Water Injection (Insulin Diluting Medium For Novolog)

Trade Name : Insulin Diluting Medium for NovoLog

Novo Nordisk

INJECTION, SOLUTION

Strength 1 mL/mL

WATER

Delivery Process

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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 Water Injection (Insulin Diluting Medium For Novolog) which is also known as Insulin Diluting Medium for NovoLog and Manufactured by Novo Nordisk. It is available in strength of 1 mL/mL per ml. Read more

Water Injection (Insulin Diluting Medium For Novolog) 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
  • Dosage and Administration ()-----------------12/2018
  • Dosage and Administration ()-----------------11/2019
  • u00a0
  • 5.2
  • NOVOLOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
  • u2022
  • 1
  • See Full Prescribing Information for important administration and dosage instructions ().
  • Subcutaneous injection ():
  • Continuous Subcutaneous Infusion (Insulin Pump) ():
  • Intravenous Administration ()
  • NOVOLOG 100 units per mL (U-100) is available as a clear and colorless solution for injection in:
  • Each presentation contains 100 Units of insulin aspart per mL (U-100)
  • NOVOLOG is contraindicated:
  • No data
  • Never share
  • Hyperglycemia or hypoglycemia with changes in insulin regimen:
  • Hypoglycemia:
  • Medication Errors:
  • Hypersensitivity reactions:
  • Hypokalemia:
  • Fluidn- retention and heart failure with concomitant use of thiazolidinediones (TZDs):
  • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction:
  • Adverse reactions observed with NOVOLOG include: hypoglycemia, allergic reactions, local 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.
  • No data
  • 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
  • u2022
  • (8.4).
  • 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.
  • NOVOLOG (insulin aspart injection) is a rapid-acting human insulin analog used to lower blood glucose. NOVOLOG 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 (baker's yeast). Insulin aspart has the empirical formula CHN0S and a molecular weight of 5825.8.
  • NOVOLOG is a sterile, aqueous, clear, and colorless solution, that contains insulin aspart 100 units/mL, glycerin 16 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 mcg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.58 mg/mL and water for injection. NOVOLOG has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Never Share a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill Cartridge or PenFill Cartridge Device Between Patients
  • Advise patients that they must never share NOVOLOG FlexPen, NOVOLOG FlexTouch, 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 NOVOLOG vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens n .
  • 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 NOVOLOG 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 .
  • Hypoglycemia with Medication Errors
  • Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products n .
  • Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions have occurred with NOVOLOG. Inform patients of the symptoms of hypersensitivity reactions n .
  • Administration
  • NOVOLOG must only be used if the solution is clear and colorless with no particles visible. Instruct patients that when injecting NOVOLOG, they must press and hold down the dose button until the dose counter shows 0 and then keep the needle in the skin and count slowly to 6 as the prescribed dose is not completely delivered until 6 seconds later. If the needle is removed earlier, the full dose may not be delivered (a possible under-dose may occur by as much as 20%). Inform the patient to increase the frequency of checking their blood glucose and that possible additional insulin administration may be necessary.
  • If 0 does not appear in the dose counter after continuously pressing the dose button, the patient may have used a blocked needle. In this case they would have received insulin u2013 even though the dose counter has moved from the original dose that was set. Instruct the patient to change the needle as described in Section 5 of the Instructions for Use and repeat all steps in the IFU starting with Section 1: Prepare your pen with a new needle. n
  • Patients Using Continuous Subcutaneous Insulin Pumpsn- Array
  • Before using an insulin pump with NOVOLOG, read the pump label to make sure the pump has been evaluated with NOVOLOG.
  • Rx only
  • Date of Issue: 11/2019
  • Version: 27
  • Novo Nordisk, NOVOLOG, PenFill, Novolin, FlexPen, FlexTouch, NovoFine, and NovoTwist are registered trademarks of Novo Nordisk A/S.
  • Patent Information: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2002-2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about NOVOLOG contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • NovoLog (Nu014c-vu014d-log)
  • (insulin aspart injection)
  • Do not share your NovoLog FlexPen, NovoLog FlexTouch, PenFill cartridge or PenFill cartridge compatible insulin delivery device 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 NovoLog?
  • Who should not take NovoLog?
  • Do not take NovoLog if you:
  • Before taking NovoLog, tell your healthcare provider about all your medical conditions including, if you are:
  • Before you start taking NovoLog, talk to your healthcare provider about low blood sugar and how to manage it.
  • How should I take NovoLog?
  • What should I avoid while taking NovoLog?
  • While taking NovoLog do not:
  • What are the possible side effects of NovoLog?
  • NovoLog may cause serious side effects that can lead to death, including:
  • Low blood sugar (hypoglycemia).
  • Your insulin dose may need to change because of:
  • Other common side effects of NovoLog may include:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of NovoLog. 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 NovoLog.
  • 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 NovoLog that is written for health professionals. Do not use NovoLog for a condition for which it was not prescribed. Do not give NovoLog to other people, even if they have the same symptoms that you have. It may harm them.
  • What are the ingredients in NovoLog?
  • 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
  • NovoLog (Nu014c-vu014d-log)
  • (insulin aspart injection)
  • 10 mL multiple-dose vial (100 Units/mL, U-100)
  • Read this Instructions for Use before you start taking NovoLog 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.
  • Supplies you will need to give your NovoLog injection:
  • Preparing your NovoLog dose:
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Step 7:
  • Step 8:
  • Step 9:
  • Step 10:
  • (Figure J)
  • Step 11: n- The needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.
  • Step 12:
  • After your injection:
  • How should I store NovoLog?
  • General information about the safe and effective use of NovoLog
  • 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
  • NovoLog is a registered trademark of Novo Nordisk A/S
  • Patent Information: n
  • u00a9 2002-2019 Novo Nordisk
  • For information about NovoLog contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • www.novonordisk-us.com
  • Revised: 11/2019
  • INSTRUCTIONS FOR USE
  • NovoLogn- (Nu014c-vu014d-log) PenFill 3 mL cartridge 100 Units/mL (U-100)
  • (insulin aspart injection)
  • Supplies you will need to give your NovoLog injection:
  • (Figure A)
  • How to use the NovoLog 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.n
  • Step 5:
  • (Figure G)
  • Select your dose
  • Step 6:
  • (Figure H)
  • Inject your dose
  • Step 7:
  • (Figure J)
  • You may see a drop of NovoLog 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 NovoLog PenFill cartridge?
  • Before use:
  • PenFill cartridges in use:
  • Generaln- Information about the safe and effective use of NovoLog.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • u00a9 2002-2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • Revised: 11/2019
  • INSTRUCTIONS FOR USE
  • NovoLog (Nu014c-vu014d-log) FlexTouch Pen
  • (insulin aspart injection)
  • Supplies you will need to give your NovoLog injection:
  • Preparing your NovoLog FlexTouch Pen:
  • Step 1:
  • (Figure B)
  • Step 2:
  • (Figure C)
  • Step 3:
  • (Figure D)
  • Step 4:
  • (Figure E)
  • Step 5:
  • (Figure F)
  • Step 6:
  • (Figure G)
  • Priming your NovoLog FlexTouch Pen:
  • Step 7:
  • (Figure H)
  • Step 8:
  • (Figure I)
  • Step 9:
  • (Figure J)
  • Selecting your dose:
  • Step 10:
  • (Figure K)
  • (Figure L)
  • Giving your injection:
  • Step 11:
  • (Figure M)
  • Step 12:
  • (Figure N)
  • Step 13:
  • (Figure O)
  • (Figure P)
  • Step 14:
  • (Figure Q)
  • Step 15:
  • (Figure R)
  • (Figure S)
  • Step 16:
  • (Figure T)
  • After your injection:
  • How should I store my NovoLog FlexTouch Pen?
  • General Information about the safe and effective use of NovoLog.
  • 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 2002-2019 Novo Nordisk
  • INSTRUCTIONS FOR USE
  • NovoLog (Nu014c-vu014d-log) FlexPen
  • (insulin aspart injection)
  • Introduction
  • Please read the following instructions carefully before using your NovoLog FlexPen.
  • Do not share your NovoLog FlexPen 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.
  • NovoLog FlexPen is a disposable, single-patient-use, dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. NovoLog FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.
  • Getting ready
  • Make sure you have the following items:
  • Preparing your NovoLog FlexPen
  • Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. NovoLog should look clear and colorless. Do not use your NovoLog FlexPen if the liquid contains particles or is colored.
  • A
  • Wipe the rubber stopper with an alcohol swab.
  • B. Attaching the needle
  • Remove the protective tab from a disposable needle.
  • Screw the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).
  • Never place a disposable needle on your NovoLog FlexPen until you are ready to take your injection.
  • C.
  • D.
  • Giving the airshot before each injection
  • Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:
  • E.
  • F.
  • G.
  • A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
  • If you do not see a drop of insulin after 6 times, do not use the NovoLog FlexPen and contact Novo Nordisk at 1-800-727-6500.
  • A small air bubble may remain at the needle tip, but it will not be injected.
  • Selecting your dose
  • Check and make sure that the dose selector is set at 0.
  • H.
  • The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the push-button as insulin will come out.
  • You cannot select a dose larger than the number of units left in the cartridge.
  • You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear because you may get an incorrect dose.
  • Giving the injection
  • Do the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.
  • NovoLog can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.
  • Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. use the same injection site for each injection. inject where the skin has pits, is thickened, or has lumps. inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • I.
  • Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button when injecting.
  • Turning the dose selector will not inject insulin.
  • J.
  • You may see a drop of insulin at the needle tip. 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 an alcohol swab. n
  • After the injection
  • Do not recap the needle.
  • If you do not have a sharps container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.
  • K
  • Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
  • How should I store NovoLog FlexPen?
  • Maintenance
  • For the safe and proper use of your FlexPen be sure to handle it with care. Avoid dropping your FlexPen as it may damage it. If you are concerned that your FlexPen is damaged, use a new one. You can clean the outside of your FlexPen by wiping it with a damp cloth. Do not soak or wash your FlexPen as it may damage it. Do not refill your FlexPen.
  • u0394
  • u0394
  • u0394
  • u0394
  • u0394 Do not
  • get a serious infection from them.
  • u0394
  • u0394
  • Nordisk.
  • u0394
  • u0394
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2019
  • NDC 0169-7501-11
  • List 750111
  • NovoLogn
  • Insulin aspart Injection
  • 10 mL 100 units/mL
  • Rx only
  • U-100
  • NDC 0169-3303-12 List 330312
  • NovoLogn
  • PenFilln
  • Insulin aspart Injection
  • For Single Patient Use Only
  • 3 mL cartridges
  • 100 units/mL (U-100)
  • 5 cartridges per package
  • For use with Novo Nordisk 3 mL PenFill cartridge compatible delivery devices, with or without the addition of a NovoPen 3 PenMate, and NovoFine disposable needles.
  • Keep in a cold place.
  • Avoid freezing.
  • Protect from light.
  • Rx only
  • NDC 0169-6339-10 List 633910
  • NovoLog FlexPenn
  • Prefilled Syringe
  • Insulin aspart Injection
  • For Single Patient Use Only
  • 100 units/mL (U-100)
  • 5 x 3 mL Prefilled Insulin Syringes
  • Rx only
  • For use with NovoFine, NovoFine Plus or n- NovoTwist disposable needles.
  • Keep in a cold place.
  • Avoid freezing.
  • Protect from light.
  • Dispense in this sealed carton.
  • NDC 0169-6338-10 List 633810
  • NovoLog FlexTouchn
  • Insulin aspart Injection
  • For Single Patient Use Only
  • 100 units/mL (U-100)
  • 5 x 3 mL Prefilled Pens
  • For subcutaneous use only
  • Rx Only
  • Recommended for use withn- NovoFine, NovoFine Plus or n- 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.
  • List: 200190 NDC 0169-2001-90
  • Insulin Diluting Medium for NovoLogu00ae
  • 10 mL
  • Use only with NovoLogu00ae

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