Aspirin Cardio tablets gastro-resistant

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

acetylsalicylic acid

Доступно од:

Bayer Bitterfeld GmbH

АТЦ код:

B01AC06

INN (Међународно име):

acetylsalicylic acid

Дозирање:

100mg

Фармацеутски облик:

tablets gastro-resistant

Јединице у пакету:

(28/2x14/) in blister

Тип рецептора:

OTC

Статус ауторизације:

Registered

Датум одобрења:

2019-03-11

Карактеристике производа

SPC/Aspirin® Cardio100 mg_D19
16854/30828/33171
12/2019
PRESCRIBING INFORMATION
(SUMMARY OF PRODUCT CHARACTERISTICS / SPC)
1.
NAME OF DRUG PRODUCT
ASPIRIN® CARDIO100 MG
Gastro-resistant tablet
Acetylsalicylic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gastro-resistant tablet contains: 100 mg acetylsalicylic acid
(Ph.Eur.).
For the full list of excipients, see section 6.1.
3.
PRESENTATION
Gastro-resistant tablets
4.
CLINICAL DATA
4.1
INDICATIONS
-
Unstable angina pectoris – as part of the standard treatment;
-
Acute myocardial infarction – as part of the standard treatment;
-
Reinfarction prophylaxis;
-
Following operations or other interventions in arterial blood vessels
(e.g. after ACVB,
in PTCA);
-
To
prevent
transient
ischaemic
attacks
(TIA)
and
cerebral
infarction
following
manifestation of the precursor stages.
Note:
Aspirin® Cardio100 mg is not suitable for the treatment of pain due
to its amount of active
substance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_For unstable angina pectoris_
A daily dose of one Aspirin® Cardio100 mg gastro-resistant tablet
(equivalent to 100 mg
acetylsalicylic acid per day) is recommended.
_For acute myocardial infarction _
A daily dose of one Aspirin® Cardio100 mg gastro-resistant tablet
(equivalent to 100 mg
acetylsalicylic acid per day) is recommended.
SPC/Aspirin® Cardio100 mg_D19
16854/30828/33171
12/2019
2
_For reinfarction prophylaxis _
A daily dose of three Aspirin® Cardio100 mg gastro-resistant tablets
(equivalent to 300 mg
acetylsalicylic acid per day) is recommended.
_Following operations or other interventions in arterial blood vessels
(e.g. after ACVB, in _
_PTCA) _
A daily dose of one Aspirin® Cardio100 mg gastro-resistant tablet
(equivalent to 100 mg
acetylsalicylic acid per day) is recommended.
The most favourable time for starting treatment with Aspirin®
Cardio100 mg after an
aortocoronary venous bypass (ACVB) would appear to be 24 hours after
the operation.
_To _
_prevent _
_transient _
_ischaemic _
_attacks _
_(TIA) _
_and _