Country: Israel
Language: English
Source: Ministry of Health
APIXABAN
TEVA ISRAEL LTD
B01AF02
FILM COATED TABLETS
APIXABAN 2.5 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
APIXABAN
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
2020-06-28
APIXABAN TEVA PATIENT SAFETY INFORMATION CARD APIXABAN 2.5 MG, 5 MG REPORTING OF SUSPECTED ADVERSE REACTIONS For further information, see the consumer leaflet approved by the Ministry of Health Side effects can be reported to the Ministry of Health using the online form. for side effect reporting that is found in the Ministry of Health homepage: WWW.HEALTH.GOV.IL or via the link: HTTPS://SIDEEFFECTS.HEALTH.GOV.IL or through the registration holder Teva Israel Ltd via: SAFETY.ISRAEL@TEVA.CO.IL MORE INFORMATION Teva Israel Ltd. P.O.B 3190 124 Dvora HaNevi'a St. Tel Aviv, Israel Phone: 1-800-805-005 This card was approved in accordance with the instructions of the Ministry of Health in February 2023 API-PAT-ENG-01 CONCOMITANT MEDICATIONS Medication Dose CASES WHICH REQUIRE SEEKING IMMEDIATE MEDICAL ATTENTION: Bleeding, which may be life threatening. An allergic reaction, including rash, edema, swelling of the face, lips, mouth, tongue and/or throat, and breathing difficulty (rare). SIDE EFFECTS: SIDE EFFECTS MAY OCCUR WHEN TAKING ANTICOAGULANTS. YOU SHOULD BE AWARE OF THEM AND SEEK MEDICAL TREATMENT IF NECESSARY. FOR A FULL LIST OF SIDE EFFECTS, SEE THE CONSUMER LEAFLET. THE MOST COMMON SIDE EFFECT IS BLEEDING. EXPRESSIONS OF HEMORRHAGING MAY INCLUDE, AMONG OTHERS • Gastro-intestinal bleeding, which may be expressed by blood in stools or black/dark stools, pain (such as abdominal pain) and swelling • Blood in urine (red or pink urine), blood in urine discovered in a urine test • Bleeding eyes, nose or gums • Bloody cough and bloody vomit (vomiting of blood or a granular coffee-like substance) • Secretion of blood or fluids from cuts and wounds, cuts that bleed for a long time • Unusual bleeding or bleeding that fails to stop spontaneously • Headache, dizziness, anemia expressed in fatigue and pallor, nausea RISK FACTORS OF INCREASED BLEEDING MAY BE: A liver disease which causes a coagulation disorder and risk of bleeding. An injury or medical condition with an increased risk of bleeding, such as an act Read the complete document