AMLODIPINE/VALSARTAN NOVARTIS 5/160 amlodipine 5 mg/valsartan 160 mg film-coated tablets blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

valsartan, Quantity: 160 mg; amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Mevcut itibaren:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Adı):

amlodipine besilate,Valsartan

Farmasötik formu:

Tablet, film coated

Kompozisyon:

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

Uygulama yolu:

Oral

Paketteki üniteler:

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

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

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

Ürün özeti:

Visual Identification: Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and ECE 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

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2008-08-12

Ürün özellikleri

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