Omeprazole-Asteria Cap. 20mg 20mg capsules

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

omeprazole

Dostępny od:

Hankook Korus Pharm Co.

Kod ATC:

A02BC01

INN (International Nazwa):

omeprazole

Dawkowanie:

20mg

Forma farmaceutyczna:

capsules

Sztuk w opakowaniu:

(30/3x10/) and (100/10x10/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2017-06-05

Charakterystyka produktu

_Summary of Product Characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipient(s)
3.
PHARMACEUTICAL FORM
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
4.2
Posology and method of administration
4.3
Contraindications
4.4
Special warnings and precautions
4.5
Interaction with other medicinal products and other forms of
interaction.
4.6
Fertility, pregnancy and lactation
4.7
Effects on ability to drive and use machines
4.8
Undesirable effects
5.
PHARMACOLOGICAL PROPERIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group:, ATC code:
5.2
Pharmacokinetic properties.
5.3
Preclinical safety data
6.
PHARMACEUTICAL PARTICULARS
6.1
Excipients
6.2
Incompatibilities
6.3
Shelf life
6.4
Special precautions for storage
6.5
Nature and contents of container
6.6
Special precautions for disposal and other handing
7.
Marketing authorisation holder
8.
Marketing authorisation number(s)
9.
Date of first authorisation/renewal of the authorisation
10.
Date of revision of the text
_Summary of Product Characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
Omeprazole-Asteria Cap. 20mg
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Quantity/ Cap.
Use
1
Omerpazole
20mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/ Cap.
Use
1
Sucrose
161.63mg
Inactive
2
Anhydrous Lactose
8mg
Inactive
3
Hypromellose
9.08mg
Inactive
4
Hydoxypropyl Cellulose
6mg
Inactive
5
Sodium Lauryl Sulfate
0.5mg
Inactive
6
Sodium Phosphate
0.8mg
Inactive
(dehydrate)
7
Hypromellose Phthalate
26.83mg
Inactive
8
Diethyl Phthalate
0.16mg
Inactive
9
Acetone
-
Inactive
10
Ethanol
-
Inactive
3. PHARMACEUTICAL FORM
Hard capsule
_Summary of Product Characteristics_
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Duodenal Ulcer (adults) : Omeprazole capsule is indicated for
short-term treatment of active
duodenal ulcer in adults. Most patients heal within four weeks. Some
patients may require an
additional four weeks of therapy.
Omeprazole capsule in combination with clarithromycin and