PRADAXA 110

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 110 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

المجال العلاجي:

DABIGATRAN ETEXILATE

الخصائص العلاجية:

Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.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 110 mg capsules
Updated Patient Information Leaflet
Boehringer Ingelheim
June 2020
Page 1 of 8
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The dispensing of this medicine requires a physician’s prescription
PRADAXA
®
110 MG CAPSULES
ACTIVE INGREDIENT:
Each capsule of PRADAXA 110 contains: 110 mg dabigatran etexilate (as
mesilate)
Inactive ingredients and allergens: 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 to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Pradaxa contains the active ingredient dabigatran etexilate which
belongs to a group of medicines called
anticoagulants.
Pradaxa is intended for adults, to:
1.
prevent thrombosis of the veins following elective knee replacement or
hip replacement orthopedic
surgeries.
2.
prevent stroke and systemic embolism in adult patients suffering from
irregular heart beat (atrial fibrillation)
that is not in addition to a heart valve disease.
3.
treat thrombosis in the leg veins (deep vein thrombosis (DVT)) and in
the pulmonary blood vessels
(pulmonary embolism (PE)), and prevent recurrent thrombosis in these
blood vessels.
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 a list of inactive ingredients, see Section 6).

You suffer from severe renal impairment.

You suffer from active bleeding.

You suffer from any disease in any of the body organs, which may
increase the risk of severe bleeding
(for example stomach ulcer, injury or bleeding in the brain, or if you
have recently had surgery in your
brain or eyes).

خصائص المنتج

Pradaxa 110
Prescribing Information
Boehringer Ingelheim
January 2022
1
PRADAXA 110
DABIGATRAN ETEXILATE 110 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 110
Prescribing Information
Boehringer Ingelheim
January 2022
2
1.
NAME OF THE MEDICINAL PRODUCT
Pradaxa 110
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each hard capsule contains 110 mg of dabigatran etexilate (as
mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Capsules with light blue, opaque cap and light blue, opaque body of
size 1 (approx. 19 x 7 mm)filled with
yellowish pellets. The cap is imprinted with the Boehringer Ingelheim
company symbol, the body
with “R110”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary prevention of venous thromboembolic events (VTE) in adult
patients who have undergone
elective total hip replacement surgery or total knee replacement
surgery.
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (NVAF
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
D