ADEMPAS FILM-COATED TABLET 2.0mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Riociguat micronized

可用日期:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC代码:

C02KX05

剂量:

2.00mg

药物剂型:

TABLET, FILM COATED

组成:

Riociguat micronized 2.00mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)

授权状态:

ACTIVE

授权日期:

2014-11-24

资料单张

Page: 1 of 27
Adempas_CCDS07_Jan 2022
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1.0 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2.0 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 0.5 mg, 1.0 mg,
1.5 mg, 2.0 mg or 2.5 mg
riociguat.
3.
PHARMACEUTICAL FORM
Adempas 0.5 mg film-coated tablets:
White tablets marked with the Bayer cross on one side and 0.5 and an
“R” on the other side.
Adempas 1.0 mg film-coated tablets:
Pale yellow tablets marked with the Bayer cross on one side and 1 and
an “R” on the other
side.
Adempas 1.5 mg film-coated tablets:
Yellow-orange tablets marked with the Bayer cross on one side and 1.5
and an “R” on the
other side.
Adempas 2.0 mg film-coated tablets:
Pale orange tablets marked with the Bayer cross on one side and 2 and
an “R” on the other
side.
Adempas 2.5 mg film-coated tablets:
Red-orange tablets marked with the Bayer cross on one side and 2.5 and
an “R” on the other
side.
Page: 2 of 27
Adempas_CCDS07_Jan 2022
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4):
Adempas is indicated for the treatment of adult patients with WHO
functional Class II
to III symptoms
•
Inoperable CTEPH,
•
Persistent or recurrent CTEPH after surgical treatment
to improve exercise capacity ( see section 5.1.2).
Pulmonary arterial hypertension (PAH, WHO Group 1):
Adempas is indicated for the treatment of adult patients with WHO
functional class II to III
PAH to improve exercise capacity ( see section 5.1.2).
Efficacy was shown in patients on riociguat monotherapy or in
combination with endothelin
receptor antagonists or prostanoids.
Studies establishing effectiveness included predominately patients
with WHO functional
class II-III and etiologies of idiopathic or heritable PAH or PAH
associated with connective
tissue disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF A

产品特点

Page: 1 of 27
Adempas_CCDS07_April 2021
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1.0 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2.0 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 0.5 mg, 1.0 mg,
1.5 mg, 2.0 mg or 2.5 mg
riociguat.
3.
PHARMACEUTICAL FORM
Adempas 0.5 mg film-coated tablets:
White tablets marked with the Bayer cross on one side and 0.5 and an
“R” on the other side.
Adempas 1.0 mg film-coated tablets:
Pale yellow tablets marked with the Bayer cross on one side and 1 and
an “R” on the other
side.
Adempas 1.5 mg film-coated tablets:
Yellow-orange tablets marked with the Bayer cross on one side and 1.5
and an “R” on the
other side.
Adempas 2.0 mg film-coated tablets:
Pale orange tablets marked with the Bayer cross on one side and 2 and
an “R” on the other
side.
Adempas 2.5 mg film-coated tablets:
Red-orange tablets marked with the Bayer cross on one side and 2.5 and
an “R” on the other
side.
Page: 2 of 27
Adempas_CCDS07_April 2021
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4):
Adempas is indicated for the treatment of adult patients with WHO
functional Class II
to III symptoms
•
Inoperable CTEPH,
•
Persistent or recurrent CTEPH after surgical treatment
to improve exercise capacity ( see section 5.1.2).
Pulmonary arterial hypertension (PAH, WHO Group 1):
Adempas is indicated for the treatment of adult patients with WHO
functional class II to III
PAH to improve exercise capacity ( see section 5.1.2).
Efficacy was shown in patients on riociguat monotherapy or in
combination with endothelin
receptor antagonists or prostanoids.
Studies establishing effectiveness included predominately patients
with WHO functional
class II-III and etiologies of idiopathic or heritable PAH or PAH
associated with connective
tissue disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD