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STEGLATRO(ertugliflozin tablets)(二十六)
2018-06-21 09:29:39 来源: 作者: 【 】 浏览:14976次 评论:0
afe and effective use of STEGLATRO. 
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STEGLATRO for a condition for which it was not prescribed. Do not give STEGLATRO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about STEGLATRO that is written for health professionals. 
For more information about STEGLATRO, go to www.steglatro.com or call 1-800-622-4477. 
What are the ingredients in STEGLATRO?
Active ingredient: ertugliflozin.
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate. The tablet film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide, and iron oxide red. 
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
 For patent information, go to: www.merck.com/product/patent/home.html. Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. 
All rights reserved.
usmg-mk8835-t-1712r000 
 
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label 
 
NDC 0006-5363-03
 
Steglatro™
(ertugliflozin) tablets 
 
5 mg 
 
Dispense the accompanying Medication Guide
to each patient. 
 
Each tablet contains 6.48 mg ertugliflozin L-pyroglutamic
acid (equivalent to 5 mg ertugliflozin).
 
Rx only 
 
30 Tablets 
 
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label 
 
PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label 
 
NDC 0006-5364-03
 
Steglatro™
(ertugliflozin) tablets 
 
15 mg 
 
Dispense the accompanying Medication Guide
to each patient. 
 
Each tablet contains 19.43 mg ertugliflozin L-pyroglutamic
acid (equivalent to 15 mg ertugliflozin).
 
Rx only 
 
30 Tablets 
 
PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label 
 
INGREDIENTS AND APPEARANCE 
 
STEGLATRO   
ertugliflozin tablet, film coated 
 
Product Information 
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-5363 
Route of Administration ORAL 
 
 
Active Ingredient/Active Moiety 
 
Ingredient Name
 
Basis of Strength
 
Strength
 
ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP) ERTUGLIFLOZIN 5 mg 
Inactive Ingredients 
 
Ingredient Name
 
Strength
 
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)   
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)   
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)   
MAGNESIUM STEARATE (UNII: 70097M6I30)   
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG2
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