Dabigatran etexilate Biocon 110 mg hard capsules

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

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Διαθέσιμο από:

Biocon Pharma Malta Limited The Victoria Centre Unit 2 Lower Ground Floor Valletta Road Mosta MST 9012 , Malta

Φαρμακολογική κατηγορία (ATC):

B01AE07

INN (Διεθνής Όνομα):

DABIGATRAN ETEXILATE 110 mg

Φαρμακοτεχνική μορφή:

HARD CAPSULE

Σύνθεση:

DABIGATRAN ETEXILATE 110 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTITHROMBOTIC AGENTS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2024-03-11

Φύλλο οδηγιών χρήσης

                                1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE BIOCON 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 Biocon is and what it is used for
2.
What you need to know before you take Dabigatran etexilate Biocon
3.
How to take Dabigatran etexilate Biocon
4.
Possible side effects
5.
How to store Dabigatran etexilate Biocon
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE BIOCON IS AND WHAT IT IS USED FOR
Dabigatran etexilate Biocon 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 Biocon 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 Biocon 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 BIOCON
DO NOT TAKE DABIGATRAN ETEXILATE BIOCON
-
if you are allergic to dabigatran etexilate or any of the other
ingredie
                                
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Αρχείο Π.Χ.Π.

                                1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate Biocon 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 than18
years of age.
For age appropriate dose forms, see section 4.2.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dabigatran etexilate Biocon 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 SURGERY
TREA
                                
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