Aspicor 100

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

제품 특성 요약 제품 특성 요약 (SPC)
14-02-2017

유효 성분:

acetylsalicylic acid

제공처:

Coral Laboratories Ltd.

INN (International Name):

acetylsalicylic acid

복용량:

100mg

약제 형태:

tablets gastro-resistant

처방전 유형:

OTC

제품 특성 요약

                                PRODUCT : ASPICOR 100 (Gastro-resistant Acetylsalicylic acid Tablets
BP 100 mg)
COUNTRY : REPUBLIC OF ARMENIA
THE SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT :
TRADE NAME : ASPICOR 100
DOSE
: 100 mg
DOSAGE FORM : Gastro-resistant Tablet For Oral Use.
2.
COMPLETE QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE PRODUCT
COMPOSITION :
Each gastro-resistant tablet contains :
acetylsalicylic acid 100 mg
Excipients
q.s.
Colour : Titanium Dioxide
SR.
NO.
APPROVED NAME
(INN)
LABEL
CLAIM
PER TABLET
(IN MG)
OVERAGES
QTY./TABLET
IN MG
COATING OF PURIFIED TALC
1
Stearic Acid
2.00
---
2.00
2
Purified Talc
8.00
---
8.00
3
Isopropyl Alcohol
0.4902
---
0.4902
4
Dichloromethane
0.9803
---
0.9803
LUBRICATION
5
Acetylsalicylic acid
(Directly Compressible
Granules)
100.00
---
100.00
6
Calcium Hydrogen Phosphate
23.00
---
23.00
7
Microcrystalline Cellulose
15.00
---
15.00
8
Croscarmellose Sodium
5.00
---
5.00
TOTAL
153.00
---
153.00
ENTERIC COATING
9
Cellulose Acetate Phthalate
15.30
---
15.30
10
Isopropyl Alcohol
75.00
---
75.00
11
Dichloromethane
200.00
---
200.00
12
Titanium Dioxide
1.50
---
1.50
PRODUCT : ASPICOR 100 (Gastro-resistant Acetylsalicylic acid Tablets
BP 100 mg)
COUNTRY : REPUBLIC OF ARMENIA
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastro-resistant acetylsalicylic acid Tablets BP indicated in the
following:
-Secondary prevention of myocardial infarction.
- Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris.
- History of unstable angina pectoris, except during the acute phase.
- Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG).
- Coronary angioplasty, except during the acute phase.
- Secondary prevention of transient ischaemic attacks (TIA) and
ischaemic cerebrovascular
accidents (CVA), provided intracerebral haemorrhages have been ruled
out.
Gastro-resistant Acetylsalicylic acid Tablets BP is not recommended in
emergency
situations. It is restricted to secondary prevention with chronic
treat
                                
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