TRASENTAN 62.5

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

BOSENTAN AS MONOHYDRATE

Beszerezhető a:

RAFA LABORATORIES LTD

ATC-kód:

C02KX01

Gyógyszerészeti forma:

TABLETS

Összetétel:

BOSENTAN AS MONOHYDRATE 62.5 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

GENVION CORPORATION, CANADA

Terápiás terület:

BOSENTAN

Terápiás javallatok:

Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV. Reduction in the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer disease

Engedély dátuma:

2021-09-30

Betegtájékoztató

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
TRASENTAN 62.5
TRASENTAN 125
TABLETS
ACTIVE INGREDIENT:
TRASENTAN 62.5: Each tablet contains Bosentan monohydrate equivalent
to 62.5 mg of Bosentan.
TRASENTAN 125: Each tablet contains Bosentan monohydrate equivalent to
125 mg of Bosentan.
For a list of the other ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for treating 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.
Patient safety information card
In addition to the leaflet, Trasentan has a patient safety information
card concerning potential harm to an unborn
baby (fetus). This card contains important safety information that you
should know before starting and during the
treatment. Read the patient safety information card and the patient
leaflet before using this medicine. Keep the
card and leaflet so you can read it again if you need to.
Do not take Trasentan if you are pregnant because using this medicine
may harm the fetus (see Section 2 'Before
using this medicine' under the subsections 'Do not use this medicine
if' and 'Fertility, pregnancy and breastfeeding').
If you are a woman of childbearing age and it is possible for you to
get pregnant, perform a pregnancy test before
starting treatment with Trasentan and routinely every month while
taking this medicine, as well as a month after
completing the treatment. Confirm each time that the pregnancy test
result is negative. You must use a reliable
contraceptive to prevent pregnancy while you are taking Trasentan, and
for one more month after completing your
treatment (see section 2 'Fertility, pregnancy and breastfeeding').
1.
WHAT IS THE MEDICINE INTENDED FOR?
•
To treat pulmonary a