XARELTO 10 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RIVAROXABAN

متاح من:

BAYER ISRAEL LTD

ATC رمز:

B01AX06

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

RIVAROXABAN 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAYER AG., GERMANY

المجموعة العلاجية:

RIVAROXABAN

المجال العلاجي:

RIVAROXABAN

الخصائص العلاجية:

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE), adults (following completion of at least 6 months therapy for DVT or PE).

تاريخ الترخيص:

2015-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Each tablet contains:
Rivaroxaban 10 mg
Inactive ingredients and allergens in the preparation: See section 6
“Further Information” and in section 2
“Important information regarding some of the ingredients of the
medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have further questions, refer to the doctor
or pharmacist.
In addition to the leaflet, the Xarelto 10 mg preparation is provided
with a patient safety information card.
This card contains important information that you must know and abide
by before starting and during
treatment with Xarelto 10 mg.
Read the Patient Safety Information Card and the patient leaflet
before starting to use the preparation.
Keep the card and leaflet for further reading if necessary.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm
them even if it seems to you that their ailment is similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
Xarelto 10 mg is intended for:
- preventing venous thrombosis in adults following elective hip or
knee replacement surgery.
- preventing recurrence of venous thrombosis in the legs (deep vein
thrombosis) and in the blood vessels of the
lungs (pulmonary embolism) after completion of 6 months of treatment
for a previous deep vein thrombosis
or pulmonary embolism.
THERAPEUTIC GROUP: Xarelto 10 mg belongs to a group of medicines
called antithrombotic agents and acts
by lowering the tendency to form blood clots by blocking a factor
involved in the blood-clotting process
(Factor 10a).
2) BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ you are sensitive (allergic) to rivaroxaban or to any of the other
ingredients contained in the medicine.
For the list of inactive ingredients, see section 6 “Further
Information”.
∙ you are su

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect:
Each film-coated tablet contains 27.9 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 red, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and "10" 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 10mg. Please ensure you are familiar with this
material as it contains important
safety information.
Patient safety information card
The marketing of Xarelto 10 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 10 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.
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