ESOMEPRAZOLE MEDI MARKET 40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESOMEPRAZOLE AS SODIUM

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

A02BC05

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

ESOMEPRAZOLE AS SODIUM 40 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORIES NORMON S.A., SPAIN

Therapeutic area:

ESOMEPRAZOLE

Therapeutic indications:

Esomeprazole Medi Market for injection and infusion is indicated in adults for:• Gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate. • Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. Esomeprazole Medi Market 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:gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and/or severe symptoms of reflux.

Authorization date:

2021-07-26

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Esomeprazole Medi Market 40 mg Powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 40 mg vial contains esomeprazole sodium 42.5 mg, equivalent to
esomeprazole 40 mg.
Excipient with known effect: Sodium. Each vial contains approximately
3.28 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for injection and infusion.
White or almost white porous lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Esomeprazole Medi Market 40 mg for injection and infusion is indicated
in adult for:
•
Gastroesophageal reflux disease (GERD) in patients with esophagitis
and/or severe
symptoms of reflux as an alternative to oral therapy when oral intake
is not appropriate.
•
Prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or
duodenal ulcers.
Esomeprazole Medi Market 40 mg 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:
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 esophagitis should be treated with 40 mg
once daily. Patients
treated symptomatically for reflux disease should be treated with 20
mg once daily.
Usually the IV treatment duration is short and transfer to oral
treatment should be made as
soon as possible.
Prevention of rebleeding of gastric and duodenal ulcers.
Following therapeutic endoscopy for acute bleeding gastric or duodenal
ulcers, 80 mg should
be administered as a bolus infusion over 30 minutes, followed by a
continuous intravenous
infusion of 8 mg/h given over 3 days (72 hours).
The parenteral treatmen