Apixaban Teva 5 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

APIXABAN 5 mg/stuk

Dostupno od:

Teva B.V. Swensweg 5 2031 GA HAARLEM

INN (International ime):

APIXABAN 5 mg/stuk

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)

Administracija rute:

Oraal gebruik

Datum autorizacije:

2020-11-17

Uputa o lijeku

rvg 125129 EU PIL IB-007-R met NL info clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN TEVA 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
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 the blood
vessels of your legs and/or lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE IF:
•
YOU ARE ALLERGIC
to ap

Svojstava lijeka

1
rvg 125129 EU PIL IB-006 met NL info clean
SUMMARY OF PRODUCT CHARACTERISTICS
2
rvg 125129 EU PIL IB-006 met NL info clean
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Teva 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 102 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light pink, film coated, modified oval shape tablet, debossed with
“TV” on one side and with “G2” on
the other side of the tablet. Dimension: 9.9 – 10.5 mm length, 5.0
– 5.6 mm width, 4.2 – 4.8mm
thickness.
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
_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 and
treatment of PE is 10 mg
taken orally twice daily for the first 7 days followed by 5 mg taken
orally twice daily. As per available
medical g