Humulin N (Sterile Diluent)

Trade Name : Diluent

Eli Lilly and Company

INJECTION, SOLUTION

Strength 1 mL/mL

Storage and handling for Diluent

WATER

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Humulin N (Sterile Diluent) which is also known as Diluent and Manufactured by Eli Lilly and Company. It is available in strength of 1 mL/mL per ml. Read more

Humulin N (Sterile Diluent) 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

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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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.

About GNH

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HUMULINu00a0N is an intermediate-acting recombinant human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.n
HUMULINu00a0N is an intermediate-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ()n

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Only administer subcutaneously (in abdominal wall, thigh, upper arm, or buttocks). ()n
Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ()n
Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ()n
See Full Prescribing Information for dosage adjustments due to drug interactions and patients with renal and hepatic impairment. (, )n
May use with a meal-time insulin if indicated. ()n

HUMULINu00a0N injectable suspension: 100u00a0units per mL (U-100) is a white and cloudy suspension available as:n
Injectable suspension: 100 units per mL (U-100) available as:n

10u00a0mL multiple-dose vial ()n
3u00a0mL multiple-dose vial ()n
3u00a0mL single-patient-use HUMULINu00a0N KwikPen ()n

HUMULINu00a0N is contraindicated:n

During episodes of hypoglycemia. ()n
In patients with hypersensitivity to HUMULINu00a0N or any of its excipients. ()n

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Never share a HUMULIN N KwikPen or syringe between patients, even if the needle is changed. ()
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Hypoglycemia
Hypersensitivity Reactions
Hypokalemia
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs)

The following adverse reactions are discussed elsewhere in the labeling:n
The following additional adverse reactions have been identified during post-approval use of HUMULINu00a0N. Because 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.n
Adverse reactions observed with HUMULINu00a0N include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and edema. ()n
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Drugs that Affect Glucose Metabolism
Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine)

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Excess insulin administration may cause hypoglycemia and hypokalemia . Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level 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.n

HUMULINu00a0N (isophane insulin human suspension) is an intermediate-acting human insulin. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of . HUMULINu00a0N is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation. The amino acid sequence of HUMULINu00a0N is identical to human insulin and has the empirical formula CHNOS with a molecular weight of 5808.n
HUMULINu00a0N is a sterile, white and cloudy suspension that contains isophane insulin human suspension (NPH) for subcutaneous use. Each milliliter of HUMULINu00a0N contains 100u00a0units of insulin human, 0.35u00a0mg of protamine sulfate, 16u00a0mg of glycerin, 3.78u00a0mg of dibasic sodium phosphate, 1.6u00a0mg of metacresol, 0.65u00a0mg of phenol, zinc oxide content adjusted to provide 0.025u00a0mg zinc ion, and Water for Injection. The pH is 7.0 to 7.5. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.n

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Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the sister chromatid exchange assay and the gradient plate and unscheduled DNA synthesis assays.n

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Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

PATIENT INFORMATIONHUMULINn- Arrayn- (HU-mu-lin) N(isophane insulin human suspension)
Do not share your HUMULIN N KwikPen 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 HUMULIN N?
Who should not use HUMULIN N?
Do not use HUMULIN N if you:
Before using HUMULIN N, tell your healthcare provider about all your medical conditions including, if you:
Before you start using HUMULIN N, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use HUMULIN N?
Your HUMULIN N dose may need to change because of:
What should I avoid while using HUMULIN N?
While using HUMULIN N do not:
What are the possible side effects of HUMULIN N?
HUMULIN N may cause serious side effects that can lead to death, including:
Get emergency medical help if you have:
The most common side effects of HUMULIN N include:
These are not all the possible side effects of HUMULIN N. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
General information about the safe and effective use of HUMULIN N:
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 HUMULIN N that is written for health professionals. Do not use HUMULIN N for a condition for which it was not prescribed. Do not give HUMULIN N to other people, even if they have the same symptoms that you have. It may harm them.n
What are the ingredients in HUMULIN N?
Active Ingredient:
Inactive Ingredients:
For more information, call 1-800-545-5979 or go to www.humulin.com.n
This Patient Information has been approved by the U.S. Food and Drug Administration.
Patient Information revised November 2019n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
LINN-0004-PPI-20191115n

Instructions for UseHUMULIN (HU-mu-lin) N(isophane insulin human suspension)multiple-dose vial (100 Units/mL, U-100)
Read the Instructions for Use before you start taking HUMULIN N and each time you get a new HUMULIN N vial. 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.n
Do not share your 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.
Supplies needed to give your injection:
Preparing your HUMULIN N dose:
Giving your HUMULIN N injection:
Disposing of used needles and syringes:
How should I store HUMULIN N?
All unopened HUMULIN N vials:
After HUMULIN N vials have been opened:
General information about the safe and effective use of HUMULIN N.
If you have any questions or problems with your HUMULIN, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN and insulin, go to www.humulin.com.n
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Humulin is a trademark of Eli Lilly and Company.
Instructions for Use revised: November 2019n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
LINNVL-0004-IFU-20191115n

Instructions for Use
HUMULINn- Arrayn- N KwikPenn- Array
(isophane insulin human suspension)
100u00a0units/mL, 3u00a0mL single-patient-use pen
Read the Instructions for Use before you start taking HUMULINu00a0N and each time you get another KwikPen. 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.n
Do not share your HUMULINu00a0N KwikPen 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.
HUMULINu00a0N KwikPen (u201cPenu201d) is a disposable single-patient-use prefilled pen containing 300u00a0units of HUMULINu00a0N. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 1u00a0unit of insulin. You can give from 1 to 60u00a0units in a single injection. The Plunger only moves a little with each injection, and you may not notice that it moves. The Plunger will only reach the end of the cartridge when you have used all 300u00a0units in the Pen.n
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
How to recognize your HUMULIN N KwikPen
Supplies you will need to give your injection
Preparing your Pen
Priming your Pen
Prime before each injection.
Selecting your dose
Giving your injection
After your injection
Disposing of Pens and Needles
Storing your Pen
Unused Pens
In-use Pen
General information about the safe and effective use of your Pen
Troubleshooting
If you have any questions or problems with your HUMULINu00a0N KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULINu00a0N KwikPen and insulin, go to www.lilly.com.n
Scan this code to launchn
www.humulin.comn
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
HUMULIN and HUMULIN KwikPen are trademarks of Eli Lilly and Company.n
Revised: November 2019n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
Copyright u00a9 2013, 2019, Eli Lilly and Company. All rights reserved.n
LINNKP-0006-IFU-20191115n

NDC 0002-8315-01n
10 mLn
100 units per mLn
Humulinu00ae Nn
NPHn
isophane insulin humann
suspensionn
For subcutaneous use only.n
U-100n
www.lilly.comn
Lillyn

5x3 mLn
prefilled pensn
NDC 0002-8805-59n
HP-8805n
Humulin N KwikPenn
NPHn
isophane insulin n
human suspensionn
For Single Patient Use Onlyn
Dispense in this sealed carton
Read Insulin Delivery Device Instructions for Usen
For subcutaneous use only.n
prefilled insulin delivery devicen
U-100 100 units per mLn
Needles not includedn
This device is suitable for use with Becton, Dickinson and Company's insulin pen needles.n
Lillyn

PACKAGE CARTON u2013 STERILE DILUENT Vial 10mL 1ct
1u2013ND 800
Lilly
10 mL
STERILE DILUENT FOR
HUMALOG U-100
insulin lispro injection
HUMULIN R U-100
REGULAR insulin human injection
Insulin Lispro U-100
Injection
WARNING: Use ONLY with insulins listed on side panel.

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