Human Insulin - R (Novolin)

Trade Name : Novolin

Novo Nordisk

INJECTION, SOLUTION

Strength 100 [iU]/mL

INSULIN HUMAN

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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 - R (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 - R (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

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About GNH

No data

Dosage and Administration () ---------------------------------- 11/2019
Warnings and Precautions () ------------------------------------ 11/2019

NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
NOVOLIN R is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ().

No data

Subcutaneous injection:
Intravenous use:

Injection: NOVOLIN R 100 units per mL (U-100) is available as:

NOVOLIN R 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 NOVOLINu00a0R. 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 R.
Hypokalemia
NOVOLIN R can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions
NOVOLIN R 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 R.
Lipodystrophy
Administration of insulin subcutaneously, including NOVOLIN R, 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 R have been identified during postapproval use.
Peripheral edema
Insulins, including NOVOLIN R, 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 R, 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. Increases in titers of anti-insulin antibodies that react with human insulin have been observed in patients treated with NOVOLIN R.
Adverse reactions observed with NOVOLIN R include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema ()n
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or

Table 1: Clinically Significant Drug Interactions with NOVOLIN R

Drugs that may increase the risk of hypoglycemia:
Drugs that may decrease the blood glucose lowering effect: n- Array
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, particularly when given intravenously, 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 n

NOVOLIN R (insulin human injection) is a short-acting human insulin. It is a polypeptide hormone structurally identical to regular human insulin and is produced by recombinant DNA technology, utilizing (bakeru2019s yeast) as the production organism. NOVOLIN R has the empirical formula CHNOS and a molecular weight of 5808.
Figure 1: Structural formula of NOVOLIN R
NOVOLIN R for subcutaneous or intravenous use is a sterile, clear, aqueous, and colorless solution that contains insulin human 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc approximately 21 mcg/mL and water for injection. The pH is adjusted to 7.0 u2013 7.8. Hydrochloric acid 2N and sodium hydroxide 2N are added to adjust pH.

No data

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of NOVOLIN R.
NOVOLIN R 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.
Standard reproduction and teratology studies in animals, including fertility assessments have not been conducted with NOVOLIN R.

No data

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Never Share a NOVOLIN R FlexPen or Syringe between Patients
Advise patients using NOVOLIN R vials or 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 R 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 R. 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.
ReliOnis a registered trademark of Wal-Mart Stores, Inc. and is used under license by Novo Nordisk Inc.
Patent Information: http://novonordisk-us.com/products/product-patents.html
u00a9 2002-2019 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 R contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
www.novonordisk-us.com
1-800-727-6500

Patient Information
NOVOLINR (NO-voe-lin)
(insulin human injection) for subcutaneous or intravenous use
Do not share your Novolin R 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 Novolin R?
Novolin R 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 R?
Do not use Novolin R if you:
Before using Novolin R, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take,
Before you start using Novolin R, talk to your healthcare provider about low blood sugar and how ton- manage it.
How should I use Novolin R?
Keep Novolin R and all medicines out of the reach of children.
Your dose of Novolin R may need to change because of:
What should I avoid while using Novolin R?
While using Novolin Rn
What are the possible side effects of Novolin R?
Novolin R may cause serious side effects that can lead to death, including:
Get emergency medical help if you have:
The most common side effects of Novolin R include:
These are not all of the possible side effects of Novolin R. 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 Novolin R
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Novolin R for a condition for which it was not prescribed. Do not give Novolin R 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 R. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolin R that is written for healthcare providers.
For more information about Novolin R, call 1-800-727-6500 or go to .
What are the ingredients in Novolin R?
Active ingredient:
Inactive ingredients:
Novolin, FlexPen and Novo Nordisk are registered trademarks of Novo Nordisk A/S.
u00a9 2002-2019 Novo Nordisk
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Novolin R contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 11/2019
Patient Instructions for Use
Novolin R 10 mL multiple-dose vial (100 Units/mL, U-100)
Please read the following Instructions for Use carefully before using your Novolin R 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before. There may be new information.
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 R vial?
1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.
2. Look at the vial and the insulin. The insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap had been removed before your first use of the vial, or if the insulin is cloudy, colored, or contains any particles, do not use it and call Novo Nordisk at 1-800-727-6500.
3. Wash your hands with soap and water. Clean your injection site with an alcohol swab and let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.
4. If you are using a new vial, pull off the tamper-resistant cap.
Wipe the rubber stopper with an alcohol swab.
5. Do not roll or shake the vial. Shaking right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.
6. Pull back the plunger on the syringe until the black tip reaches the marking for the number of units you will inject.
7. Push the needle through the rubber stopper of the vial.
8. Push the plunger all the way in to force air into the vial.
9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose.
10. If there are any air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles present in the syringe back into the vial.
11. Check to make sure you have the right dose of Novolin R in the syringe.
12. Pull the syringe out of the vialu2019s rubber stopper.
13. Novolin R 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. For each injection, change (rotate) your injection site within the area of skin that you use. Do not use the same injection site for reach injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Your healthcare provider should tell you if you need to pinch the skin before and while inserting the needle.u00a0u00a0Thisu00a0canu00a0vary from patient to patient so it is important tou00a0asku00a0youru00a0healthcare provider if you did notu00a0receive instructionsu00a0on pinching the skin. Insert the needle into the skin. Press the plunger of the syringe to inject the insulin. When you are finished injecting the insulin, pull the needle out of your skin. You may see a drop of Novolin R at the needle tip. This is normal and has no effect on the dose you just received. If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol wipe. n
14. After your injection, do not recap the needle. Place used syringes, needles and used insulin vials in a disposable puncture-resistant sharps container, or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or coffee can.
15. Ask your healthcare provider about the right way to throw away used syringes and needles. There may be state or local laws about the right way to throw away used syringes and needles. Do not throw away used needles and syringes in household trash or recycle.
How should I mix Novolin R with NPH insulin?
Different insulins should be mixed only under instruction from a healthcare provider. Novolin R should be mixed with NPH insulin right before use. When you are mixing Novolin R insulin with NPH insulin, always n
1. Add together the total number of units of NPH and Novolin R that you need to inject. Your total dose of medicine to inject will be the amount of NPH and Novolin R in the syringe after drawing up both insulins. For example, if you need 5 units of NPH and 2 units of Novolin R, the total dose of insulin in the syringe would be 7 units.
Preparing your NPH and Novolin R insulins for injection:
2. Roll the NPH vial between your hands until all of the liquid in the vial is cloudy.
3. Pull the plunger of the syringe down so that the dark end is lined up to the number of units needed for your NPH insulin. This will draw into the syringe the same amount of air as the NPH dose needed.
4. Put the needle through the rubber stopper of the cloudy NPH insulin bottle. After you inject the air into the NPH vial, remove the needle from the vial but do not withdraw any of the NPH insulin. Putting air in the bottle makes it easier to draw the insulin out of the bottle.
5. Pull the plunger of the syringe down to the number of units needed for your Novolin R insulin. After you draw the air into the syringe, inject the air into the Novolin R vial.
Drawing up and mixing your NPH and Novolin R insulins for injection:
6. With the needle in place, turn the clear insulin vial of Novolin R upside down and slowly pull the plunger back to a few units beyond the right dose of Novolin R. The tip of the needle must be in the Novolin R liquid to get the full dose and not an air dose.
7. Check the syringe for air bubbles. If you see air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top. Then slowly push the plunger to the marking for your correct dose. This process should move any air bubbles in the syringe back into the vial.
8. After withdrawing the needle from the Novolin R vial, insert the needle into the NPH vial.
9. Turn the NPH vial upside down with the syringe and needle still in the vial. Slowly pull the plunger back to withdraw your NPH dose.
Remember the total dose of medicine in the syringe should be your total dose of NPH and Novolin R insulins. (See Step 1 under u201cHow should I mix Novolin R with NPH insulin?u201d)
10. Inject your insulin right away otherwise it might not work properly.
How should I store Novolin R?
This Patient Instructions for Use has been approved by the Food and Drug Administration.
Date of Issue: 11/2019
Novolin is a registered trademark of Novo Nordisk A/S.
u00a9 2002-2019 Novo Nordisk
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about Novolin R contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
Instructions For Use
Novolin R FlexPenn
(insulin human injection)
for subcutaneous use
Introduction
Please read the following instructions carefully before using your Novolin R FlexPen.
Do not share your Novolin R 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 R 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. Novolin R 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 R FlexPen without help from a person trained to use Novolin R FlexPen.
Getting ready
Make sure you have the following items:
Preparing your Novolin R 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 R should look clear and colorless. Do not use your Novolin R FlexPen if the liquid contains particles or is colored.
A.
Wipe the rubber stopper with an alcohol swab.
Attaching the needle
B.
Screw the needle tightly onto your Novolin R FlexPen. It is important that the needle is put on straight (see diagram B).
Never place a disposable needle on your Novolin R FlexPen until you are ready to take your injection.
C.
D.
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:
E.
F.
G.
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.
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 R 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.
J.
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.
How should I store Novolin R FlexPen?
Maintenance
For the safe and proper use of your Novolin R FlexPen be sure to handle it with care. Avoid dropping your Novolin R FlexPen as it may damage it. If you are concerned that your Novolin R FlexPen is damaged, use a new one. You can clean the outside of your Novolin R FlexPen by wiping it with a damp cloth. Do not soak or wash your Novolin R FlexPen as it may damage it. Do not refill your Novolin R FlexPen.
Do not
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 11/2019

NDC n
NovolinR
(insulin human injection)n
100 units/mL
10 mL multi-dose vial
Novo Nordiskn

NDC n
NovolinR
(insulin human injection)
100 units/mL
10 mL multi-dose vial
ReliOnn

NovolinR
FlexPenn
(insulin human injection) n
100 units/mL (U-100)
For Single Patient Use Only
5 x 3 mL Prefilled Pens
For subcutaneous use only
Recommended for use with NovoFine, NovoFinen
Plus or NovoTwist 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.
novo nordiskn

NovolinR
FlexPenn
(insulin human injection)
100 units/mL (U-100)
For Single Patient Use Only
5 x 3 mL Prefilled Pens
For subcutaneous use only
Recommended for use with NovoFine, NovoFinen
Plus or NovoTwist 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.
ReliOnn

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Human Insulin - R (Novolin)

Trade Name : Novolin

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Human Insulin - R (Novolin)

Trade Name : Novolin

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

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Losartan Potassium (Losartan Potassium)

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