Apo-Esomeprazole 20mg tablets delayed-release

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

esomeprazole (esomeprazole magnesium)

متاح من:

Apotex Inc.

ATC رمز:

A02BC05

INN (الاسم الدولي):

esomeprazole (esomeprazole magnesium)

جرعة:

20mg

الشكل الصيدلاني:

tablets delayed-release

الوحدات في الحزمة:

(30/3x10/) blisters

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2015-06-09

خصائص المنتج

APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 1 of 22
1. NAME OF THE MEDICINAL PRODUCT
Apo-Esomeprazole Tablets 20 mg and 40 mg
(Esomeprazole Magnesium Delayed Release Tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT
FUNCTION
% W/W
MG/TABLET
% W/W
MG/TABLET
20 MG
40 MG CORE
Esomeprazole Magnesium IH
#
Active
10.35
20.7
10.35
41.4
Copovidone (Kollidon VA64)
##
Binder
87.8
175.6
87.8
351.2
Colloidal Silicon Dioxide NF
Glidant/Anti-
Adherent
0.25
0.5
0.25
1.0
Magnesium Stearate NF
(Vegetable Source)
Lubricant
1.6
3.2
1.6
6.4
TOTAL CORE WEIGHT
100
200
100
400
COATING
Triethyl Citrate NF (Citroflex 2)
Plasticizer
0.70
0.75
0.70
0.9
Talc 500 mesh USP
Glidant / Anti-
caking Agent
1.64
1.75
1.64
2.1
Titanium Dioxide USP
Pigment/
Opacifier
3.72
3.96
3.67
4.7
Red-Ferric Oxide NF
(Orange Shade #34690)
Colouring
Agent
0.03
0.03
0.20
0.25
Yellow Ferric Oxide NF
Colouring
Agent
0.01
0.01
0.04
0.05
Methacrylic Acid Copolymer
NF Dispersion (30% Solids)
Polymer
23.47
25(**7.5)
23.44
30(**9.0)
Purified Water USP *
Solvent /
Carrier
70.42
75.0
70.31
90.0
TOTAL COATING SOLUTION
100
14
100
17
TOTAL TABLET WEIGHT
--
214
--
417
#
20.7 mg and 41.4 mg Esomeprazole Magnesium is equivalent to 20 mg and
40 mg Esomeprazole
respectively.
##
The amount of Copovidone added is adjusted based on the potency of
Esomeprazole Magnesium.
* Purified water evaporates during the coating procedure.
** Methacrylic Acid Copolymer Dispersion NF contains 30% solids. The
amounts in the brackets
represent the solid content of Methacrylic Acid Copolymer Dispersion
NF.
3. PHARMACEUTICAL FORM
Delayed-Release Tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
APO-ESOMEPRAZOLE
(esomeprazole
magnesium)
is
indicated
for
treatment
of
conditions where a reduction in gastric acid secretion is required
such as:
APPENDIX 1.9
THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
_ _
Page 2 of 22

reflux esophagitis

maintenance treatment of patients with reflux esophagitis

nonerosive reflux disease (NERD) (i.e.