PRADAXA 150

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DABIGATRAN ETEXILATE AS MESILATE

متاح من:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC رمز:

B01AE07

الشكل الصيدلاني:

CAPSULES

تركيب:

DABIGATRAN ETEXILATE AS MESILATE 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

المجموعة العلاجية:

DABIGATRAN ETEXILATE

المجال العلاجي:

DABIGATRAN ETEXILATE

الخصائص العلاجية:

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

تاريخ الترخيص:

2015-02-28

نشرة المعلومات

Pradaxa 75 mg capsules
Updated Patient Information Leaflet
Boehringer Ingelheim
June 2020
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
PRADAXA
®
75 MG
CAPSULES
ACTIVE INGREDIENT:
Each capsule of PRADAXA 75 contains: 75 mg dabigatran etexilate (as
mesilate)
Inactive ingredients and allergens in the medicine - See section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further questions, ask your
physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it
seems to you that their illness is similar.
Patient information card:
This card contains important safety information which you should know
prior to beginning treatment with
Pradaxa and during the treatment with Pradaxa.
The card contains information intended for both the patient and the
healthcare staff. It provides guidance for
the patients on how to minimize the risk of bleeding resulting from
treatment with any anticoagulant agent.
In addition, the card contains personal details of the patient and
information regarding Pradaxa for the
healthcare staff.
Present this card to any healthcare professional involved in your
treatment.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Pradaxa contains the active ingredient dabigatran etexilate that
belongs to a group of medicines called
anticoagulants. Pradaxa is intended for prevention of thrombosis of
the veins following elective knee
replacement or hip replacement orthopedic surgeries in adults.
THERAPEUTIC GROUP: Anticoagulants.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredient or to any of the
other ingredients that this medicine
contains (for the list of inactive ingredients, see section 6).

You suffer from severe renal impairment.

You suffer from active

خصائص المنتج

Pradaxa 75
Prescribing Information
Boehringer Ingelheim
January 2022
1
PRADAXA 75
DABIGATRAN ETEXILATE 75 mg
Hard Capsules
PRESCRIBING INFORMATION
The marketing of Pradaxa is subject to a risk management plan (RMP)
including a “Patient safety
information card”. The “Patient safety information card”,
emphasizes important safety information
that the patient should be aware of before and during treatment.
Please explain to the patient the
need to review the card before starting treatment.
_Please provide patient safety information card (patient card) to each
patient who is prescribed with _
_Pradaxa. Explain to the patient the implications of anticoagulant
treatment including the need for _
_compliance. Please also explain the signs of bleeding and when to
seek medical attention. _
_The patient card will inform physicians and dentists about the
patient‘s anticoagulation treatment _
_and will contain emergency contact information. The patient should be
instructed to carry the _
_patient alert card at all times and present it to every health care
provider_.
Pradaxa 75
Prescribing Information
Boehringer Ingelheim
January 2022
2
1.
NAME OF THE MEDICINAL PRODUCT
Pradaxa 75
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
hard
capsule contains 75 mg of dabigatran etexilate (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
.
Capsules with white, opaque cap and white, opaque body of size 2
(approx. 18 x 6 mm
)
filled with yellowish
pellets. The cap is imprinted with the Boehringer Ingelheim company
symbol, the body with “R7
5”.
WARNING: DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE
CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE
Discontinuing Pradaxa places patients at an increased risk of
thrombotic events.
If anticoagulation with Pradaxa must be discontinued for a reason
other than pathological
bleeding, consider coverage with another anticoagulant [see Special
warnings and
precautions for use (section 4.4)].
Pradaxa 75
Prescribing Information
Boehr