Insulin Degludec Injection (Tresiba)

Trade Name : Tresiba

Novo Nordisk

INJECTION, SOLUTION

Strength 200 U/mL

INSULIN DEGLUDEC Insulin [CS],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 Degludec Injection (Tresiba) which is also known as Tresiba and Manufactured by Novo Nordisk. It is available in strength of 200 U/mL per ml. Read more

Insulin Degludec Injection (Tresiba) 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

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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
  • Dosage and Administration ()u2026u2026u2026u2026u2026.u2026u2026u2026u2026u2026u202611/2019
  • Warnings and Precautions ( )u2026u2026u2026u2026u2026u2026.u2026u2026u2026u2026u2026.11/2019
  • TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
  • Limitations of Use
  • TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ().
  • Limitations of Use:
  • u2022
  • No data
  • 2.3n- 2.4
  • Injection: TRESIBA is available as a clear and colorless solution:
  • TRESIBA injection is available in the following package sizes:
  • TRESIBA is contraindicated:
  • No data
  • Never share
  • Hyperglycemia or hypoglycemia with changes in insulin regimen: n- ().
  • 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 also discussed elsewhere:
  • Adverse reactions commonly associated with TRESIBA are:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-800-727-6500 or FDA at 1-800-FDA-1088 or
  • u2022
  • 6.1
  • Table 5 includes clinically significant drug interactions with TRESIBA.
  • Table 5: Clinically Significant Drug Interactions with TRESIBA
  • Drugs that may increase the risk of hypoglycemia:
  • Drugs that may decrease the blood glucose lowering effect:
  • Drugs that may increase or decrease the blood glucose lowering effect:
  • Drugs that may blunt the signs and symptoms of hypoglycemia:
  • 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 . 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 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 reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.
  • TRESIBA (insulin degludec injection) is a long-acting basal human insulin analog for subcutaneous injection. Insulin degludec is produced by a process that includes expression of recombinant DNA in followed by chemical modification.
  • Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nu03b5-hexadecandioyl-u03b3-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of CHNOS and a molecular weight of 6103.97. It has the following structure:
  • TRESIBA is a sterile, aqueous, clear, and colorless solution that contains insulin degludec 100 units/mL (U-100) or 200 units/mL (U-200).
  • For the 100 units/mL solution, each mL contains 100 units (600 nmol) of insulin degludec and glycerol (19.6 mg), metacresol (1.72 mg), phenol (1.50 mg), zinc (32.7 mcg), and Water for Injection, USP.
  • For the 200 units/mL solution, each mL contains 200 units (1200 nmol) of insulin degludec and glycerol (19.6 mg), metacresol (1.72 mg), phenol (1.50 mg), zinc (71.9 mcg), and Water for Injection, USP.
  • TRESIBA has a pH of approximately 7.6. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • No data
  • Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin degludec. In a 52-week study including human insulin (NPH insulin) as comparator (6.7 units/kg/day), Sprague-Dawley rats were dosed subcutaneously with insulin degludec at 3.3, 6.7, and 10 units/kg/day, resulting in 5 times the human exposure (AUC) when compared to a human subcutaneous dose of 0.75 units/kg/day. Human insulin was dosed at 6.7 units/kg/day. No treatment-related increases in incidences of hyperplasia, benign or malignant tumors were recorded in female mammary glands from rats dosed with insulin degludec and no treatment related changes in the female mammary gland cell proliferation were found using BrdU incorporation. Further, no treatment related changes in the occurrence of hyperplastic or neoplastic lesions were seen in other tissues in animals dosed with insulin degludec when compared to vehicle or human insulin.
  • Genotoxicity testing of insulin degludec was not performed.
  • In a combined fertility and embryo-fetal study in male and female rats, treatment with insulin degludec up to 21 units/kg/day (approximately 5 times the human subcutaneous dose of 0.75 units/kg/day, based on units/body surface area) prior to mating and in female rats during gestation had no effect on mating performance and fertility.
  • The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in patients with type 1 diabetes and used in combination with a mealtime insulin was evaluated in three randomized, open-label, treat-to-target, active-controlled trials in adults and one randomized, open-label, treat-to-target, active-controlled trial in pediatric patients 1 year of age and older. The efficacy of TRESIBA administered once-daily either at the same time each day or at any time each day in adult patients with type 2 diabetes and used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents was evaluated in six randomized, open-label, treat-to-target active-controlled trials.
  • Adult patients treated with TRESIBA achieved levels of glycemic control similar to those achieved with LANTUS (insulin glargine 100 units/mL) and LEVEMIR (insulin detemir) and achieved statistically significant improvements compared to sitagliptin.
  • No data
  • Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Never Share a TRESIBA FlexTouch Pen, Needle, or Syringe Between Patients
  • Advise patients that they should never share a TRESIBA FlexTouch pen device with another person, even if the needle is changed. Advise patients using TRESIBA vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia
  • Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.
  • Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision .
  • Medication Errors
  • Inform patients to always check the insulin label before each injection . Inform patients that the dose counter of TRESIBA FlexTouch pen shows the number of units of TRESIBA to be injected. NO dose re-calculation is required . Instruct patients to never use a syringe to remove TRESIBA from the FlexTouch disposable insulin prefilled pen.
  • Rx Only
  • Date of Issue: 11/2019
  • Version: 8
  • Novo Nordiskn n- TRESIBAn n- FlexTouchn- LEVEMIRn- NOVOLOGn- NovoFinen n- NovoTwistn n- registered trademarks of Novou00a0Nordisk A/S.
  • u00a9 2015-2019 Novo Nordisk
  • PATENT Information: n
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvu00e6rd, Denmark
  • For information about TRESIBA contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536
  • 1-800-727-6500
  • www.novonordisk-us.com
  • TRESIBAu00ae (treu2013SI-bah)
  • Do not share your TRESIBA FlexTouch insulin delivery device with other people, even if the needle has changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.
  • What is TRESIBA?
  • Who should not take TRESIBA?
  • Do not take TRESIBA if you:
  • Before taking TRESIBA, tell your healthcare provider about all your medical conditions including, if you are:
  • Before you start taking TRESIBA, talk to your healthcare provider about low blood sugar and how to manage it.
  • How should I take TRESIBA?
  • What should I avoid while taking TRESIBA?
  • While taking TRESIBA do not:
  • What are the possible side effects of TRESIBA?
  • TRESIBA may cause serious side effects that can lead to death, including:
  • Your insulin dose may need to change because of:
  • Common side effects of TRESIBA may include:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of TRESIBA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of TRESIBA.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRESIBA that is written for health professionals. Do not use TRESIBA for a condition for which it was not prescribed. Do not give TRESIBA to other people, even if they have the same symptoms that you have. It may harm them.
  • What are the ingredients in TRESIBA?
  • Active Ingredient:
  • Inactive Ingredients:
  • Manufactured by:
  • For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2019
  • Instructions for Use
  • TRESIBA (treu2013SI-bah)
  • (insulin degludec injection)
  • 10 mL multiple-dose vial (100 units/mL, U-100)
  • Read this Instructions for Use before you start taking TRESIBA and each time you get a refill. 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.
  • The vial is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and insulin syringe.
  • Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
  • Supplies you will need to give your TRESIBA injection:
  • Preparing your TRESIBA dose:
  • After your injection:
  • Disposing of your used needles and syringes:
  • Put your used insulin needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • How should I store TRESIBA?
  • Before use:
  • Vial in use:
  • General information about the safe and effective use of TRESIBA
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvu00e6rd, Denmark
  • Novo Nordisk and TRESIBA are registered trademarks of Novo Nordisk A/S.
  • Patent Information:
  • u00a9 2015-2019 Novo Nordisk
  • For information contact:
  • Plainsboro, NJ 08536
  • 1-800-727-6500 (Se habla espau00f1ol)
  • Revised: 11/2019
  • Instructions for Use
  • TRESIBA (tre-SI-bah) FlexTouch Pen 100 units/mL
  • (insulin degludec injection)
  • Supplies you will need to give your TRESIBA injection:
  • Preparing your TRESIBA FlexTouch Pen:
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Priming your TRESIBA FlexTouch Pen:
  • Step 7:
  • Step 8:
  • Step 9:
  • shows u201c0u201d. The u201c0u201d must line up with the dose pointer.
  • Selecting your dose:
  • Step 10:
  • TRESIBA FlexTouch Pen 100 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed. n
  • Check to make sure the dose selector is set at 0.
  • with your dose (See Figure K).
  • Giving your injection:
  • Step 11:
  • Step 12:
  • Step 13:
  • Step 14:
  • Step 15:
  • Step 16:
  • After your injection:
  • How should I store my TRESIBA FlexTouch Pen?
  • Before use:
  • Pen in use:
  • General Information about the safe and effective use of TRESIBA.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Revised: 11/2019
  • For more information go ton
  • u00a9 2015-2019 Novo Nordisk
  • Instructions for Use
  • TRESIBA (tre-SI-bah) FlexTouch Pen 200 units/mL
  • (insulin degludec injection)
  • Supplies you will need to give your TRESIBA injection:
  • Preparing your TRESIBA FlexTouch Pen:
  • (Figure A)
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Priming your TRESIBA FlexTouch Pen:
  • Step 7:
  • Step 8:
  • Step 9:
  • Selecting your dose:
  • Step 10:
  • TRESIBA FlexTouch Pen 200 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed. n
  • Check to make sure the dose selector is set at 0.
  • Giving your injection:
  • Step 11:
  • Step 12:
  • Step 13:
  • Step 14:
  • Step 15:
  • Step 16:
  • After your injection:
  • How should I store my TRESIBA FlexTouch Pen?
  • Before use:
  • Pen in use:
  • General Information about the safe and effective use of TRESIBA.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • Revised: 11/2019
  • For more information go to n
  • u00a9 2015-2019 Novo Nordisk
  • NDC 0169-2662-11 List 266211
  • TRESIBAn
  • 100 units/mL (U-100)
  • For subcutaneous use only
  • Rx Only
  • One 10 mL vial
  • NDC 0169-2660-15
  • List: 266015
  • TRESIBAn
  • FlexTouchn
  • (insulin degludec injection)
  • For Single Patient Use Only
  • 100 units/mL (U-100)
  • 5u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Rx Only
  • Recommended for use with NovoFine, n- NovoFine Plus or NovoTwist disposable needles.
  • Keep in a cold place until first use.
  • Store at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C).
  • Do not freeze.
  • After first use, store between 36u00b0F to 86u00b0F (2u00b0C to 30u00b0C).
  • Protect from light.
  • Dispense in this sealed carton.
  • NDC 0169-2550-13
  • List: 255013
  • TRESIBAn
  • FlexTouchn
  • (insulin degludec injection)
  • For Single Patient Use Only
  • 200 units/mL (U-200)
  • 3u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Rx Only
  • Recommended for use with n- NovoFine, NovoFine Plus or NovoTwist disposable needles.n- disposable needles.
  • Keep in a cold place until first use.
  • Store at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C).
  • Do not freeze.
  • After first use, store between 36u00b0F to 86u00b0F (2u00b0C to 30u00b0C).
  • Protect from light.
  • Dispense in this sealed carton.

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