LIXIANA 60 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

EDOXABAN AS TOSYLATE

Dostupné z:

MEDISON PHARMA LTD

ATC kód:

B01AF03

Forma lieku:

FILM COATED TABLETS

Zloženie:

EDOXABAN AS TOSYLATE 60 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

DAIICHI SANKYO EUROPE GMBH

Terapeutické oblasti:

EDOXABAN

Terapeutické indikácie:

• Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years,diabetes mellitus, prior stroke or transient ischaemic attack (TIA).• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults

Dátum Autorizácia:

2021-03-01

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Lixiana 15 mg
Lixiana 30 mg
Lixiana 60 mg
Film coated tablets
Each film-coated tablet contains 15, 30 or 60 mg edoxaban,
respectively.
For a list of inactive and allergenic ingredients in the preparation,
see section 6 “Further information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information
about the medicine. If you have further questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness - Do not pass
it on to others. It may harm them even if it
seems to you that their illness is similar.
In addition to the leaflet, there is a patient safety information card
for Lixiana
This card contains important safety information which you should be
aware of and follow prior to starting
treatment and during the course of treatment with Lixiana.
The patient leaflet and patient safety information card must be read
before starting use of the preparation.
Keep the card handy for further review as the need arises.
1. WHAT IS THE MEDICINE INTENDED FOR?
Lixiana is intended for:
•
The prevention of stroke and systemic embolism in adult patients with
nonvalvular atrial
fibrillation (NVAF) who have one or more additional risk factors, such
as congestive heart
failure, hypertension, age of 75 and above, diabetes mellitus, prior
stroke or transient
ischaemic attack (TIA).
•
For treatment and prevention of recurrent deep vein thrombosis (DVT)
and pulmonary
embolism (PE) in adults.
Therapeutic group: Antithrombotic drugs, direct factor Xa inhibitors
in the coagulation cascade.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive (allergic) to edoxaban or to any of the other
ingredients contained in the
medicine (see section 6 “Further information”)
•
You are actively bleeding
•
You have an illness or medical condition that poses an increas

Súhrn charakteristických

PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Lixiana 15 mg film-coated tablets
Lixiana 30 mg film-coated tablets
Lixiana 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lixiana 15 mg film-coated tablets
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Lixiana 30 mg film-coated tablets
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Lixiana 60 mg film-coated tablets
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Lixiana 15 mg film-coated tablets
Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed
with “DSC L15”.
Lixiana 30 mg film-coated tablets
Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with
“DSC L30”.
Lixiana 60 mg film-coated tablets
Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed
with “DSC L60”.
Patient safety information card
The marketing of Lixiana is subject to a Risk management plan (RMP)
including a 'patient safety
information card'. The 'patient safety information card', emphasizes
important safety information that the
patient should be aware of before and during the treatment. Please
explain to the patient the need to
review the card before starting treatment.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Lixiana is indicated in prevention of stroke and systemic embolism in
adult patients with nonvalvular
atrial fibrillation (NVAF) with one or more risk factors, such as
congestive heart failure, hypertension,
age ≥ 75 years, diabetes mellitus, prior stroke or transient
ischaemic attack (TIA).
Lixiana is indicated in treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and
for the 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 _
The recommended dose is 60 mg edo