Esomeprazole 40 mg Powder for Solution for Injection/Infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Esomeprazole sodium

Disponibil de la:

Accord Healthcare Limited

Codul ATC:

A02BC; A02BC05

INN (nume internaţional):

Esomeprazole sodium

Dozare:

40 milligram(s)

Forma farmaceutică:

Powder for solution for injection/infusion

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Proton pump inhibitors; esomeprazole

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2014-11-24

Prospect

THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY
Esomeprazole Sodium Injection contains 40 mg of
esomeprazole, as a sodium salt. Each vial also
contains disodium edetate and sodium hydroxide (< 1
mmol sodium).
Vials are for single use only. If the entire reconstituted
content of the vial is not required for a single dose, any
unused solution should be discarded.
For further information on dose recommendations and
storage conditions, see sections 3 and 5, respectively.
PREPARATION AND ADMINISTRATION OF RECONSTITUTED
SOLUTION:
For the reconstitution of solution, withdraw the plastic
cap of colour at the top of the vial of Esomeprazole
Sodium Injection, and pierce the stopper in the centre
of the designed circle, by maintaining the needle
vertically, in order to be able to cross the stopper
correctly.
The reconstituted solution for injection or infusion
should be clear and colourless to very slightly yellow. It
should be inspected visually for particulate matter and
discolouration before administration and only clear
solution should be used.
The shelf life after reconstitution in terms of chemical
and physical stability has been demonstrated for 12
hours at 25°C. However, from a microbiological point
of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would
normally not be longer than 12 hours at 2-8°C, unless
reconstitution has taken place in controlled and
validated aseptic conditions.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESOMEPRAZOLE 40 MG
POWDER FOR SOLUTION FOR
INJECTION/INFUSION
Esomeprazole (as sodium salt)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
If
you
get
any
side
effects,
talk
to
your
doctor
pharmacist or nurse. This includes any possible side
effects not l

Caracteristicilor produsului

Health Products Regulatory Authority
24 June 2019
CRN008VPR
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole 40 mg Powder for Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg Esomeprazole (as sodium salt).
Excipient with known effect:
Each vial contains <1 mmol sodium.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Solution for Injection/Infusion
White to off white, porous cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole 40 mg Powder for Solution for Injection/Infusion is
indicated in adults for:
• gastric antisecretory treatment when the oral route is not
possible, such as:
- gastroesophageal reflux disease (GERD) in patients with esophagitis
and/or severe symptoms of reflux.
- healing of gastric ulcers associated with NSAID therapy.
- prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.
• prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal ulcers.
Esomeprazole 40 mg Powder for Solution for Injection/Infusion is
indicated in children and adolescents aged 1-18 years for :
• gastric antisecretory treatment when the oral route is not
possible, such as:
- gastroesophageal reflux disease (GERD) in patients with erosive
reflux esophagitis and/or severe symptoms of reflux.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
GASTRIC ANTISECRETORY TREATMENT WHEN THE ORAL ROUTE IS NOT POSSIBLE
Patients who cannot take oral medication may be treated parenterally
with 20–40 mg once daily. Patients with reflux
oesophagitis should be treated with 40 mg once daily. Patients treated
symptomatically for reflux disease should be treated
with 20 mg once daily.
For healing of gastric ulcers associated with NSAID therapy the usual
dose is 20 mg once daily. For prevention of gastric and
duodenal ulcers associated with NSAID therapy, patients at risk should
be treated with 20 mg onc