Dabigatran Sandoz Capsule 110mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DABIGATRAN ETEXILATE MESILATE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DABIGATRAN ETEXILATE MESILATE

Unit dalam pakej:

30 Caplets; 10 Caplets; 60 Caplets

Dikeluarkan oleh:

MSN Laboratories Private Limited

Risalah maklumat

DABIGATRAN SANDOZ CAPSULE
Dabigatran etexilate (75mg, 110mg, 150mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET:
1.
What Dabigatran Sandoz is used for
2.
How Dabigatran Sandoz works
3.
Before you use Dabigatran Sandoz
4.
How to use Dabigatran Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dabigatran
Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT DABIGATRAN SANDOZ IS USED FOR
75 mg/ 110 mg: DABIGATRAN
SANDOZ is used to prevent the
formation of blood clots in the veins
after knee or hip replacement surgery in
adults.
110 mg/ 150 mg: DABIGATRAN
SANDOZ is a medicine which is used to
reduce the risk of brain or body vessel
obstruction by blood clot formation in
adult patients with an abnormal heart
beat (atrial fibrillation) and additional
risk factors. DABIGATRAN SANDOZ
is a blood thinner medicine that lowers
the risk of blood clot formation.
DABIGATRAN SANDOZ is used to
treat blood clots in the veins of your legs
and lungs and to prevent blood clots
from reoccurring in the vein of your legs
and lungs.
HOW DABIGATRAN SANDOZ WORKS
DABIGATRAN SANDOZ is a medicine
which contains the active substance
dabigatran etexilate. It works by
blocking a substance in the body which
is involved in blood clot formation.
BEFORE YOU USE DABIGATRAN SANDOZ
-
_When you must not use it _
•
if you are allergic to dabigatran
etexilate or any of the other
ingredients of this medicine.
_ _
•
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.
•
if you have an increased tendency
to bleed. This may be inborn, of
unknown cause or due to other
medicines.
•
if you have a severely reduced
liver function or liver disease
which could possibly cause death.
•
if you are taking oral ketoconazole
or itraconazole, medicines to treat
fungal infections.
•
if you are taking oral cyclosporine

Ciri produk

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PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Sandoz Capsule 75mg
Dabigatran Sandoz Capsule 110mg
Dabigatran Sandoz Capsule 150mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dabigatran Sandoz Capsule 75mg
Each capsule contains 75mg of Dabigatran.
Each capsule contains 86.475mg Dabigatran Etexilate Mesilate
equivalent to 75mg Dabigatran.
Dabigatran Sandoz Capsule 110mg
Each capsule contains 110mg of Dabigatran.
Each capsule contains 126.830mg Dabigatran Etexilate Mesilate
equivalent to 110mg Dabigatran.
Dabigatran Sandoz Capsule 150mg
Each capsule contains 150mg of Dabigatran.
Each capsule contains 172.950mg Dabigatran Etexilate Mesilate
equivalent to 150mg Dabigatran.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
Dabigatran Sandoz Capsule 75mg
White to light yellow colored blend compressing granular powder,
pellets in Size “2” capsule having White opaque cap
imprinted “MD” and White opaque body imprinted “75” with black
ink.
Dabigatran Sandoz Capsule 110mg
White to light yellow colored blend compressing granular powder,
pellets in Size “l” capsule having White opaque cap
imprinted “MD” and White opaque body imprinted “110” with
black ink.
Dabigatran Sandoz Capsule 150mg
White to light yellow colored blend compressing granular powder,
pellets in Size “0” capsule having White opaque cap
imprinted “MD” and White opaque body imprinted “150” with
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
75mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
110mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
Reduction of the risk of stroke and systemic embolism in patients with
non-valvular atrial fibrillation. Treatment of deep
vein thrombosis (DVT) and pulmonary emboli