Ticagrelor Sandoz

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Ticagrelor 90mg

Tilgængelig fra:

Sandoz New Zealand Limited

Dosering:

90 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Ticagrelor 90mg Excipient: Calcium hydrogen phosphate dihydrate Maize starch Mannitol Opadry yellow 88A220017 Purified talc Purified water Sodium stearyl fumarate Starch

Recept type:

Prescription

Terapeutiske indikationer:

Co-administered with acetylsalicylic acid (aspirin), this product 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.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, Aluminium-OPA/Alu/PVC or Aluminium/PVC/PE/PVDC in outer carton - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2019-11-27

Indlægsseddel

TICAGRELOR SANDOZ
®
1
TICAGRELOR
SANDOZ
®
_ticagrelor tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Ticagrelor
Sandoz. It does not contain all the
available information that is known
about Ticagrelor Sandoz.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ticagrelor
Sandoz 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 TICAGRELOR
SANDOZ IS USED FOR
Ticagrelor Sandoz in combination
with aspirin is to be used in adults
only. You have been given
Ticagrelor Sandoz because you have
had:
•
a heart attack, or
•
unstable angina (angina or chest
pain that is not well controlled)
Ticagrelor Sandoz reduces the
chances of having another heart
attack or of dying from a disease
related to your heart or blood vessels.
HOW TICAGRELOR
SANDOZ WORKS
Ticagrelor Sandoz contains a
medicine called ticagrelor. This
belongs to a group of medicines
called anti-platelet medicines.
Platelets (also called thrombocytes)
are very small cells in your blood
that help to stop bleeding. When a
blood vessel is damaged, they clump
together to help form a blood clot.
This stops bleeding.
However, clots can also form inside a
damaged blood vessel. This can be
very dangerous because:
•
the clot can cut off the blood
supply completely – this can
cause a heart attack (myocardial
infarction) or stroke
•
the clot can partly block the blood
vessels to the heart – this reduces
the blood flow to the heart. This
can cause chest pain which comes
and goes (called ‘unstable
angina’)
Ticagrelor Sandoz helps stop the
clumping of platelets. This reduces
the chance of a blood clot forming
that can block a blood vessel. This
means that Ticagrelor Sandoz
reduces the chance of you having
another heart attack, che

Produktets egenskaber

231031-ticagrelor sandoz-ds-v1.0
Page 1 of 29
NEW ZEALAND DATA SHEET
TICAGRELOR SANDOZ
® (TICAGRELOR)
1.
PRODUCT NAME
Ticagrelor Sandoz
®
60 mg film-coated tablets
Ticagrelor Sandoz
®
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” on one side and plain on
the other.
90 mg - Round, biconvex, yellow, film coated tablets, marked with
‘90’ on one side and plain
on the other.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Ticagrelor Sandoz, 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.
D
OSE AND METHOD OF ADMINISTRATION
ACUTE CORONARY SYNDROMES
In patients with Acute Coronary Syndromes [ACS], ticagrelor 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 ticagrelor 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.
Patients taking ticagrelor should also take a daily low maintenance
dose of aspirin of 75 -150
mg, unless specifically contraindicated. An