Insulin Aspart Injection (Fiasp)

Trade Name : Fiasp

Novo Nordisk

INJECTION, SOLUTION

Strength 100 [iU]/mL

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

Insulin Aspart Injection (Fiasp) 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.

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  • No data
  • Indications and Usage ()u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026..12/2019
  • Dosage and Administration (, )u2026u2026u2026u2026u2026u2026u2026u2026u202612/2019
  • Warnings and Precautions (, )u2026u2026u2026u2026u2026u2026u2026u2026u2026..12/2019
  • FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
  • u2022
  • 1
  • No data
  • Subcutaneous injection (n- ):
  • Arrayn- Array
  • Continuous Subcutaneous Infusion (Insulin Pump) n- (n- ):n- Array
  • Arrayn- Array
  • Intravenous Infusion:
  • Injection: 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in:
  • Injection: 100 units/mL (U-100):
  • FIASP is contraindicated
  • No data
  • Never share
  • Hyperglycemia or hypoglycemia with changes in insulin regimen
  • Hypoglycemia:
  • Hypoglycemia due to medication errors
  • Hypokalemia
  • Hypersensitivity reactions:
  • Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs):
  • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction:
  • The following adverse reactions are also discussed elsewhere:
  • Adverse reactions observed with FIASP include: hypoglycemia, allergic reactions, hypersensitivity, injection/infusion site reactions, lipodystrophy, and weight gain ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or
  • Table 5 includes clinically significant drug interactions with FIASP.
  • Table 5. Clinically Significant Drug Interactions with FIASP
  • 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
  • Excess insulin administration may cause 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 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.
  • FIASP (insulin aspart injection) is a rapid-acting insulin analog for subcutaneous or intravenous administration used to lower blood glucose. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing . Insulin aspart has the empirical formula CHN0S and a molecular weight of 5825.8 daltons.
  • FIASP (insulin aspart injection) is an aqueous, sterile, clear and colorless solution. Each mL contains 100 units of insulin aspart and the inactive ingredients: arginine (as L-arginine hydrochloride), USP (3.48 mg); disodium phosphate dihydrate, USP (0.53 mg); glycerol, USP (3.3 mg); metacresol, USP (1.72 mg); niacinamide, USP (20.8 mg); phenol, USP (1.50 mg); zinc (as zinc acetate), USP (19.6 mcg) and water for injection, USP. FIASP has a pH of 7.1. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
  • No data
  • In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, insulin aspart increased the incidence of mammary gland tumors in females when compared to untreated controls. The incidence of mammary tumors for insulin aspart was not significantly different than for regular human insulin. The relevance of these findings to humans is not known.
  • Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, micronucleus test in mice, and in UDS test in rat liver hepatocytes.
  • In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.
  • No data
  • No data
  • Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
  • Never Share a FIASP FlexTouch Pen Device, PenFill Cartridge or PenFill Cartridge Device Between Patients
  • Advise patients that they should never share a FIASP FlexTouch pen device, PenFill cartridge or PenFill cartridge devices with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using FIASP 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. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of FIASP 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.
  • 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 .
  • Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions .
  • Hypoglycemia due to Medication Errors
  • Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.
  • Patients Using Continuous Subcutaneous Insulin Pumps
  • Date of Issue: 12/2019
  • Version: 6
  • Novo Nordisk, FIASP, NovoLog, FlexTouch, and PenFillare registered trademarks of Novo Nordisk A/S.
  • PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2019 Novo Nordisk A/S
  • Manufactured by:Novo Nordisk A/SDK-2880 Bagsvaerd, Denmark
  • For information about FIASP contact:Novo Nordisk Inc.800 Scudders Mill RoadPlainsboro, New Jersey 085361-800-727-6500www.novonordisk-us.com
  • FIASP (feeu2019 asp)
  • for subcutaneous or intravenous use
  • Do not share your FIASP 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.
  • What is FIASP?
  • Who should not take FIASP?n- Do not take FIASP if you:
  • Before taking FIASP, tell your healthcare provider about all your medical conditions including, if you:
  • Before you start taking FIASP, talk to your healthcare provider about low blood sugar and how to manage it.
  • How should I take FIASP?
  • What should I avoid while taking FIASP?n- While taking FIASP do not:
  • What are the possible side effects of FIASP?n- FIASP may cause serious side effects that can lead to death, including:
  • Your insulin dose may need to change because of:
  • Common side effects of FIASP may include:
  • These are not all the possible side effects of FIASP. 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 FIASP.
  • 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 FIASP that is written for health professionals. Do not use FIASP for a condition for which it was not prescribed. Do not give FIASP to other people, even if they have the same symptoms that you have. It may harm them.
  • What are the ingredients in FIASP?
  • 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: 12/2019
  • Instructions for Use
  • FIASP (feeu2019 asp)
  • (insulin aspart injection)
  • 10 mL multiple-dose vial (100 units/mL, U-100)
  • Read this Instructions for Use before you start taking FIASP 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 FIASP injection:
  • Preparing your FIASP dose:
  • Giving your FIASP injection:
  • 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 FIASP?
  • All unopened vials:
  • After vials have been opened:
  • General information about the safe and effective use of FIASP
  • 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
  • FIASP is a registered trademark of Novo Nordisk A/S.
  • PATENT Information: n
  • u00a9 2019 Novo Nordisk
  • For information about FIASP contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • www.novonordisk-us.com
  • Revised: 10/2019
  • Instructions for Use
  • FIASP (feeu2019 asp) FlexTouch Pen
  • (insulin aspart injection)
  • Supplies you will need to give your FIASP injection:
  • Preparing your FIASP FlexTouch Pen:
  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the FIASP 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.
  • FIASP should look clear and colorless. use FIASP if it is thick, cloudy, or is colored.
  • Do not
  • Always n- Do not reuse
  • Priming your FIASP FlexTouch Pen:
  • Selecting your dose:
  • Giving your injection:
  • After your injection:
  • How should I store my FIASP FlexTouch Pen?
  • Before use:
  • Pen in use:
  • General Information about the safe and effective use of FIASP:
  • 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: 10/2019
  • For more information go to
  • u00a9 2019 Novo Nordisk
  • Instructions for Use
  • FIASPn- (feeu2019asp) PenFill 3 mL cartridge 100 Units/mL (U-100)
  • (insulin aspart injection)
  • Arrayn- Array
  • Supplies you will need to give your FIASP injection:
  • (Figure A)
  • How to use the FIASP PenFill cartridge
  • (Figure B)
  • Step 1:
  • (Figure C)
  • Prepare your device with a new needle
  • Step 2:
  • (Figure D)
  • Step 3:
  • (Figure E)
  • Step 4:
  • (Figure F)
  • A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.
  • Check the insulin flow
  • Step 5:
  • (Figure G)
  • Select your dose
  • Step 6:
  • (Figure H)
  • Inject your dose
  • Step 7:
  • (Figure I)
  • (Figure J)
  • You may see a drop of FIASP at the needle tip after injecting. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with a cotton gauze and cover with an adhesive bandage, if necessary. n
  • After your injection
  • Step 8:
  • (Figure K)
  • (Figure L)
  • Step 9:
  • (Figure M)
  • How should I store my FIASP PenFill cartridge?
  • Before use:
  • PenFill cartridges in use:
  • General Information about the safe and effective use of FIASP.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • u00a9 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • Revised: 10/2019
  • NDC 0169-3201-11 List 320111
  • FIASP
  • (insulin apart injection)
  • 10 mL 100 units/mL (U-100)
  • Rx only
  • NDC 0169-3204-15 List 320415
  • FIASPn- FlexTouch
  • (insulin aspart 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 NovoTwistn
  • disposable needles.
  • Keep in a refrigerator at 36u00b0 to 46u00b0F (2u00b0 to 8u00b0C) until first use.
  • After first use store at 36u00b0 to 86u00b0F (2u00b0 to 30u00b0C).
  • Do not freeze.
  • Protect from light.
  • Dispense in this sealed carton.
  • FIASP PenFilln
  • (insulin aspart injection)
  • 100 units/mL (U-100)
  • For Subcutaneous Use
  • For use with Novo Nordisk 3 mL PenFillu00ae cartridge compatible delivery devices, NovoPen Echo, and NovoFine/NovoFine Plus or NovoTwistu00ae disposable needles.
  • Not in-use (unopened) cartridges: Refrigerate at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C) in the original carton. In-use (opened) cartridge: Keep at room temperature below 86u00b0F (30u00b0C). Once stored at room temperature, discard after 28 days. Do not freeze. Protect from light.
  • Rx only
  • 3 mL cartridges
  • 5 cartridges per package

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