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Insulin Glargine (Toujeo)

Trade Name : TOUJEO

Sanofi-Aventis U.S. LLC

INJECTION, SOLUTION

Strength 300 U/mL

INSULIN GLARGINE Insulin [Chemical/Ingredient],Insulin Analog [EPC]

Delivery Process

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Insulin Glargine (Toujeo) which is also known as TOUJEO and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 300 U/mL per ml. Read more

Insulin Glargine (Toujeo) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.
  • Limitations of Use
  • TOUJEO is not recommended for the treatment of diabetic ketoacidosis.
  • TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ()
  • Limitations of Use
  • Not recommended for treating diabetic ketoacidosis. ()
  • No data
  • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. (, , )
  • Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day. ()
  • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ()
  • Do not dilute or mix with any other insulin or solution. ()
  • Closely monitor glucose when changing to TOUJEO and during initial weeks thereafter. ()
  • Injection: 300 units per mL of insulin glargine available as a clear, colorless, solution in:
  • Injection: 300 units/mL insulin glargine in:
  • 1.5 mL TOUJEO SoloStar single-patient-use prefilled pen ()
  • 3 mL TOUJEO Max SoloStar single-patient-use prefilled pen ()
  • TOUJEO is contraindicated:
  • During episodes of hypoglycemia ()
  • Hypersensitivity to TOUJEO or one of its excipients ()
  • No data
  • Never share
  • Hyperglycemia or hypoglycemia with changes in insulin regimen:
  • Hypoglycemia:
  • Medication errors:
  • Hypersensitivity reactions:
  • Hypokalemia:
  • Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs):
  • The following adverse reactions are discussed elsewhere:
  • Adverse reactions commonly associated with TOUJEO (u22655%) are:
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. (, )
  • Table 3 includes clinically significant drug interactions with TOUJEO.
  • Drugs that affect glucose metabolism:
  • Antiadrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine):
  • No data
  • Excess insulin administration may cause hypoglycemia and hypokalemia Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
  • TOUJEO (insulin glargine injection) is a long-acting insulin supplied as a sterile solution for subcutaneous injection containing 300 units/mL of insulin glargine.
  • Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Chemically, insulin glargine is 21-Gly-31-32-Di-Arg-human insulin and has the empirical formula CHNOSand a molecular weight of 6063. Insulin glargine has the following structural formula:
  • Each milliliter of TOUJEO contains 300 units (10.91 mg) insulin glargine dissolved in a clear aqueous fluid.
  • The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: 90 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.
  • The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: 90 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.
  • The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4. At pH 4, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of a precipitate from which small amounts of insulin glargine are slowly released.
  • No data
  • In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day). The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.
  • Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT test) and in tests for detection of chromosomal aberrations (cytogenetics in V79 cells and in Chinese hamsters).
  • In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day), maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • u00a92019 sanofi-aventis U.S. LLC
  • LANTUS, TOUJEO, SoloStar, and TOUJEO Max SoloStar are registered trademarks of sanofi-aventis U.S. LLC.
  • No data
  • Instructions for Use
  • Read this first
  • Do not share your TOUJEO SoloStar pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • TOUJEO contains 300 units/mL insulin glargine
  • People who are blind or have vision problems should not use the TOUJEO SoloStar pen without help from a person trained to use the TOUJEO SoloStar pen.
  • Important information
  • Learn to inject
  • Need help?
  • If you have any questions about your pen or about diabetes, ask your healthcare provider, go toor call sanofi-aventis at.
  • Extra items you will need:
  • Places to inject
  • Get to know your pen
  • Step 1: Check your pen
  • Take a new pen out of the refrigerator at leasthour before you inject. Cold insulin is more painful to inject.
  • If you have other injector pens
  • Step 2: Attach a new needle
  • Handling needles
  • Step 3: Do a safety test
  • Always do a safety test before each injection to:
  • If the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. If you see insulin coming out of the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar.
  • If no insulin appears:
  • If you see air bubbles
  • Step 4: Select the dose
  • How to read the dose window
  • The dose selector dials by 1 unit.
  • Even numbers are shown in line with the dose pointer:
  • Odd numbers are shown as a line between even numbers:
  • Units of insulin in your pen
  • Step 5: Inject your dose
  • If you find it hard to press the injection button in,force it as this may break your pen. See the section below for help.
  • If you find it hard to press the button in:
  • Step 6: Remove the needle
  • Use by
  • How to store your pen
  • Before first use
  • After first use
  • How to care for your pen
  • Handle your pen with care
  • Protect your pen from dust and dirt
  • Throwing your pen away
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Revised: November 2019
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • u00a92019 sanofi-aventis U.S. LLC
  • * The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC.
  • TOUJEO Max SoloStar (Too-Jay-o)(insulin glargine injection)3 mL single-patient-use prefilled pen
  • Read this first
  • Do not share your TOUJEO Max SoloStar pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • TOUJEO contains 300 units/mL insulin glargine
  • People who are blind or have vision problems should not use the TOUJEO Max SoloStar pen without help from a person trained to use the TOUJEO Max SoloStar pen.
  • Important information
  • Learn to inject
  • Need help?
  • If you have any questions about your pen or about diabetes, ask your healthcare provider, go to or call sanofi-aventis at .
  • Extra items you will need:
  • Places to inject
  • Get to know your pen
  • Step 1: Check your pen
  • Take a new pen out of the refrigerator at least hour before you inject. Cold insulin is more painful to inject.
  • If you have other injector pens
  • Step 2: Attach a new needle
  • Handling needles
  • Step 3: Do a safety test
  • Always do a safety test before each injection to:
  • If the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. If you see insulin coming out of the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar.
  • If you see air bubbles
  • Step 4: Select the dose
  • How to read the dose window
  • The dose selector dials by 2 units.
  • Each line in the dose window is an even number.
  • Units of insulin in your pen
  • Step 5: Inject your dose
  • If you find it hard to press the injection button in, force it as this may break your pen. See the section below for help.
  • If you find it hard to press the injection button in:
  • Step 6: Remove the needle
  • Use by
  • How to store your pen
  • Before first use
  • After first use
  • How to care for your pen
  • Handle your pen with care
  • Protect your pen from dust and dirt
  • Throwing your pen away
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Revised: November 2019
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • u00a92019 sanofi-aventis U.S. LLC
  • * The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC.
  • NDC 0024-5869-03
  • Rx ONLY
  • Toujeo SoloStarn insulin glargine injection
  • For Single Patient Use Only
  • 300 Units/mL (U-300)
  • Solution for injection in a disposable insulin delivery device Do not remove insulin with syringe Always use a new needle Do not mix with other insulins For subcutaneous Injection only Use only if solution is clear and colorless with no particles visible
  • Use within 56 days after opening *Needles not included (see back panel) Three prefilled pens, 450 units/1.5mL each u2013 Dispense in this sealed carton
  • SANOFI
  • NDC 0024-5871-02
  • Rx ONLY
  • ToujeoMax SoloStarn insulin glargine injection
  • For Single Patient Use Only
  • 300 Units/mL (U-300) Adjusts by 2 units
  • For subcutaneous injection only Solution for injection in a disposable insulin delivery device Do not remove insulin with syringe Always use a new needle Do not mix with other insulins Use only if solution is clear and colorless with no particles visible Use within 56 days after opening *Needles not included (see back panel) Two prefilled pens, 900 units/3mL each u2013 Dispense in this sealed carton
  • SANOFI

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