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Insulin Glargine (Basaglar)

Trade Name : BASAGLAR

Eli Lilly and Company

INJECTION, SOLUTION

Strength 100 [iU]/mL

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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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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 (Basaglar) which is also known as BASAGLAR and Manufactured by Eli Lilly and Company. It is available in strength of 100 [iU]/mL per ml. Read more

Insulin Glargine (Basaglar) 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
  • BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.n
  • Limitations of Use
  • BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.n
  • BASAGLAR 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. ()n
  • Limitations of Use
  • No data
  • Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use. (, , )n
  • Administer subcutaneously once daily at any time of day, but at the same time every day. ()n
  • Rotate injection sites into the abdominal area, thigh, or deltoid to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ()n
  • Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter. ()n
  • Do not dilute or mix with any other insulin or solution. ()n
  • Injection: 100u00a0units per mL (U-100) clear, colorless, sterile solution, available as:n
  • Injection: 100u00a0units/mL (U-100) is available as: ()n
  • 3u00a0mL single-patient-use BASAGLAR KwikPenn
  • 3u00a0mL single-patient-use BASAGLAR Tempo Penn
  • BASAGLAR is contraindicated:n
  • During episodes of hypoglycemia. ()n
  • Hypersensitivity to BASAGLAR or one of its excipients. ()n
  • 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:n
  • Adverse reactions commonly associated with insulin glargine products (5% or greater incidence) are:n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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. ()n
  • Table 6
  • Drugs that affect glucose metabolism:
  • Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine):
  • No data
  • Excess insulin administration relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening 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 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.n
  • Insulin glargine injection is a long-acting insulin for subcutaneous use. Insulin glargine is a recombinant human insulin analog . BASAGLAR 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-30-a-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:n
  • BASAGLAR (insulin glargine injection) is a clear, colorless, sterile aqueous solution for subcutaneous use. Each milliliter of BASAGLAR (insulin glargine injection) contains 100u00a0units of insulin glargine (3.6378u00a0mg).n
  • The 3u00a0mL BASAGLAR prefilled pen presentations contain the following inactive ingredients per mL: glycerin (17u00a0mg), metacresol (2.7u00a0mg), zinc (30u00a0mcg), zinc oxide content adjusted to provide 0.03u00a0mg zinc ion, and Water for Injection, USP.n
  • The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%. BASAGLAR has a pH of approximately 4.n
  • No data
  • In mice and rats, standard two-year carcinogenicity studies with another insulin glargine product were performed at doses up to 0.455u00a0mg/kg, which was for the rat approximately 10 times and for the mouse approximately 5 times the recommended human subcutaneous starting dose of 10u00a0units/day (0.008u00a0mg/kg/day), based on mg/m. 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.n
  • Another insulin glargine product 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).n
  • In a combined fertility and prenatal and postnatal study of another insulin glargine product in male and female rats at subcutaneous doses up to 0.36u00a0mg/kg/day, which was approximately 7 times the recommended human subcutaneous starting dose of 10u00a0units/day (0.008u00a0mg/kg/day), based on mg/m, 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.n
  • No data
  • No data
  • See FDA-approved patient labeling (Patient Information and Instructions for Use).n
  • BAS-0004-PPI-20191125n
  • Instructions for Use
  • BASAGLARn- Arrayn- KwikPenn- Array
  • insulin glargine injection (100 units/mL, 3 mL single-patient-use pen)
  • Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLAR KwikPen. 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.n
  • Do not share your BASAGLAR KwikPen 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.
  • BASAGLAR KwikPen (u201cPenu201d) is a disposable single-patient-use prefilled pen containing 300 units (3mL) of BASAGLAR. One pen contains multiple doses of medicine.n
  • People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.n
  • How to recognize your BASAGLAR KwikPen
  • Supplies needed to give your injection
  • Preparing your Pen
  • Priming your Pen
  • Prime before each injection.
  • Selecting your dose
  • The Pen will not let you dial more than the number of units left in the Pen.n
  • Giving your injection
  • After your injection
  • Disposing of Pens and Needles
  • Storing your BASAGLAR KwikPen
  • Unused Pens
  • In-use Pen
  • General information about the safe and effective use of your Pen
  • Troubleshooting
  • If you have any questions or problems with your BASAGLAR KwikPen, contact Lilly at 1-800-LillyRx (1-800- 545-5979) or call your healthcare provider for help. For more information on BASAGLAR KwikPen and insulin, go to www.basaglar.com.n
  • Scan this code to launch www.basaglar.comn
  • This Instructions for Use have been approved by the U.S. Food and Drug Administration. BASAGLAR and BASAGLAR KwikPen are trademarks of Eli Lilly and Company.n
  • Instructions for Use revised: November 2019n
  • Marketed by:n
  • Lilly USA, LLCn
  • Indianapolis, IN 46285, USAn
  • Copyright u00a9 2015, 2019, Eli Lilly and Company. All rights reserved.n
  • BASKP-0007-IFU-20191125n
  • Instructions for Use
  • BASAGLARn- Arrayn- Tempo Penu2122
  • insulin glargine injection (100u00a0units/mL, 3u00a0mL pen, single-patient-use)
  • Read the Instructions for Use before you start using BASAGLAR and each time you get another BASAGLAR Tempo Pen. 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.n
  • Do not share your BASAGLAR Tempo 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.
  • BASAGLAR Tempo Pen (u201cPenu201d) is a disposable single-patient-use prefilled pen containing 300u00a0units (3mL) of BASAGLAR. One pen contains multiple doses of medicine.n
  • People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.n
  • This BASAGLAR Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.n
  • How to recognize your BASAGLAR Tempo Pen
  • Supplies needed to give your injection
  • Preparing your Pen
  • Priming your Pen
  • Prime before each injection.
  • Selecting your dose
  • Giving your injection
  • After your injection
  • Disposing of Pens and Needles
  • Storing your BASAGLAR Tempo Pen
  • Unopened Pens
  • In-use Pen
  • General information about the safe and effective use of your Pen
  • Troubleshooting
  • If you have any questions or problems with your BASAGLAR Tempo Pen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on BASAGLAR Tempo Pen and insulin, go to www.basaglar.com.n
  • Scan this code to launchn
  • www.basaglar.comn
  • This Instructions for Use have been approved by the U.S. Food and Drug Administration.n
  • BASAGLAR is a registered trademark and Tempo Pen is a trademark of Eli Lilly and Company.n
  • Instructions for Use issued: 11/2019n
  • Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USAn
  • Copyright u00a9 2019, Eli Lilly and Company. All rights reserved.n
  • BASTP-0002-IFU-20191125n
  • PACKAGE CARTON u2013 BASAGLAR KwikPen 80 UNIT PEN
  • Dispense in this sealed carton.
  • NDC 0002-7715-59n
  • Basaglarn
  • KwikPenn
  • insulin glargine injectionn
  • For Single Patient Use Onlyn
  • U-100n
  • 100 units per mLn
  • 5 x 3 mL prefilled pensn
  • prefilled insulin delivery devicen
  • Can inject from in a single injectionn
  • Rx onlyn
  • For subcutaneous use.n
  • Read Basaglar KwikPen Instructions for Use.n
  • NEEDLES NOT INCLUDEDn
  • This device is recommended for use with Becton, Dickinson & Company's insulin pen needles.n
  • Lillyn
  • PACKAGE CARTON u2013 BASAGLAR Tempo Pen 80 UNIT PEN
  • Dispense in this sealed carton.
  • NDC 0002-8214-05n
  • Basaglarn
  • Tempo Penu2122n
  • insulin glargine injectionn
  • For Single Patient Use Onlyn
  • U-100n
  • 100 units per mLn
  • 5 x 3 mL prefilled pensn
  • prefilled insulin delivery devicen
  • Can inject from in a single injectionn
  • Rx onlyn
  • For subcutaneous use only.n
  • Read Basaglar Tempo Penu2122 Instructions for Use.n
  • NEEDLES NOT INCLUDEDn
  • This device is recommended for use with Becton, Dickinson & Company's insulin pen needles.n
  • Lillyn

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