TRACLEER 62.5 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

BOSENTAN AS MONOHYDRATE

제공처:

J-C HEALTH CARE LTD

ATC 코드:

C02KX01

약제 형태:

FILM COATED TABLETS

구성:

BOSENTAN AS MONOHYDRATE 62.5 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

ACTELION PHARMACEUTICALS LTD., SWITZERLAND

치료 그룹:

BOSENTAN

치료 영역:

BOSENTAN

치료 징후:

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.

승인 날짜:

2022-05-31

제품 특성 요약

1
Tracleer 62.5 mg and Tracleer 125 mg_PI_ December-2023
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 film-coated tablets
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Tracleer 125 mg film-coated tablets
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
sayessentially ‘sodium-free’
.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablets):
Tracleer 62.5 mg film-coated tablets
Orange-white, round, biconvex, film-coated tablets, embossed with
“62.5” on one
side.
Tracleer 125 mg film-coated tablets
Orange-white, oval, biconvex, film-coated tablets, embossed with
“125” on one side.
Patient Alert Card
The marketing of Tracleer is subject to a risk management plan (RMP)
including
'Patient Alert Card'. The 'Patient Alert Card' emphasizes important
safety information
that the patient should be aware of before and during treatment. The
Patient Alert
Card is included in the pack, please explain to the patient the need
to review the card
before starting treatment.
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)].
2
Tracleer 62.5 mg and Tracleer 125 mg_PI_ December-2023
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of pulmonary arterial hypertension (PAH) in patients of WHO
functional
class II-IV.
Reductio