Brilinta

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Ticagrelor 90mg;  ;  ;  

Tersedia dari:

AstraZeneca Limited

INN (Nama Internasional):

Ticagrelor 90 mg

Dosis:

90 mg

Bentuk farmasi:

Film coated tablet

Komposisi:

Active: Ticagrelor 90mg       Excipient: Calcium hydrogen phosphate Hyprolose Hypromellose Iron oxide yellow Macrogol 400 Magnesium stearate Mannitol Purified talc Purified water   Sodium starch glycolate Titanium dioxide

Unit dalam paket:

Blister pack, PVC/PVDC/Al sample blister sheet, 14 tablets

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Ajinomoto OmniChem SA

Indikasi Terapi:

BRILINTA, co-administered with acetylsalicylic acid (aspirin), is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) · in patients with Acute Coronary Syndromes (unstable angina [UA], non ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). · in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al sample blister sheet - 14 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-PVDC/AL blister sheet - 56 tablets - 36 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

2011-03-24

Selebaran informasi

Brilinta
®
CMI 080621
Copyright
1(6)
BRILINTA
®
TICAGRELOR 60 MG OR 90 MG FILM COATED TABLETS.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
BRILINTA. It does not contain all
the information that is known about BRILINTA.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking BRILINTA
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT BRILINTA IS USED FOR
BRILINTA in combination with aspirin is to be used in adults only. You
have been given BRILINTA because
you have had:

a heart attack, or

unstable angina (angina or chest pain that is not well controlled)
BRILINTA reduces the chances of having another heart attack or of
dying from a disease related to your
heart or blood vessels.
HOW BRILINTA WORKS
BRILINTA contains the active substance called ticagrelor.
This belongs to a group of medicines called
anti-platelet medicines.
BRILINTA affects cells called ‘platelets’ (also called
thrombocytes).
These very small blood cells help
stop bleeding by clumping together to plug tiny holes in blood vessels
that are cut or damaged.
However, platelets can also form clots inside diseased blood vessels
in the heart and brain. This can
be very dangerous because:

the clot can cut off the blood supply completely -
this can cause a heart attack (myocardial
infarction), or

the clot can partly block the blood vessels to the heart - this
reduces the blood flow to the heart
and can cause chest pain which comes and goes (called ‘unstable
angina’)
BRILINTA helps stop the clumping of platelets. This reduces the chance
of a blood clot forming that can
reduce blood flow.
This medicine is only available with a doctor’s prescription.
BEFORE YOU USE BRILINTA
_WHEN YOU MUST NOT USE I

Karakteristik produk

B
RILINTA
Data Sheet 160622
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
B
RILINTA
®
60 mg film-coated tablets
B
RILINTA
®
90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
60 mg: each tablet contains 60 mg ticagrelor.
90 mg: each tablet contains 90 mg ticagrelor.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
60 mg - Round, biconvex, pink, film coated tablets, marked with
“60” above “T” on one side
and plain on the other.
90 mg - Round, biconvex, yellow, film coated tablets, marked with
‘90’ above ‘T’ on one side
and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
B
RILINTA
, co-administered with acetylsalicylic acid (aspirin), is indicated
for the prevention of
atherothrombotic events (cardiovascular death, myocardial infarction
and stroke)

in patients with Acute Coronary Syndromes (unstable angina [UA], non
ST elevation
Myocardial
Infarction
[NSTEMI]
or
ST
elevation
Myocardial
Infarction
[STEMI]);
including patients managed medically, and those who are managed with
percutaneous
coronary
intervention
(PCI)
or
coronary
artery
by-pass
grafting
(CABG).

in patients with a history of myocardial infarction (MI occurred at
least one year ago)
and a high risk of developing an atherothrombotic event.
For further information, please refer to section 5.1.
4.2
DOSE AND METHOD OF ADMINISTRATION
ACUTE CORONARY SYNDROMES
In patients with Acute Coronary Syndromes, B
RILINTA
treatment should be initiated with a
single 180 mg loading dose (two tablets of 90 mg) and then continued
at 90 mg twice daily.
Treatment is recommended for at least 12 months unless discontinuation
of B
RILINTA
is
clinically indicated (see section 5.1).
After one year, patients initiated on 90 mg twice daily
may continue treatment with 60 mg twice daily without interruption.
B
RILINTA
Data Sheet 160622
Copyright
2
Patients taking B
RILINTA
should also take a daily low maintenance dose of aspirin of 75 -150
mg, unless specifically contraindicated. An initial