Niperten Combi tablets

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)

제공처:

KRKA-RUS LLC

ATC 코드:

C07FB07

INN (국제 이름):

bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)

복용량:

5mg+ 5mg

약제 형태:

tablets

패키지 단위:

(30/3x10/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2017-09-05

제품 특성 요약

1.3.1
Bisoprolol + Amlodipine
SPC, Labeling and Package Leaflet
AM
SmPCPIL079216_2
17.01.2017 – Updated: 17.01.2017
Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Niperten
®
Combi 5 mg/5 mg tablets
Niperten
®
Combi 5 mg/10 mg tablets
Niperten
®
Combi 10 mg/5 mg tablets
Niperten
®
Combi
10 mg/10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Niperten Combi 5 mg/5 mg tablets
Each tablet contains 5 mg amlodipine (as amlodipine besilate) and 5 mg
bisoprolol fumarate.
Niperten Combi 5 mg/10 mg tablets
Each tablet contains 5 mg amlodipine (as amlodipine besilate) and 10
mg bisoprolol fumarate.
Niperten Combi 10 mg/5 mg tablets
Each tablet contains 10 mg amlodipine (as amlodipine besilate) and 5
mg bisoprolol fumarate.
Niperten Combi 10 mg/10 mg tablets
Each tablet contains 10 mg amlodipine (as amlodipine besilate) and 10
mg bisoprolol fumarate.
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg/5 mg tablets: Round, biconvex, white tablets with bevelled edges
and scored on one side.
5 mg/10 mg tablets: Oval, biconvex, white tablets scored on one side.
10 mg/5 mg tablets: Round, slightly biconvex, white tablets with
bevelled edges, scored on one side
and engraved with CS on other side.
10 mg/10 mg tablets: Round, slightly biconvex, white tablets with
bevelled edges and scored on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (for substitution of the same doses of amlodipine and
bisoprolol used as monotherapy)._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended daily dose is 1 tablet of specific strength.
The dose is adjusted and titrated by the attending physician
individually for each patient by using
Niperten Combi components in monotherapy.
_Therapy duration _
Therapy with Niperten Combi is long-term.
1.3.1
Bisoprolol + Amlodipine
SPC, Labeling and Package Leaflet
AM
SmPCPIL079216_2
17.01.2017 – Updated: 17.01.2017
Page 2 of 12
_Hepatic impairment _
In patients with hepatic impairment, amlodipine elimination may be
delayed. Special