PHARMACOR DABIGATRAN dabigatran etexilate (as mesilate) 110 mg capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

dabigatran etexilate mesilate, Quantity: 126.83 mg (Equivalent: dabigatran etexilate, Qty 110 mg)

متاح من:

Pharmacor Pty Ltd

الشكل الصيدلاني:

Capsule, hard

تركيب:

Excipient Ingredients: hypromellose phthalate; microcrystalline cellulose; macrogol 600; ethanol; butylated hydroxytoluene; tartaric acid; povidone; isopropyl alcohol; purified water; dichloromethane; citric acid monohydrate; hyprolose; purified talc; titanium dioxide; hypromellose; brilliant blue FCF; allura red AC; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer; macrogol 8000

طريقة التعاطي:

Oral

الوحدات في الحزمة:

10, 30, 60

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Dabigatran is indicated for Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.

ملخص المنتج:

Visual Identification: White to pale yellow pellets in HPMC capsule size 0 light blue opq body & light blue opq cap imprinted 110 on body & Dab on cap in black ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2022-08-24

نشرة المعلومات

PHARMACOR DABIGATRAN
_CAPSULES _
_ _
_dabigatran etexilate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pharmacor
Dabigatran.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again.
WHAT PHARMACOR
DABIGATRAN IS USED FOR
Pharmacor Dabigatran contains the
active substance dabigatran etexilate
(as dabigatran etexilate mesilate).
After oral use, dabigatran etexilate is
rapidly converted in the body to its
active form dabigatran. It belongs to
a group of medicines called
anticoagulants. Some people refer to
anticoagulant medicines as "blood
thinners". Dabigatran works by
inhibiting a specific protein in the
blood, called thrombin. Thrombin
contributes to the formation of blood
clots. Dabigatran prevents the
formation of blood clots.
Pharmacor Dabigatran has been
prescribed to you for one of the
following uses:
•
to prevent the formation of blood
clots in the veins after knee or hip
replacement surgery in adults
•
to reduce the risk of brain (stroke)
and/or other body vessel
obstruction by blood clot
formation in adults with an
abnormal heart beat rhythm called
non-valvular atrial fibrillation
•
to treat blood clots in the veins of
your legs and lungs and to prevent
blood clots from re-occurring in
the veins of your legs and/or
lungs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS

خصائص المنتج

Pharmacor Dabigatran
Ver: 00
1
AUSTRALIAN PRODUCT INFORMATION- PHARMACOR DABIGATRAN CAPSULES
(DABIGATRAN ETEXILATE MESILATE)
1. NAME OF THE MEDICINE:
Dabigatran Etexilate Mesilate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Dabigatran 75 mg Capsules
Each capsule contains Dabigatran Etexilate Mesilate equivalent to
Dabigatran Etexilate 75 mg
Pharmacor Dabigatran 110 mg Capsules
Each capsule contains Dabigatran Etexilate Mesilate equivalent to
Dabigatran Etexilate 110 mg
Pharmacor Dabigatran 150 mg Capsules
Each capsule contains Dabigatran Etexilate Mesilate equivalent to
Dabigatran Etexilate 150 mg
List of excipients with known effect
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Capsules, Hard
Pharmacor Dabigatran 75 mg Capsules
White to pale yellow pellets filled in HPMC capsule size ''1" light
cream opaque cap and light
cream opaque body imprinted with "75" on body and “DAB” on cap in
black ink.
Pharmacor Dabigatran 110 mg Capsules
White to pale yellow pellets filled in HPMC capsule size "0" light
blue opaque cap and light blue
opaque body imprinted with "110" on body and "DAB" on cap in black
ink.
Pharmacor Dabigatran 150 mg Capsules
White to pale yellow pellets filled in HPMC capsule size “0EL”
light blue opaque cap and light
cream opaque body imprinted with “150” on body and “DAB” on
cap in black ink.
Pharmacor Dabigatran
Ver: 00
2
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of venous thromboembolic events in adult patients who have
undergone major
orthopaedic surgery of the lower limb (elective total hip or knee
replacement). (see Section 4.2
Dose and method of administration for details of treatment duration).
Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation and
at least one additional risk factor for stroke.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and for the prevention
of recurrent DVT and PE in adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
Ph