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NovoLog® Mix 70/30
(70% insulin aspart protamine suspension and 30% insulin aspart) Injection, [rDNA origin]) Suspension for
Subcutaneous Injection
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NovoLog Mix 70/30 is a blood glucoseÂlowering agent with an earlier onset and an intermediate duration of action. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's part (NovoLog) has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da.
Figure 1: Structural formula of insulin aspart
 |
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) is a uniform, white, sterile suspension that contains insulin aspart 100 Units/mL.
Inactive ingredients for the 10 mL vial are mannitol 36.4 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 μg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.58 mg/mL, and protamine sulfate 0.32 mg/mL.
Inactive ingredients for the NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) FlexPen are glycerol 16.0 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 μg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.877 mg/mL, and protamine sulfate 0.32 mg/mL. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.
Important Limitations of Use:
In premix insulins, such as Novolog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is an insulin analog with an earlier onset and intermediate duration of action in comparison to the basal human insulin premix. The addition of protamine to the rapid-acting aspart insulin analog (NovoLog) results in insulin activity that is 30% short-acting and 70% long-acting. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). The dosage of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) must be individualized. The written prescription for NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should include the full name, to avoid confusion with NovoLog (insulin aspart) and Novolin 70/30 (human premix).
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should appear uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should not be used after the printed expiration date.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should not be administered intravenously or used in insulin infusion pumps. Dose regimens of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) will vary among patients and should be determined by the health care professional familiar with the patient's recommended glucose treatment goals, metabolic needs, eating habits, and other lifestyle variables.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is a suspension that must be visually inspected and resuspended immediately before use.
The NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) vial should be rolled gently in your hands in a horizontal position 10 times to mix it. The rolling procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Resuspension is easier when the insulin has reached room temperature.
The NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen should be rolled 10 times gently between your hands in a horizontal position. Thereafter, turn the NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen upside down so that the glass ball moves from one end of the reservoir to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Before each subsequent injection, turn the disposable NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen upside down so that the glass ball moves from one end of the reservoir to the other at least 10 times and until the suspension appears uniformly white and cloudy. Inject immediately.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is available in the following package sizes: each presentation contains 100 units of insulin aspart per mL (U-100).
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is available in the following package sizes: each presentation contains 100 Units of insulin aspart per mL (U-100).
10 mL vials NDC 0169-3685-12
3 mL NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen NDC 0169-3696-19
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) vials and NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen are latex free.
Unused NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should be stored in a refrigerator between 2°C and 8°C (36°F to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) or use NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) if it has been frozen.
Vials: After initial use, a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. Open vials may be refrigerated.
Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen: Once a NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 14 days, but should not be exposed to excessive heat or sunlight. A NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen in use must NOT be stored in the refrigerator. Keep the disposable NovoLog Mix 70/30 FlexPen away from direct heat and sunlight. An unpunctured NovoLog Mix 70/30 FlexPen can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep any unused NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen in the carton so it will stay clean and protected from light.
These storage conditions are summarized in the following table:
| Not in-use (unopened) Room Temperature (below 30°C [86°F]) | Not in-use (unopened) Refrigerated (2°C - 8°C [36°F- 46°F]) | In-use (opened) Room Temperature (below 30°C [86°F]) | |
| 10 mL vial | 28 days | Until expiration date | 28 days (refrigerated/room temperature) |
| 3 ml NovoLog Mix 70/30 FlexPen | 14 days | Until expiration date | 14 days (Do not refrigerate) |
Manufactured by: Novo Nordisk A/S,DK-2880 Bagsvaerd, Denmark. For information about NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) contact: Novo Nordisk Inc., Princeton, New Jersey 08540, 1-800-727-6500. www.novonordisk-us.com
Clinical trials are conducted under widely varying designs, therefore, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
Table 1: Treatment-Emergent Adverse Events in Patients with
Type 1 diabetes mellitus (Adverse events with frequency ≥ 5% are included.)
| Preferred Term | NovoLog Mix70/30 (N=55) |
Novolin 70/30 (N=49) |
||
| N | % | N | % | |
| Hypoglycemia | 38 | 69 | 37 | 76 |
| Headache | 19 | 35 | 6 | 12 |
| Influenza-like symptoms | 7 | 13 | 1 | 2 |
| Dyspepsia | 5 | 9 | 3 | 6 |
| Back pain | 4 | 7 | 2 | 4 |
| Diarrhea | 4 | 7 | 3 | 6 |
| Pharyngitis | 4 | 7 | 1 | 2 |
| Rhinitis | 3 | 5 | 6 | 12 |
| Skeletal pain | 3 | 5 | 2 | 4 |
| Upper respiratory tract infection | 3 | 5 | 1 | 2 |
Table 2: Treatment-Emergent Adverse Events in Patients with
Type 2 diabetes mellitus (Adverse events with frequency ≥ 5% are
included.)
| Preferred Term | NovoLog Mix70/30 (N=85) | Novolin 70/30 (N=102) | ||
| N | % | N | % | |
| Hypoglycemia | 40 | 47 | 51 | 50 |
| Upper respiratory tract infection | 10 | 12 | 6 | 6 |
| Headache | 8 | 9 | 8 | 8 |
| Diarrhea | 7 | 8 | 2 | 2 |
| Neuropathy | 7 | 8 | 2 | 2 |
| Pharyngitis | 5 | 6 | 4 | 4 |
| Abdominal pain | 4 | 5 | 0 | 0 |
| Rhinitis | 4 | 5 | 2 | 2 |
Additional adverse reactions have been identified during post-approval use of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. They include medication errors in which other insulins have been accidentally substituted for NovoLog Mix 70/30 [see PATIENT INFORMATION].
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
Included as part of the PRECAUTIONS section.
The short and long-acting components of insulin mixes, including NovoLog Mix 70/30, cannot be titrated independently. Because NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) has peak pharmacodynamic activity between 1-4 hours after injection, it should be administered within 15 minutes of meal initiation [see CLINICAL PHARMACOLOGY]. The dose of insulin required to provide adequate glycemic control for one of the meals may result in hyper- or hypoglycemia for the other meal. The pharmacodynamic profile may also be inadequate for patients who require more frequent meals.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should not be mixed with any other insulin product.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should not be used intravenously.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should not be used in insulin infusion pumps.
Glucose monitoring is recommended for all patients with diabetes. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. Changes may also be necessary during illness, emotional stress, and other physiologic stress in addition to changes in meals and exercise.
The pharmacokinetic and pharmacodynamic profiles of all insulins may be altered by the site used for injection and the degree of vascularization of the site. Smoking, temperature, and exercise contribute to variations in blood flow and insulin absorption. These and other factors contribute to inter- and intra-patient variability.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen is for use by one person only.
Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) .
The timing of hypoglycemia may reflect the time-action profile of the insulin formulation [see CLINICAL PHARMACOLOGY]. Other factors, such as changes in dietary intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [See DRUG INTERACTIONS]. As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g. patients who are fasting or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating machinery.
Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control [see DRUG INTERACTIONS].
All insulin products, including NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia that, if left untreated, may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g. patients using potassium-lowering medications or patients taking medications sensitive to potassium concentrations).
Clinical or pharmacology studies with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) in diabetic patients with various degrees of renal impairment have not been conducted. As with other insulins, the requirements for NovoLog Mix 70/30 may be reduced in patients with renal impairment. [see CLINICAL PHARMACOLOGY]
Clinical or pharmacology studies with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) in diabetic patients with various degrees of hepatic impairment have not been conducted. As with other insulins, the requirements for NovoLog Mix 70/30 may be reduced in patients with hepatic impairment. [see CLINICAL PHARMACOLOGY]
Local Reactions- As with other insulin therapy, patients may experience reactions such as erythema, edema or pruritus at the site of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . In some instances, these reactions may be related to the insulin molecule, other components in the insulin preparation including protamine and cresol, components in skin cleansing agents, or injection techniques. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.
Systemic Reactions- Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening.
Specific anti-insulin antibodies as well as cross-reacting anti-insulin antibodies were monitored in a 3-month, open-label comparator trial as well as in a long-term extension trial. Changes in cross-reactive antibodies were more common after NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) than with Novolin® 70/30 but these changes did not correlate with change in HbA1c or increase in insulin dose. The clinical significance of these antibodies has not been established. Antibodies did not increase further after long-term exposure ( > 6 months) to NovoLog Mix 70/30.
[see FDA-Approved Patient Labeling]
Maintenance of normal or near-normal glucose control is a treatment goal in diabetes mellitus and has been associated with a reduction in diabetic complications. Patients should be informed about potential risks and advantages of NovoLog Mix 70/30 therapy including the possible adverse reactions. Patients should also be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo- and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dose, instruction for use of injection devices, and proper storage of insulin. See PATIENT INFORMATION supplied with the product. Patients should be informed that frequent, patient-performed blood glucose measurements are needed to achieve optimal glycemic control and avoid both hyper- and hypoglycemia, and diabetic ketoacidosis.
The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery.
Accidental substitutions between NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) and other insulin products have been reported. Patients should be instructed to always carefully check that they are administering the appropriate insulin to avoid medication errors between NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) and any other insulin. The prescription for NovoLog Mix 70/30 should be written clearly in order to avoid confusion with other insulin products, for example, NovoLog or Novolin 70/30. In addition, the written prescription should clearly indicate the presentation, for example FlexPen or vial.
Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with NovoLog, the rapid-acting component of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , at 10, 50, and 200 U/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area, respectively). At a dose of 200 U/kg/day, NovoLog increased the incidence of mammary gland tumors in females when compared to untreated controls. The incidence of mammary tumors found with NovoLog was not significantly different from that found with regular human insulin. The relevance of these findings to humans is not known.
NovoLog was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.
In fertility studies in male and female rats, NovoLog at subcutaneous doses up to 200 U/kg/day (approximately 32 times the human subcutaneous dose, based on U/body surface area) had no direct adverse effects on male and female fertility, or on general reproductive performance of animals.
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. 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 such patients.
An open-label, randomized study compared the safety and efficacy of NovoLog (the rapid-acting component of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ) versus human insulin in the treatment of pregnant women with Type 1 diabetes (322 exposed pregnancies (NovoLog: 157, human insulin: 165)). Two-thirds of the enrolled patients were already pregnant when they entered the study. Since only one-third of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Mean HbA1c of ~ 6% was observed in both groups during pregnancy, and there was no significant difference in the incidence of maternal hypoglycemia.
Animal reproduction studies have not been conducted with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . However, subcutaneous reproduction and teratology studies have been performed with NovoLog (the rapid-acting component of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ) and regular human insulin in rats and rabbits. In these studies, NovoLog was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of NovoLog did not differ from those observed with subcutaneous regular human insulin. NovoLog, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 U/kg/day (approximately 32-times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area), and in rabbits at a dose of 10 U/kg/day (approximately three times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area). The effects are probably secondary to maternal hypoglycemia at high doses. No significant effects were observed in rats at a dose of 50 U/kg/day and rabbits at a dose of 3 U/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 U/kg/day for rats and equal to the human subcutaneous dose of 1.0 U/kg/day for rabbits based on U/body surface area.
Female patients should be advised to discuss with their physician if they intend to, or if they become pregnant. There are no adequate and well-controlled studies of the use of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) in pregnant women.
It is unknown whether insulin aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) or NovoLog in lactating women. Women with diabetes who are lactating may require adjustments of their insulin doses.
Safety and effectiveness of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) have not been established in pediatric patients.
Clinical studies of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this population.
Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. 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.
NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is contraindicated
The primary activity of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is the regulation of glucose metabolism. Insulins, including NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
The two euglycemic clamp studies described below assessed glucose utilization after dosing of healthy volunteers. NovoLog Mix 70/30 has an earlier onset of action than human premix 70/30 in studies of normal volunteers and patients with diabetes. The onset of action is between 10-20 minutes for NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) compared to 30 minutes for Novolin 70/30. The mean ± SD time to peak activity for NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is 2.4 hr ± 0.8hr compared to 4.2 hr ± 0.4 hr for Novolin 70/30. The duration of action may be as long as 24 hours (see Figure 2).
Figure 2: Pharmacodynamic Activity Profile of NovoLog Mix
70/30 and Novolin 70/30 in healthy subjects.
 |
The single substitution of the amino acid proline with aspartic acid at position B28 in insulin aspart (NovoLog) reduces the molecule'stendency to form hexamers as observed with regular human insulin. The rapid absorption characteristics of NovoLog are maintained by NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . The insulin aspart in the soluble component of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is absorbed more rapidly from the subcutaneous layer than regular human insulin. The remaining 70% is in crystalline form as insulin aspart protamine which has a prolonged absorption profile after subcutaneous injection.
The relative bioavailability of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) compared to NovoLog and Novolin 70/30 indicates that the insulins are absorbed to similar extent. In euglycemic clamp studies in healthy volunteers (n=23) after dosing with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) (0.2 U/kg), a mean maximum serum concentration (Cmax) of 23.4 ± 5.3 mU/L was reached after 60 minutes. The mean half-life (t½) of NovoLog Mix 70/30 was about 8 to 9 hours. Serum insulin levels returned to baseline 15 to 18 hours after a subcutaneous dose of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Similar data were seen in a separate euglycemic clamp study in healthy volunteers (n=24) after dosing with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) (0.3 U/kg). A Cmax of 61.3 ± 20.1 mU/L was reached after 85 minutes. Serum insulin levels returned to baseline 12 hours after a subcutaneous dose.
The Cmax and the area under the insulin concentration-time curve (AUC) after administration of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) was approximately 20% greater than those after administration of Novolin 70/30, (see Fig. 3 for pharmacokinetic profiles).
Figure 3: Pharmacokinetic Profiles of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) and
Novolin 70/30
 |
NovoLog has a low binding to plasma proteins, 0 to 9%, similar to regular human insulin. After subcutaneous administration in normal male volunteers (n=24), NovoLog was more rapidly eliminated than regular human insulin with an average apparent half-life of 81 minutes compared to 141 minutes for regular human insulin.
The effect of sex, age, obesity, ethnic origin, renal and hepatic impairment, pregnancy, or smoking, on the pharmacodynamics and pharmacokinetics of NovoLog Mix 70/30 has not been studied.
In standard biological assays in mice and rabbits, one unit of NovoLog has the same glucose-lowering effect as one unit of regular human insulin. However, the effect of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is more rapid in onset compared to Novolin (human insulin) 70/30 due to its faster absorption after subcutaneous injection.
In a three-month, open-label trial, patients with Type 1 (n=104) or Type 2 (n=187) diabetes were treated twice daily (before breakfast and before supper) with NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) or Novolin 70/30. Patients had received insulin for at least 24 months before the study. Oral hypoglycemic agents were not allowed within 1 month prior to the study or during the study. The small changes in HbA1c were comparable across the treatment groups (see Table 3).
Table 3: Glycemic Parameters at the End of Treatment [Mean
± SD (N subjects)]
| NovoLog Mix 70/30 | Novolin 70/30 | |
| Type 1, N=104 | ||
| Fasting Blood Glucose (mg/dL) | 174 ± 64 (48) | 142 ± 59 (44) |
| 1.5 Hour Post Breakfast (mg/dL) | 187 ± 82 (48) | 200 ± 82 (42) |
| 1.5 Hour Post Dinner (mg/dL) | 162 ± 77 (47) | 171 ± 66 (41) |
| HbA1c (%) Baseline | 8.4 ± 1.2 (51) | 8.5 ± 1.1 (46) |
| HbA1c (%) Week 12 | 8.4 ± 1.1 (51) | 8.3 ± 1.0 (47) |
| Type 2, N=187 | ||
| Fasting Blood Glucose (mg/dL) | 153 ± 40 (76) | 152 ± 69 (93) |
| 1.5 Hour Post Breakfast (mg/dL) | 182 ± 65 (75) | 200 ± 80 (92) |
| 1.5 Hour Post Dinner (mg/dL) | 168 ± 51 (75) | 191 ± 65 (93) |
| HbA1c (%) Baseline | 8.1 ± 1.2 (82) | 8.2 ± 1.3 (98) |
| HbA1c (%) Week 12 | 7.9 ± 1.0 (81) | 8.1 ± 1.1 (96) |
The significance, with respect to the long-term clinical sequelae of diabetes, of the differences in postprandial hyperglycemia between treatment groups has not been established.
Specific anti-insulin antibodies as well as cross-reacting anti-insulin antibodies were monitored in the 3-month, open-label comparator trial as well as in a long-term extension trial
In a 34-week, open-label trial, insulin-naïve patients with type 2 diabetes currently treated with 2 oral antidiabetic agents were switched to treatment with metformin and pioglitazone. During an 8-week optimization period metformin and pioglitazone were increased to 2500 mg per day and 30 or 45 mg per day, respectively. After the optimization period, subjects were randomized to receive either NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) twice daily added on to the metformin and pioglitazone regimen or continue the current optimized metformin and pioglitazone therapy. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) was started at a dose of 6 IU twice daily (before breakfast and before supper). Insulin doses were titrated to a pre-meal glucose goal of 80-110 mg/dL. The total daily insulin dose at the end of the study was 56.9 ± 30.5 IU.
Table 4: Combination Therapy with Oral Agents and Insulin
in Patients with Type 2 Diabetes Mellitus [Mean (SD)]
| Treatment duration 24-weeks | NovoLog Mix
70/30 +
Metformin + Pioglitazone |
Metformin + Pioglitazone |
| HbA1c | ||
| Baseline mean ± SD (n) | 8.1 ±1.0 (102) | 8.1 ±1.0 (98) |
| End-of-study mean ±SD (n) - LOCF | 6.6 ± 1.0 (93) | 7.8 ±1.2 (87) |
| Adjusted Mean change from baseline ±SE (n)* | -1.6 ±0.1 (93) | -0.3 ±0.1 (87) |
| Treatment difference mean ±SE* | -1.3 ±0.1 | |
| 95% CI* | (-1.6, -1.0) | |
| Percentage of subjects reaching HbA1c < 7.0% | 76% | 24% |
| Percentage of subjects reaching HbA1 < ≤ 6.5% | 59% | 12% |
| Fasting Blood Glucose (mg/dL) | ||
| Baseline Mean ± SD (n) | 173 ±39.8 (93) | 163 ±35.4 (88) |
| End of Study Mean ± SD (n) – LOCF | 130 ±50.0 (90) | 162 ±40.8 (84) |
| Adjusted Mean change from baseline ±SE (n)* | -43.0 ±5.3 (90) | -3.9 ±5.3 (84) |
| End-of-Study Blood Glucose (Plasma) (mg/dL) | ||
| 2 Hour Post Breakfast | 138 ±42.8 (86) | 188 ± 57.7 (74) |
| 2 Hour Post Lunch | 150 ±41.5 (86) | 176 ±56.5 (74) |
| 2 Hour Post Dinner | 141 ±57.8 (86) | 195 ±60.1 (74) |
| % of patients with severe hypoglycemia** | 3 | 0 |
| % of patients with minor hypoglycemia** | 52 | 3 |
| Weight gain at end of study (kg)** | 4.6 ±4.3 (92) | 0.8 ±3.2 (86) |
| *Adjusted mean per group, treatment difference,
and 95% CI were obtained based on an ANCOVA model with treatment, FPG
stratum, and secretagogue stratum as fixed factors and baseline HbA1c
as the covariate. **If metabolic control is improved by intensified insulin therapy, an increased risk of hypoglycemia and weight gain may occur. |
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In a 28-week, open-label trial, insulin-naïve patients with type 2 diabetes with fasting plasma glucose above 140 mg/dL currently treated with metformin ± thiazolidinedione therapy were randomized to receive either NovoLog Mix 70/30 twice daily [before breakfast and before supper] or insulin glargine once daily1 (see Table 5). NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) was started at an average dose of 5-6 IU (0.07 ± 0.03 IU/kg) twice daily (before breakfast and before supper), and bedtime insulin glargine was started at 10-12 IU (0.13 ± 0.03 IU/kg). Insulin doses were titrated weekly by decrements or increments of -2 to +6 units per injection to a pre-meal glucose goal of 80-110 mg/dL. The metformin dose was adjusted to 2550 mg/day. Approximately one-third of the patients in each group were also treated with pioglitazone (30 mg/day). Insulin secretagogues were discontinued in order to reduce the risk of hypoglycemia. Most patients were Caucasian (53%), and the mean initial weight was 90 kg.
Table 5: Combination Therapy with Oral Agents and Two Types
of Insulin in Patients with Type 2 Diabetes Mellitus [Mean (SD)]
| Treatment duration 28-weeks | NovoLog Mix 70/30 + Metformin ± Pioglitazone | Insulin Glargine +Metformin ± Pioglitazone |
| Number of patients | 117 | 116 |
| HbA1c | ||
| Baseline mean (%) | 9.7 ±1.5 (117) | 9.8 ± 1.4 (114) |
| End-of-study mean | 6.9 ±1.2 (108) | 7.4 ±1.2 (114) |
| Mean change from baseline | -2.7 ±1.6 (108) | -2.4 ±1.5 (114) |
| Percentage of subjects reaching HbA1c < 7.0% | 66% | 40% |
| Total Daily Insulin Dose at end of study (U) | 78 ±40 (117) | 51 ±27 (116) |
| % of patients with severe hypoglycemia | 0 | 0 |
| % of minor hypoglycemia | 43 | 16 |
| Weight gain at end of study | 5.4 ±4.8 (117) | 3.5 ±4.5 (116) |
REFERENCES
1. Raskin R, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005; 28:260-265.
NovoLog® Mix 70/30
(70% insulin aspart protamine suspension and 30% insulin aspart) Injection,
[rDNA origin]
Read the Patient Information leaflet that comes with NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
What is NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.
It is not known if NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is safe or effective in children.
Who should not use NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
Do not take NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) if:
What should I tell my healthcare provider before taking NovoLog® Mix 70/30?
Before you use NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) , tell your healthcare provider if you:
Tell your healthcare provider about all medicines you take, including prescriptions and non-prescription medicines, vitamins and herbal supplements.
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) may affect the way other medicines work, and other medicines may affect how NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) works. Your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) dose may change if you take other medicines.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers and pharmacist when you get a new medicine.
How should I take NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
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Your insulin dosage may need to change because of:
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See the end of this patient information for instructions about preparing and giving your injection.
What should I consider while using NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
What are the possible side effects of NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) may cause serious side effects, including:
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Very low blood sugar can cause you to pass out (loss of consciousness), seizures, and death. Talk to your healthcare provider about how to tell if you have low blood sugar and what to do if this happens while taking NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar.
Talk to your healthcare provider if low blood sugar is a problem for you. Your dose of NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) may need to be changed.
The most common side effects of NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) include:
These are not all of the possible side effects from NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) . Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
All Unopened NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) :
After NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) has been opened:
Never use insulin after the expiration date that is printed on the label and carton.
Keep NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) and all medicines out of the reach of children.
General advice about NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin))
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) for a condition for which it was not prescribed. Do not give NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about NovoLog® Mix 70/30. If you would like more information about NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) that is written for healthcare professionals. For more information call 1-800-7276500 or go to www.novonordisk-us.com.
What are the ingredients in NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ?
All NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) vials and NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® are latex free.
Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 2311 and is available at www.diabetes.org.
Patient Instructions for Use
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen®
Read the following instructions carefully before you start using your NovoLog® Mix 70/30 FlexPen® and each time you get a refill. There may be new information. You should read the instructions even if you have used Novolog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® before.
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. NovoLog® Mix 70/30 FlexPen® is designed to be used with NovoFine® needles.
NovoLog Mix® 70/30 FlexPen® should not be used by people who are blind or have severe visual problems without the help of a person who has good eyesight and who is trained to use the NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® the right way.
Getting ready
Make sure you have the following items:
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PREPARING YOUR NOVOLOG® MIX 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FLEXPEN®
Before your first injection with a new NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® you must mix the insulin:
A. Let the insulin reach room temperature before you use it. This makes it easier to mix.
Pull off the pen cap (see diagram A).
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B. Roll the pen between your palms 10 times – it is important that the pen is kept horizontal (see diagram B).
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C. Then gently move the pen up and down ten times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other (see diagram C).
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Repeat rolling and moving the pen until the liquid appears white and cloudy.
For every following injection move the pen up and down between positions 1 and 2 at least ten times until the liquid appears white and cloudy.
After mixing, complete all the following steps of the injection right away. If there is a delay, the insulin will need to be mixed again.
Wipe the rubber stopper with an alcohol swab.
Before you inject, there must be at least 12 units of insulin left in the cartridge to make sure the remaining insulin is evenly mixed. If there are less than 12 units left, use a new NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® .
Attaching the needle
D. Remove the protective tab from a disposable needle.
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Screw the needle tightly onto your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® . It is important that the needle is put on straight (see diagram D).
Never place a disposable needle on your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® until you are ready to take your injection.
E. Pull off the big outer needle cap (see diagram E).
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F. Pull off the inner needle cap and dispose of it (see diagram F).
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Giving the airshot before each injection:
Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to make sure you take the right dose of insulin:
G. Turn the dose selector to select 2 units (see diagram G).
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H. Hold your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram H).
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I. Keep the needle pointing upwards, press the push-button all the way in (see diagram I). The dose selector returns to 0.
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A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
If you do not see a drop of insulin after 6 times, do not use the NovoLog Mix® 70/30 FlexPen® and contact Novo Nordisk at 1-800-727-6500.
A small air bubble may remain at the needle tip, but it will not be injected.
SELECTING YOUR DOSE
Check and make sure that the dose selector is set at 0.
J. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.
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The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram J). When turning the dose selector, be careful not to press the push-button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.
GIVING THE INJECTION
Do the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.
K. Insert the needle into your skin.
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Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram K). Be careful only to push the button when injecting.
Turning the dose selector will not inject insulin.
L. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram L). This will make sure that the full dose has been given.
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You may see a drop of NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with an alcohol swab. Do not rub the area.
After the injection
Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® after each injection. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.
The NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
M. Put the pen cap on the NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® and store the NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® without the needle attached (see diagram M).
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FUNCTION CHECK
If your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® is not working the right way, follow the steps below:
The insulin should fill the lower part of the big outer needle cap (see diagram N). If NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® has released too much or too little insulin, do the function check again. If the same problem happens again, do not use your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® and contact Novo Nordisk at 1-800-727-6500.
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Maintenance
Your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® is designed to work accurately and safely. It must be handled with care. Avoid dropping your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® as it may damage it. If you are concerned that your NovoLog® Mix 70/30 FlexPen® is damaged, use a new one. You can clean the outside of your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® by wiping it with a damp cloth. Do not soak or wash your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen® as it may damage it. Do not refill your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) FlexPen®.
NovoLog®, FlexPen®, NovoFine®, are trademarks of Novo Nordisk
A/S.
NovoLog® is covered by US Patent Nos. 5,547,930, 5,618,913, 5,834,422,
5,840,680, 5,866,538 and other patents pending.
FlexPen® is covered by US Patent Nos. 6,582,404, 6,004,297, 6,235,004 and
other patents pending.
© 2002-2010 Novo Nordisk Inc.
Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, For information about NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) ® contact: Novo Nordisk Inc., 100 College Road West, Princeton, New Jersey 08540
Patient Instructions for Use
NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) 10ml vial (100 Units/mL, U-100)
Read the following Patient Instructions for Use carefully before you start using your NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) 10ml vial and each time you get a refill. There may be new information. You should read the instructions even if you have used NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) 10ml vials before.
Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
Never re-use syringes and needles.
How should I prepare and deliver the injection using the NovoLog® Mix 70/30 10 ml vial?
Helpful information for people with diabetes is published by the American Diabetes Association, 1660 Duke Street, Alexandria, VA 22314.
