Side Effects, Interactions, Warning, Dosage Uses. WARNINGSIncluded as part of the PRECAUTIONS section. PRECAUTIONSNever Share A LEVEMIR Flex. Touch Between Patients. LEVEMIR Flex. Touch must never be shared between. Brand Manual Novo Nordisk Inc PhoneSharing poses a risk for transmission. Dosage Adjustment And Monitoring. Glucose monitoring is essential for all patients. Changes to an insulin regimen should be made. Changes in insulin strength, manufacturer, type, or. As with all insulin preparations, the time course of. LEVEMIR may vary in different individuals or at different times in. Download Free Pc Login Now Windows 7 Iso. Administration. LEVEMIR should only be administered subcutaneously. Do not administer LEVEMIR intravenously or. The intended duration of activity of LEVEMIR is dependent on. Intravenous or intramuscular administration. Hypoglycemia. Do not use LEVEMIR in insulin infusion pumps. Do not dilute or mix LEVEMIR with any other insulin or. If LEVEMIR is diluted or mixed, the pharmacokinetic or. LEVEMIR. and the mixed insulin may be altered in an unpredictable manner. Hypoglycemia. Hypoglycemia is the most common adverse reaction of. LEVEMIR. The risk of hypoglycemia increases with. When a GLP 1 receptor agonist is used in combination with. LEVEMIR, the LEVEMIR dose may need to be lowered or more conservatively. ADVERSE REACTIONS. All patients must be educated to recognize and manage. Severe hypoglycemia can lead to unconsciousness or convulsions. Severe hypoglycemia requiring the assistance of another person or parenteral. LEVEMIR. The timing of hypoglycemia usually reflects the. Other factors. such as changes in food intake e. DRUG INTERACTIONS. Brand Manual Novo Nordisk Inc LevemirThere are numerous benefits of human growth hormone, HGH, in the extension of the human span of optimal health. Modern medicine has been studying the pros and cons of. This NCSL report provides an indepth 50state look at state laws requiring or mandating insurance coverage for diabetes as well as Medicaid coverage and statebased. The prolonged effect of subcutaneous LEVEMIR may delay. As with all insulins, use caution in patients with. The patients ability to concentrate and react may be impaired as a. Latest news from AFSPA on Federal Employees Health. This may present a risk in situations where these. Early warning symptoms of hypoglycemia may be different. DRUG INTERACTIONS. These situations may result in. Hypersensitivity And Allergic Reactions. Severe, life threatening, generalized allergy, including. LEVEMIR. Renal Impairment. No difference was observed in the pharmacokinetics of. However, some studies with human insulin have shown. Careful glucose monitoring and dose adjustments of insulin, including LEVEMIR. CLINICAL. PHARMACOLOGY. Hepatic Impairment. Tunisia/AFFILIATE/www-novonordisk-tn/images/changing-diabetes.jpg' alt='Brand Manual Novo Nordisk Inc Pennsylvania' title='Brand Manual Novo Nordisk Inc Pennsylvania' />Non diabetic individuals with severe hepatic impairment. However, some studies with human insulin have shown increased circulating. Careful glucose monitoring. LEVEMIR, may be necessary in. CLINICAL PHARMACOLOGY. Drug Interactions. Some medications may alter insulin requirements and. DRUG. INTERACTIONS. Fluid Retention And Heart Failure With Concomitant Use Of. PPAR gamma Agonists. Thiazolidinediones TZDs, which are peroxisome. PPAR gamma agonists, can cause dose related fluid. Fluid retention. may lead to or exacerbate heart failure. Patients treated with insulin. LEVEMIR, and a PPAR gamma agonist should be observed for signs and. If heart failure develops, it should be managed. PPAR gamma agonist must be considered. Patient Counseling Information. See FDA Approved Patient Labeling PATIENT INFORMATION and Instructions for UseNever Share A LEVEMIR Flex. Touch Between Patients. Advise patients that they must never share a LEVEMIR Flex. Touch. with another person, even if the needle is changed, because doing so carries a. Instructions For Patients. Patients should be informed that changes to insulin. Patients. should be informed about the potential side effects of insulin therapy. Patients. should be informed that the ability to concentrate and react may be impaired as. This may present a risk in situations where these. Hp Probook 4540S Driver. Patients who have frequent hypoglycemia or reduced or absent warning. Accidental mix ups between LEVEMIR and other insulins. To avoid medication. LEVEMIR and other insulins, patients should be instructed to. LEVEMIR must only be used if the solution is clear and. Patients must be advised that LEVEMIR must. NOT be diluted or mixed with any other insulin or solution. Patients should be instructed on self management. Patients should be instructed on. Patients should receive proper training on how to use. Levemir. Instruct patients that when injecting Levemir, they must press and. When the dose counter returns to 0. If the. needle is removed earlier, they may see a stream of insulin coming from the. If so, the full dose will not be delivered a possible under dose. If 0 does not appear in the dose counter after. In this case they would not have received any insulin even though the. If the patient did have a blocked needle, instruct them. Section 5 of the Instructions for Use and. IFU starting with Section 1 Prepare your pen with a. Make sure the patient selects the full dose needed. Patients with diabetes should be advised to inform their. Refer patients to the LEVEMIR PATIENT INFORMATION for additional. Nonclinical Toxicology. Carcinogenicity, Mutagenicity, Impairment Of Fertility. Standard 2 year carcinogenicity studies in animals have. Insulin detemir tested negative for genotoxic potential in. In a fertility and embryonic development study, insulin. Unitskgday, based on plasma AUC ratio. There were no effects on. Use In Specific Populations. Pregnancy. Pregnancy Category BRisk Summary. The background risk of birth defects, pregnancy loss, or. Female patients should be advised to. LEVEMIR. A randomized controlled clinical trial of pregnant women with. I diabetes using LEVEMIR during pregnancy did not show an increase in the. Reproductive toxicology studies in non diabetic. Clinical Considerations. The increased risk of adverse events in pregnancies. Because insulin requirements vary. Human Data. In an, open label, clinical study, women with type 1. LEVEMIR once or twice daily or NPH insulin. Insulin aspart was administered before each. A total of 1. 52 women in the LEVEMIR arm and 1. NPH arm. were or became pregnant during the study Total pregnant women 3. Approximately one half of the study participants in each arm were randomized as. NPH or to other insulins prior to conception and. In the 3. 10 pregnant women, the mean. Hb. A1c was lt 7 at 1. In the intent to treat population, the adjusted mean. Hb. A1c standard error at gestational week 3. LEVEMIR treated. NPH treated patients n1. Adverse reactions in pregnant patients occurring at an. Table 7. The two most common adverse. These are consistent with findings. Table 1, ADVERSE REACTIONS., and are not. Table 7. The incidence of adverse reactions of pre eclampsia was. LEVEMIR and NPH insulin groups. Out of the total number of cases of pre eclampsia, eight 8. LEVEMIR group and 1 case in the NPH insulin group required. The rates of pre eclampsia observed in the study are within. Pre eclampsia is a. All events were considered unlikely related to trial treatment. In all nine 9 cases requiring hospitalization the women had healthy infants. Events of hypertension, proteinuria and edema were reported less frequently in. LEVEMIR group than in the NPH insulin group as a whole. There was no. difference between the treatment groups in mean blood pressure during pregnancy. In the NPH insulin group there were 6 serious adverse. Placenta. previa, Placenta previa hemorrhage, and Premature separation of placenta. Antepartum haemorrhage. There were none. reported in the LEVEMIR group. The incidence of early fetal death abortions was. LEVEMIR and NPH treated patients 6. The. abortions were reported under the following terms Abortion spontaneous.