Eliquis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-03-2024
Charakterystyka produktu
(SPC)
08-03-2024
Sprawozdanie z oceny publicznego
(PAR)
01-08-2018
Składnik aktywny:
Apixaban
Dostępny od:
Bristol-Myers Squibb / Pfizer EEIG
Kod ATC:
B01AF02
INN (International Nazwa):
apixaban
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Arthroplasty; Venous Thromboembolism
Wskazania:
For Eliquis 2.5 mg film-coated tablets: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).For Eliquis 5 mg film-coated tablets: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).
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
2011-05-18
Ulotka dla pacjenta
70
B. PACKAGE LEAFLET
71
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELIQUIS 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 Eliquis is and what it is used for
2.
What you need to know before you take Eliquis
3.
How to take Eliquis
4.
Possible side effects
5.
How to store Eliquis
6.
Contents of the pack and other information
1.
WHAT ELIQUIS IS AND WHAT IT IS USED FOR
Eliquis contains 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.
Eliquis 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 to other organs and prevent normal blood
flow to that organ (also
known as a systemic embolism). A str
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eliquis 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg apixaban.
Excipient(s) with known effect
Each 2.5 mg film-coated tablet contains 51.4 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 tablets (diameter of 5.95 mm) debossed with 893 on one
side and 2½ 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 orally twice daily.
3
_Dose reduction _
The recommende
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