Dabigatran Etexilate Zentiva k.s. 110 mg hard capsule

国家: 马耳他

语言: 英文

来源: Medicines Authority

可用日期:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC代码:

B01AE07

INN（国际名称）:

DABIGATRAN ETEXILATE 110 mg

药物剂型:

HARD CAPSULE

组成:

DABIGATRAN ETEXILATE 110 mg

处方类型:

POM

治疗领域:

ANTITHROMBOTIC AGENTS

授权状态:

Authorised

授权日期:

2024-03-11

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
DABIGATRAN ETEXILATE ZENTIVA K.S. 110 MG HARD CAPSULES
dabigatran etexilate
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dabigatran Etexilate Zentiva k.s. is and what it is used for
2.
What you need to know before you take Dabigatran Etexilate Zentiva
k.s.
3.
How to take Dabigatran Etexilate Zentiva k.s.
4.
Possible side effects
5.
How to store Dabigatran Etexilate Zentiva k.s.
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE ZENTIVA K.S. IS AND WHAT IT IS USED FOR
Dabigatran Etexilate Zentiva k.s. contains the active substance
dabigatran etexilate and belongs to a
group of medicines called anticoagulants. It works by blocking a
substance in the body which is
involved in blood clot formation.
Dabigatran Etexilate Zentiva k.s. is used in adults to:
-
prevent the formation of blood clots in the veins after knee or hip
replacement surgery.
-
prevent blood clots in the brain (stroke) and other blood vessels in
the body if you have a
form of irregular heart rhythm called nonvalvular atrial fibrillation
and at least one additional risk
factor.
-
treat blood clots in the veins of your legs and lungs and to prevent
blood clots from re-
occurring in the vein of your legs and lungs.
Dabigatran Etexilate Zentiva k.s. is used in children to:
- treat blood clots and to prevent blood clots from reoccurring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DABIGATRAN ETEXILATE ZENTIVA
K.S.
DO NOT TAKE DABIGATRAN ETEXILATE ZENTIVA K.S.
-
if you

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Zentiva k.s. 110 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 126.83 mg of dabigatran etexilate (as
mesilate) equivalent to 110 mg of
dabigatran etexilate. For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Off white to pale yellow coloured pellets filled in blue hard capsules
size 1 (approx. 19.4 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary prevention of venous thromboembolic events (VTE) in adult
patients who have undergone
elective total hip replacement surgery or total 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 ischemic attack (TIA); age ≥
75 years; heart failure (NYHA Class ≥ II); diabetes mellitus;
hypertension.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
DVT and PE in adults.
Treatment of VTE and prevention of recurrent VTE in paediatric
patients from birth to less than
18 years of age.
For age appropriate dose forms, see section 4.2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dabigatran Etexilate Zentiva k.s. capsules can be used in adults and
paediatric patients aged 8 years or
older who are able to swallow the capsules whole.
There are other age appropriate dose forms for the treatment of
children below 8 years.
When changing between the formulations, the prescribed dose may need
to be altered. The dose stated
in the relevant dosing table of a formulation should be prescribed
based on the weight and age of the
child.
_PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY _
_ _
The recommended doses of dabigatran etexilate and the duration of
therapy for primary prevention of
venous thromboembolism in orthopaedic surgery are shown in table 1.
2
TABLE 1:
DOSE RECOMMENDATIONS AND DURATION OF THERAPY FOR PRIMARY PREVENTION OF
VTE IN
ORTHOPAEDIC