PRADAXA dabigatran etexilate 150 mg (as dabigatran etexilate mesilate) capsule blister pack
Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
Foglio illustrativo
(PIL)
23-03-2021
Scheda tecnica
(SPC)
23-03-2021
Relazione pubblica di valutazione
(PAR)
15-11-2017
Principio attivo:
dabigatran etexilate mesilate, Quantity: 172.95 mg (Equivalent: dabigatran etexilate, Qty 150 mg)
Commercializzato da:
Boehringer Ingelheim Pty Ltd
INN (Nome Internazionale):
dabigatran etexilate mesilate
Forma farmaceutica:
Capsule, hard
Composizione:
Excipient Ingredients: dimeticone 350; purified talc; hyprolose; purified water; indigo carmine; hypromellose; carrageenan; Acacia; potassium chloride; titanium dioxide; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Via di somministrazione:
Oral
Confezione:
10s, 60s
Tipo di ricetta:
(S4) Prescription Only Medicine
Indicazioni terapeutiche:
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.
Dettagli prodotto:
Visual Identification: Oblong capsule with light blue opaque cap and white opaque body. The cap is printed in black with the BI company symbol and the body with 'R150'.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Stato dell'autorizzazione:
Licence status A
Data dell'autorizzazione:
2011-04-29
Foglio illustrativo
PRADAXA
®
_CAPSULES_
_dabigatran etexilate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pradaxa.
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 PRADAXA IS USED
FOR
Pradaxa 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.
Pradaxa 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 FOR YOU.
Your doctor may have prescribed
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Scheda tecnica
PRADAXA PI0122-28
1
AUSTRALIAN PRODUCT INFORMATION – PRADAXA
® (DABIGATRAN ETEXILATE) CAPSULE
1 NAME OF THE MEDICINE
dabigatran etexilate (as dabigatran etexilate mesilate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PRADAXA are hard capsules for oral administration.
PRADAXA 75 mg hard capsules contain 75 mg dabigatran etexilate.
PRADAXA 110 mg hard capsules contain 110 mg dabigatran etexilate.
PRADAXA 150 mg hard capsules contain 150 mg dabigatran etexilate.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Capsules 75 mg:
Imprinted hypromellose capsules with white opaque cap and body
of size 2 filled with yellowish pellets. The cap is imprinted with the
Boehringer Ingelheim company symbol, the body with R75.
Capsules 110mg:
Imprinted hypromellose capsules with light blue opaque cap and
body of size 1 filled with yellowish pellets. The cap is imprinted
with the Boehringer Ingelheim company symbol, the body with
R110.
Capsules 150 mg:
Imprinted hypromellose capsules with light blue opaque cap and
white opaque body of size 0 filled with yellowish pellets. The cap
is imprinted with the Boehringer Ingelheim company symbol, the
body with R150.
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
PRADAXA capsules can be taken with or without food. PRADAXA should be
swallowed whole
with a full glass of water, to facilitate delivery to the stomach.
The capsule should not be chewed, broken, or opened as this may
increase the ris
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