untreated
infection

they are bleeding,
especially if the bleeding is
inside the skull or the
intestines

they have other heart
problems which req

Ficha técnica

Page 1 of 18
NEW ZEALAND DATA SHEET
INDOMETHACIN AGILA
_INDOMETHACIN SODIUM TRIHYDRATE POWDER FOR INJECTION 1 MG _
_ _
DESCRIPTION
Indomethacin Agila (indomethacin sodium trihydrate (also known as
indometacin sodium trihydrate)) for
intravenous administration is lyophilised indomethacin sodium
trihydrate.
Indomethacin sodium trihydrate is designated chemically as
1_H_-Indole-3-acetic acid, 1-(4-chlorobenzoyl)-5-
methoxy-2-methyl-, sodium salt, trihydrate.
Its molecular weight is 433.82 g/mol.
Its molecular formula is C
19
H
15
ClNNaO
4
.3H
2
O and
Its structural formula is:
CAS Number:
74252-25-8
Each vial contains indomethacin sodium trihydrate equivalent to 1 mg
indomethacin as a sterile white to yellow
lyophilised powder or plug. Variations in the size of the lyophilised
plug and the intensity of colour have no
relationship to the quality or amount of indomethacin present in the
vial.
pKa value for Indomethacin is 4.5.
Indomethacin Agila contains no other excipients.
PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory agent which inhibits
prostaglandin synthesis. Although the
exact mechanism of action through which indomethacin causes closure of
a patent ductus arteriosus is not
known, it is believed to be through inhibition of prostaglandin
synthesis. Indomethacin has been shown to be
a potent inhibitor of prostaglandin synthesis, both _ in vitro_ and _
in vivo._ In human newborns with certain
congenital heart malformations, PGE 1 dilates the ductus arteriosus.
In fetal and newborn lambs, E type
prostaglandins have also been shown to maintain the patency of the
ductus, and as in human newborns,
indomethacin causes its constriction.
Studies in premature infants with patent ductus arteriosus indicated
that, after the first dose of intravenous
indomethacin, there was a transient reduction in cerebral blood flow
velocity and cerebral blood flow. Similar
decreases in mesenteric blood flow and velocity have been observed.
The clinical significance of these effects
has not been established.
Page 2 of 18
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