HUMULIN 70/30 70/30- insulin human injection, suspension
REMEDYREPACK INC.
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HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus.
Inspect HUMULIN 70/30 visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN 70/30 if particulate matter is seen. Do not mix HUMULIN 70/30 with any other insulins or diluents.
HUMULIN 70/30 should only be administered subcutaneously. Administer in the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy, rotate the injection site within the same region from one injection to the next [see Adverse Reactions ( 6)] .
Do not administer HUMULIN 70/30 intravenously or intramuscularly and do not use HUMULIN 70/30 in an insulin infusion pump.
Individualize and adjust the dosage of HUMULIN 70/30 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2, 5.3), and Use in Specific Populations ( 8.6, 8.7)] .
The proportion of rapid acting and long acting insulin is fixed in a premixed insulin such as HUMULIN 70/30. Independent adjustment of the basal or prandial dose is not possible when using a premixed insulin.
Physiological factors, disease states and concomitant drugs may impact the onset and duration of action of all insulins. HUMULIN 70/30 dose requirements may change with changes in level of physical activity, meal patterns (i.e., macronutrient content or timing of food intake), during major illness, or with some coadministered drugs [see Warnings and Precautions ( 5.3), Drug Interactions ( 7), and Use in Specific Populations ( 8.6, 8.7)] .
HUMULIN 70/30 should be given subcutaneously approximately 30-45 minutes before a meal.
HUMULIN 70/30 injectable suspension: 100 units per mL (U-100) is available as:
HUMULIN 70/30 is contraindicated:
HUMULIN 70/30 pens and HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3)] or hyperglycemia. These changes should be made cautiously and under close medical supervision and the frequency of blood glucose monitoring should be increased.
Hypoglycemia is the most common adverse reaction associated with insulins, including HUMULIN 70/30. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions ( 7)] , or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of HUMULIN 70/30 may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [see Clinical Pharmacology ( 12.2)] . Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [see Drug Interactions ( 7)] . Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations ( 8.6, 8.7)] .
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including HUMULIN 70/30. If hypersensitivity reactions occur, discontinue HUMULIN 70/30; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions ( 6)] . HUMULIN 70/30 is contraindicated in patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Contraindications ( 4)] .
All insulin products, including HUMULIN 70/30, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including HUMULIN 70/30, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
The following adverse reactions are discussed elsewhere in the labeling:
The following additional adverse reactions have been identified during post-approval use of HUMULIN 70/30. 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.
Allergic Reactions
Some patients taking HUMULIN 70/30 have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions ( 5.4)] .
Peripheral Edema
Some patients taking HUMULIN 70/30 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy
Administration of insulin subcutaneously, including HUMULIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.2)] in some patients.
Weight gain
Weight gain has occurred with some insulin therapies including HUMULIN 70/30 and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity
Development of antibodies that react with human insulin have been observed with all insulin, including HUMULIN 70/30.
The risk of hypoglycemia associated with HUMULIN 70/30 use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
The glucose lowering effect of HUMULIN 70/30 may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
The glucose lowering effect of HUMULIN 70/30 may be increased or decreased when co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
The signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.3)] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMULIN 70/30.
Pregnancy Category B
Risk Summary
All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes, insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking HUMULIN 70/30.
Human Data
While there are no adequate and well-controlled studies of HUMULIN 70/30 in pregnant women, evidence from published literature suggests that good glycemic control in patients with diabetes during pregnancy provides significant maternal and fetal benefits.
Animal Data
Reproduction and fertility toxicity studies were not performed in animals.
Endogenous insulin is present in human milk; it is unknown whether HUMULIN 70/30 is present in human milk. Insulin orally ingested is degraded in the gastrointestinal tract. No adverse reactions associated with infant exposure to insulin through the consumption of human milk have been reported. Good glucose control supports lactation in patients with diabetes. Women with diabetes who are lactating may require adjustments in their insulin dose.
Safety and effectiveness of HUMULIN 70/30 in patients less than 18 years of age has not been established.
The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3)] . Patients with advanced age using any insulin, including HUMULIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see Warnings and Precautions ( 5.3)] .
The effect of renal impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3)] . Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.
The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology ( 12.3)] . Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.
Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3, 5.5)] . 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.
HUMULIN 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) is a human insulin suspension. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN 70/30 is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation and mixing with human insulin injection. The amino acid sequence of HUMULIN 70/30 is identical to human insulin and has the empirical formula C 257H 383N 65O 77S 6 with a molecular weight of 5808.
HUMULIN 70/30 is a sterile white suspension. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, 0.24 mg of protamine sulfate, 16 mg of glycerin, 3.78 mg of dibasic sodium phosphate, 1.6 mg of metacresol, 0.65 mg of phenol, zinc oxide content adjusted to provide 0.025 mg zinc ion, and Water for Injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.
HUMULIN 70/30 lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
HUMULIN 70/30 combines an intermediate-acting insulin with the more rapid onset of action of regular human insulin. In healthy males (n=18) given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the pharmacologic effect began at approximately 50 minutes (range: 30 to 90 minutes) ( see Figure 1). The effect was maximal at approximately 3.5 hours (range: 1.5 to 6.5 hours) and the mean duration of action was relatively long (approximately 23 hours; range: 18-24 hours).
Figure 1 should be considered only as a representative example since the time course of action of insulin may vary in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables [see Warnings and Precautions ( 5.3)] .
Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of HUMULIN 70/30 or HUMULIN ® R U‑100 (0.3 unit/kg) in Healthy Subjects.
Absorption — In healthy male subjects given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the mean peak serum concentration occurred at 2.2 hours (range: 1 to 5 hours) after dosing.
Metabolism — The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of insulin.
Elimination — Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve.
Specific Populations
The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN 70/30 have not been studied.
Careful glucose monitoring and dose adjustments of insulin, including HUMULIN 70/30, may be necessary in patients with renal or hepatic dysfunction [see Use in Specific Populations ( 8.6, 8.7)] .
Carcinogenicity and fertility studies were not performed in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.
HUMULIN 70/30 100 units per mL (U-100) is available as:
10 mL vials | NDC 0002-8715-01 (HI-710) |
3 mL vials | NDC 0002-8715-17 (HI-713) |
5 x 3 mL prefilled pen | NDC 0002-8770-59 (HP-8770) |
5 x 3 mL HUMULIN 70/30 KwikPen (prefilled) | NDC 0002-8803-59 (HP-8803) |
Each prefilled HUMULIN 70/30 pen and HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 pens and HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person.
Protect from heat and light. Do not freeze. Do not use after the expiration date.
Not In-Use (Unopened) HUMULIN 70/30 Vials
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.
Room Temperature
If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days.
In-Use (Opened) HUMULIN 70/30 Vials
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Vials must be used within 31 days or be discarded, even if they still contain HUMULIN 70/30.
Room Temperature
If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31 days, even if the vial still contains HUMULIN 70/30.
Not In-Use (Unopened) HUMULIN 70/30 Pen and KwikPen
Refrigerated
Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.
Room Temperature
If stored at room temperature, below 86°F (30°C) the pen must be discarded after 10 days.
In-Use (Opened) HUMULIN 70/30 Pen and KwikPen
Refrigerated
Do NOT store in a refrigerator.
Room Temperature
Store at room temperature, below 86°F (30°C) and the pen must be discarded after 10 days, even if the pen still contains HUMULIN 70/30. See storage table below:
Not In-Use (Unopened)
Refrigerated | Not In-Use (Unopened)
Room Temperature | In-Use (Opened) | |
10 mL vial
3 mL vial | Until expiration date | 31 days | 31 days, refrigerated/room temperature |
3 mL pen
3 mL HUMULIN 70/30 KwikPen (prefilled) | Until expiration date | 10 days | 10 days, room temperature.
Do not refrigerate. |
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Never Share a HUMULIN 70/30 Pen, HUMULIN 70/30 KwikPen, or Syringe Between Patients
Advise patients that they must never share a HUMULIN 70/30 pen or HUMULIN 70/30 KwikPen with another person, even if the needle is changed. Advise patients using HUMULIN 70/30 vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Hypoglycemia
Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia especially at initiation of HUMULIN 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 [see Warnings and Precautions ( 5.3)] .
Inform patients that accidental mix-ups between HUMULIN 70/30 and other insulins have been reported. Instruct patients to always carefully check that they are administering the correct insulin (e.g., by checking the insulin label before each injection) to avoid medication errors between HUMULIN 70/30 and other insulins.
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with HUMULIN 70/30. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.4)] .
Females with Reproductive Potential
Advise females of reproductive potential with diabetes to inform their doctor if they are pregnant or are contemplating pregnancy [see Use in Specific Populations ( 8.1)] .
Visual Inspection Prior to Use
Instruct patients to visually inspect HUMULIN 70/30 before use and to use HUMULIN 70/30 only if it contains no particulate matter and appears uniformly cloudy after mixing [see Dosage and Administration ( 2.1)] .
Expiration Date
Instruct patients not to use HUMULIN 70/30 after the printed expiration date.
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HUMULIN ® and HUMULIN ® 70/30 KwikPen ® are trademarks of Eli Lilly and Company.
Literature revised February 25, 2015
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.
LIN7030-0001-USPI-20150225
PATIENT INFORMATION
HUMULIN
® (HU-mu-lin) 70/30
(70% human insulin isophane suspension and
30% human insulin injection [rDNA origin])
Do not share your HUMULIN 70/30 Pen, HUMULIN 70/30 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 70/30?
Who should not use HUMULIN 70/30?
Do not use HUMULIN 70/30 if you:
Before using HUMULIN 70/30, tell your healthcare provider about all your medical conditions including, if you:
Before you start using HUMULIN 70/30, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use HUMULIN 70/30?
Your HUMULIN 70/30 dose may need to change because of:
What should I avoid while using HUMULIN 70/30?
While using HUMULIN 70/30 do not:
What are the possible side effects of HUMULIN 70/30?
HUMULIN 70/30 may cause serious side effects that can lead to death, including:
Treatment with TZDs and HUMULIN 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:
The most common side effects of HUMULIN 70/30 include:
General information about the safe and effective use of HUMULIN 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 HUMULIN 70/30 that is written for health professionals. Do not use HUMULIN 70/30 for a condition for which it was not prescribed. Do not give HUMULIN 70/30 to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in HUMULIN 70/30?
Active Ingredient: insulin human (rDNA origin)
Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide
For more information, call 1-800-545-5979 or go to www.humulin.com.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Patient Information revised February 25, 2015
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.
LIN7030-0001-PPI-20150225
Instructions for Use
HUMULIN
® (HU-mu-lin) 70/30
(70% human insulin isophane suspension and
30% human insulin injection [rDNA origin])
vial (100 Units/mL, U-100)
Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get a new HUMULIN 70/30 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.
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:
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Preparing your HUMULIN 70/30 dose:
Step 1:
Gently roll the vial between the palms of your hands at least 10 times. |
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Step 2:
Invert the vial at least 10 times. Do not shake. Mixing is important to make sure you get the right dose. Humulin 70/30 should look white and cloudy after mixing. Do not use it if it looks clear or contains any lumps or particles. | |
Step 3:
If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper. |
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Step 4:
Wipe the Rubber Stopper with an alcohol swab. |
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Step 5:
Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose. |
(Example Dose: 20 units shown) |
Step 6:
Push the needle through the Rubber Stopper of the vial. |
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Step 7:
Push the plunger all the way in. This puts air into the vial. |
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Step 8:
Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose. If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. |
(Example Dose: 20 units Plunger is shown at 24 units) |
Step 9:
Slowly push the Plunger up until the tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose. |
(Example Dose: 20 units shown) |
Step 10:
Pull the syringe out of the vial's Rubber Stopper. |
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Giving your HUMULIN 70/30 injection:
Step 11:
Choose your injection site. HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms. Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose. |
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Step 12:
Insert the needle into your skin. |
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Step 13:
Push down on the Plunger to inject your dose. The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose. |
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Step 14:
Pull the needle out of your skin.
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Disposing of used needles and syringes:
How should I store HUMULIN 70/30?
All unopened HUMULIN 70/30 vials:
After HUMULIN 70/30 vials have been opened:
General information about the safe and effective use of HUMULIN 70/30.
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.
Scan this code to launch the humulin.com website
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: February 25, 2015
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.
LIN7030VL-0001-IFU-20150225
Instructions for Use
HUMULIN
® 70/30 KwikPen
®
(70% human insulin isophane suspension
30% human insulin injection [rDNA origin])
Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get another HUMULIN ® 70/30 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.
Do not share your HUMULIN 70/30 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.
HUMULIN 70/30 KwikPen (“Pen”) is a disposable pen containing 3 mL (300 units) of U-100 HUMULIN ® 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) insulin. You can inject from 1 to 60 units in a single injection.
HUMULIN 70/30 KwikPen has a blue and brown Label with a matching brown Dose Knob (See the KwikPen Parts diagram below).
This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your HUMULIN 70/30 injection:
Preparing HUMULIN 70/30 KwikPen:
Step 1:
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Step 2:
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Step 3:
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Step 4:
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Step 5:
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Step 6:
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Step 7:
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Priming the HUMULIN 70/30 KwikPen:
Prime the HUMULIN 70/30 KwikPen before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.
Step 8:
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Step 9:
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Step 10:
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Selecting your dose:
Step 11:
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(Example: 10 units shown) (Example: 15 units shown) |
Giving your HUMULIN 70/30 injection:
Step 12:
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Step 13:
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Step 14:
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Step 15:
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Step 16:
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Step 17:
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Step 18:
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After your injection:
How should I store my HUMULIN 70/30 KwikPen?
General information about the safe and effective use of HUMULIN 70/30 KwikPen.
Example:
First used on _______ + 10 days = Throw out on ______
Date Date
Pen 1 - First used on _______ Throw out on _______
Date Date
Pen 2 - First used on _______ Throw out on _______
Date Date
Pen 3 - First used on _______ Throw out on _______
Date Date
Pen 4 - First used on _______ Throw out on _______
Date Date
Pen 5 - First used on _______ Throw out on _______
Date Date
If you have any questions or problems with your HUMULIN 70/30 KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN 70/30 KwikPen and insulin, go to www.lilly.com.
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.
Revised: March 12, 2015
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright © 2013, 2015, Eli Lilly and Company. All rights reserved.
HUMULIN 70/30 KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1:2000. |
LIN7030KP-0002-IFU-20150312
DRUG: Humulin 70/30 70/30
GENERIC: Insulin human
DOSAGE: INJECTION, SUSPENSION
ADMINSTRATION: SUBCUTANEOUS
NDC: 52125-415-08
ACTIVE INGREDIENT(S):
INACTIVE INGREDIENT(S):
PACKAGING: 10 mL in 1 VIAL
HUMULIN 70/30
70/30
insulin human injection, suspension |
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Labeler - REMEDYREPACK INC. (829572556) |