SEGLUROMET 2.5/500 ertugliflozin/metformin hydrochloride 2.5 mg/500 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 500 mg; ertugliflozin pyroglutamic acid, Quantity: 3.238 mg (Equivalent: ertugliflozin, Qty 2.5 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; crospovidone; Carnauba Wax; povidone; microcrystalline cellulose; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; iron oxide red

Administration route:

Oral

Units in package:

14, 56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEGLUROMET (ertugliflozin 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 ertugliflozin and metformin is appropriate [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION]

Product summary:

Visual Identification: Pink, oval, film-coated tablets debossed with '2.5/500' 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

Authorization status:

Registered

Authorization date:

2018-05-17

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Summary of Product characteristics

Product and Consumer Medicine Information Licence
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ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
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YOU or YOUR means any legal person or entity who accesses or downloads
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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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