Apixaban Accord

Ország: Európai Unió

Nyelv: angol

Forrás: EMA (European Medicines Agency)

Aktív összetevők:

Apixaban

Beszerezhető a:

Accord Healthcare S.L.U.

ATC-kód:

B01AF02

INN (nemzetközi neve):

apixaban

Terápiás csoport:

Antithrombotic agents

Terápiás terület:

Venous Thromboembolism; Stroke; Arthroplasty

Terápiás javallatok:

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 (see section 4.4 for haemodynamically unstable PE patients).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 (see section 4.4 for haemodynamically unstable PE patients).

Termék összefoglaló:

Revision: 2

Engedélyezési státusz:

Authorised

Engedély dátuma:

2020-07-23

Betegtájékoztató

82
B. PACKAGE LEAFLET
83
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN ACCORD 2.5 MG FILM-COATED TABLETS
apixaban
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Apixaban Accord is and what it is used for
2.
What you need to know before you take Apixaban Accord
3.
How to take Apixaban Accord
4.
Possible side effects
5.
How to store Apixaban Accord
6.
Contents of the pack and other information
1.
WHAT APIXABAN ACCORD IS AND WHAT IT IS USED FOR
Apixaban Accordcontains the active substance apixaban and belongs to a
group of medicines called
anticoagulants. This medicine helps to prevent blood clots from
forming by blocking Factor Xa, which
is an important component of blood clotting.
Apixaban Accord is used in adults:
-
to prevent blood clots (deep vein thrombosis [DVT]) from forming after
hip or knee replacement
operations. After an operation to the hip or knee you may be at a
higher risk of developing blood
clots in your leg veins. This can cause the legs to swell, with or
without pain. If a blood clot travels
from your leg to your lungs, it can block blood flow causing
breathlessness, with or without chest
pain. This condition (pulmonary embolism) can be life-threatening and
requires immediate medical
attention.
-
to prevent a blood clot from forming in the heart in patients with an
irregular heart beat (atrial
fibrillation) and at least one additional risk factor. Blood clots may
break off and travel to the brain
and lead to a stroke or travelto other organs and prevent norma

Termékjellemzők

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Accord 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg apixaban.
Excipients with known effect
Each 2.5 mg film-coated tablet contains 51.97 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Yellow, round shaped, approximate 6.00 mm in diameter, biconvex,
film-coated tablet debossed with
“IU1” on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 (see section 4.4 for haemodynamically unstable PE
patients).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE (VTEp): elective hip or knee replacement surgery _
The recommended dose of apixaban is 2.5 mg taken orally twice daily.
The initial dose should be
taken 12 to 24 hours after surgery.
Physicians may consider the potential benefits of earlier
anticoagulation for VTE prophylaxis as well
as the risks of post-surgical bleeding in deciding on the time of
administration within this time
window.
_In patients undergoing hip replacement surgery _
The recommended duration of treatment is 32 to 38 days.
_In patients undergoing knee replacement surgery _
The recommended duration of treatment is 10 to 14 days.
_Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation (NVAF) _
The recommended dose of apixaban is 5 mg taken