Esomeprazol Actavis Pdr for Soln Inj/Inf 40mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ESOMEPRAZOLE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

A02BC05

INN (International Name):

ESOMEPRAZOLE 40 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

ESOMEPRAZOLE 40 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2016-06-16

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESOMEPRAZOL ACTAVIS 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
esomeprazole
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 Esomeprazol Actavis is and what it is used for
2.
What you need to know before Esomeprazol Actavis is given to you
3.
How Esomeprazol Actavis is given to you
4.
Possible side effects
5.
How to store Esomeprazol Actavis
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOL ACTAVIS IS AND WHAT IT IS USED FOR
Esomeprazol Actavis 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.
Esomeprazol Actavis 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
-
‘Gastro-oesophageal reflux disease’ (GORD). 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).
Esomeprazol Actavis 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
-
‘Gastro-oesophageal reflux disease’ (GORD). 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.
2.
WHAT YOU

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Esomeprazol Actavis 40 mg powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg
of esomeprazole.
Excipient with known effect:
This medicinal product contains less than1 mmol sodium (23mg) per
vial, i.e. essentially sodium
free.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion (powder for
injection/infusion)
White to off-white porous powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esomeprazol Actavis for injection and infusion is indicated in adults
for:
-
Gastric antisecretory treatment when the oral route is not possible,
such as:
-
gastro-oesophageal reflux disease (GORD) in patients with oesophagitis
and/or severe
symptoms of reflux.
-
healing of gastric ulcers associate 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.
Esomeprazol Actavis
for injection and infusion is indicated in children and adolescents
aged 1–18
years for:
-
Gastric antisecretory treatment when the oral route is not possible,
such as:
-
gastro-oesophageal reflux disease (GORD) in patients with erosive
reflux oesophagitis
and/or severe symptoms of reflux.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
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
therap