Acetylsalicylsyra Aurobindo 100 mg Enterotablett

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

acetylsalicylsyra

Διαθέσιμο από:

Aurobindo Pharma (Malta) Limited

Φαρμακολογική κατηγορία (ATC):

B01AC06

INN (Διεθνής Όνομα):

acetylsalicylic acid

Δοσολογία:

100 mg

Φαρμακοτεχνική μορφή:

Enterotablett

Σύνθεση:

acetylsalicylsyra 100 mg Aktiv substans; laktosmonohydrat Hjälpämne

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

Förpacknings: Blister, 168 tabletter; Blister, 84 tabletter; Blister, 30 tabletter

Καθεστώς αδειοδότησης:

Avregistrerad

Ημερομηνία της άδειας:

2020-08-17

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Acetylsalicylsyra Aurobindo 100 mg gastro-resistant tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 100 mg acetylsalicylic acid.
Excipient(s) with known effect:
Each 100 mg gastro-resistant tablet contains 60 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
White coloured, round shaped (diameter 8 mm) and biconvex
gastro-resistant tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is restricted to secondary prevention with chronic
treatment:
-
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.
is not recommended in emergency situations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Posology
Adults
_Secondary prevention of myocardial infarction:_
The recommended dose is 100 mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 100 mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The recommended dose is 100 mg once daily.
_Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG):_
The recommended dose is 100 mg once daily.
_Coronary angioplasty, except during the acute phase:_
The recommended dose is 100 mg once daily.
_Secondary prevention of transient ischaemic attacks (TIA) and
ischaemic cerebrovascular accidents _
_(CVA), provided intracerebral haemorrhages have been ruled out:_
The recommended dose is 100 mg o