XARELTO 2.5 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

RIVAROXABAN

Inapatikana kutoka:

BAYER ISRAEL LTD

ATC kanuni:

B01AF01

Dawa fomu:

FILM COATED TABLETS

Tungo:

RIVAROXABAN 2.5 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

BAYER HEALTHCARE MANUFACTURING S.R.L, ITALY

Eneo la matibabu:

RIVAROXABAN

Matibabu dalili:

Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel , is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

Idhini ya tarehe:

2019-04-30

Taarifa za kipeperushi

ً
اضيأ بيبطلا كيصوي فوس .هتاذ دحب درفنم
ءاودك غلم 2.5 وتليراسك كل ىطع
ُ
ي نل
∙
:ةيلاتلا ةيودلأا ىدحإ لوانتب
وأ نيريپسأ مسإب فرعي يذلا كيليسيلاس
ليتيسأ ضمح -
.ليرچوديپولك عم ةيوس كيليسيلاس ليتيسأ
ضمح -
ةعرجلا( ةيفاضلإا ةيودلأا نم اهلوانت
كيلع بجاولا ةيئاودلا ةعرجلا صوصخب
بيبطلا كدشريس
ةرم كيليسيلاس ليتيسأ ضمح نم غلم 100 ىلإ
غلم 75 نيب يه ةداع اهب ىصوملا ةيئاودلا
كيليسيلاس ليتيسأ ضمح نم غلم 100 ىتح غلم
75 تاذ ةيموي ةيئاود ةعرج وأ مويلا يف
.)ليرچوديپولك نم غلم 75 اهردق ةيموي
ةيئاود ةعرج عم ةيوس
.اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي
لا
دعب كلذو نكمي ام عرسأب ةداح ةيجات
ةمزلاتم دعب غلم 2.5 وتليراسك ـب جلاعلا
ءدب بجي
ىفشتسملا لوخد دعب ةعاس 24 نكمي ام ركبأ
،ةداحلا ةيجاتلا ةمزلاتملا رارقتسإ
قيقحت
.ةنقح ةطساوب ىطعي يذلا رثختلا داضمب
جلاعلا فاقيإ هيف متي ةداع يذلا تقولا
يفو
نييارشلا ضرم كيدل صخ
ُ
ش اذإ غلم 2.5 وتليراسك ـب جلاعلا أدبت
ىتم كبيبط كدشريس
.ةيطيحملا نييارشلا ضرم وأ ةيجاتلا
.جلاعلا ةرتف صوصخب كبيبط ررقيس
لوانتل ىرخأ قرط لوح كبيبط عم ثدحت
،لماكلا هلكشب صرقلا علب بعصتست تنك اذإ
.غلم 2.5 وتليراسك
.هلوانت لبق ةرشابم ،حافتلا سورهم وأ
ءاملا عم هطلخو صرقلا قحس ناكملإاب
بوبنأ قيرط نع قوحسملا غلم 2.5 وتليراسك
كئاطعإب كبيبط موقيس ،ةجاحلا تع

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 2.5 mg
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect:
Each film-coated tablet contains 35.70 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and "2.5" and a triangle on the other side.
Prescriber guide
This product is marketed with
prescriber guide providing recommendations for the risk minimization
in the use of Xarelto 2.5 mg. Please ensure you are familiar with this
material as it contains important
safety information.
Patient safety information card
The marketing of Xarelto 2.5 mg is subject to a risk management plan
(RMP) including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that
the patient should be aware of before and during treatment. Please
explain to the patient the need to
review the card before starting treatment.
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES
THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
A.
PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK
OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including
XARELTO, increases
the risk of thrombotic events. If anticoagulation with XARELTO is
discontinued for a
reason other than pathological bleeding or completion of a course of
therapy, consider
coverage with another anticoagulant _[see posology and method of
administration (4.2), _
_and special warnings and precautions for use(4.4)]_.
B.
SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas have occurred in patients treated with
XARELTO who
are receiving neuraxial anesthesia or undergoing spinal puncture.
These hematomas
may result in long-term or permanent paralysis. Consider these risks
when scheduling
patients fo