AMLODIPINE/VALSARTAN NOVARTIS 10/160 amlodipine 10 mg/valsartan 160 mg film-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); valsartan, Quantity: 160 mg

제공처:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

amlodipine besilate,Valsartan

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide red; iron oxide yellow

관리 경로:

Oral

패키지 단위:

28 tablets (4 x 7 tabs), 30 tablets, 14 tablets, 56 tablets, 7 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

AMLODIPINE/VALSARTAN NOVARTIS is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

제품 요약:

Visual Identification: Light yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and UIC on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2008-08-12

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION –
AMLODIPINE/VALSARTAN NOVARTIS
 5/80
(AMLODIPINE /VALSARTAN) FILM-COATED TABLET
AMLODIPINE/VALSARTAN NOVARTIS

5/160
(AMLODIPINE /VALSARTAN) FILM-COATED TABLET
AMLODIPINE/VALSARTAN NOVARTIS
 10/160
(AMLODIPINE /VALSARTAN) FILM-COATED TABLET
AMLODIPINE/VALSARTAN NOVARTIS
 5/320
(AMLODIPINE /VALSARTAN) FILM-COATED TABLET
AMLODIPINE/VALSARTAN NOVARTIS
 10/320
(AMLODIPINE /VALSARTAN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Amlodipine/valsartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMLODIPINE/VALSARTAN NOVARTIS 5/80, AMLODIPINE/VALSARTAN NOVARTIS
5/160,
AMLODIPINE/VALSARTAN NOVARTIS 10/160, AMLODIPINE/VALSARTAN NOVARTIS
5/320
and AMLODIPINE/VALSARTAN NOVARTIS 10/320 are available as film-coated
tablets in five
strengths containing amlodipine (5 or 10 mg) and valsartan (80, 160 mg
or 320mg) as: 5/80
mg, 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
AMLODIPINE/VALSARTAN NOVARTIS 5/80 (5 mg amlodipine and 80 mg
valsartan): Dark
yellow, round film-coated tablet with bevelled edge, debossed with NVR
on one side and NV
on the other.
AMLODIPINE/VALSARTAN NOVARTIS 5/160 (5 mg amlodipine and 160 mg
valsartan): Dark
yellow, ovaloid film-coated tablet with bevelled edge, debossed with
NVR on one side and
ECE on the other.
AMLODIPINE/VALSARTAN NOVARTIS 10/160 (10 mg amlodipine and 160 mg
valsartan):
Light yellow, ovaloid film-coated tablet with bevelled edge, debossed
with NVR on one side
and UIC on the other.
AMLODIPINE/VALSARTAN NOVARTIS 5/320 (5 mg amlodipine and 320 mg
valsartan): Very
dark yellow, ovaloid film-coated tablet with bevelled edge, debossed
with NVR on one side
and CSF on the other.
AMLODIPINE/VALSARTAN NOVARTIS 10/320 (10 mg amlodipine and 320 mg
valsartan): Dark
yellow, ovaloid film-coated tablet with bevelled edge, debossed with
NVR on one side and
LUF on the other.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AMLODIPINE/VALSARTAN NOVARTIS is indicated for