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Humalog KwikPen manual

Humalog KwikPen 75/25 manual

Humalog KwikPen 50/50 manual

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Humalog

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Humalog Premixed Insulins

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Hypothetical patient profile. Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Select Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50 • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or any of the excipients contained in the formulation. • Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously. • Humalog, Humalog Mix 75/25, and Humalog Mix50/50 should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. • Hypoglycemia is the most common adverse effect of insulin therapy, including Humalog, Humalog Mix75/25, and Humalog Mix50/50 therapy. The risk of hypoglycemia increases with tighter glycemic control. Severe hypoglycemia may be life threatening and can cause seizures or death. Click here for additional Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50. Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Select Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50 • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or any of the excipients contained in the formulation. • Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously. • Humalog, Humalog Mix 75/25, and Humalog Mix50/50 should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. • Hypoglycemia is the most common adverse effect of insulin therapy, including Humalog, Humalog Mix75/25, and Humalog Mix50/50 therapy. The risk of hypoglycemia increases with tighter glycemic control. Severe hypoglycemia may be life threatening and can cause seizures or death. Click here for additional Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50. Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Select Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50 • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or any of the excipients contained in the formulation. • Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously. • Humalog, Humalog Mix 75/25, and Humalog Mix50/50 should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. • Hypoglycemia is the most common adverse effect of insulin therapy, including Humalog, Humalog Mix75/25, and Humalog Mix50/50 therapy. The risk of hypoglycemia increases with tighter glycemic control. Severe hypoglycemia may be life threatening and can cause seizures or death. • Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. Click here for additional Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50. Indication for Glucagon Glucagon is indicated as a treatment for severe hypoglycemia. Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. Select Safety Information for Glucagon • Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma. • Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. In patients with insulinoma, intravenous administration of glucagon may produce an initial increase in blood glucose; however, because of glucagon's hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate. Click here for additional Important Safety Information for glucagon. Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Select Safety Information for Humalog Use in Pumps • Adverse reactions associated with Humalog in patients receiving continuous subcutaneous insulin infusion: - In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions (0.09/month versus 0.10/month) and infusion-site reactions (2.6% versus 2.6%) were similar for Humalog versus regular human insulin treated patients, respectively. - In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion-site adverse events were infusion-site erythema and infusion-site reaction. • Humalog Mix75/25 and Humalog Mix50/50 should never be used in a pump.* Click here for additional Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50. Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Indication for Glucagon Glucagon is indicated as a treatment for severe hypoglycemia. Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. In addition to our downloadable patient education materials, the following resources are available that may help your patients initiate a Humalog brand of mealtime insulin: Managing Your Diabetes with Humalog Managing Your Diabetes^® with Humalog^® is an online or in-person training class for patients who have just started on the Humalog brand of insulin. Conducted in your office or another location by a Diabetes Educator, this complimentary, 1-hour session covers topics including: How diabetes affects the body Targets for glucose levels How Humalog^® and Humalog premixed insulins work Pen-user training Visit www.ManagingYourDiabetes.com to schedule a training class in your office or other location. An online version of the Managing Your Diabetes with Humalog training program is also available. Small Steps: Starting Humalog Kit Patient starter kit to help them begin Humalog mealtime insulin therapy. The kit contains: Informative brochure Instructional DVD Log book for patients to track their glucose levels and progress Pediatric Starter Kit The Pediatric Starter Kit is a support tool for pediatric patients and their caregivers. The kit contains: Food Spinner—a carbohydrate-counting tool Log book Glucagon brochure I Have Diabetes ID card Raising a Child with Diabetes parent brochure Voucher for Humalog What Kids Need to Know About Diabetes brochure Carbohydrate Counting for Children with Diabetes brochure Small Steps: Learning About Mealtime Insulin Teaching Tool Step-by-step, interactive, patient education resource that helps facilitate conversation focused on mealtime insulin therapy. Small Steps Real Talk: A Conversation About Mealtime Insulin An educational resource designed to help facilitate meaningful dialogue between you and your patients. Includes 3 sections: About Mealtime Insulin Small Steps DVD Your Mealtime Profile Nutrition in the Fast Lane^™ This booklet includes over 1000 menu options offered by 39 fast-food chains, to help patients make healthy choices. The Lilly Glucagon Emergency Kit Helps insulin users be prepared. Used to treat severe hypoglycemia by increasing blood glucose concentration. Next Topic: Reimbursement Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Humalog^® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. All of these insulin products contain 100 units per mL. Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50 Contraindications Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or any excipients contained in the formulation. Warnings and Precautions Dose Adjustment, Monitoring, and Considerations: Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously. Concomitant oral antidiabetic treatment may need to be adjusted. The time course of action for Humalog, Humalog Mix75/25, and Humalog Mix50/50 may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the delivery site, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan, or experience illness, emotional disturbances, or other stress may require insulin dose adjustment. Humalog differs from regular human insulin by its rapid onset of action and shorter duration of activity. Humalog should be given within 15 minutes before or immediately after a meal. Humalog Mix75/25 and Humalog Mix50/50 are intended only for subcutaneous administration and should be given within 15 minutes before a meal. Hypoglycemia: Hypoglycemia is the most common adverse effect of Humalog, Humalog Mix75/25, and Humalog Mix50/50. The risk of hypoglycemia increases with tighter glycemic control. Educate patients to recognize and manage hypoglycemia. Hypoglycemia can happen suddenly and symptoms may vary for each person and may change over time. Early warning symptoms of hypoglycemia may be different or less pronounced under conditions such as long-standing diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control. These situations may result in severe hypoglycemia and possibly loss of consciousness prior to the patient’s awareness of hypoglycemia. Severe hypoglycemia may be life threatening and can cause seizures or death. Use caution in patients with hypoglycemia unawareness and who may be predisposed to hypoglycemia. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. The timing of hypoglycemia usually reflects the time-action profile of the administered insulins. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia. Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50. Hypokalemia: Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (eg, patients using potassium-lowering medications or medications sensitive to serum potassium concentrations). Renal or Hepatic Impairment: Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment. Mixing of Insulins: Patients should be advised NOT to mix Humalog Mix75/25 or Humalog Mix50/50 with any other insulin. Humalog for subcutaneous injection should not be mixed with insulins other than NPH insulin. If Humalog is mixed with NPH insulin, Humalog should be drawn into the syringe first. Injection should occur immediately after mixing. Humalog Use in a Subcutaneous Insulin Infusion Pump: Humalog should not be diluted or mixed when used in an external insulin pump. Change Humalog in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days. Malfunction of the insulin pump or infusion set or insulin degradation can rapidly lead to hyperglycemia and ketosis. Prompt correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with Humalog may be required. Train patients using an insulin pump to administer insulin by injection and to have alternate insulin therapy available in case of pump failure. Humalog Mix75/25 and Humalog Mix50/50 should never be used in a pump. Drug Interactions: Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required. Adverse Reactions Adverse reactions associated with Humalog, Humalog Mix75/25, and Humalog Mix50/50 include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema. Use in Specific Populations Pediatrics: Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. Please click to access Full Prescribing Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50. Please see full user manual that accompanies the pen. HI BOI HCP ISI 08JUN2011 Indication for Glucagon Glucagon is indicated as a treatment for severe hypoglycemia. Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. Important Safety Information for Glucagon Contraindications Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma. Warnings Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. In patients with insulinoma, intravenous administration of glucagon may produce an initial increase in blood glucose; however, because of glucagon’s hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate. Exogenous glucagon also stimulates the release of catecholamines. In the presence of pheochromocytoma, glucagon can cause the tumor to release catecholamines, which may result in a sudden and marked increase in blood pressure. Generalized allergic reactions, including urticaria, respiratory distress, and hypotension, have been reported in patients who received glucagon by injection. Precautions Glucagon is effective in treating hypoglycemia only if sufficient liver glycogen is present. Therefore, hypoglycemia associated with states of starvation, adrenal insufficiency, or chronic hypoglycemia should be treated with glucose. Patients and family members should become familiar with the technique of preparing glucagon before a severe hypoglycemic emergency arises. To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Blood glucose determinations should be obtained to monitor the patient with hypoglycemia until patient is asymptomatic, and patients should be advised to inform their physician when hypoglycemic reactions occur. One-half the adult dose should be used in pediatric patients weighing less than 44 lbs (20 kg). Any unused portion should be discarded. Pregnancy Category B: There are no adequate and well-controlled clinical studies of the use of glucagon in pregnant or nursing women. Adverse Reactions Severe adverse reactions are very rare, although nausea and vomiting may occur occasionally. For more safety information, please click to access Information for the User and Information for the Physician. HI GLUC HCP ISI 21APR2011 Humalog^®, Humalog^® KwikPen^™, and HumaPen^® MEMOIR^™ are registered trademarks of Eli Lilly and Company and are available by prescription only. Humalog^® is a registered trademark of Eli Lilly and Company and is available by prescription only. Humalog^® and Humalog^® KwikPen^™ are registered trademarks of Eli Lilly and Company and are available by prescription only. Humalog^® and Humalog^® KwikPen^™ are registered trademarks of Eli Lilly and Company and are available by prescription only. Humalog^®, Humalog^® KwikPen^™, and HumaPen^® MEMOIR^™ are registered trademarks of Eli Lilly and Company and are available by prescription only. Humalog^® Mix75/25^™ and Humalog^® Mix50/50^™ are trademarks of Eli Lilly and Company and are available by prescription only. Humalog^® Mix75/25^™, Humalog^® Mix50/50^™, Humalog^® Mix75/25^™ KwikPen^™, and Humalog^® Mix50/50^™ KwikPen^™ are trademarks of Eli Lilly and Company and are available by prescription only. HumaPen^® LUXURA^™ is a registered trademark of Eli Lilly and Company. HumaPen^® LUXURA^™ HD is available by prescription only. The glucagon design is a trademark of Eli Lilly and Company. Glucagon is available by prescription only. Other product names mentioned herein are the trademarks of their respective owners. Nutrition in the Fast Lane^™ is a trademark of Eli Lilly and Company. Humulin^® is a registered trademark of Eli Lilly and Company. Managing Your Diabetes^® is a registered trademark of Eli Lilly and Company. BD, BD Logo, and BD AutoShield are trademarks of Becton, Dickinson and Company. Adobe^® Reader^® is a registered trademark of Adobe Systems Incorporated.

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