Esomeprazole 40mg Powder for Solution for Injection/Infusion

Страна: Мальта

мова: англійська

Джерело: Malta Medicines Authority

Активний інгредієнт:

ESOMEPRAZOLE

Доступна з:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Код атс:

A02BC05

ІПН (Міжнародна Ім'я):

ESOMEPRAZOLE 40 mg

Фармацевтична форма:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Склад:

ESOMEPRAZOLE 40 mg

Тип рецепту:

POM

Терапевтична области:

DRUGS FOR ACID RELATED DISORDERS

Статус Авторизація:

Withdrawn

Дата Авторизація:

2015-08-14

інформаційний буклет

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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 listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Esomeprazole Sodium Injection is and what it is used for
2. What you need to know before Esomeprazole Sodium Injection is given
to you
3. How Esomeprazole Sodium Injection is given to you
4. Possible side effects
5. How to store Esomeprazole Sodium Injection
6. Contents of the pack and other information
1. WHAT ESOMEPRAZOLE SODIUM INJECTION IS AND WHAT IT IS USED FOR
Esomeprazole Sodium Injection contains a medicine called esomeprazole.
This belongs to a group of
medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your
stomach produces.
Esomeprazole Sodium Injection is used for the short-term treatment of
certain conditions, when you
are unable to have treatment by mouth. It is used to treat the
following conditions:
Adults
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the
gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and
heartburn.
•
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole can also be used to stop stomach ulcers from forming if
you are taking NSAIDs.
•
Prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal
ulcers.
Children and adolescents aged 1-18 years
•
‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the
gullet (the tube which connects your thro

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Esomeprazole 40 mg Powder for Solution for Injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
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.
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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 once daily.
Usually the intravenous t