TRACLEER 125 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

BOSENTAN

Dostupné z:

J-C HEALTH CARE LTD

ATC kód:

C02KX01

Forma lieku:

FILM COATED TABLETS

Zloženie:

BOSENTAN 125 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

ACTELION PHARMACEUTICALS LTD., SWITZERLAND

Terapeutické skupiny:

BOSENTAN

Terapeutické oblasti:

BOSENTAN

Terapeutické indikácie:

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

Dátum Autorizácia:

2012-05-31

Súhrn charakteristických

1
Tracleer 62.5 mg and Tracleer 125 mg_PI_ 8-2021
TRACLEER
®
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Tracleer 62.5 mg film-coated tablets
Tracleer 125 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Tracleer 62.5 mg
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Tracleer 125 mg
Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Excipient with known effect
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say
essentially ‘sodium-free’
.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablets):
Orange-white, round, biconvex, film-coated tablets, embossed with
“62,5” on one
side.
Orange-white, oval, biconvex, film-coated tablets, embossed with
“125” on one side.
A Patient Alert Card providing important safety information that
patients need to be
aware of before and during treatment with Tracleer is included in the
pack.
•
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Tracleer to a pregnant female because it may cause
fetal harm [see
Contraindications (4.3) and Fertility, pregnancy and lactation (4.6)].
Females of reproductive potential: Exclude pregnancy before the start
of treatment,
monthly during treatment, and 1 month after stopping treatment.
Prevent pregnancy
during treatment and for one month after stopping treatment by using
acceptable
methods of contraception [see Fertility, pregnancy and lactation
(4.6)].
The marketing of Tracleer is subject to a Risk Evaluation and
Mitigation Strategy
(REMS) Program. Each patient should receive a Patient alert card,
emphasizing the
risks of embryo fetal toxicity.
2
Tracleer 62.5 mg and Tracleer 125 mg_PI_ 8-2021
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATI