Esomeprazole Orifarm 10 mg Enterogranulat till oral suspension i dospåse

Страна: Швеция

Език: шведски

Източник: Läkemedelsverket (Medical Products Agency)

Активна съставка:

esomeprazolmagnesium

Предлага се от:

Orifarm Generics A/S

АТС код:

A02BC05

INN (Международно Name):

esomeprazole magnesium

дозиране:

10 mg

Лекарствена форма:

Enterogranulat till oral suspension i dospåse

Композиция:

esomeprazolmagnesium 10,353 mg Aktiv substans; glukosmonohydrat Hjälpämne; sockersfärer Hjälpämne

Вид предписание :

Receptbelagt

Каталог на резюме:

Förpacknings: Dospåse, 28 st; Dospåse, 30 st; Dospåse, 32 st; Dospåse, 35 st; Dospåse, 37 st; Dospåse, 50 st; Dospåse, 56 st

Статус Оторизация:

Godkänd

Дата Оторизация:

2021-03-17

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esomeprazole Orifarm 10 mg gastro-resistant granules for oral
suspension in sachet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains: 10 mg esomeprazole (as esomeprazole magnesium).
Excipients with known effect: Each sachet contains 4 mg sucrose and 3
g glucose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant granules for oral suspension in sachet.
A mix of light yellow and off-white to cream colored fine granules.
The oral suspension is a thick light
yellow liquid containing suspended pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Esomeprazole Orifarm is primarily indicated for:
Paediatric population
_Children 1-11 years old_
Gastroesophageal Reflux Disease (GERD)
_-_
treatment of endoscopically proven erosive reflux esophagitis
_-_
symptomatic treatment of gastroesophageal reflux disease (GERD)
_Children over 4 years of age_
In combination with antibiotics in treatment of duodenal ulcer caused
by
_Helicobacter pylori._
_Adults and adolescents from the age of 12 years_
For indications in patients from the age of 12 years reference is made
to gastro-resistant tablets
containing esomeprazole.
Esomeprazole Orifarm may also be used by patients having difficulty
swallowing dispersed gastro-
resistant tablets containing esomeprazole.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paediatric population
_Children 1–11 years with a bodyweight of ≥ 10 kg_
_Gastroesophageal Reflux Disease (GERD)_
_-_
Treatment of endoscopically proven erosive reflux esophagitis
_-_
Weight ≥10 - <20 kg: 10 mg once daily for 8 weeks.
_-_
Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks.
_-_
Symptomatic treatment of gastroesophageal reflux disease (GERD)
_-_
10 mg once daily for up to 8 weeks.
Doses over 1 mg/kg/day have not been studied.
_Children over 4 years of age_
_Treatment of duodenal ulcer caused by Helicobacter pylori_
When selecting appropriate combination therapy, consideration should