Xarelto
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
02-08-2023
Karatteristiċi tal-prodott
(SPC)
02-08-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
02-02-2021
Ingredjent attiv:
rivaroxaban
Disponibbli minn:
Bayer AG
Kodiċi ATC:
B01AF01
INN (Isem Internazzjonali):
rivaroxaban
Grupp terapewtiku:
Antithrombotic agents
Żona terapewtika:
Arthroplasty, Replacement; Venous Thromboembolism
Indikazzjonijiet terapewtiċi:
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, 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.Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.AdultsPrevention 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.Paediatric population Treatment 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.Paediatric population Treatment 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.
Sommarju tal-prodott:
Revision: 40
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2008-09-30
Fuljett ta 'informazzjoni
235
B. PACKAGE LEAFLET
236
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
XARELTO 2.5 MG FILM-COATED TABLETS
rivaroxaban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xarelto is and what it is used for
2.
What you need to know before you take Xarelto
3.
How to take Xarelto
4.
Possible side effects
5.
How to store Xarelto
6.
Contents of the pack and other information
1.
WHAT XARELTO IS AND WHAT IT IS USED FOR
You have been given Xarelto because
-
you have been diagnosed with an acute coronary syndrome (a group of
conditions that
includes heart attack and unstable angina, a severe type of chest
pain) and have been
shown to have had an increase in certain cardiac blood tests.
Xarelto reduces the risk in adults of having another heart attack or
reduces the risk of
dying from a disease related to your heart or your blood vessels.
Xarelto will not be given to you on its own. Your doctor will also
tell you to take either:
•
acetylsalicylic acid or
•
acetylsalicylic acid plus clopidogrel or ticlopidine.
or
-
you have been diagnosed with a high risk of getting a blood clot due
to a coronary artery
disease or peripheral artery disease which causes symptoms.
Xarelto reduces the risk in adults of getting blot clots
(atherothrombotic events).
Xarelto will not be given to you on its own. Your doctor will also
tell you to take
acetylsalicylic acid.
In some cases, if you get Xarelto after a procedure to open a narrowed
or closed artery of
your leg to restore blood flow, your doctor may also prescribe
clopi
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 33.92 mg lactose (as 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with
ASA plus clopidogrel or
ticlopidine, is indicated for the prevention of atherothrombotic
events in adult patients after an acute
coronary syndrome (ACS) with elevated cardiac biomarkers (see sections
4.3, 4.4 and 5.1).
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
•
_ACS _
Patients taking Xarelto 2.5 mg twice daily should also take a daily
dose of 75 - 100 mg ASA or a daily
dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg
clopidogrel or a standard daily
dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for ischaemic
events against the bleeding risks. Extension of treatment beyond 12
months should be done on an
individual patient basis as experience up to 24 months is limited (see
section 5.1).
Treatment with Xarelto should be started as soon as possible after
stabilisation of the ACS event
(including revascularisation procedures); at the earliest 24 hours
after admission to hospital and at the
time when parenteral anticoagulation therapy would no
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