JANUMET XR 50/500 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/500 mg extended release tablet bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

metformin hydrochloride, Quantity: 500 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg (Equivalent: sitagliptin, Qty 50 mg)

Pieejams no:

Merck Sharp & Dohme (Australia) Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Metformin hydrochloride,sitagliptin phosphate monohydrate

Zāļu forma:

Tablet, modified release

Kompozīcija:

Excipient Ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; microcrystalline cellulose; Carnauba Wax; titanium dioxide; hyprolose; indigo carmine aluminium lake

Ievadīšanas:

Oral

Vienības iepakojumā:

56 tablets, 14 tablets - starter pack

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

JANUMET XR (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].

Produktu pārskats:

Visual Identification: Light blue, bi-convex oval, film coated tablet, debossed "78" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizācija statuss:

Licence status A

Autorizācija datums:

2013-11-01

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION –
JANUMET
® (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN
HYDROCHLORIDE) 50 MG/500 MG, 50 MG/850 MG & 50 MG/1000 MG
JANUMET
® XR (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN
HYDROCHLORIDE MODIFIED RELEASE) 50 MG/500 MG, 50 MG/1000 MG &
100 MG/1000 MG
1
NAME OF THE MEDICINE
sitagliptin phosphate monohydrate/metformin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JANUMET and JANUMET XR both contain sitagliptin phosphate and
metformin
hydrochloride. JANUMET tablets consist of sitagliptin and an
immediate-release formulation
of metformin, and JANUMET XR tablets consist of sitagliptin and a
modified release
formulation of metformin.
JANUMET is available for oral administration as film-coated tablets
containing sitagliptin
phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg
sitagliptin as free
base and 500 mg metformin hydrochloride (JANUMET 50 mg/500 mg), 850 mg
metformin
hydrochloride (JANUMET 50 mg/850 mg) or 1000 mg metformin
hydrochloride (JANUMET
50 mg/1000 mg).
JANUMET XR is available for oral administration as film-coated tablets
containing sitagliptin
phosphate monohydrate equivalent to 50 mg sitagliptin as free base and
either 500 mg
metformin hydrochloride modified release (JANUMET XR 50 mg/500 mg*),
or 1000 mg
metformin hydrochloride modified release (JANUMET XR 50 mg/1000 mg).
Additionally,
JANUMET XR is available for oral administration as tablets containing
sitagliptin phosphate
monohydrate equivalent to 100 mg sitagliptin as free base and 1000 mg
metformin
hydrochloride modified release (JANUMET XR 100 mg/1000 mg).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
JANUMET 50 mg/500 mg - a light pink, film coated tablet with "575" on
one side and plain
on the other.
JANUMET 50 mg/850 mg - a pink, film coated tablet with "515" on one
side and plain on the
other.
JANUMET 50 mg/1000 mg - a red, film coated tablet with "577" on one
side and plain on the
other.
JANUMET XR consists of a modified release m