Apixaban Hexal 5 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

APIXABAN 5 mg/stuk

INN (International ime):

APIXABAN 5 mg/stuk

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

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

Administracija rute:

Oraal gebruik

Datum autorizacije:

2021-09-24

Uputa o lijeku

Sandoz B.V.
Page 1/10
Apixaban Hexal 5 mg, filmomhulde tabletten
RVG 125882
20220726
1.3.1.3 Bijsluiter
Januari 2024
_ _
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
APIXABAN HEXAL 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 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 stroke can be life-threatening and
requires immediate
medical attention.
•
to treat blood clots in the veins of your legs (deep vein thrombosis)
and in the blood vessels of
your lungs (pulmonary embolism), and to prevent blood clots from
re-occurring in th

Svojstava lijeka

Sandoz B.V.
Page 1/34
Apixaban Hexal 5 mg, filmomhulde tabletten
RVG 125882
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Dec 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Apixaban Hexal 5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect
Each 5 mg film-coated tablet contains 96 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)
Pink, oval, biconvex, film coated tablets, debossed with “AX” on
one side and “5” on the other side,
with a width of 5.0 – 5.7 mm and a length of 9.6 – 10.3 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 2/34
Apixaban Hexal 5 mg, filmomhulde tabletten
RVG 125882
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Dec 2023
_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.
_Dose reduction_
The recommended dose of apixaban is 2.5 mg taken orally twice daily in
patients with NVAF and at
least two of the following characteristics: age ≥ 80 years, body
weight ≤ 60 kg, or serum creatinine
≥ 1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE (VTEt)_
The recommended dose of apixaban for the treatment of acute DVT