Abatixent 2,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

APIXABAN 2,5 mg/stuk

INN (Algemene Internationale Benaming):

APIXABAN 2,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-09-24

Bijsluiter

Sandoz B.V.
Page 1/13
Abatixent 2,5 mg filmomhulde tabletten
RVG 125876
1313-V3
1.3.1.3 Bijsluiter
Mei 2022
_ _
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
ABATIXENT 2,5 MG FILMOMHULDE TABLETTEN
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 [Nationally Completed Name] is and what it is used for
2.
What you need to know before you take [Nationally Completed Name]
3.
How to take [Nationally Completed Name]
4.
Possible side effects
5.
How to store [Nationally Completed Name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally Completed Name] 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.
[Nationally Completed Name] 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 be

Productkenmerken

Sandoz B.V.
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Abatixent 2,5 mg filmomhulde tabletten
RVG 125876
1311-v2
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2022
1.
NAAM VAN HET GENEESMIDDEL
Abatixent 2,5 mg filmomhulde tabletten
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 48 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)
Yellow, round, biconvex, film coated tablet, debossed “AX” on one
side and “2.5” on the other side
with a diameter of 5.7 – 6.5 mm.
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
Sandoz B.V.
Page 2/36
Abatixent 2,5 mg filmomhulde tabletten
RVG 125876
1311-v2
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2022
_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 replace