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Insulin Aspart (Novolog Mix 70/30)

Trade Name : NovoLog Mix 70/30

Novo Nordisk

INJECTION, SUSPENSION

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 (Novolog Mix 70/30) which is also known as NovoLog Mix 70/30 and Manufactured by Novo Nordisk. It is available in strength of 100 [iU]/mL per ml. Read more

Insulin Aspart (Novolog Mix 70/30) 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

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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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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 (2.1)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026 11/2019
  • Dosage and Administration (2.2)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.12/2018
  • Warnings and Precautions (5.2)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.. 11/2019
  • NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in patients with diabetes mellitus.
  • Limitations of Use:
  • NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in patients with diabetes mellitus.
  • Limitations of Use:
  • No data
  • NOVOLOG MIX 70/30 is 100 units per mL (U-100), 70% insulin aspart protamine and 30% insulin aspart, is available as a white and cloudy injectable suspension:
  • Injectable suspension: NOVOLOG MIX 70/30 is 100 units per mL (U-100), 70% insulin aspart protamine and 30% insulin aspart, is available as: n
  • NOVOLOG MIX 70/30 is contraindicated
  • No data
  • Hyperglycemia or hypoglycemia with changes in insulin regimen:
  • Hypoglycemia:
  • Medication Errors:
  • Hypersensitivity reactions:
  • Hypokalemia:
  • Fluid retention and heart failure withn- thiazolidinediones (TZDs)
  • The following adverse reactions are also discussed elsewhere:
  • Adverse reactions observed with insulin therapy 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 .
  • Table 3: Clinically Significant Drug Interactions with NOVOLOG MIX 70/30
  • 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: a
  • the signs and symptoms of hypoglycemia:
  • 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.
  • NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart injection) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NOVOLOG MIX 70/30 is a blood-glucose-lowering agent with an earlier onset and an intermediate duration of action. 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 (bakeru2019s yeast). Insulin aspart (NOVOLOG) has the empirical formula CHNOS and a molecular weight of 5825.8 Da.
  • Figure 1. Structural formula of insulin aspart
  • NOVOLOG MIX 70/30 is a uniform, white, sterile suspension that contains insulin aspart 100 units/mL.
  • Inactive ingredients are glycerol 16.0 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 u03bcg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.877 mg/mL, and protamine sulfate 0.32 mg/mL. NOVOLOG MIX 70/30 has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the(Patient Information and Instructions for Use).
  • Never Share a NOVOLOG MIX 70/30 FlexPen between Patients
  • Advise patients that they must never share NOVOLOG MIX 70/30 FlexPen device with another person even if the needle is changed. Advise patients using NOVOLOG MIX 70/30 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 MIX 70/30 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 n .
  • Hypoglycemia with Medication Errors
  • Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products .
  • Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions have occurred with NOVOLOG MIX 70/30. Inform patients of the symptoms of hypersensitivity reactions .
  • Administration
  • Version: 16
  • Novo Nordisk, NOVOLOG, FlexPen, and Novolin are registered trademarks of Novo Nordisk A/S.
  • Patent Information: n
  • u00a9 2002 u2013 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about NOVOLOG MIX 70/30 contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • NovoLog Mix 70/30
  • (insulin aspart protamine and insulin aspart injectable suspension)
  • Do not share your NovoLog Mix 70/30 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.
  • What is NovoLog Mix 70/30?
  • Who should not take NovoLog Mix 70/30?
  • Do not take NovoLog Mix 70/30 if you:
  • Before taking NovoLog Mix 70/30, tell your healthcare provider about all your medical conditions including, if you are:
  • Before you start taking NovoLog Mix 70/30, talk to your healthcare provider about low blood sugar and how to manage it.
  • How should I take NovoLog Mix 70/30?
  • What should I avoid while taking NovoLog Mix 70/30?
  • While taking NovoLog Mix 70/30 do not:
  • What are the possible side effects of NovoLog Mix 70/30?
  • NovoLog Mix 70/30 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 Mix 70/30 may include:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of NovoLog Mix 70/30. 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 Mix 70/30.
  • 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 Mix 70/30 that is written for health professionals. Do not use NovoLog Mix 70/30 for a condition for which it was not prescribed. Do not give NovoLog Mix 70/30 to other people, even if they have the same symptoms that you have. It may harm them.
  • What are the ingredients in NovoLog Mix 70/30?
  • 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
  • NovoLogn- Mix 70/30 (Nu014c-vu014d-Log-MIX-SEV-en-tee-THIR-tee)
  • (insulin aspart protamine and insulin aspart injectable suspension)
  • 10 mL multiple-dose vial (100 Units/mL, U-100)
  • Read this Instructions for Use before you start taking NovoLog Mix 70/30 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 Mix 70/30 injection:
  • Preparing your NovoLog Mix 70/30 dose:
  • Step 1:
  • Step 2:
  • Step 3:
  • Step 4:
  • Step 5:
  • Step 6:
  • Step 7:
  • Step 8:
  • Step 9:
  • Step 10:
  • Giving your injection:
  • Step 11:
  • Step 12:
  • Step 13:
  • After your injection:
  • How should I store NovoLog Mix 70/30?
  • General information about the safe and effective use of NovoLog Mix 70/30
  • 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
  • NovoLog is a registered trademark of Novo Nordisk A/S
  • PATENT Information: n
  • u00a9 2002-2019 Novo Nordisk
  • For information about NovoLog Mix 70/30 contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • www.novonordisk-us.com
  • INSTRUCTIONS FOR USE
  • NovoLog Mix 70/30 FlexPenn
  • (Nu014c-vu014d-Log-MIX-SEV-en-tee-THIR-tee)
  • (insulin aspart protamine and insulin aspart injectable suspension)
  • Read the following instructions carefully before you start using your NovoLog Mix 70/30 FlexPen and each time you get a refill. There may be new information. You should read the instructions even if you have used NovoLog Mix 70/30 FlexPen before.
  • Do not share your NovoLog Mix 70/30 FlexPen with other people, even if the needle has been changed.
  • NovoLog Mix 70/30 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 Mix 70/30 FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.
  • Peoplen- who are blind or have vision problems should not use NovoLog Mix 70/30 FlexPen without help from a person trained to use NovoLog Mix 70/30 FlexPen
  • Getting ready
  • Make sure you have the following items:
  • Preparing your NovoLog Mix 70/30 FlexPen
  • Before your first injection with a new NovoLog Mix 70/30 FlexPen you must mix the insulin:
  • A. Let the insulin reach room temperature before you use it. This makes it easier to mix.
  • Pull off the pen cap (see diagram A).
  • B. Roll the pen between your palms 10 times - it is important that the pen is kept horizontal (see diagram B).
  • C. Then gently move the pen up and down ten times between position and as shown, so the glass ball moves from one end of the cartridge to the other (see diagram C).
  • u00a0Repeat rolling and moving the pen until the liquid appears white and cloudy. Do not use the pen if the liquid appears discolored or contains particles.
  • For every following injection
  • After mixing, complete all the following steps of the injection right away. If there is a delay, the insulin will need to be mixed again.
  • Wipe the rubber stopper with an alcohol swab.
  • Attaching the needle
  • D. Remove the protective tab from a disposable needle.
  • Screw the needle tightly onto your NovoLog Mix 70/30 FlexPen. It is important that the needle is put on straight (see diagram D).
  • Never place a disposable needle on your NovoLog Mix 70/30 FlexPen until you are ready to take your injection.u00a0
  • u00a0u00a0
  • E. Pull off the big outer needle cap (see diagram E).
  • F. Pull off the inner needle cap and throw it away (dispose of it) (see diagram F).
  • never put the inner needle cap back on the needle.
  • Giving the airshot before each injection
  • Before each injection small amounts of air may collect in the cartridge during normal use. :
  • G. Turn the dose selector to select 2 units (see diagram G).
  • H. Hold your NovoLog Mix 70/30 FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram H).
  • I. Keep the needle pointing upwards, press the push-button all the way in (see diagram I). The dose selector returns to 0.
  • 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 Mix 70/30 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.
  • J. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.
  • 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 J). 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.
  • Array
  • Giving the injection
  • K. Insert the needle into your skin.
  • Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram K). Be careful only to push the button when injecting.
  • Turning the dose selector will not inject insulin.
  • L. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram L). This will make sure that the full dose has been given.
  • 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.
  • M. Put the pen cap on the NovoLog Mix 70/30 FlexPen and store the NovoLog Mix 70/30 FlexPen without the needle attached (see diagram M). Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
  • How should I store NovoLog Mix 70/30 FlexPen?
  • Maintenance
  • For the safe and proper use of your NovoLog Mix 70/30 FlexPen be sure to handle it with care. Avoid dropping your NovoLog Mix 70/30 FlexPen as it may damage it. If you are concerned that your NovoLog Mix 70/30 FlexPen is damaged, use a new one. You can clean the outside of your NovoLog Mix 70/30 FlexPen by wiping it with a damp cloth. Do not soak or wash your NovoLog Mix 70/30 FlexPen as it may damage it. Do not refill your NovoLog Mix 70/30 FlexPen.
  • Do not
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2019
  • NovoLog Mix 70/30
  • NDC 0169-3685-12
  • List 368512
  • insulin aspart protamine
  • and insulin aspart injectable suspension
  • 100 units/mL 10 mL
  • Shake carefully before using. See enclosed insert for proper technique.
  • Rx only
  • U-100
  • novo nordiskn
  • NDC 0169-3696-19
  • List 369619
  • NovoLog Mix 70/30
  • FlexPen Prefilled Syringe
  • insulin aspart protamine and
  • insulin aspart injectable suspension
  • For Single Patient Use Only
  • 100 units/mL (U-100)
  • 5x3 mL Prefilled insulin Syringes
  • Shake carefully before using.
  • See enclosed insert for proper technique.
  • Rx only
  • For use with NovoFine, n- NovoFine Plus or NovoTwistn n- disposable needles.
  • Keep in a cold place. n- Avoid freezing.n- Protect from light.
  • Dispense in this sealed carton.

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