RIVAROXABAN PROPHARM 15 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

RIVAROXABAN

Disponible desde:

PROPHARM LTD

Código ATC:

B01AF01

formulario farmacéutico:

FILM COATED TABLETS

Composición:

RIVAROXABAN 15 MG

Vía de administración:

PER OS

tipo de receta:

Not required

Fabricado por:

ADALVO LIMITED, MALTA

Área terapéutica:

RIVAROXABAN

indicaciones terapéuticas:

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT),and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Fecha de autorización:

2023-12-20

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
RIVAROXABAN PROPHARM 15 MG
RIVAROXABAN PROPHARM 20 MG
FILM-COATED TABLETS
Each tablet contains:
rivaroxaban 15 mg
rivaroxaban 20 mg
Inactive ingredients and allergens in the preparation: see section 6
“Further information” and
section 2 under “Important information about some of the ingredients
of the medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to your doctor or
pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It
may harm them even if it seems to you that their ailment is similar.
In addition to the leaflet, the Rivaroxaban Propharm is provided with
a patient safety information
card.
This card contains important information that you must know and abide
by before starting and
during treatment with Rivaroxaban Propharm.
Read the Patient Safety Information Card and the patient leaflet
before starting to use the
preparation.
Keep the card and leaflet for further reading if necessary.
1. WHAT IS THE MEDICINE INTENDED FOR?
Rivaroxaban Propharm is intended for adults with the following
conditions:
•
to prevent blood clots in brain (stroke) and other blood vessels in
the body in patients with an
irregular heart rhythm called non-valvular atrial fibrillation and
with one or more of the following
risk factors: congestive heart failure, high blood pressure, age (75
or older), diabetes, prior
stroke, or transient ischemic attack.
•
to treat blood clots in the veins of the legs (deep vein thrombosis)
and in the blood vessels of
the lungs (pulmonary embolism) and to prevent the recurrence of blood
clots in the blood
vessels of the legs and/or lungs.
Rivaroxaban Propharm is intended for children and adolescents below
the age of 18 who weigh
between 30 kg to 50 kg:
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