Insulin Detemir (Levemir)

Trade Name : Levemir

Novo Nordisk

INJECTION, SOLUTION

Strength 100 [iU]/mL

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

Delivery Process

Submit a Request

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

Submit a Request

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

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 Detemir (Levemir) which is also known as Levemir and Manufactured by Novo Nordisk. It is available in strength of 100 [iU]/mL per ml. Read more

Insulin Detemir (Levemir) 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.

Inquire directly from our website and get 5% off on any medicine!

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

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
  • Dosage and Administration () 11/2019
  • Warnings and Precautions () 11/2019
  • LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
  • Limitations of Use
  • LEVEMIR is not recommended for the treatment of diabetic ketoacidosis.
  • LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus ().
  • Limitations of Use:
  • u2022
  • No data
  • 2.3n- 2.4
  • Injection: 100 unit per mL (U-100), is a clear, colorless, solution available as:
  • Injection 100 units/mL (U-100) available as:
  • LEVEMIR is contraindicated:
  • No data
  • Never Share
  • Hyperglycemia or hypoglycemia with changes in insulin regimen:
  • Hypoglycemia:
  • Hypoglycemia due to 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 associated with LEVEMIR include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Table 7 includes clinically significant drug interactions with LEVEMIR.
  • Table 7: Clinically Significant Drug Interactions with LEVEMIR
  • Drugs that Increase Hypoglycemia Risk or Increase or Decrease Blood Glucose Lowering Effect:
  • Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine):
  • No data
  • An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia n n . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes 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.
  • LEVEMIR (insulin detemir injection) is a solution for subcutaneous use. Insulin detemir is a long-acting recombinant human insulin analog. LEVEMIR is produced by a process that includes expression of recombinant DNA in followed by chemical modification.
  • Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of CHONS and a molecular weight of 5916.9. It has the following structure:
  • Figure 1: Structural Formula of Insulin Detemir
  • LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of LEVEMIR contains 100 units (14.2 mg/mL) insulin detemir, 65.4 mcg zinc, 2.06 mg m-cresol, 16.0 mg glycerol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LEVEMIR has a pH of approximately 7.4.
  • No data
  • Standard 2-year carcinogenicity studies in animals have not been performed. Insulin detemir tested negative for genotoxic potential in the reverse mutation study in bacteria, human peripheral blood lymphocyte chromosome aberration test, and the mouse micronucleus test.
  • In a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times a human dose of 0.5 units/kg/day, based on plasma AUC ratio). There were no effects on fertility in the rat.
  • The efficacy and safety of LEVEMIR given once-daily at bedtime or twice-daily (before breakfast and at bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH insulin in open-label, randomized, parallel studies of 1155 adults with type 1 diabetes mellitus, 347 pediatric patients with type 1 diabetes mellitus, and 869 adults with type 2 diabetes mellitus. The efficacy and safety of LEVEMIR given twice-daily was compared to once-daily insulin glargine in an open-label, randomized, parallel study of 320 patients with type 1 diabetes. The evening LEVEMIR dose was titrated in all trials according to pre-defined targets for fasting blood glucose. The pre-dinner blood glucose was used to titrate the morning LEVEMIR dose in those trials that also administered LEVEMIR in the morning. In general, the reduction in HbA with LEVEMIR was similar to that with NPH insulin or insulin glargine.
  • No data
  • See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)
  • Never Share a LEVEMIR FlexTouch between Patients
  • Advise patients that they must never share a LEVEMIR FlexTouch pen with another person, even if the needle is changed. Advise patients using LEVEMIR vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens n
  • Hypoglycemia
  • Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LEVEMIR therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia.
  • Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery n
  • Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions have occurred with LEVEMIR. Inform patients on the symptoms of hypersensitivity reactions n
  • Medication Errors
  • Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products .
  • Novo Nordiskn- Levemirn- NovoLogn- FlexTouchn n- NovoFine, and NovoTwist are registered trademarks of Novo Nordisk A/S.
  • Patent Information: https://www.novonordisk-us.com/products/product-patents.html
  • u00a9 2005-2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about LEVEMIR contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • www.novonordisk-us.com
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2019
  • Patient Instructions For Use
  • u00a0n n n
  • Please read the following Instructions for use carefully before using your LEVEMIR 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before.
  • How should I use the LEVEMIR 10 mL vial?
  • Using the 10 mL vial:
  • How should I inject LEVEMIR with a syringe?
  • If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.
  • Revised: 11/2019
  • Novo Nordisk and LEVEMIR are registered trademarks of Novo Nordisk A/S
  • PATENT Information: https://www.novonordisk-us.com/products/product-patents.html
  • u00a9 2005-2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about LEVEMIR contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • Instructions for Use
  • Levemir (LEVu2013uh-mere) FlexTouchPen
  • (insulin detemir injection)
  • Supplies you will need to give your Levemir injection:
  • Preparing your Levemir FlexTouch Pen:
  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the Levemir FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
  • Levemir should look clear and colorless. use Levemir if it is thick, cloudy, or is colored.
  • Do not
  • Always n- Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Priming your Levemir FlexTouch Pen:
  • Selecting your dose:
  • Giving your injection:
  • After your injection:
  • How should I store my Levemir FlexTouch Pen?
  • General Information about the safe and effective use of Levemir:
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Revised: 11/2019
  • For more information go to
  • u00a9 2005-2019 Novo Nordisk
  • Levemirn
  • FlexTouchn
  • Read before first use
  • Levemirn
  • Insulin detemir injection
  • NDC 0169-3687-12
  • List 368712
  • 100 units/mL (U-100)
  • For subcutaneous use only
  • Rx Only
  • One 10 mL Vial
  • novo nordiskn
  • NDC 0169-6438-10 List 643810
  • LevemirFlexTouchn
  • Insulin detemir injection
  • For Single Patient Use Only
  • 100 units/mL (U-100)
  • 5x3 mL Prefilled Pens
  • For subcutaneous use only
  • Rx Only
  • Recommended for use with
  • NovoFine, NovoFine Plus or
  • NovoTwist disposable needles.
  • Keep in a cold place until first use.
  • Store at 2u00b0 - 8u00b0C (36u00b0 - 46u00b0F).
  • Avoid freezing.
  • Protect from light.
  • Dispense in this sealed carton.

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.