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Insulin Glargine (Lantus Solostar)

Trade Name : Lantus Solostar

sanofi-aventis U.S. LLC

INJECTION, SOLUTION

Strength 100 [iU]/mL

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

Delivery Process

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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 (Lantus Solostar) which is also known as Lantus Solostar and Manufactured by sanofi-aventis U.S. LLC. It is available in strength of 100 [iU]/mL per ml. Read more

Insulin Glargine (Lantus Solostar) 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

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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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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.

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  • No data
  • No data
  • LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
  • Limitations of Use
  • LANTUS is not recommended for the treatment of diabetic ketoacidosis.
  • LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ()
  • Limitations of Use
  • Not recommended for treating diabetic ketoacidosis. ()
  • No data
  • Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes prior insulin use. (, , )
  • Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ()
  • Do not dilute or mix with any other insulin or solution. ()
  • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ()
  • Closely monitor glucose when changing to LANTUS and during initial weeks thereafter. ()
  • Injection: 100 units per mL (U-100) available as:
  • Injection: 100 units/mL (U-100) available as:
  • 10 mL multiple-dose vial ()
  • 3 mL single-patient-use SoloStar prefilled pen ()
  • LANTUS is contraindicated:
  • During episodes of hypoglycemia ()
  • Hypersensitivity to LANTUS 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 LANTUS include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain. ()
  • 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.
  • Table 8 includes clinically significant drug interactions with LANTUS.
  • Drugs that affect glucose metabolism
  • Antiadrenergic Drugs
  • No data
  • Excess insulin administration may cause hypoglycemia and hypokalemia . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise 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. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.
  • LANTUS (insulin glargine injection) is a sterile solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analog that is a long-acting, parenteral blood-glucose-lowering agent . Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a basal insulin. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic 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 are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21-Gly-30a-L-Arg-30b-L-Arg-human insulin and has the empirical formula CHNOS and a molecular weight of 6063. Insulin glargine has the following structural formula:
  • LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 units (3.6378 mg) insulin glargine.
  • The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection.
  • The 3 mL prefilled pen presentation contains the following inactive ingredients per mL: 30 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. LANTUS has a pH of approximately 4.
  • 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) on a mg/kg basis. Histiocytomas were found at injection sites in male rats and mice in acid vehicle containing groups and are considered a response to chronic tissue irritation and inflammation in rodents. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle.
  • 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 vitro in V79 cells and in vivo 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
  • Novaplus is a registered trademark of Vizient, Inc.
  • u00a92019 sanofi-aventis U.S. LLC
  • LANTUS, TOUJEO and SoloStar are registered trademarks of sanofi-aventis U.S. LLC.
  • This Patient Information has been approved by the U.S. Food and Drug AdministrationApproved: November 2019
  • Instructions for UseLANTUS (LAN-tus)(insulin glargine injection) for subcutaneous use10 mL Vial (100 Units/mL, U-100)
  • Read the Instructions for Use before you start taking LANTUS and each time you get a new LANTUS vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • Do not share your LANTUS syringes 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.
  • Supplies needed to give your injection:
  • Preparing your LANTUS dose:
  • Step 1:
  • If you are using a new vial, remove the protective cap. remove the stopper.
  • Step 2:
  • Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of LANTUS before use.
  • Step 3:
  • Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.
  • Step 4:
  • Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.
  • Step 5:
  • Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.
  • Step 6:
  • Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.
  • Giving your LANTUS injection:
  • Step 7:
  • Choosing your injection site: LANTUS is injected under the skin (subcutaneously) of your upper arm, thigh, or stomach area (abdomen). Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject your dose.
  • Step 8:
  • Step 9:
  • Disposing of used needles and syringes:
  • How should I store LANTUS?
  • 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
  • Novaplus is a registered trademark of Vizient, Inc.
  • This Patient Information has been approved by the U.S. Food and Drug Administration
  • Revised: November 2019
  • LANTUS SOLOSTAR Single-Patient-Use Prefilled Pen
  • Your healthcare professional has decided that SoloStar is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar.
  • Read these instructions carefully before using your SoloStar. If you are not able to follow all the instructions completely on your own, use SoloStar only if you have help from a person who is able to follow the instructions.
  • Do not share your LANTUS 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.
  • People who are blind or have vision problems should not use LANTUS SoloStar single-patient-use prefilled pen without help from a person trained to use LANTUS SoloStar single-patient-use prefilled pen.
  • Follow these instructions completely each time you use SoloStar to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.
  • SoloStar is a disposable pen for the injection of insulin. Each SoloStar contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of insulin have been given.
  • Keep this leaflet for future reference.
  • If you have any questions about SoloStar or about diabetes, ask your healthcare professional, go to www.lantus.com or call sanofi-aventis at 1-800-633-1610.
  • Important information for use of SoloStar:
  • Places to inject
  • Step 1. Check the insulin
  • Step 2. Attach the needle
  • Do not re-use needles. Always use a new sterile needle for each injection. This helps prevent contamination and potential needle blocks.
  • Step 3. Perform a Safety test
  • Arrayn- Always
  • You may have to perform the safety test several times before insulin is seen.
  • Step 4. Select the dose
  • You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.
  • Step 5. Inject the dose
  • Step 6. Remove and discard the needle
  • Always remove the needle after each injection and store SoloStar without a needle attached. This helps prevent:
  • Storage Instructions
  • Please check the leaflet for the insulin for complete instructions on how to store SoloStar.
  • If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.
  • Keep SoloStar out of the reach and sight of children.
  • Keep your SoloStar in cool storage (36u00b0Fu201346u00b0F [2u00b0Cu20138u00b0C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator or next to a freezer pack.
  • Once you take your SoloStar out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86u00b0F (30u00b0C). Do not use it after this time.SoloStar in use must not be stored in a refrigerator.
  • Do not use SoloStar after the expiration date printed on the label of the pen or on the carton.
  • Protect SoloStar from light.
  • Discard your used SoloStar as required by your local authorities.
  • Maintenance
  • Protect your SoloStar from dust and dirt.
  • You can clean the outside of your SoloStar by wiping it with a damp cloth.
  • Do not soak, wash, or lubricate the pen as this may damage it.
  • Your SoloStar is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.
  • 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
  • Novaplus is a registered trademark of Vizient, Inc.
  • * The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC
  • NDC 0088-5021-01 Rx only
  • Lantusn insulin glargineinjection
  • 100 units/mL(U-100) For subcutaneousinjection only
  • Do not mix withother insulins
  • Use only if solutionis clear and colorlesswith no particles visible
  • Use with U-100syringe only
  • One 10 mL multiple-dose vial
  • novaplusn
  • NDC 0088-5020-05n n
  • Lantus SoloStarn n- insulin glargine injectionn- For Single Patient Use Onlyn- 100 units/mLn- Five
  • Solution for injection in a disposable insulin delivery device tttttttn n For subcutaneous injection onlyUse only if solution is clear and colorless with no particles visible tttttttUse within 28 days after initial use (see back panel)
  • NOVAPLUSn

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