XARELTO 15 MG

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

RIVAROXABAN MICRONIZED

Предлага се от:

BAYER ISRAEL LTD

АТС код:

B01AX06

Лекарствена форма:

FILM COATED TABLETS

Композиция:

RIVAROXABAN MICRONIZED 15 MG

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

BAYER HEALTHCARE MANUFACTURING S.R.L, ITALY

Терапевтична област:

RIVAROXABAN

Терапевтични показания:

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT),and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Дата Оторизация:

2018-01-04

Листовка

بولطملا تقولا يف ءاودلا اذه لوانت تيسن
اذإ
ةرم غلم 20 وتليراسك وأ غلم 15 وتليراسك نم
دحاو صرق تاذ ةيئاودلا ةعرجلا يف •
لاوحلأا نم لاح يأب زوجي لا نكل كركذت
لاح ةيئاود ةعرج لوانت بجي ،مويلا يف
ةعرجلا لوانت بجي !مويلا سفن يف ءاود
يتعرج وأ ةفعاضم ةيئاود ةعرج لوانت
.بيبطلا ةراشتسإو داتعملاك مويلا يف ةرم
قايسلا يفو يلاتلا مويلا يف ةمداقلا
ةيئاودلا
لوانت بجي مويلا يف نيترم غلم 15 رايع نم
دحاو صرق تاذ ةيئاودلا ةعرجلا يف •
موي يف غلم 15 رايع نم نيصرق نم رثكأ
لوانت زوجي لا .كركذت لاح ةيئاود ةعرج
ةيئاود ةعرج ىلع لوصحلل
ً
اعم غلم 15 رايع نم نيصرق لوانت ناكملإاب
.دحاو
نم دحاو صرق لوانتب رارمتسلإا بجي
يلاتلا مويلا يف .دحاو مويل غلم 30 اهردق
.مويلا يف نيترم غلم 15 رايع
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
نودب ءاودلاب جلاعلا نع فقوتلا زوجي لاف
،ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
.ةريطخ تلااح ثودح عنميو جلاعي وتليراسك
نلأ
ً
ارظن بيبطلا ةراشتسإ
.ءاودلل ةيئاقولاو ةيجلاعلا ةردقلاب
رضت كنإف ءاودلا لوانت نع تفقوت اذإ ةعرجلا نم دكأتلاو ءاودلا عباط صيخشت
بجي !ةمتعلا يف ةيودأ لوانت زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت ةرم لك يف ةيئاودلا
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
ةيبناجلا �

Данни за продукта

1
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 15 mg
Film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient
with known effect:
Each film-coated tablet contains 25.4 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature)
marked with the
BAYER-cross on one side and “15” 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 15mg. Please ensure you are
familiar with this material as
it contains important safety information.
Patient safety information card
The marketing of Xarelto 15 mg is subject to a risk management plan
(RMP) including a
'patient safety information card' (Patient card). Please provide a
patient card to each patient
who is prescribed with Xarelto 15 mg. 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 and the
implications of this treatment including the need for compliance.
Please also explain the signs
of important adverse events and instruct the patient when to seek
medical care.
2
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/EPI