국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
KRKA-RUS LLC
C07FB07
bisoprolol (bisoprolol fumarate), amlodipine (amlodipine besilate)
5mg+ 10mg
tablets
(30/3x10/) in blister
Prescription
Registered
2017-09-05
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 전체 문서 읽기