Human Insulin - 70/30 (Novolin)

Trade Name : Novolin

Novo Nordisk

INJECTION, SUSPENSION

Strength 100 [iU]/mL

INSULIN HUMAN

Delivery Process

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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.

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

Human Insulin - 70/30 (Novolin) 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.

Read more
  • No data
  • Dosage and Administration ().u2026u2026u2026u2026u2026u2026u2026u2026.u2026u2026u2026.11/2019
  • Warnings and Precautions ()u2026u2026.u2026u2026u2026u2026u2026.u2026u2026...u2026u202611/2019
  • NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Limitations of Use:
  • In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
  • NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-acting human insulin, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. ()
  • No data
  • NOVOLIN 70/30 injectable suspension, 70% human insulin isophane and 30% human insulin, 100 units per mL (U-100), is a white and cloudy suspension available as:
  • Injectable suspension: NOVOLIN 70/30 100 units per mL (U-100), 70% human insulin isophane and 30% human insulin, is available as:
  • NOVOLIN 70/30 is contraindicated:
  • No data
  • 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 also discussed elsewhere in the labeling:
  • Adverse Reactions from Clinical Studies or Postmarketing Reports
  • The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLINu00a070/30. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
  • Adverse reactions associated with insulin initiation and glucose control intensification
  • Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
  • Hypersensitivity reactions
  • Severe, life-threatening, generalized allergy, including anaphylaxis.
  • Hypoglycemia
  • Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN 70/30.
  • Hypokalemia
  • NOVOLIN 70/30 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
  • Injection site reactions
  • NOVOLIN 70/30 can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN 70/30.
  • Lipodystrophy
  • Administration of insulin subcutaneously, including NOVOLIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.
  • Localized Cutaneous Amyloidosis
  • Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
  • Medication Errors
  • Medication errors in which other insulins have been accidentally substituted for NOVOLIN 70/30 have been identified during postapproval use.
  • Peripheral edema
  • Insulins, including NOVOLIN 70/30, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
  • Weight gain
  • Weight gain can occur with insulin therapies, including NOVOLIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
  • Immunogenicity
  • As with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. The incidence of antibody formation with NOVOLINu00a070/30 is unknown.
  • Adverse reactions observed with NOVOLIN 70/30 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema. ()
  • Table 1: Clinically Significant Drug Interactions with NOVOLIN 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:
  • Drugs that may blunt 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 can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately .
  • NOVOLIN 70/30 (human insulin isophane suspension and human insulin injection) is a mixture of 70% of human insulin isophane, an intermediate-acting human insulin, and 30% of human insulin, a short-acting human insulin. Human insulins are produced by recombinant DNA technology, utilizing (bakeru2019s yeast) as the production organism. NOVOLIN 70/30 has the empirical formula CHNOS and a molecular weight of 5808.
  • Figure 1: Structural formula of human insulin
  • NOVOLIN 70/30 is a sterile, white and cloudy suspension that contains human insulin isophane suspension (NPH) and human insulin injection (regular) for subcutaneous use, 100 units/mL, glycerol 16 mg/mL, metacresol 1.5 mg/mL, zinc approximately 20.5 mcg/mL (vial), zinc approximately 30.1 mcg/mL (FlexPen), phenol 0.65 mg/mL, disodium phosphate dihydrate 2.4 mg/mL, protamine sulfate approximately 0.25 mg/mL, and water for injection. The pH is adjusted to 7.1-7.5. Hydrochloric acid 2N and sodium hydroxide 2N are added to adjust pH.
  • No data
  • Carcinogenicity and fertility studies were not performed in animals.
  • Human insulin is not mutagenic in the following tests: The chromosomal aberration assay in human lymphocytes, the micronucleus assay in mouse polychromatic erythrocytes, and the mutation frequency assay in Chinese hamster cells.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Never Share a NOVOLIN 70/30 FlexPen or Syringe between Patients
  • Advise patients using NOVOLIN 70/30 vials or NOVOLIN 70/30 FlexPen not to share needles, syringes, or FlexPen 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 NOVOLIN 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 .
  • Hypoglycemia due to 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 NOVOLIN 70/30. Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur .
  • Novolin, FlexPen and Novo Nordisk are registered trademarks of Novo Nordisk A/S.
  • ReliOn is a registered trademark of Wal-Mart Stores, Inc. and is used under license by Novo Nordisk Inc.
  • Patent Information: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • ReliOnbrand manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For Wal-Mart Stores Inc.
  • For information about NOVOLIN 70/30 contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • www.novonordisk-us.com
  • 1-800-727-6500
  • No data
  • No data
  • No data
  • No data
  • No data
  • u00a0
  • Patient Information
  • NOVOLIN 70/30 (NO-voe-lin)
  • (human insulin isophane suspension and human insulin injection)
  • for subcutaneous use
  • Do not share your Novolin 70/30 FlexPen or syringes 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 Novolinn- 70/30?
  • Novolin 70/30 is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
  • Who should not use Novolin 70/30?
  • Do not use Novolin 70/30 if you:
  • Before using Novolin 70/30, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • vitamins, or herbal supplements.
  • Before you start using Novolin 70/30, talk to your healthcare provider about low blood sugar and how to
  • manage it.
  • How should I use Novolin 70/30?
  • Keep Novolin 70/30 and all medicines out of the reach of children.
  • Your dose of Novolin 70/30 may need to change because of:
  • What should I avoid while using Novolin 70/30?
  • While using Novolin 70/30n
  • What are the possible side effects of Novolin 70/30?
  • Novolin 70/30 may cause serious side effects that can lead to death, including:
  • Treatment with TZDs and Novolin 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
  • These are not all of the possible side effects of Novolin 70/30. Call your doctor formedical 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 Novolin 70/30
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. use Novolin 70/30 for a condition for which it was not prescribed. give Novolin 70/30 to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about Novolin 70/30. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Novolin 70/30 that is written for healthcare providers. For more information, call 1-800-727-6500 or go to www.novonordisk-us.com.
  • What are the ingredients in Novolin 70/30?
  • Active ingredient:
  • Inactive ingredients: n- Array
  • Novolinn- FlexPen and Novo Nordiskn- Arrayn- are registered trademarks of Novo Nordisk A/S.
  • u00a9 2005 u2013 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about Novolin 70/30 contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 11/2019
  • Patient Instructions for Use
  • Novolin 70/30 10 mL multiple-dose vial (100 Units/mL, U-100)
  • Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
  • Never re-use syringes and needles.
  • How should I use the Novolin 70/30 vial?
  • How should I store Novolin 70/30?
  • Revised: 11/2019
  • Instructions For Use
  • Novolin 70/30 FlexPenn
  • (human insulin isophane suspension and human insulin injection)
  • for subcutaneous use
  • Introduction
  • Please read the following instructions carefully before using your Novolin 70/30 FlexPen.
  • Do not share your Novolin 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.
  • Novolin 70/30 FlexPen is a disposable dial-a-dose, single-patient-use, insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. Novolin 70/30 FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.
  • People who are blind or have vision problems should not use Novolin 70/30 FlexPen without help from a person trained to use Novolin 70/30 FlexPen.
  • Getting ready
  • Make sure you have the following items:
  • Preparing your Novolin 70/30 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. Novolin 70/30 should look white and cloudy after mixing.
  • A.
  • Pull off the pen cap (see diagram A).
  • B.n- 1n- 2
  • Repeat moving the pen until the liquid appears white and cloudy. Do not use the pen if the liquid appears discolored or contains particles.
  • For everyn- 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
  • C.
  • Screw the needle tightly onto your Novolin 70/30 FlexPen. It is important that the needle is put on straight (see diagram C).
  • Never place a disposable needle on your Novolin 70/30 FlexPen until you are ready to take your injection.
  • D.
  • E.
  • 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. To avoid injecting air and to make sure you take the right dose of insulin:
  • F.
  • G.
  • H.
  • 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 Novolin 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.
  • I.
  • 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 I). 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.
  • Giving the injection
  • Give 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.
  • Novolin 70/30 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.
  • For each injection, change (rotate) your injection site within the area of skin that you use. 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.
  • J.
  • Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram J). Be careful only to push the button when injecting.
  • Turning the dose selector will not inject insulin.
  • K.
  • 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 a gauze pad or 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.
  • L.
  • How should I store Novolin 70/30 FlexPen?
  • Maintenance
  • For the safe and proper use of your Novolin 70/30 FlexPen be sure to handle it with care. Avoid dropping your Novolin 70/30 FlexPen as it may damage it. If you are concerned that your Novolin 70/30 FlexPen is damaged, use a new one. You can clean the outside of your Novolin 70/30 FlexPen by wiping it with a damp cloth. Do not soak or wash your Novolin 70/30 FlexPen as it may damage it. Do not refill your Novolin 70/30 FlexPen.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Issued: 11/2019
  • NDC n
  • Novolinn n
  • (human insulin isophane suspension and
  • human insulin injection)
  • 100 units/mL 10 mL multi-dose vial
  • Novo Nordiskn
  • NDC n
  • Novolinn n
  • (human insulin isophane suspension and
  • human insulin injection)
  • 100 units/mL 10 mL multi-dose vial
  • ReliOnn
  • NDC 0169-3007-15
  • List: 300715
  • Novolin 70/30
  • FlexPenn n
  • (human insulin isophane suspension
  • and human insulin injection)
  • 100 units/mL (U-100)
  • For Single Patient Use Only
  • 5u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Recommended for use with NovoFine, NovoFine Plus or NovoTwistn
  • disposable needles.
  • Until first use: Keep in a cold place.
  • Store at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).
  • Do not freeze.
  • In-use: Keep at room temperature below 30u00b0C (86u00b0F).
  • Protect from light.
  • Dispense in this sealed carton.
  • Shake carefully before using.
  • See enclosed insert for proper technique.
  • 70/30
  • novo nordiskn
  • NDC 0169-3007-25
  • List: 300725
  • Novolin 70/30
  • FlexPenn n
  • (human insulin isophane suspension
  • and human insulin human injection)
  • 100 units/mL (U-100)
  • For Single Patient Use Only
  • 5u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Recommended for use with NovoFine, NovoFine Plus or NovoTwistn
  • disposable needles.
  • Until first use: Keep in a cold place.
  • Store at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).
  • Do not freeze.
  • In-use: Keep at room temperature below 30u00b0C (86u00b0F).
  • Protect from light.
  • Dispense in this sealed carton.
  • Shake carefully before using.
  • See enclosed insert for proper technique.
  • 70/30
  • ReliOnn

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