AKM DABIGATRAN dabigatran etexilate (as mesilate) 75 mg capsule bottle pack

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

dabigatran etexilate mesilate, Quantity: 86.475 mg (Equivalent: dabigatran etexilate, Qty 75 mg)

থেকে পাওয়া:

Pharmacor Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

রচনা:

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

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

60

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Visual Identification: White to pale yellow pellets in HPMC capsule size "1" light cream opaque cap and body imprinted with "DAB" on cap and "75" on body in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2022-08-24

তথ্য লিফলেট

AKM DABIGATRAN
_CAPSULES _
_ _
_dabigatran etexilate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AKM 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 AKM DABIGATRAN
IS USED FOR
AKM 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.
AKM 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 MEDICINE
HAS BEEN PRESCRIBED

পণ্য বৈশিষ্ট্য

AKM Dabigatran
Ver: 00
1
AUSTRALIAN PRODUCT INFORMATION- AKM DABIGATRAN CAPSULES
(DABIGATRAN ETEXILATE MESILATE)
1. NAME OF THE MEDICINE:
Dabigatran Etexilate Mesilate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM Dabigatran 75 mg Capsules
Each capsule contains Dabigatran Etexilate Mesilate equivalent to
Dabigatran Etexilate 75 mg
AKM Dabigatran 110 mg Capsules
Each capsule contains Dabigatran Etexilate Mesilate equivalent to
Dabigatran Etexilate 110 mg
AKM 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
AKM 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.
AKM 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.
AKM 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.
AKM 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
AKM Dabigatran capsules can be taken with or without foo