Land: Israël
Taal: Engels
Bron: Ministry of Health
RIVAROXABAN MICRONIZED
BAYER ISRAEL LTD
B01AX06
FILM COATED TABLETS
RIVAROXABAN MICRONIZED 20 MG
PER OS
Required
BAYER AG., GERMANY
RIVAROXABAN
RIVAROXABAN
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 more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
2017-01-31
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 Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Xarelto 20 mg Film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg rivaroxaban. Excipient with known effect: Each film-coated tablet contains 22.9 mg lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” 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 20 mg. Please ensure you are familiar with this material as it contains important safety information. Patient safety information card The marketing of Xarelto 20 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 20 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/ Lees het volledige document