NovoRapid?
NovoRapid? FlexPen?
(100 U/ml x 3 ml)
Special Charge Injection 100u/1mL x 3 mL x 5 ( ?93.9/branch)
Drug name
Generic name: Mentholatum Insulin injection
Trade name: Novorapid? NovoRapid? (NovoRapid? FlexPen?)
English name: Insulin Aspart Injection
Hanyu Pinyin: MenDongYiDaoSu Zhusheye
The main components of this product and their chemical names are: Mentholated insulin (the amino acid chain of human insulin is converted from proline at position B28 to proline at position B28 by biotechnology. The proline at position B28 of the amino acid chain of human insulin is replaced by aspartic acid by biotechnology)
Other ingredients are: glycerol, phenol, m-cresol, zinc chloride, sodium chloride, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injection.
This product is an insulin injection pen with a pre-filled refill containing 3mls of rapid-acting insulin analog.
This product is a unique insulin injection pen with an adjustable knob scale to select the dose to be injected, and is used in conjunction with a Novocain needle of 8mm or less in length? for use in conjunction. The Novo Needle? The box is labeled with , indicating that the needle is a short-cap needle.
Properties
This product is a clear, colorless aqueous solution.
Pharmacology and toxicology
The hypoglycemic effect of Mentholatum is achieved by the binding of Mentholatum molecules to insulin receptors on muscle and adipocytes to promote glucose uptake while inhibiting the release of hepatic glycogen.
The proline at position B28 of the amino acid chain of human insulin is replaced by aspartic acid in this product, so that the tendency to form a hexamer in soluble human insulin is reduced in Mentholatum insulin. As a result, subcutaneous absorption is faster compared to soluble human insulin.
Pharmacokinetics
Mentholated insulin has a more rapid onset of action, a more dramatic decrease in postprandial blood glucose concentrations, and a shorter duration of action after subcutaneous injection than soluble human insulin.
The average time to reach maximum blood levels of insulin is 50% of that of soluble human insulin, and in patients with type 1 diabetes, the time to peak is approximately 40 minutes after subcutaneous injection.
Drug concentrations return to basal values approximately 4-5 hours after injection.
The drug is absorbed rapidly. However, there are age-group differences in maximum blood concentrations, so attention should be paid to individualizing treatment with this product.
Indications
For the treatment of diabetes.
Dosage
This product has a faster onset of action and shorter duration of action than soluble human insulin, and because of the rapid onset of action, it must usually be injected immediately before a meal.
If necessary, it may be given immediately after a meal.
The dosage of this product varies from person to person and should be determined by a physician based on the patient's condition. It should generally be combined with intermediate-acting or long-acting insulin at least once daily.
Insulin requirements are usually 0.5-1.0 units per kilogram of body weight per day. 2/3 of the dosage is mealtime insulin and the other 1/3 is basal insulin.
Good metabolic control in diabetic patients can effectively delay the onset and progression of late comorbidities. Therefore, intensive metabolic control, including blood glucose level testing, is recommended.
This product is injected subcutaneously at sites of choice on the abdominal wall, thighs, deltoid region, and gluteal muscle region. Injection sites should be rotated within the same injection area.
After subcutaneous injection in the abdominal wall, it takes effect within 10-20 minutes, so it is necessary to eat a meal or a fast food containing carbohydrates within 10 minutes after injection.
The maximum duration of action is 1-3 hours after injection, and the hypoglycemic effect lasts for 3-5 hours.
Precautions for use of this product
Do not use this product if it is no longer clear or colorless.
To prevent cross-contamination, this product is for personal use only.
Draw the needle after each injection. Otherwise, the liquid will leak through the needle when the ambient temperature changes.
Do not hit or drop this product.
Do not estimate the actual insulin injection dose based on the insulin residual scale.
Do not refill this product for use.
Adverse Reactions
Low Blood Glucose Reactions
Low blood glucose reactions are relatively common among the adverse reactions that occur in patients treated with insulin. Hypoglycemic symptoms often occur suddenly.
Common Adverse Reactions
Oedema and refractive errors may occur in the early stages of insulin therapy, but these are mostly transient.
Allergic reactions
Localized allergic reactions (e.g., redness, swelling, and itching) at the injection site may occur with insulin therapy. These reactions are usually temporary and will disappear on their own with continued treatment.
Systemic allergic reactions are rare and may be life-threatening.
Lipoatrophy may occur at the injection site if the injection site is not properly rotated within the injection area.
Contraindications
Hypoglycemia. Hypersensitivity to menopausal insulin or any of the ingredients in this product.Cautions
Hyperglycemia and diabetic ketoacidosis (especially predisposed to occur in patients with type 1 diabetes mellitus) can be caused by insufficient doses of insulin injections or by interruption of therapy. The first symptoms of hyperglycemia usually appear gradually over about a few hours to a few days. Symptoms include thirst, frequent urination, nausea, vomiting, drowsiness, dry red skin, dry mouth, loss of appetite, and an acetone odor on the breath. The presence of hyperglycemia may lead to death if left untreated.
Injections of this product should be timed closely to meal times, i.e., immediately before meals. The rapid onset of action makes it important to consider both the patient's comorbidities and whether the combination delays the absorption of food.
Concomitant diseases, especially infections, usually increase the patient's insulin requirements.
With renal or hepatic insufficiency, the patient's insulin requirements are usually reduced.
The process of switching patients to a different brand or type of insulin preparation must be done under close medical supervision. Changes in any of the following may result in a change in dosage: insulin specification, brand, type, species (animal, human insulin, or insulin analog), and/or manufacturing process. Patients switching from other insulins to this product may require an increase in the number of daily injections or a dose adjustment. If a dose adjustment is needed, it should be made at the time of the first dose, or within a few weeks or months of starting treatment.
Patients with significant improvement in glycemic control (e.g., those receiving intensive insulin therapy) will have altered prodromal symptoms of hypoglycemia and should be alerted.
If symptoms of hypoglycemia occur, they will occur earlier after injection of this product than with soluble human insulin because of the rapid onset pharmacodynamic profile of insulin analogs.
Missing meals or engaging in unplanned, high-intensity physical activity may result in hypoglycemia.
Effects on Driving and Mechanical Manipulation Abilities
Low blood glucose may impair a patient's ability to concentrate and react. Impairment of these abilities can be dangerous (e.g., during driving a car and operating machinery).
Patients should be specifically warned to avoid hypoglycemic reactions while driving, especially those with poor or absent hypoglycemic prodromes and those with frequent previous hypoglycemic episodes. In these cases, the patient's ability to operate safely should be considered first.
Medication for Pregnant and Nursing Women
The results of systematic studies of this product for use in pregnant women are limited.
Pregnant women with diabetes mellitus are recommended to be treated with intensive glycemic control and monitoring throughout pregnancy and at the time of planned pregnancy. Insulin requirements usually decrease during early pregnancy; they gradually increase during the middle and late stages of pregnancy.
There are no restrictions on the use of this product in nursing women. The use of insulin in nursing mothers is not harmful to the infant. However, the dose of this product may need to be adjusted accordingly.
Children's Use
Children should use this product only if rapid onset of action is more favorable compared to soluble insulin. For example, when the timing of injections is related to meal times.
Medication in elderly patients
Please follow your doctor's instructions.
Drug Interactions
Many drugs are known to affect glucose metabolism.
Medications that may reduce insulin requirements:
Oral hypoglycemic agents (OHAs), octreotide,monoamine oxidase inhibitors (MAOIs), non-selective ? -adrenergic blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, ethanol, anabolic steroids, and thiamine preparations.
Medications that may increase insulin requirements:
Oral contraceptives, thiazide diuretics, glucocorticoids, thyroid hormones, sympathetic stimulants, and danazol.? -blockers may mask hypoglycemic symptoms.
Ethanol can exacerbate and prolong the hypoglycemic effects caused by insulin.
Drug overdose
Varying degrees of hypoglycemic reactions can occur with drug overdose: symptoms include cold sweats, pale and chilled skin, fatigue, nervousness or tremors, anxiety, unusual tiredness or debility, mood disorders, poor concentration, drowsiness, excessive hunger, visual abnormalities, headache, nausea, and palpitations. Severe hypoglycemic reactions can lead to loss of consciousness and/or convulsions and temporary or permanent brain damage or even death.
Mild hypoglycemic reactions can be treated with oral glucose or sugary foods. Therefore, diabetics are advised to carry sugar cubes or sugary foods such as cookies with them.
For severe hypoglycemic reactions, glucagon (0.5-1.0mg) can be given intramuscularly or subcutaneously by trained personnel or glucose intravenously by medical personnel if the patient has lost consciousness. If the patient does not respond to glucagon within 10-15 minutes, glucose IV must be given immediately.
After the patient's sanity is restored, oral carbohydrates are recommended to avoid relapse.
Specifications
100 units per milliliter.
3 ml each
Packaging
5 units per box
Expiration date
This product is valid for 2 years
Storage
Unused product should be refrigerated in a refrigerator at 2-8°C (not too close to the freezer), not frozen.
Do not store this product being used in the refrigerator, store at room temperature (no more than 30?C) for up to 4 weeks after beginning use.
Cap the pen when not in use and store away from light.
Keep out of reach of children.
Expiration date is stated on the box, do not use expired medication.
Release Date
Imported Drug Registration No.
Imported Drug Registration No.: S20020032
Manufacturer
Company Name: Novo Nordisk A/S
Novo Nordisk A/S
Production Address: Novo Alle, DK-. 2880 Bagsvaerd, Denmark
Telephone: 0045 4444 8888
Fax: 0045 4443 8118
Corporate Enquiries:
800 810 2299 (toll free)
010 6505 8787
Fax: 010 6505 6668
NovoRapid?, Flexpen?, NovoFine? and ;NovoRapid? NovoRapid, Flexpen, NovoFine and NovoRapid. and NovoFine? are registered trademarks owned by Novo Nordisk A/S, Denmark
2004Novo Nordisk A/S
2880 Bagsvaerd, Denmark
Mentholated Insulin 30 Injections Instructions for Use
NovoRapid?30 Extra Strength?
NovoMix?30 Flexpen?
(100 U/ml x 3ml)
Drug Name
Generic Name: Mentholated Insulin 30 Injection
Trade Name: NovoMix?30 Flexpen? (NovoMix?30 Flexpen?)
English name: Insulin Aspart 30 Injection
Hanyu Pinyin: MenDongYiDaoSuSanShi Zhusheye
The main ingredients of this product and their chemical names are: this product contains 30% soluble Mentholatum insulin and 70% arginine insulin.
This product contains 30% soluble aspartic insulin and 70% arginine aspartic insulin, and its active ingredient is aspartic insulin (the proline at position B28 of the amino acid chain of human insulin is replaced by aspartic acid by using biotechnology).1U (unit) is equivalent to 0.035mg of anhydrous aspartic insulin without salt.Other ingredients: mannitol, phenol, m-cresol, zinc (chloride), sodium chloride, disodium hydrogen phosphate dihydrate, fisetin sulfate, sodium hydroxide, hydrochloric acid, and water for injection.
This product is an insulin injection pen with a preloaded cartridge containing a dual time-phase suspension consisting of mentholated insulin (rapid-acting human insulin analog) and arginated mentholated insulin (intermediate-acting human insulin analog).
This product is a unique insulin injection pen with an adjustable knob scale to select the dose to be injected, and is used in conjunction with a Novocain needle that is 8 mm or shorter in length? for use in conjunction. The Novo Needle? The box is labeled with , indicating that the needle is a short-cap needle.
Traits
This product is a white cloudy suspension.
Pharmacology and toxicology
The hypoglycemic effect of insulin is achieved through the binding of its molecules to insulin receptors on muscle and fat cells, which promotes cellular uptake and utilization of glucose, while inhibiting hepatic glucose output.
In menadione, aspartic acid replaces proline at position B28 of the amino acid chain of human insulin, which reduces the tendency of the soluble portion of the product to form hexamers, which soluble human insulin has. Thirty percent of this product consists of soluble meningococcal insulin, which has a more rapid onset of action than the soluble human insulin in biphasic (premixed) human insulin, and the other 70% is arginated meningococcal insulin, which is similar to intermediate-acting human insulin and has a longer absorbed duration of action.
Pharmacokinetics
This product is a dual-phase (premixed) human insulin. It contains 30% soluble meningococcal insulin, which has a rapid onset of action compared to conventional soluble human insulin and can therefore be administered closer to the time of a meal (0-10 minutes prior to the meal), and 70% arginated meningococcal insulin, which has an action profile similar to that of intermediate-acting human insulin. After subcutaneous injection, the product will take effect within 10-20 minutes, with the strongest effect occurring between 1-4 hours after injection and lasting up to 24 hours.
Results of a 3-month clinical trial in type 1 and type 2 diabetes showed that this product was as effective as biphasic (premixed) human insulin 30R in glycated hemoglobin control. Mentholated insulin was equal to human insulin in terms of drug dosage.
The maximum serum insulin concentration of this product was on average 50% higher than that of dual-time phase (premixed) human insulin 30R. The time to reach maximum concentration for this product was, on average, half that of biphasic (premixed) human insulin 30R. In healthy individuals, subcutaneous injection of 0.20 units of this product per kilogram of body weight achieves a maximum blood insulin concentration, averaging 140 ± 32 pmol/l, approximately 60 minutes after injection.The half-life of this product averages 8-9 hours, reflecting the rate of absorption of the fisetin-bound fraction. Serum insulin levels return to basal values 15-18 hours after subcutaneous injection. In patients with type 2 diabetes mellitus, blood insulin concentrations are maximized approximately 95 minutes after administration of this product and will remain above basal levels for more than 14 hours. No pharmacokinetic studies of this product have been performed in elderly, pediatric, and hepatic or renal impaired patients.
Indications
For the treatment of diabetes mellitus.
Dosage
The dosage of this product varies from person to person and should be determined by a physician based on the patient's condition. This product has a faster onset of action than dual-phase (premixed) human insulin, so it must generally be injected immediately before a meal. If necessary, it may be given immediately after a meal.
Insulin requirements are usually 0.5-1.0 units per kilogram of body weight per day and may be derived in whole or in part from this product. In patients with insulin resistance (e.g., cause of obesity), the daily requirement will be higher; in patients who still have residual endogenous insulin secretion, the daily requirement may be less.
Good metabolic control in patients with diabetes mellitus can delay the onset and progression of late diabetic complications. Therefore, intensive metabolic control, including monitoring of blood glucose levels, is recommended.
Insulin doses need to be adjusted when patients increase physical activity or change their daily diet. Exercise immediately after a meal increases the risk of a hypoglycemic response.
This product is injected subcutaneously at a site of choice on the thigh or abdominal wall. If convenient, the gluteal or deltoid region may also be chosen. Injection sites should be rotated within the same injection area. As with all insulins, dose, site of injection, blood flow, temperature and amount of exercise will affect the duration of action. The effect of different injection sites on the absorption of this product has not been studied.
In renal or hepatic insufficiency, patients usually require less insulin.
This product should never be administered intravenously.
Precautions for use of this product
Do not use this product if it does not appear as a homogeneous white misty suspension when rolled between the palms of the hands or shaken up and down. Do not use if there are lumps in the refill or solid white particles sticking to the bottom of the refill or the wall of the bottle in the form of frost, also do not use.
To prevent cross-contamination, this product is for one person only.
Remove the needle after each injection, otherwise when the temperature changes there will be liquid leakage from the needle and insulin concentration will change as a result.
This product cannot be refilled for use.
This product must not be used in insulin pumps.
Adverse Reactions
Of the adverse reactions that occur in patients treated with insulin, hypoglycemic reactions are more common. Symptoms of hypoglycemia, which often occur suddenly, include cold sweats, pale and chilled skin, fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, mood disorders, lack of concentration, drowsiness, excessive hunger, visual abnormalities, headache, nausea, and palpitations. Severe hypoglycemic reactions can lead to loss of consciousness and/or convulsions and temporary or permanent brain damage or even death.
Oedema and refractive errors may occur during the initial phase of insulin therapy, but these are mostly transient.
Localized allergic reactions (e.g., redness, swelling, and itching) at the injection site may occur with insulin therapy. These reactions are usually temporary and disappear on their own with continued treatment.
Systemic allergic reactions are rare and may be life-threatening.
Lipoatrophy may occur at the injection site if the injection site is not properly rotated within the injection area.
Contraindications
The following patients are contraindicated:
Hypoglycemia. Hypersensitivity to menopausal insulin or any of the ingredients in this product.Cautions
Hyperglycemia and diabetic ketoacidosis (especially predisposed to occur in patients with type 1 diabetes mellitus) can be caused by insufficient doses of insulin injections or by interruption of therapy. The first symptoms of hyperglycemia usually appear gradually over about a few hours to a few days. Symptoms include thirst, frequent urination, nausea, vomiting, drowsiness, dry red skin, dry mouth, loss of appetite, and an acetone odor on the breath. The presence of hyperglycemia may lead to death if left untreated.
Patients with significant improvement in glycemic control (e.g., those receiving intensive insulin therapy) may have altered prodromal symptoms of hypoglycemia and should be warned.
Injections of this product should be timed closely to meal times, i.e., immediately before meals. The rapid onset of action of this product makes it important to consider both the patient's comorbidities and whether the combination of drugs delays the absorption of food.
Concomitant illness, especially infection, usually increases the patient's insulin requirements.
Missing meals or engaging in unplanned, intense physical activity may lead to hypoglycemia.
Compared with biphasic (premixed) human insulin, this product significantly reduces postprandial blood glucose and maintains it until 6 hours after injection. Although the literature reports no significant difference between the two in the occurrence of hypoglycemic events, it is still recommended that the insulin dose and/or diet be adjusted according to individual circumstances.
The process of switching patients to a different brand and type of insulin preparation must be done under close medical supervision. Changes in any of the following may result in a change in dose: insulin specification, brand, type, species (animal, human insulin, or insulin analog), and/or manufacturing process. Patients may need to change their original dose after switching from other insulins to this product.
If a dosage adjustment is required, it should be made at the time of the first dose, or within a few weeks or months of starting treatment.
Insulin suspension should not be used in insulin pumps.
Effects on ability to drive and operate machinery
Low blood glucose may impair a patient's ability to concentrate and react. Impairment of these abilities can be dangerous (e.g., during driving a car and operating machinery).
Patients should be specifically warned to avoid hypoglycemic reactions while driving, especially those with poor or absent hypoglycemic prodromes and those with frequent previous hypoglycemic episodes. In these cases, the patient's ability to operate safely should be considered first.
Medication for Pregnant and Nursing Women
Clinical experience with the use of this product in pregnant women is limited.
Animal testing has not revealed any differences in embryotoxicity and teratogenicity between menopause insulin and human insulin.
Treatment of pregnant women with diabetes mellitus is recommended in the form of intensive glycemic control and monitoring throughout pregnancy and at the time of planned pregnancy. Insulin requirements usually decrease during early pregnancy; they gradually increase during the middle and late stages of pregnancy. Insulin requirements return rapidly to pre-pregnancy levels after delivery.
There are no restrictions on the use of this product in nursing women. The use of insulin by nursing mothers is not harmful to the infant. However, the dose of this product may need to be adjusted accordingly.
Children's Use
This product has not been studied in children under 18 years of age. Please follow your doctor's instructions.
Medication in Elderly Patients
Please follow your doctor's instructions.
Drug Interactions
Many drugs are known to affect glucose metabolism.
Medications that may reduce insulin requirements:
Oral hypoglycemic agents (OHAs), octreotide, monoamine oxidase (MAO) inhibitors, nonselective ? -adrenergic blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, ethanol, anabolic steroids, and thiamine preparations.
Medications that may increase insulin requirements:
Oral contraceptives, thiazide diuretics, glucocorticoids, thyroid hormones, sympathetic stimulants, and danazol.? -Blockers can mask the symptoms of hypoglycemia. Alcohol can exacerbate and prolong the hypoglycemic effects of insulin.
Drug overdose
There is no particular definition of an insulin drug overdose. However, various degrees of hypoglycemic reactions can occur with insulin overdose:
A Mild hypoglycemic reactions can be treated with oral dextrose or sugary foods. Therefore, it is recommended that diabetics carry candy bars, candies, cookies, or sugary fruit juices with them.
B For severe hypoglycemia, glucagon (0.5-1.0 mg) can be given intramuscularly or subcutaneously by trained personnel or glucose intravenously by medical personnel if the patient is unconscious. If the patient does not respond to glucagon within 10-15 minutes, glucose IV must be given immediately. After the patient's sanity is restored, oral carbohydrates are recommended to avoid relapse.
Contraindications to Compounding
The addition of other drugs to insulin may result in degradation of insulin (e.g., drugs containing sulfhydryl groups or sulfites).
This product should not be used for intravenous infusions.
Specification 100 units per milliliter. 3 ml each.
Packaging 5 units per box and 1 unit per box.
Expiration date
This product is valid for 24 months.
Storage
Unused product should be refrigerated in a refrigerator at 2-8?C (not too close to the freezer), not frozen.
Do not keep this product in the refrigerator if it is being used, after starting to use it, it can be stored at room temperature (no more than 30?C) for 4 weeks, after 4 weeks it must be discarded.
Do not use this product if it does not appear as a homogeneous white misty suspension when shaken.
Cap the pen when not in use and store away from light.
Keep out of reach of children.
The expiration date is marked on the box, do not use expired medication.
Release Date
Imported Drug Registration No.
Imported Drug Registration No.
Manufacturer
Company Name: Novo Nordisk A/S
Novo Nordisk A/S
Manufacturing Address: Novo Alle, DK-2880 Bagsvaerd, Denmark
Telephone: 0045 4444 8888
Fax: 0045 4443 8118
Corporate Enquiries:
800 810 2299 (toll free)
010 6505 8787
Fax: 010 6505 6668
NovoMix?, Flexpen?, NovoFine? and ;NovoRef? NovoFine, Flexpen, NovoFine, and NovoSharp. and NovoFine? are registered trademarks owned by Novo Nordisk A/S
2004Novo Nordisk A/S
2880 Bagsvaerd, Denmark