Insulin Human - R U-500 (Humulin)

Trade Name : Humulin

Eli Lilly and Company

INJECTION, SOLUTION

Strength 500 [iU]/mL

INSULIN HUMAN Insulin [EPC],Insulin [CS]

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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 Human - R U-500 (Humulin) which is also known as Humulin and Manufactured by Eli Lilly and Company. It is available in strength of 500 [iU]/mL per ml. Read more

Insulin Human - R U-500 (Humulin) 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

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HUMULINu00a0R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200u00a0units of insulin per day.n
The safety and efficacy of HUMULINu00a0R U-500 used in combination with other insulins has not been determined.n
The safety and efficacy of HUMULINu00a0R U-500 delivered by continuous subcutaneous infusion has not been determined.n
HUMULINu00a0R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and children with diabetes mellitus requiring more than 200u00a0units of insulin per day. ()n
Limitation of Use: The safety and efficacy of HUMULINu00a0R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULINu00a0R U-500 delivered by continuous subcutaneous infusion has not been determined. ()n

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Adhere to administration instructions to reduce the risk of dosing errors. (, , , )n
HUMULIN R U-500 is available as a single-patient-use KwikPen or multiple-dose vial. Patients using the vial must be prescribed the U-500 insulin syringe to avoid medication errors. ()n
Individualize dose of HUMULIN Ru00a0U-500 based on metabolic needs, blood glucose monitoring results and glycemic control goal. ()n
Administer HUMULINu00a0R U-500 subcutaneously two or three times daily 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (, )n
Do NOT mix HUMULINu00a0R U-500 with other insulins. ()n
Do NOT administer HUMULINu00a0R U-500 intravenously or intramuscularly. ()n
Do NOT perform dose conversion when using the HUMULINu00a0R U-500 KwikPen. The dose window of the HUMULINu00a0R U-500 KwikPen shows the number of units of HUMULINu00a0R U-500 to be injected. ()n
Do NOT transfer HUMULINu00a0R U-500 from the HUMULINu00a0R U-500 KwikPen into any syringe. ()n
Do NOT perform dose conversion when using a U-500 insulin syringe. Use only a U-500 insulin syringe with the HUMULINu00a0R U-500 vial. ()n

HUMULINu00a0R U-500 (500u00a0units per mL) injection is available in a clear, colorless solution as:n
HUMULINu00a0R U-500 (500u00a0units per mL) injection is available as: ()n

3u00a0mL single-patient-use HUMULINu00a0R U-500 KwikPen (containing 1,500u00a0units of insulin)n
20u00a0mL multiple-dose vial (containing 10,000u00a0units of insulin)n

HUMULINu00a0R U-500 is contraindicated:n

Do not use during episodes of hypoglycemia. ()n
Do not use in patients with hypersensitivity to HUMULINu00a0R U-500 or any of its excipients. ()n

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Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with Vial Presentation:
Never share a HUMULINu00a0R U-500 KwikPen or U-500 insulin syringe between patients, even if the needle is changed. ()n
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:n
The following additional adverse reactions have been identified during post-approval use of HUMULINu00a0R U-500. 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 associated with HUMULINu00a0R U-500 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ()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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Certain drugs may affect glucose metabolism and may necessitate insulin dose adjustment. (, , )n
The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine). (, )n

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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.n

HUMULINu00a0R U-500 (insulin human injection) is a human insulin solution used to lower blood glucose. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of . HUMULINu00a0R has the empirical formula CHNOS with a molecular weight of 5808.n
HUMULINu00a0R U-500 is a sterile, aqueous, and colorless solution. HUMULINu00a0R U-500 contains 500u00a0units of insulin in each milliliter. Each milliliter of HUMULINu00a0R U-500 also contains glycerin 16u00a0mg, metacresol 2.5u00a0mg, zinc oxide to supplement the endogenous zinc to obtain a total zinc content of 0.017u00a0mg/100u00a0units, and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH.n

No data

Carcinogenicity and fertility studies were not performed with HUMULINu00a0R U-500 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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See .
Patients should be counseled that HUMULINu00a0R U-500 is a 5-times concentrated insulin product. Extreme caution must be observed in the measurement of dosage because inadvertent overdose may result in serious adverse reaction or life-threatening hypoglycemia. Accidental mix-ups between HUMULINu00a0R U-500 and other insulins have been reported. To avoid medication errors between HUMULINu00a0R U-500 and other insulins, patients should be instructed to always check the insulin label before each injection .n
If using the HUMULINu00a0R U-500 KwikPen, patients should be counseled to dial and dose the prescribed number of units of insulin (no dose conversion is required) .n
When using HUMULINu00a0R U-500 from a vial, patients should be counseled to use only a U-500 insulin syringe and be informed that no dose conversion is required .n
Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of HUMULINu00a0R U-500 therapy. Patients must be instructed 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. 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. Refer patients to the HUMULINu00a0R U-500 Patient Information Leaflet for additional information .n
Inspect HUMULIN R U-500 visually for particulate matter and discoloration. Only use HUMULIN R U-500 if the solution appears clear and colorless.n
Do not dilute or mix HUMULINu00a0R U-500 with any other insulin products or solutions .n
Literature Revised: November 2019n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright u00a9 1997, 2019, Eli Lilly and Company. All rights reserved.n
LINR500-0008-USPI-20191115n

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Please read these instructions before use.
Important Information
Additional Safety Information
Before You Start
Use only a U-500 syringe to inject Humulinu00a0R U-500 insulin
Prepare
Inject
Disposal of used syringes
Storage and Handling
Unopened vials:
After the vial has been opened:
Frequently Asked Questions
Where to get more information and help
Scan this code to launch the humulin.com websiten
These Instructions for Use have been approved by the U.S. Food and Drug Administration.n
Humulin is a trademark of Eli Lilly and Company.n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
Copyright u00a9 1996, 2019, Eli Lilly and Company. All rights reserved.n
Literature issued: November 2019n
LINR500VL-0003-IFU-20191115n

Instructions for UseHUMULIN R U-500 KwikPenn
insulin human injection U-500 (500u00a0units/mL, 3u00a0mL single-patient-use pen)n
Read the Instructions for Use before you start taking HUMULINu00a0R U-500 and each time you get another Pen. 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 HUMULINu00a0R U-500 Pen 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.
HUMULINu00a0R U-500 KwikPen (u201cPenu201d) is a disposable single-patient-use prefilled pen containing 1500u00a0units of HUMULINu00a0R. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 5u00a0units of insulin. You can give from 5 to 300u00a0units 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 1500u00a0units 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 HUMULINu00a0R U-500 KwikPen
Supplies needed to give your injection
Preparing your Pen
Priming your Pen
Prime before each injection.
Selecting your dose
This Pen has been made to deliver the dose that is shown in the Dose Window. Ask your healthcare provider what your dose should be for this Pen.n
Giving your injection
After your injection
Disposing of Pens and Needles
Storing your Pen
Unused Pens
In-use Pen
What you should know if you are switching to HUMULINu00a0R U-500 KwikPen
Ask your healthcare provider what your dose should be for your Pen . Always follow your healthcare provider's instructions for dosing.n
General information about the safe and effective use of your Pen
Troubleshooting
If you have any questions or problems with your HUMULINu00a0R U-500 KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULINu00a0R U-500 KwikPen and insulin, go to www.humulin.com.n
Scan this code to launch www.humulin.comn
These Instructions for Use have been approved by the U.S. Food and Drug Administration.n
HUMULIN and HUMULINu00a0KwikPen are trademarks of Eli Lilly and Company.n
Marketed by: Lilly USA, LLCn
Indianapolis, IN 46285, USAn
Copyright u00a9 2015, 2019, Eli Lilly and Company. All rights reserved.n
Document revision date: November 2019n
LINR500KP-0004-IFU-20191115n

NDC 0002-8501-01n
20 mL
Humulin R U-500n
insulin human injectionn
10,000 units per 20 mL
500 units per mLn
Rx only
500 units/mL
Warning - Highly Concentrated
IMPORTANT: Use only with a U-500 syringe.n
For subcutaneous use only
Multiple-dose vial
www.humulin.comn
Lillyn

Dispense in this sealed carton
NDC 0002-8824-27n
HumulinR U-500 KwikPenn
insulin human injection
For Single Patient Use Onlyn
prefilled insulin delivery devicen
500 units/mLn
500 units per mLn
2 x 3 mL prefilled pensn
Rx onlyn
For subcutaneous use.n
Read HumulinR U-500 KwikPen Instructions for Use.n
NEEDLES NOT INCLUDEDn
This device is recommended for use with Becton, Dickinson and Company's insulin pen needles.n

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Insulin Human - R U-500 (Humulin)

Trade Name : Humulin

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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Insulin Human - R U-500 (Humulin)

Trade Name : Humulin

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)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

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NZ Drugs

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