Label: MERILOG- insulin aspart-szjj injection, solution
- NDC Code(s): 0024-5927-00, 0024-5928-00, 0024-5928-05
- Packager: Sanofi-Aventis U.S. LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated February 19, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MERILOG safely and effectively. See full prescribing information for MERILOG™. MERILOG (insulin aspart-szjj) injection, for ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEMERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
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2 DOSAGE AND ADMINISTRATION2.1 Important Preparation and Administration Instructions - Always check insulin labels before administration [see Warnings and Precautions (5.4)]. Inspect MERILOG visually before use. It ...
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3 DOSAGE FORMS AND STRENGTHSInjection: 100 units/mL (U-100) is a clear and colorless solution available as: 10 mL multiple-dose vial - 3 mL single-patient-use MERILOG SoloStar® prefilled pen
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4 CONTRAINDICATIONSMERILOG is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3)]. In patients with hypersensitivity to insulin aspart products or any of the excipients in MERILOG ...
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5 WARNINGS AND PRECAUTIONS5.1 Never Share a MERILOG SoloStar Prefilled Pen Between Patients - MERILOG SoloStar prefilled pen should never be shared between patients, even if the needle is changed. Patients using MERILOG ...
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6 ADVERSE REACTIONSThe following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3)] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ...
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7 DRUG INTERACTIONSThe table below presents clinically significant drug interactions with MERILOG. Drugs That May Increase the Risk of Hypoglycemia - Drugs:Antidiabetic agents, ACE inhibitors, angiotensin II ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Available information from published randomized controlled trials with insulin aspart products use during the second trimester of pregnancy have not reported an ...
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10 OVERDOSAGEExcess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments ...
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11 DESCRIPTIONInsulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - The primary activity of insulin, including insulin aspart products is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin aspart ...
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14 CLINICAL STUDIES14.1 Overview of Clinical Studies - The safety and effectiveness of subcutaneous insulin aspart were compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 ...
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16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied - MERILOG (insulin aspart-szjj) injection 100 units/mL (U-100) is available as a clear and colorless solution in: Dosage UnitNDC # One 10 mL multiple-dose vial per ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a MERILOG SoloStar Prefilled Pen between Patients - Advise patients ...
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SPL UNCLASSIFIED SECTIONManufactured by: sanofi-aventis U.S. LLC - Bridgewater, NJ 08807 - A SANOFI COMPANY - U.S. License No. 1752 - ©2025 Sanofi. All rights reserved. All trademarks mentioned in this document are the ...
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PATIENT PACKAGE INSERTPATIENT INFORMATION - MERILOG™ [mer-ih-lawg] (insulin aspart-szjj) injection, for subcutaneous use - 100 units/mL (U-100) This Patient Information has been approved by the U.S. Food and ...
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INSTRUCTIONS FOR USEMERILOG™ [mer-ih-lawg](insulin aspart-szjj)injection, for subcutaneous use 10 mL multiple-dose vial: 100 units/mL (U-100)This Instructions for Use contains information on how to inject MERILOG. Read this Instructions for Use before you start taking MERILOG and each time you get a new MERILOG vial. There may be new ...
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INSTRUCTIONS FOR USE MERILOG™ SoloStar® [mer-ih-lawg soh-loh-stahr] (insulin aspart-szjj)injection, for subcutaneous use3 mL single-patient-use prefilled pen: 100 units/mL (U-100)This Instructions for Use contains information on how to inject MERILOG. Read this Instructions for Use before you start taking MERILOG and each time you get a new MERILOG SoloStar prefilled pen ...
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PRINCIPAL DISPLAY PANEL - 10 mL Vial LabelNDC 0024-5927-00 - Rx only - Merilog™ (insulin aspart-szjj) injection - 100 units/mL (U-100) For subcutaneous injection only - Dosage: See Prescribing Information - 10 mL multiple-dose vial - Mfd by ...
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PRINCIPAL DISPLAY PANEL - 10 mL Vial CartonNDC 0024-5927-00 - Rx only - Merilog™ (insulin aspart-szjj) injection - 100 units/mL (U-100) For subcutaneous injection only - Use only with a U-100 syringe - One 10 mL multiple-dose vial - sanofi
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PRINCIPAL DISPLAY PANEL - 3 mL Pen LabelNDC 0024-5928-00 - 3 mL Prefilled Pen - Rx only - Merilog™ SoloStar® (insulin aspart-szjj) injection - For Single Patient Use Only - 100 units/mL (U-100) For subcutaneous injection only - Dosage: See ...
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PRINCIPAL DISPLAY PANEL - 3 mL Pen CartonRx only - NDC 0024-5928-05 - Merilog™ SoloStar® (insulin aspart-szjj) injection - For Single Patient Use Only - 100 units/mL (U-100) For subcutaneous injection only - Do not mix with other ...
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INGREDIENTS AND APPEARANCEProduct Information