NOVOMIX 30 FLEXPEN Biphasic Insulin Aspart 3ml - 1 Box x 5 Pieces
RXDRUG-BR-1014-1pc-laz5
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of diabetes mellitus requiring insulin.
Dosage/Direction for Use
Biphasic insulin aspart 30 dosing is individualized and determined in accordance with the needs of the patient.
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycemic control. In patients with type 2 diabetes, biphasic insulin aspart 30 can be given as monotherapy. Biphasic insulin aspart 30 can also be given in combination with oral antidiabetic drugs if the patient's blood glucose is inadequately controlled with oral antidiabetic drugs (OADs) alone.
How to Start: Insulin-Naive Patients: For patients with type 2 diabetes, the recommended starting dose of biphasic insulin aspart 30 is 6 U at breakfast and 6 U at dinner (evening meal). However, it can also be initiated once daily with 12 U at dinner (evening meal).
How to Switch: When transferring a patient from biphasic human insulin to biphasic insulin aspart 30, start with the same dose and regimen. Then titrate according to individual needs (see the following titration guideline). As with all insulin products, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
How to Intensify: Biphasic insulin aspart 30 can be intensified from once daily to twice daily. When using biphasic insulin aspart 30 once daily, it is generally recommended to move to twice-daily when reaching 30 U by splitting the dose into equal breakfast and dinner doses (50:50).
From biphasic insulin aspart 30 twice daily to thrice daily: The morning dose can be split into morning and lunchtime doses (thrice daily dosing).
How to Adjust the Dose: Adjust the dose of biphasic insulin aspart 30 on the basis of the lowest pre-meal blood glucose level from the 3 previous days.
Always change the mealtime dose preceding the measurement.
Dose adjustment can be made once a week until target HbA1c is reached.
The dose should not be increased if hypoglycemia occurred within these days.
Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
The following titration guideline is recommended for dose adjustment (see table).
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycemic control. In patients with type 2 diabetes, biphasic insulin aspart 30 can be given as monotherapy. Biphasic insulin aspart 30 can also be given in combination with oral antidiabetic drugs if the patient's blood glucose is inadequately controlled with oral antidiabetic drugs (OADs) alone.
How to Start: Insulin-Naive Patients: For patients with type 2 diabetes, the recommended starting dose of biphasic insulin aspart 30 is 6 U at breakfast and 6 U at dinner (evening meal). However, it can also be initiated once daily with 12 U at dinner (evening meal).
How to Switch: When transferring a patient from biphasic human insulin to biphasic insulin aspart 30, start with the same dose and regimen. Then titrate according to individual needs (see the following titration guideline). As with all insulin products, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
How to Intensify: Biphasic insulin aspart 30 can be intensified from once daily to twice daily. When using biphasic insulin aspart 30 once daily, it is generally recommended to move to twice-daily when reaching 30 U by splitting the dose into equal breakfast and dinner doses (50:50).
From biphasic insulin aspart 30 twice daily to thrice daily: The morning dose can be split into morning and lunchtime doses (thrice daily dosing).
How to Adjust the Dose: Adjust the dose of biphasic insulin aspart 30 on the basis of the lowest pre-meal blood glucose level from the 3 previous days.
Always change the mealtime dose preceding the measurement.
Dose adjustment can be made once a week until target HbA1c is reached.
The dose should not be increased if hypoglycemia occurred within these days.
Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
The following titration guideline is recommended for dose adjustment (see table).
Special Populations: As with all insulin products, in special populations, glucose monitoring should be intensified and the insulin aspart dosage adjusted on an individual basis.
Elderly: Biphasic insulin aspart 30 can be used in elderly patients; however there is limited experience with the use of biphasic insulin aspart 30 in combination with OADs in patients >75 years.
Renal and Hepatic Impairment: Renal or hepatic impairment may reduce the patient's insulin requirements.
Children: Biphasic insulin aspart 30 can be used in children and adolescents ≥10 years when premixed insulin is preferred. Limited clinical data exists for children 6-9 years (see Pharmacology: Pharmacodynamics under Actions). No data are available for biphasic insulin aspart 30 in children below 6 years of age.
Administration: Biphasic insulin aspart 30 is for SC administration only. Biphasic insulin aspart 30 must not be administered IV, as it may result in severe hypoglycemia. Intramuscular administration should be avoided. Biphasic insulin aspart 30 is not to be used in insulin infusion pumps. Biphasic insulin aspart 30 is administered SC by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. As with all insulin products, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Biphasic insulin aspart 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, biphasic insulin aspart 30 can be given soon after a meal.
Elderly: Biphasic insulin aspart 30 can be used in elderly patients; however there is limited experience with the use of biphasic insulin aspart 30 in combination with OADs in patients >75 years.
Renal and Hepatic Impairment: Renal or hepatic impairment may reduce the patient's insulin requirements.
Children: Biphasic insulin aspart 30 can be used in children and adolescents ≥10 years when premixed insulin is preferred. Limited clinical data exists for children 6-9 years (see Pharmacology: Pharmacodynamics under Actions). No data are available for biphasic insulin aspart 30 in children below 6 years of age.
Administration: Biphasic insulin aspart 30 is for SC administration only. Biphasic insulin aspart 30 must not be administered IV, as it may result in severe hypoglycemia. Intramuscular administration should be avoided. Biphasic insulin aspart 30 is not to be used in insulin infusion pumps. Biphasic insulin aspart 30 is administered SC by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. As with all insulin products, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Biphasic insulin aspart 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, biphasic insulin aspart 30 can be given soon after a meal.
Overdosage
A specific overdose for insulin cannot be defined, however, hypoglycemia may develop over sequential stages if too high doses relative to the patient's requirements are administered.
Mild hypoglycemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carry sugar-containing products.
Severe hypoglycemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5-1 mg) given IM or SC by a trained person or glucose given IV by a healthcare professional. Glucose must also be given IV if the patient does not respond to glucagon within 10-15 min. Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Mild hypoglycemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carry sugar-containing products.
Severe hypoglycemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5-1 mg) given IM or SC by a trained person or glucose given IV by a healthcare professional. Glucose must also be given IV if the patient does not respond to glucagon within 10-15 min. Upon regaining consciousness administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Administration
Should be taken with food: Administer immediately before or soon after a meal.
Contraindications
Hypersensitivity to biphasic insulin aspart or to any of the excipients of NovoMix 30 FlexPen.
Special Precautions
Before traveling between different time zones, the patient should seek the doctor's advice since this may mean that the patient has to take the insulin and meals at different times.
Hyperglycemia: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia and diabetic ketoacidosis. Usually the first symptoms of hyperglycemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Hypoglycemia: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement (see Overdosage and Adverse Reactions). Compared with biphasic human insulin, biphasic insulin aspart 30 may have a more pronounced glucose lowering effect up to 6 hrs after injection. This may have to be compensated for in the individual patient, through adjustment of insulin dose and/or food intake.
Patients, whose blood glucose control is greatly improved eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.
Tighter control of glucose levels can increase the potential for hypoglycemic episodes and therefore require special attention during dose intensification as outlined in Dosage & Administration.
Biphasic insulin aspart 30 should be administered in immediate relation to a meal. The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
Concomitant illness, especially infections, usually increases the patient's insulin requirements.
Concomitant diseases of the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycemia may change or become less pronounced than those experienced with their previous insulin.
Transfer from Other Insulin Products: Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analog), and/or method of manufacture may result in the need for a change in dosage.
Patients transferred to biphasic insulin aspart 30 from another type of insulin may require an increased number of daily injections or a change in dosage from that used with their usual insulin products. If an adjustment is needed, it may occur with the 1st dose or during the 1st few weeks or months.
Injection Site Reactions: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of biphasic insulin aspart 30.
Combination of Thiazolidinediones and Insulin Medicinal Products: Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered. If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and edema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Insulin Antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycemia.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions in order to avoid hypoglycemia while driving or operating a machine. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving or operating the machine should be considered these circumstances.
Use in Pregnancy & Lactation: There is limited clinical experience with biphasic insulin aspart 30 in pregnancy. Biphasic insulin aspart 30 has not been investigated in pregnant women. However, data from 2 randomized, controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively, in basal-bolus regimen) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the fetus/newborn when compared to soluble human insulin (see Pharmacology: Pharmacodynamic under Actions).
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart vs soluble human insulin (insulin aspart: 14; soluble human insulin: 13) showed similar safety profiles between treatments.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with biphasic insulin aspart 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby.
However, the biphasic insulin aspart 30 dosage, may need to be adjusted.
Hyperglycemia: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia and diabetic ketoacidosis. Usually the first symptoms of hyperglycemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Hypoglycemia: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement (see Overdosage and Adverse Reactions). Compared with biphasic human insulin, biphasic insulin aspart 30 may have a more pronounced glucose lowering effect up to 6 hrs after injection. This may have to be compensated for in the individual patient, through adjustment of insulin dose and/or food intake.
Patients, whose blood glucose control is greatly improved eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.
Tighter control of glucose levels can increase the potential for hypoglycemic episodes and therefore require special attention during dose intensification as outlined in Dosage & Administration.
Biphasic insulin aspart 30 should be administered in immediate relation to a meal. The rapid onset of action should therefore be considered in patients with concomitant diseases or treatment with other medicinal products where a delayed absorption of food might be expected.
Concomitant illness, especially infections, usually increases the patient's insulin requirements.
Concomitant diseases of the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. When patients are transferred between different types of insulin products, the early warning symptoms of hypoglycemia may change or become less pronounced than those experienced with their previous insulin.
Transfer from Other Insulin Products: Transferring a patient to a new type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (animal, human, human insulin analog), and/or method of manufacture may result in the need for a change in dosage.
Patients transferred to biphasic insulin aspart 30 from another type of insulin may require an increased number of daily injections or a change in dosage from that used with their usual insulin products. If an adjustment is needed, it may occur with the 1st dose or during the 1st few weeks or months.
Injection Site Reactions: As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of biphasic insulin aspart 30.
Combination of Thiazolidinediones and Insulin Medicinal Products: Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered. If the combination is used, patients should be observed for signs and symptoms of congestive heart failure, weight gain and edema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Insulin Antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycemia.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions in order to avoid hypoglycemia while driving or operating a machine. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving or operating the machine should be considered these circumstances.
Use in Pregnancy & Lactation: There is limited clinical experience with biphasic insulin aspart 30 in pregnancy. Biphasic insulin aspart 30 has not been investigated in pregnant women. However, data from 2 randomized, controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively, in basal-bolus regimen) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the fetus/newborn when compared to soluble human insulin (see Pharmacology: Pharmacodynamic under Actions).
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart vs soluble human insulin (insulin aspart: 14; soluble human insulin: 13) showed similar safety profiles between treatments.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with biphasic insulin aspart 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby.
However, the biphasic insulin aspart 30 dosage, may need to be adjusted.
Use In Pregnancy & Lactation
There is limited clinical experience with biphasic insulin aspart 30 in pregnancy. Biphasic insulin aspart 30 has not been investigated in pregnant women. However, data from 2 randomized, controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies respectively, in basal-bolus regimen) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the fetus/newborn when compared to soluble human insulin (see Pharmacology: Pharmacodynamic under Actions).
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart vs soluble human insulin (insulin aspart: 14; soluble human insulin: 13) showed similar safety profiles between treatments.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with biphasic insulin aspart 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby.
However, the biphasic insulin aspart 30 dosage, may need to be adjusted.
In addition, the data from a clinical trial including 27 women with gestational diabetes randomized to treatment with insulin aspart vs soluble human insulin (insulin aspart: 14; soluble human insulin: 13) showed similar safety profiles between treatments.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the 1st trimester and increase subsequently during the 2nd and 3rd trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels.
There are no restrictions on treatment with biphasic insulin aspart 30 during lactation. Insulin treatment of the breastfeeding mother presents no risk to the baby.
However, the biphasic insulin aspart 30 dosage, may need to be adjusted.
Adverse Reactions
Summary of the Safety Profile: Adverse drug reactions observed in patients using biphasic insulin aspart 30 are mainly due to the pharmacologic effect of insulin.
The most frequently reported adverse reaction during treatment is hypoglycemia. The frequencies of hypoglycemia vary with patient population, dose regimens and level of glycemic control (see Description of Selected Adverse Reactions as follows).
At the beginning of the insulin treatment, refraction anomalies, edema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of transitory nature.
Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic control decreases the risk of progression of diabetic retinopathy.
List of Adverse Reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune System Disorders: Uncommon: Urticaria, rash, eruptions. Very Rare: Anaphylactic reactions*.
Metabolism and Nutrition Disorders: Very Common: Hypoglycemia*.
Nervous System Disorders: Rare: Peripheral neuropathy (painful neuropathy).
Eye Disorders: Uncommon: Refraction disorders, diabetic retinopathy.
Skin and Subcutaneous Tissue Disorders: Uncommon: Lipodystrophy*.
General Disorders and Administration Site Conditions: Uncommon: Injection site reactions, edema.
*See Description of Selected Adverse Reactions as follows.
Description of Selected Adverse Reactions: Anaphylactic Reactions: The occurrence of generalized hypersensitivity reactions (including generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Hypoglycemia: The most frequently reported adverse reaction is hypoglycemia. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
The symptoms of hypoglycemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens and level of glycemic control. During clinical trials, the overall rates of hypoglycemia did not differ between patients treated with insulin aspart compared to human insulin.
Lipodystrophy: Lipodystrophy is reported as uncommon. Lipodystrophy may occur at the injection site.
The most frequently reported adverse reaction during treatment is hypoglycemia. The frequencies of hypoglycemia vary with patient population, dose regimens and level of glycemic control (see Description of Selected Adverse Reactions as follows).
At the beginning of the insulin treatment, refraction anomalies, edema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of transitory nature.
Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic control decreases the risk of progression of diabetic retinopathy.
List of Adverse Reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune System Disorders: Uncommon: Urticaria, rash, eruptions. Very Rare: Anaphylactic reactions*.
Metabolism and Nutrition Disorders: Very Common: Hypoglycemia*.
Nervous System Disorders: Rare: Peripheral neuropathy (painful neuropathy).
Eye Disorders: Uncommon: Refraction disorders, diabetic retinopathy.
Skin and Subcutaneous Tissue Disorders: Uncommon: Lipodystrophy*.
General Disorders and Administration Site Conditions: Uncommon: Injection site reactions, edema.
*See Description of Selected Adverse Reactions as follows.
Description of Selected Adverse Reactions: Anaphylactic Reactions: The occurrence of generalized hypersensitivity reactions (including generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Hypoglycemia: The most frequently reported adverse reaction is hypoglycemia. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
The symptoms of hypoglycemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens and level of glycemic control. During clinical trials, the overall rates of hypoglycemia did not differ between patients treated with insulin aspart compared to human insulin.
Lipodystrophy: Lipodystrophy is reported as uncommon. Lipodystrophy may occur at the injection site.
Drug Interactions
A number of medicinal products are known to interact with glucose metabolism.
The following substances may reduce the patient's insulin requirements: Oral antidiabetic drugs, MAOIs, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blocking agents may mask the symptoms of hypoglycemia and delay recovery from hypoglycemia.
Octreotide/lanreotide may both increase and decrease insulin requirement.
Alcohol may intensify and prolong the glucose-lowering effect of insulin.
The following substances may reduce the patient's insulin requirements: Oral antidiabetic drugs, MAOIs, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
The following substances may increase the patient's insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blocking agents may mask the symptoms of hypoglycemia and delay recovery from hypoglycemia.
Octreotide/lanreotide may both increase and decrease insulin requirement.
Alcohol may intensify and prolong the glucose-lowering effect of insulin.
Caution For Usage
Incompatibilities: In absence of compatibility studies, biphasic insulin aspart 30 must not be mixed with other medicinal products.
Instructions on How to Handle Biphasic Insulin Aspart 30: Before Using FlexPen: Check the label to make sure it is the right type of insulin.
Always use a new needle for each injection to prevent contamination.
Do not use biphasic insulin aspart 30 in insulin infusion pumps; if the flexpen is dropped, damaged or crushed, there is a risk of leakage of insulin; if it hasn't been stored correctly or if it has been frozen; if the insulin is not uniformly white and cloudy when it's resuspended; if clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Biphasic insulin aspart 30 is for injection under the skin (SC). Never inject the insulin directly into a vein or muscle.
Always vary the sites to inject, to avoid lumps or skin pitting. The best places to give an injection are: Front of the waist (abdomen); buttocks; front of the thighs or upper arms. The insulin will work more quickly if injected around the waist. Measure blood sugar regularly.
Biphasic insulin aspart 30 is a unique dial-a-dose insulin pen. Dose from 1-60 U in increments of 1 can be selected. Flexpen is designed and tested to be used with NovoFine disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin device in case biphasic insulin aspart 30 is lost or damage.
Preparing Biphasic Insulin Aspart 30 FlexPen: Check the label to make sure that it contains the correct type of insulin. Before the 1st injection with a new biphasic insulin aspart 30, the insulin must be resuspended: Let the insulin reach room temperature before using to make it easier to resuspend. Pull off the pen cap. Roll the pen between the palms 10 times. It is important that the pen is kept horizontal. Then move the pen up and down 10 times between the 2 positions so the glass ball moves from 1 end of the cartridge to the other. Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy. For every following injection, move the pen up and down between the 2 positions at least 10 times until the liquid appear uniformly white and cloudy. After having resuspended the insulin, complete all the following steps of injection without delay.
Always check if there are at least 12 U of insulin left in the cartridge to allow resuspension. If there are <12 U left, use a new FlexPen.
Attaching a Needle: Remove the protective tab from a new disposable needle. Screw the needle straight and tight onto biphasic insulin aspart 30. Pull off the big outer needle cap and keep it for later. Pull off the inner needle cap and dispose of it.
Always use a new needle for each injection to prevent contamination. Be careful not to bend or damage the needle before use. To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when removing it from the needle.
Checking the Insulin Flow: Prior to each injection, small amount of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing: Turn the dose selector to select 2 U. Hold biphasic insulin aspart 30 with the needle pointing upwards and tap the cartridge gently with a finger a few times to make any air bubbles collect at the top of the cartridge. Keeping the needle upwards, press the push button all the way in. The dose selector returns to 0. 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 a drop of insulin still does not appear, the pen is defective and a new one must be used.
Selecting the Dose: Check that the dose selected is set to 0. Turn the dose selector to select the number of units needed to inject. The dose can be corrected either up or down by turning the selector in either directions until the correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-button as insulin will come out. A dose larger than the number of units left in the cartridge cannot be selected.
Do not use the residual scale to measure the dose of insulin.
Making the Injection: Insert the needle into the skin. Use the injection technique shown by the doctor or nurse. Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting. Turning the dose selector will not inject insulin. Keep the push-button fully depressed and let the needle remain under the skin for at least 6 sec. This will ensure that the full dose has been injected. Withdraw the needle from the skin, then release the pressure on the push-button. Lead the needle tip into the big outer needle cap without touching the big outer cap. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle. Dispose of it carefully and put the pen cap back on.
Always remove the needle after each injection and store biphasic insulin aspart 30 without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing. Caregivers should be most careful when handling used needles to avoid needle sticks. Dispose of the FlexPen carefully without the needle attached. Do not share biphasic insulin aspart 30 with anyone else.
Maintenance: Biphasic insulin aspart 30 is designed to work accurately and safely. It must be handled with care. If it is dropped or crushed, there is a risk of damage and leakage of insulin.
Clean the exterior biphasic insulin aspart 30 by wiping it with a medicinal swab. Do not soak, wash or lubricate it as it may damage the pen.
Do not refill biphasic insulin aspart 30.
Instructions on Disposal and Other Handling: Biphasic insulin aspart 30 must not be shared. The cartridge must not be refilled.
Biphasic insulin aspart 30 must not be used if the resuspended liquid does not appear uniformly white and cloudy. The necessity of resuspending the biphasic insulin aspart 30 suspension immediately before use is to be stressed to the patient.
Biphasic insulin aspart 30 which has been frozen must not be used. The patient should be advised to discard the needle after each injection.
Instructions on How to Handle Biphasic Insulin Aspart 30: Before Using FlexPen: Check the label to make sure it is the right type of insulin.
Always use a new needle for each injection to prevent contamination.
Do not use biphasic insulin aspart 30 in insulin infusion pumps; if the flexpen is dropped, damaged or crushed, there is a risk of leakage of insulin; if it hasn't been stored correctly or if it has been frozen; if the insulin is not uniformly white and cloudy when it's resuspended; if clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Biphasic insulin aspart 30 is for injection under the skin (SC). Never inject the insulin directly into a vein or muscle.
Always vary the sites to inject, to avoid lumps or skin pitting. The best places to give an injection are: Front of the waist (abdomen); buttocks; front of the thighs or upper arms. The insulin will work more quickly if injected around the waist. Measure blood sugar regularly.
Biphasic insulin aspart 30 is a unique dial-a-dose insulin pen. Dose from 1-60 U in increments of 1 can be selected. Flexpen is designed and tested to be used with NovoFine disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin device in case biphasic insulin aspart 30 is lost or damage.
Preparing Biphasic Insulin Aspart 30 FlexPen: Check the label to make sure that it contains the correct type of insulin. Before the 1st injection with a new biphasic insulin aspart 30, the insulin must be resuspended: Let the insulin reach room temperature before using to make it easier to resuspend. Pull off the pen cap. Roll the pen between the palms 10 times. It is important that the pen is kept horizontal. Then move the pen up and down 10 times between the 2 positions so the glass ball moves from 1 end of the cartridge to the other. Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy. For every following injection, move the pen up and down between the 2 positions at least 10 times until the liquid appear uniformly white and cloudy. After having resuspended the insulin, complete all the following steps of injection without delay.
Always check if there are at least 12 U of insulin left in the cartridge to allow resuspension. If there are <12 U left, use a new FlexPen.
Attaching a Needle: Remove the protective tab from a new disposable needle. Screw the needle straight and tight onto biphasic insulin aspart 30. Pull off the big outer needle cap and keep it for later. Pull off the inner needle cap and dispose of it.
Always use a new needle for each injection to prevent contamination. Be careful not to bend or damage the needle before use. To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when removing it from the needle.
Checking the Insulin Flow: Prior to each injection, small amount of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing: Turn the dose selector to select 2 U. Hold biphasic insulin aspart 30 with the needle pointing upwards and tap the cartridge gently with a finger a few times to make any air bubbles collect at the top of the cartridge. Keeping the needle upwards, press the push button all the way in. The dose selector returns to 0. 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 a drop of insulin still does not appear, the pen is defective and a new one must be used.
Selecting the Dose: Check that the dose selected is set to 0. Turn the dose selector to select the number of units needed to inject. The dose can be corrected either up or down by turning the selector in either directions until the correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-button as insulin will come out. A dose larger than the number of units left in the cartridge cannot be selected.
Do not use the residual scale to measure the dose of insulin.
Making the Injection: Insert the needle into the skin. Use the injection technique shown by the doctor or nurse. Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting. Turning the dose selector will not inject insulin. Keep the push-button fully depressed and let the needle remain under the skin for at least 6 sec. This will ensure that the full dose has been injected. Withdraw the needle from the skin, then release the pressure on the push-button. Lead the needle tip into the big outer needle cap without touching the big outer cap. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle. Dispose of it carefully and put the pen cap back on.
Always remove the needle after each injection and store biphasic insulin aspart 30 without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing. Caregivers should be most careful when handling used needles to avoid needle sticks. Dispose of the FlexPen carefully without the needle attached. Do not share biphasic insulin aspart 30 with anyone else.
Maintenance: Biphasic insulin aspart 30 is designed to work accurately and safely. It must be handled with care. If it is dropped or crushed, there is a risk of damage and leakage of insulin.
Clean the exterior biphasic insulin aspart 30 by wiping it with a medicinal swab. Do not soak, wash or lubricate it as it may damage the pen.
Do not refill biphasic insulin aspart 30.
Instructions on Disposal and Other Handling: Biphasic insulin aspart 30 must not be shared. The cartridge must not be refilled.
Biphasic insulin aspart 30 must not be used if the resuspended liquid does not appear uniformly white and cloudy. The necessity of resuspending the biphasic insulin aspart 30 suspension immediately before use is to be stressed to the patient.
Biphasic insulin aspart 30 which has been frozen must not be used. The patient should be advised to discard the needle after each injection.
Storage
When Not in Use: Store in a refrigerator (2°C-8°C). Keep away from the cooling element. Do not freeze.
During Use or When Carried as a Spare: Do not keep in the refrigerator. Store at room temperature (below 30°C) for up to 4 weeks. Keep the pen cap on FlexPen in order to protect from light. Biphasic insulin aspart 30 must be protected from excessive heat and light.
After removing biphasic insulin aspart 30 from the refrigerator, it is recommended to allow it to reach room temperature before resuspending the insulin as instructed for the 1st time use.
Shelf-Life: 24 months.
During Use or When Carried as a Spare: Do not keep in the refrigerator. Store at room temperature (below 30°C) for up to 4 weeks. Keep the pen cap on FlexPen in order to protect from light. Biphasic insulin aspart 30 must be protected from excessive heat and light.
After removing biphasic insulin aspart 30 from the refrigerator, it is recommended to allow it to reach room temperature before resuspending the insulin as instructed for the 1st time use.
Shelf-Life: 24 months.
Action
Pharmacotherapeutic Group: Drugs used in diabetes. Insulins and analogs for injection, intermediate-acting combined with fast-acting. ATC Code: A10AD05.
Pharmacology: Pharmacodynamics: NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analog) and protamine-crystallized insulin aspart (intermediate-acting human insulin analog). The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70. Insulin aspart is equipotent to human insulin on a molar basis. HbA1c after 16 weeks of treatment did not differ between patients with biphasic insulin aspart 30 combined with metformin and patients with metformin plus sulfonylurea. In this trial, 57% of the patients had baseline HbA1c >9%. In these patients, treatment with biphasic insulin aspart 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
In 1 study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycemic agents alone, were randomized to treatment with twice daily biphasic insulin aspart 30 (117 patients) or once daily insulin glargine (116 patients). After 28 weeks treatment following the dosing guideline, the mean reduction in HbA1c was 2.8% with biphasic insulin aspart 30 (mean at baseline=9.7%). With biphasic insulin aspart 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/L (from 14.0 mmol/L at baseline to 7.1 mmol/L).
In patients with type 2 diabetes, a meta-analysis showed a reduced risk of overall nocturnal hypoglycemic episodes and major hypoglycemia with biphasic insulin aspart 30 compared to biphasic human insulin 30. The risk of overall daytime hypoglycemic episodes was higher in patients treated with biphasic insulin aspart 30.
Pediatric Population: A 16-week clinical trial comparing postprandial glycemic control of meal-related biphasic insulin aspart 30 with meal-related human insulin/biphasic human insulin 30 and bedtime neutral protamine hagedorn (NPH) insulin was performed in 167 subjects 10-18 years. Mean HbA1c remained similar to baseline throughout the trial in both treatment groups, and there was no difference in hypoglycemia rate with biphasic insulin aspart 30 or biphasic human insulin 30.
In a smaller (54 subjects) and younger (age range 6-12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycemic episodes and the postprandial glucose increase was significantly lower with biphasic insulin aspart 30 compared to biphasic human insulin 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with biphasic insulin aspart 30.
Elderly: The pharmacodynamic properties of biphasic insulin aspart 30 have not been investigated in the elderly. However, a randomized, double-blind cross-over pharmacokinetics/pharmacodynamics (PK/PD) trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients 65-83 years, mean age 70 years). The relative differences in the pharmacodynamic properties (GIRmax, AUCGIR, 0-120 min) between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy subjects and in younger subjects with diabetes.
Pharmacokinetics: In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with human insulin. The insulin aspart in the soluble phase of biphasic insulin aspart 30 comprises 30% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin. The remaining 70% is in crystalline form as protamine-crystallized insulin aspart; this has a prolonged absorption profile similar to human NPH insulin. The maximum serum insulin concentration is, on average, 50% higher with biphasic insulin aspart 30 than with biphasic human insulin 30. The time to maximum concentration is, on average, half of that for biphasic human insulin 30. In healthy volunteers, a mean maximum serum concentration of 140±32 pmol/L was reached about 60 min after an SC dose of 0.2 U/kg body weight. The mean t½ of biphasic insulin aspart 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hrs. Serum insulin levels returned to baseline 15-18 hrs after a SC dose. In type 2 diabetic patients, the maximum concentration was reached about 95 min after dosing and concentrations well above zero for not less than 14 hrs post-dosing were measured.
Renal and Hepatic Impairment: The pharmacokinetics of biphasic insulin aspart 30 has not been investigated in patients with renal or hepatic impairment.
Pediatric Population: The pharmacokinetics of biphasic insulin aspart 30 has not been investigated in children or adolescents.
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults. However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Elderly: The pharmacokinetic properties of biphasic insulin aspart 30 have not been investigated in the elderly patients. However, the relative differences in pharmacokinetic properties between insulin aspart and soluble human insulin in elderly subjects (65-83 years, mean age 70 years) with type 2 diabetes, were similar to those observed in healthy subjects and in younger subjects with diabetes. A decreased absorption rate was observed in elderly subjects, resulting in a later tmax [82 (interquartile range: 60-120) min], whereas Cmax was similar to that observed in younger subjects with type 2 diabetes and slightly lower than in subjects with type 1 diabetes.
Toxicology: Preclinical Safety Data: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction. In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
Pharmacology: Pharmacodynamics: NovoMix 30 is a biphasic suspension of insulin aspart (rapid-acting human insulin analog) and protamine-crystallized insulin aspart (intermediate-acting human insulin analog). The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70. Insulin aspart is equipotent to human insulin on a molar basis. HbA1c after 16 weeks of treatment did not differ between patients with biphasic insulin aspart 30 combined with metformin and patients with metformin plus sulfonylurea. In this trial, 57% of the patients had baseline HbA1c >9%. In these patients, treatment with biphasic insulin aspart 30 in combination with metformin resulted in significantly lower HbA1c than metformin in combination with sulfonylurea.
In 1 study, patients with type 2 diabetes, insufficiently controlled on oral hypoglycemic agents alone, were randomized to treatment with twice daily biphasic insulin aspart 30 (117 patients) or once daily insulin glargine (116 patients). After 28 weeks treatment following the dosing guideline, the mean reduction in HbA1c was 2.8% with biphasic insulin aspart 30 (mean at baseline=9.7%). With biphasic insulin aspart 30, 66% and 42% of the patients reached HbA1c levels below 7% and 6.5%, respectively, and mean FPG was reduced by about 7 mmol/L (from 14.0 mmol/L at baseline to 7.1 mmol/L).
In patients with type 2 diabetes, a meta-analysis showed a reduced risk of overall nocturnal hypoglycemic episodes and major hypoglycemia with biphasic insulin aspart 30 compared to biphasic human insulin 30. The risk of overall daytime hypoglycemic episodes was higher in patients treated with biphasic insulin aspart 30.
Pediatric Population: A 16-week clinical trial comparing postprandial glycemic control of meal-related biphasic insulin aspart 30 with meal-related human insulin/biphasic human insulin 30 and bedtime neutral protamine hagedorn (NPH) insulin was performed in 167 subjects 10-18 years. Mean HbA1c remained similar to baseline throughout the trial in both treatment groups, and there was no difference in hypoglycemia rate with biphasic insulin aspart 30 or biphasic human insulin 30.
In a smaller (54 subjects) and younger (age range 6-12 years) population, treated in a double-blind, cross-over trial (12 weeks on each treatment) the rate of hypoglycemic episodes and the postprandial glucose increase was significantly lower with biphasic insulin aspart 30 compared to biphasic human insulin 30.
Final HbA1c was significantly lower in the biphasic human insulin 30 treated group compared with biphasic insulin aspart 30.
Elderly: The pharmacodynamic properties of biphasic insulin aspart 30 have not been investigated in the elderly. However, a randomized, double-blind cross-over pharmacokinetics/pharmacodynamics (PK/PD) trial comparing insulin aspart with soluble human insulin was performed in elderly patients with type 2 diabetes (19 patients 65-83 years, mean age 70 years). The relative differences in the pharmacodynamic properties (GIRmax, AUCGIR, 0-120 min) between insulin aspart and soluble human insulin in the elderly were similar to those seen in healthy subjects and in younger subjects with diabetes.
Pharmacokinetics: In insulin aspart substitution of amino acid proline with aspartic acid at position B28 reduces the tendency to form hexamers as observed with human insulin. The insulin aspart in the soluble phase of biphasic insulin aspart 30 comprises 30% of the total insulin; this is absorbed more rapidly from the subcutaneous layer than the soluble insulin component of biphasic human insulin. The remaining 70% is in crystalline form as protamine-crystallized insulin aspart; this has a prolonged absorption profile similar to human NPH insulin. The maximum serum insulin concentration is, on average, 50% higher with biphasic insulin aspart 30 than with biphasic human insulin 30. The time to maximum concentration is, on average, half of that for biphasic human insulin 30. In healthy volunteers, a mean maximum serum concentration of 140±32 pmol/L was reached about 60 min after an SC dose of 0.2 U/kg body weight. The mean t½ of biphasic insulin aspart 30, reflecting the absorption rate of the protamine bound fraction, was about 8-9 hrs. Serum insulin levels returned to baseline 15-18 hrs after a SC dose. In type 2 diabetic patients, the maximum concentration was reached about 95 min after dosing and concentrations well above zero for not less than 14 hrs post-dosing were measured.
Renal and Hepatic Impairment: The pharmacokinetics of biphasic insulin aspart 30 has not been investigated in patients with renal or hepatic impairment.
Pediatric Population: The pharmacokinetics of biphasic insulin aspart 30 has not been investigated in children or adolescents.
However, the pharmacokinetic and pharmacodynamic properties of soluble insulin aspart have been investigated in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes.
Insulin aspart was rapidly absorbed in both age groups, with similar tmax as in adults. However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Elderly: The pharmacokinetic properties of biphasic insulin aspart 30 have not been investigated in the elderly patients. However, the relative differences in pharmacokinetic properties between insulin aspart and soluble human insulin in elderly subjects (65-83 years, mean age 70 years) with type 2 diabetes, were similar to those observed in healthy subjects and in younger subjects with diabetes. A decreased absorption rate was observed in elderly subjects, resulting in a later tmax [82 (interquartile range: 60-120) min], whereas Cmax was similar to that observed in younger subjects with type 2 diabetes and slightly lower than in subjects with type 1 diabetes.
Toxicology: Preclinical Safety Data: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity and toxicity to reproduction. In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth, insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
MedsGo Class
Insulin Preparations
Features
Brand
Novomix 30 Flexpen
Full Details
Dosage Strength
100 IU / ml
Drug Ingredients
- Insulin Biphasic Aspart
Drug Packaging
Suspension for Injection (S.C.) 3ml x 5's
Generic Name
Biphasic Insulin Aspart 30
Dosage Form
Suspension for Injection (S.C.)
Registration Number
BR-1014
Drug Classification
Prescription Drug (RX)
View all variations as list
| CODE | Dosage Strength | Drug Packaging | Availability | Price | ||
|---|---|---|---|---|---|---|
|
RXDRUG-BR-1014-1pc
|
In stock
|
₱47700 | |||
|
RXDRUG-BR-1014-1pc-laz5
|
In stock
|
₱2,38500 |
Please sign in so that we can notify you about a reply