Tarka tablets modified-release film-coated

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

trandolapril, verapamil (verapamil hydrochloride)

可用日期:

AbbVie Deutschland GmbH & Co. KG

ATC代码:

C09BB10

INN（国际名称）:

trandolapril, verapamil (verapamil hydrochloride)

剂量:

2mg+ 180mg

药物剂型:

tablets modified-release film-coated

每包单位数:

(28/2x14/) in blister

处方类型:

Prescription

授权状态:

Registered

授权日期:

2020-07-17

产品特点

Trandolapril - Verapamil
SOLID 1000311530
v9.0
COMPANY CORE DATA
SHEET
TRANDOLAPRIL/VERAPAMIL
Date of approval: 24-Sep-2014
Date of previous approval: 14-Jan-2014
Abbott
Confidential information
1/28
This information is confidential
_NAME OF THE MEDICINAL PRODUCT_
Tarka 180 mg / 2 mg, modify-released, film-coated tablets.
Tarka 240 mg / 4 mg, modify-released, film-coated tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarka is supplied as tablets or capsules containing immediate release
trandolapril and
sustained release verapamil.
Tarka 180 mg / 2 mg, bilayer tablet:
Each bilayer tablet contains 180 mg verapamil hydrochloride and 2 mg
trandolapril.
Excipient: Each 2 mg/180 mg bilayer tablet contains up to 108.625 mg
lactose (as lactose
monohydrate).
Tarka 240 mg / 4 mg, bilayer tablet:
Each bilayer tablet contains 240 mg verapamil hydrochloride and 4 mg
trandolapril.
Excipient: Each 4 mg/240 mg bilayer tablet contains 110.37 mg lactose
(as lactose
monohydrate).
For the full list of excipients, see List of excipients section.
PHARMACEUTICAL FORM
Tarka 180 mg / 2 mg, bilayer tablet:
Please see local registration
Tarka 240 mg / 4 mg, bilayer tablet:
Please see local registration
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Tarka is indicated for the treatment of essential hypertension in
patients whose blood pressure
has been normalized with the individual components in the same
proportion of doses or in
patients whose blood pressure is not adequately controlled on
trandolapril or verapamil alone.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Posology
_Adults:_
The usual dosage is one tablet or capsule daily.
SPECIAL POPULATIONS
_Pediatric population:_
The safety and efficacy of Tarka in children and adolescents have not
yet been established.
Trandolapril - Verapamil
SOLID 1000311530
v9.0
COMPANY CORE DATA
SHEET
TRANDOLAPRIL/VERAPAMIL
Date of approval: 24-Sep-2014
Date of previous approval: 14-Jan-2014
Abbott
Confidential information
2/28
This information is confidential
Therefore use in this age group is no