STEGLUJAN 5/100 ertugliflozin/sitagliptin (as phosphate monohydrate) 5 mg/100 mg film-coated tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg); ertugliflozin pyroglutamic acid, Quantity: 6.48 mg (Equivalent: ertugliflozin, Qty 5 mg)

Fáanlegur frá:

Merck Sharp & Dohme (Australia) Pty Ltd

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: microcrystalline cellulose; Carnauba Wax; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; calcium hydrogen phosphate; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black

Stjórnsýsluleið:

Oral

Einingar í pakka:

28, 7

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

STEGLUJAN (ertugliflozin and sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE]

Vörulýsing:

Visual Identification: Beige, almond-shaped, film-coated tablets debossed with '554' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2018-05-17

Upplýsingar fylgiseðill

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Product and Consumer Medicine Information Licence
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ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
PARTIES
YOU or YOUR means any legal person or entity who accesses or downloads
a PI Document or CMI Document from Our website
and
US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS *
NATURE OF AGREEMENT *
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website. *
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities. *
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