Pradaxa

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Dabigatran etexilate mesilate

MAH:

Boehringer Ingelheim International GmbH

ATC_code:

B01AE07

INN:

dabigatran etexilate

therapeutic_group:

Antithrombotic agents

therapeutic_area:

Arthroplasty, Replacement; Venous Thromboembolism

therapeutic_indication:

Pradaxa 75 mgPrimary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.Pradaxa 110 mgPrimary prevention of venous thromboembolic events 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.Pradaxa 150 mgPrevention 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.

leaflet_short:

Revision: 40

authorization_status:

Authorised

authorization_date:

2008-03-17

PIL

179
B. PACKAGE LEAFLET
180
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRADAXA 75 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 Pradaxa is and what it is used for
2.
What you need to know before you take Pradaxa
3.
How to take Pradaxa
4.
Possible side effects
5.
How to store Pradaxa
6.
Contents of the pack and other information
1.
WHAT PRADAXA IS AND WHAT IT IS USED FOR
Pradaxa 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.
Pradaxa is used in adults to:
-
prevent the formation of blood clots in the veins after knee or hip
replacement surgery.
Pradaxa is used in children to:
-
treat blood clots and to prevent blood clots from reoccurring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRADAXA
DO NOT TAKE PRADAXA
-
if you are allergic to dabigatran etexilate or any of the other
ingredients of this medicine (listed
in section 6).
-
if you have severely reduced kidney function.
-
if you are currently bleeding.
-
if you have a disease in an organ of the body that increases the risk
of serious bleeding (e.g.,
stomach ulcer, injury or bleeding in the brain, recent surgery of the
brain or eyes).
-
if you have an increased tendency to bleed. This may be inborn, of
unknown cause or due to
other medicines.
-
if you are taking medicines to prevent blood clotting (e.g. warfarin,
rivaroxaban, apixaban or
heparin), except when

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pradaxa 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg of dabigatran etexilate (as
mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Capsules with white, opaque cap and white, opaque body of size 2
(approx. 18 × 6 mm) filled with
yellowish pellets. The cap is imprinted with the Boehringer Ingelheim
company symbol, the body with
“R75”.
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.
Treatment of VTE and prevention of recurrent VTE in paediatric
patients from the time the child is
able to swallow soft food to less than 18 years of age.
For age appropriate dose forms, see section 4.2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pradaxa capsules can be used in adults and paediatric patients aged 8
years or older who are able to
swallow the capsules whole. Pradaxa coated granules can be used in
children aged less than 12 years
as soon as the child is able to swallow soft food.
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
VTE in orthopaedic surgery are shown in table 1.
3
TABLE 1:
DOSE RECOMMENDATIONS AND DURATION OF THERAPY FOR PRIMARY PREVENTION OF
VTE IN
ORTHOPAEDIC SURGERY
TREATMENT INITIATION
ON THE DAY OF SURGERY
1-4 HOURS AFTER
COMPLETED SURGERY
MAINTENANCE DOSE
STARTING ON THE
FIRST DAY AFTER
SURGERY
DURATION OF
MAINTENANCE
DOSE
Patients following elective knee
replacement surgery
single capsule of
110 mg dabigatran
etexilate
220 mg dabigatran
ete