AMLODIPINE/VALSARTAN NOVARTIS10/320 amlodipine 10 mg/valsartan 320 mg film-coated tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); valsartan, Quantity: 320 mg

Inapatikana kutoka:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Jina la Kimataifa):

amlodipine besilate,Valsartan

Dawa fomu:

Tablet, film coated

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

30, 14, 56, 7, 28

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

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

Idhini hali ya:

Registered

Idhini ya tarehe:

2010-08-09

Tabia za bidhaa

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