BRILINTA ticagrelor 90 mg tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

ticagrelor, Quantity: 90 mg

থেকে পাওয়া:

AstraZeneca Pty Ltd

INN (আন্তর্জাতিক নাম):

Ticagrelor

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

Excipient Ingredients: hyprolose; purified talc; iron oxide yellow; macrogol 400; hypromellose; mannitol; calcium hydrogen phosphate dihydrate; titanium dioxide; magnesium stearate; sodium starch glycollate type A

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

14 tablets (sample), 56 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

BRILINTA, in combination with aspirin, is indicated for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction and stroke) in adult 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).

পণ্য সারাংশ:

Visual Identification: Round, biconvex, yellow, film-coated tablets with diameter of 9 mm. Tablets are marked with '90' directly above 'T' on one side and plain on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

2011-06-21

তথ্য লিফলেট

BRILINTA
®
_Ticagrelor 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
You have been given BRILINTA
because you have had:
•
a heart attack, or
•
unstable angina (angina or chest
pain that is not well controlled).
HOW BRILINTA WORKS
BRILINTA contains a medicine
called ticagrelor. This belongs to a
group of medicines called anti-
platelet medicines.
Platelets 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')
BRILINTA helps stop the clumping
of platelets. This reduces the chance
of a blood clot forming that can
block a blood vessel. This means that
BRILINTA reduces the chance of
you having another heart attack,
chest pain or stroke.
Your doctor will usually also tell you
to take acetylsalicylic acid (aspirin).
This is another medicine, which
affects platelets.
Your doctor will have explained why
you are being treated with
BRILINTA and told you what dose
to take.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information

পণ্য বৈশিষ্ট্য

BRILINTA Product Information
Doc ID-001619899 V15.0
1(35)
AUSTRALIA PRODUCT INFORMATION
BRILINTA
® (TICAGRELOR)
1.
NAME OF THE MEDICINE
Ticagrelor.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ticagrelor is a white or off-white to pale pink crystalline powder.
The log P
(octanol/water) has been measured to >4.0 at pH 7.4. The molecule has
no pKa
values within physiological range and does not demonstrate pH
dependent
solubility. It is non-hygroscopic, exhibiting no significant increase
in water content
after exposure at 40°C/75% RH.
Each tablet contains 90 mg of ticagrelor. The film-coated tablets
include the
following excipients - mannitol, calcium hydrogen phosphate dihydrate,
sodium
starch glycollate, hyprolose, magnesium stearate, hypromellose,
titanium dioxide,
purified talc, macrogol 400, iron oxide yellow. The orodispersible
tablets include
the following excipients - mannitol, microcrystalline cellulose,
crospovidone, xylitol,
calcium hydrogen phosphate, sodium stearylfumarate, hyprolose,
colloidal
anhydrous silica. BRILINTA does not contain gluten.
3.
PHARMACEUTICAL FORM
BRILINTA FILM-COATED TABLETS
Round, biconvex, yellow, film-coated tablets. The tablets are marked
with “90”
above “T” on one side and plain on the other.
BRILINTA ORODISPERSIBLE TABLETS
Round, flat, bevelled edged, white to pale pink, orodispersible
tablets. The tablets
are marked with “90” above “TI” on one side and plain on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRILINTA, in combination with aspirin, is indicated for the prevention
of
atherothrombotic events (cardiovascular death, myocardial infarction
and stroke)
in adult 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).
BRILINTA Product Information
Doc ID-001619899 V15.0
2(35)
4.2
DOSE AND