Pradaxa
Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Foglio illustrativo
(PIL)
31-05-2020
Scheda tecnica
(SPC)
10-07-2020
Principio attivo:
Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110 mg; ;
Commercializzato da:
Boehringer Ingelheim (NZ) Ltd
INN (Nome Internazionale):
Dabigatran etexilate 126.83 mg (equivalent to dabigatran 110 mg)
Dosaggio:
110 mg
Forma farmaceutica:
Capsule
Composizione:
Active: Dabigatran etexilate mesylate 126.83mg equivalent to dabigatran etexilate 110 mg Excipient: Acacia Dimeticone Hyprolose Hypromellose HPMC capsule size 1 - (TT70-14-2-2) Purified talc Tartaric acid TekPrint black SW-9008
Confezione:
Blister pack, Al/Al - starter pack, 10 capsules
Classe:
Prescription
Tipo di ricetta:
Prescription
Prodotto da:
Boehringer Ingelheim Bidachem SpA
Indicazioni terapeutiche:
Prevention of venous thromboembolic events in patients who have undergone major orthopaedic surgery.
Dettagli prodotto:
Package - Contents - Shelf Life: Blister pack, Al/Al - starter pack - 10 capsules - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Al/Al - 30 capsules - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Al/Al - 60 capsules - 36 months from date of manufacture stored at or below 30°C protect from moisture
Data dell'autorizzazione:
2007-03-27
Foglio illustrativo
PRADAXA NZ
CMI v04
1
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.medsafe.govt.nz/Consumers/c
mi/CMIForm.asp 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 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.
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Scheda tecnica
PRADAXA NZ DS v07
1
NEW ZEALAND DATASHEET
1.
PRODUCT NAME
PRADAXA 75 mg hard capsules
PRADAXA 110 mg hard capsules
PRADAXA 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRADAXA 75 mg hard capsules
Each hard capsule contains 75 mg dabigatran etexilate (as mesilate)
PRADAXA 110 mg hard capsules
Each hard capsule contains 110 mg dabigatran etexilate (as mesilate)
PRADAXA 150 mg hard capsules
Each hard capsule contains 150 mg dabigatran etexilate (as mesilate)
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
PRADAXA 75 mg hard capsules
Capsules with white, opaque cap and white, opaque body of size 2
filled with yellowish pellets. The
cap is imprinted in black ink with the Boehringer Ingelheim company
symbol, the body with “R75”.
PRADAXA 110 mg hard capsules
Capsules with light blue, opaque cap and light blue, opaque body of
size 1 filled with yellowish
pellets. The cap is imprinted in black ink with the Boehringer
Ingelheim company symbol, the body
with “R110”.
PRADAXA 150 mg hard capsules
Capsules with light blue, opaque cap and white, opaque body of size 0
filled with yellowish pellets.
The cap is imprinted in black ink with the Boehringer Ingelheim
company symbol, the body with
“R150”.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of stroke, systemic embolism and reduction of vascular
mortality in patients with
nonvalvular atrial fibrillation with one or more of the following risk
factors:
•
Previous stroke, transient ischaemic attack, or systemic embolism
•
Left ventricular ejection fraction <40%
•
Symptomatic heart failure, ≥New York Heart Association Class 2
•
Age ≥75 years
•
Age ≥65 years associated with one of the following: diabetes
mellitus, coronary artery
disease or hypertension.
Prevention of venous thromboembolic events in patients who have
undergone major orthopaedic
surgery.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary
embolism (PE) and prevention of
related death following treatment with
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