BRILINTA TABLET 60 MG

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Ticagrelor

Tersedia dari:

ASTRAZENECA SINGAPORE PTE LTD

Kode ATC:

B01AC24

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

Ticagrelor 60 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

AstraZeneca AB

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2017-07-07

Karakteristik produk

1
BRILINTA
® 60MG
(TICAGRELOR)
1.
NAME OF MEDICINAL PRODUCT
BRILINTA
®
(ticagrelor), 60 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg of ticagrelor.
For excipients, see section List of excipients.
3.
PHARMACEUTICAL FORM
60 mg - Round, biconvex, pink, film-coated tablets. The tablets are
marked with “60”
above “T” on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRILINTA 60 mg is indicated for the prevention of thrombotic events
(cardiovascular
death, myocardial infarction and stroke) in patients with a history of
myocardial infarction
(MI occurred at least one year ago) and a high risk of developing a
thrombotic event.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
BRILINTA 60mg twice daily is the recommended dose when an extended
treatment is
required for patients with a history of MI of at least one year and a
high risk of an
atherothrombotic event (see section on clinical efficacy).
In patients with a history of Myocardial Infarction
(MI occurred at least one year ago) no
loading dose of BRILINTA is required and the recommended dose is 60 mg
twice daily.
Patients taking BRILINTA should also take a daily low maintenance dose
of acetylsalicylic
acid (ASA) of 75-150 mg, unless specifically contraindicated.
Patients should discontinue their current antiplatelet therapy before
initiating BRILINTA
with low dose ASA at the next scheduled dose.
Patients initiated on BRILINTA 90 mg twice daily at the time of the
acute event, after one
year, may continue treatment with 60 mg twice daily without
interruption. Treatment can
also be initiated up to two years from the spontaneous myocardial
infarction, or within one
year after stopping previous ADP receptor antagonist treatment.
2
Treatment with BRILINTA should be continued in patients with a history
of MI for as long
as the patient remains at high risk of an atherothrombotic event for a
duration up to three
years.
Efficacy
and
safety
data
are
insufficient
to
establish
whether
the
b