Nuo he Rui te chong
NovoRapid？ FlexPen？
(100 unit/ml x 3 ml)
Special injection 100u/ 1mL x 3 mL x 5 (? 93.9/ piece)
Drug name
Generic name: insulin aspart injection
Product name: Novo Horizonte? Techong? (NovoRapid？ FlexPen？ )
English name: insurance as part of injection
Chinese pinyin: a fast pig house in the doorway
The main component of this product and its chemical name are insulin aspart (proline at position B28 of human insulin amino acid chain is replaced by aspartic acid by biotechnology).
Other ingredients include 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, and the refill contains 3 ml of quick-acting insulin analogues.
This product is a unique insulin injection pen, and the injection dosage can be selected by adjusting the dial scale, as well as a Novozyme needle with a length of less than 8 mm. Use together. Nuohe needle? The box is marked with, indicating that the needle is a short hat needle.
Character; Role; letter
This product is a transparent colorless aqueous solution.
Pharmacology and toxicology
The hypoglycemic effect of insulin aspart is achieved by combining insulin aspart with insulin receptors on muscle and fat cells, promoting glucose absorption and inhibiting glycogen release.
In this product, proline at position B28 of human insulin amino acid chain was replaced by aspartic acid, so the tendency of hexamer formation in soluble human insulin in aspartic acid insulin decreased. Therefore, compared with soluble human insulin, subcutaneous absorption is faster.
pharmacokinetics
Insulin aspart takes effect faster than soluble human insulin, and the postprandial blood glucose concentration decreases more significantly, and the duration of action after subcutaneous injection is shorter.
The average time for insulin aspart to reach the highest plasma concentration is 50% of that of soluble human insulin. 1 The peak time of diabetic patients is about 40 minutes after subcutaneous injection.
About 4-5 hours after injection, the drug concentration returned to the basic value.
This product absorbs quickly. However, the highest blood concentration of different age groups is different, so we should pay attention to the individualization of this product.
indicate
Can be used for treating diabetes.
dosage
Compared with soluble human insulin, this product takes effect faster and lasts shorter. Because it takes effect quickly, it is generally required to inject immediately before meals.
It can be taken immediately after meals if necessary.
The dosage of this product varies from person to person and should be decided by the doctor according to the patient's condition. Generally, it should be used in combination with moderate or long-acting insulin at least once a day.
The demand for insulin is usually 0.5- 1.0 units per kilogram of body weight per day. Among them, 2/3 doses were dietary insulin, and the other 1/3 doses were basal insulin.
Good metabolic control of diabetic patients can effectively delay the occurrence and progress of late complications. Therefore, it is suggested to strengthen metabolic control, including blood sugar level detection.
This product can be injected subcutaneously into abdominal wall, thigh, deltoid muscle area and gluteal muscle area. The injection point should rotate in the same injection area.
After subcutaneous injection into abdominal wall, it takes effect within 10-20 minutes, so you need to eat meals or fast food containing carbohydrates within 10 minutes after injection.
The maximum action time is 65438+ 0-3 hours after injection, and the hypoglycemic effect can last for 3-5 hours.
Matters needing attention in using this product
Do not use this product if it is no longer transparent or colorless.
To prevent cross infection, this product is for personal use only.
Remove the needle after each injection. Otherwise, when the ambient temperature changes, liquid will leak through the needle.
Do not bump or drop this product.
Please do not estimate the actual injection dose of insulin according to the insulin balance.
Do not refill this product for use.
counteraction
Hypoglycemia reaction
Hypoglycemia is more common in the adverse reactions of patients treated with insulin. Hypoglycemia symptoms often appear suddenly.
Common adverse reactions
Edema and ametropia may appear in the initial stage of insulin treatment, but most of these phenomena are transient.
anaphylactic reaction
During insulin treatment, local allergic reactions (such as redness, swelling, itching, etc.) may occur at the injection point. These reactions are usually temporary and will disappear on their own in the process of continuing treatment.
Systemic allergic reactions are rare and may be life-threatening.
If the injection point at the injection site is not rotated properly, fat atrophy may occur at the injection site.
taboo
hypoglycemia
Allergic to insulin aspart or any component in this product.
Matters needing attention
When the insulin injection dose is insufficient or the treatment is interrupted, it will cause hyperglycemia and diabetic ketoacidosis (especially 1 diabetic patients). Usually, the initial symptoms of hyperglycemia gradually appear in about a few hours to a few days. Symptoms include thirst, frequent urination, nausea, vomiting, lethargy, dry and red skin, dry mouth, loss of appetite and acetone breath. If left untreated, high blood sugar may lead to death.
The injection time of this product should be closely related to the meal time, that is, immediately before meals. This product takes effect quickly, so it is necessary to consider the complications of patients and whether the combination of drugs can delay the absorption of food.
With diseases, especially infections, patients usually need more insulin.
When renal function or liver function is insufficient, patients usually need less insulin.
The process of patients switching to different brands or types of insulin preparations must be carried out under strict medical monitoring. Changes in the following aspects may lead to changes in dosage: insulin specification, brand, type, type (animal, human insulin or insulin analogue) and/or production process. After switching from other insulin to this product, patients may need to increase the number of injections per day or adjust the dose. If the dosage needs to be adjusted, it should be adjusted at the time of first administration or within weeks or months after starting treatment.
Patients with significantly improved blood sugar control (such as patients receiving intensive insulin therapy) will have some changes in the symptoms of hypoglycemia, so patients should be reminded.
If hypoglycemia symptoms appear, the time of hypoglycemia symptoms after injection of this product will be earlier than that of soluble human insulin due to the pharmacodynamic characteristics of rapid onset of insulin analogues.
Miseating meals or engaging in unplanned high-intensity physical activity may lead to hypoglycemia.
Influence on driving and mechanical operation ability
Hypoglycemia may damage patients' attention and reaction ability. If these abilities are damaged, it will cause danger (such as driving and operating machinery).
Patients should be specially reminded to avoid hypoglycemia reaction when driving, especially those patients whose symptoms of hypoglycemia are not obvious or lacking, and those who have had hypoglycemia frequently in the past. Under the above circumstances, the first thing to consider is whether the patient can operate safely.
Medication for pregnant and lactating women
The systematic research results of this product for pregnant women are limited.
It is suggested that blood sugar control and monitoring should be strengthened for pregnant women with diabetes during the whole pregnancy and planned pregnancy. The demand for insulin in early pregnancy usually decreases; It gradually increases in the second and third trimester of pregnancy.
There are no restrictions on the use of this product by lactating women. The use of insulin by lactating mothers will not harm the baby. However, the dosage of this product may need to be adjusted accordingly.
Children's medication
Children should use this product only if it is more beneficial to take effect quickly than soluble insulin. For example, when the injection time is related to the meal time.
Medication for elderly patients
Please follow the doctor's advice.
drug interaction
Many drugs are known to affect glucose metabolism.
Drugs that may reduce insulin demand:
Oral hypoglycemic agents (OHAs), octreotide, monoamine oxidase inhibitor (MAOIs), nonselective? Adrenaline blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, ethanol, anabolic steroids and thiamine preparations.
Drugs that may increase insulin demand:
Oral contraceptives, thiazide diuretics, glucocorticoids, thyroid hormones, sympathetic stimulants and danazol. ? -Blockers may mask hypoglycemia symptoms.
Ethanol can aggravate and prolong the hypoglycemic effect caused by insulin.
excessive
Excessive medication can lead to different degrees of hypoglycemia: its symptoms include cold sweat, pale and cold skin, fatigue, nervousness or tremor, anxiety, abnormal fatigue or weakness, emotional disorder, inattention, drowsiness, excessive hunger, abnormal vision, headache, nausea and palpitation. Severe hypoglycemia can lead to loss of consciousness and/or convulsion, temporary or permanent brain function damage, and even death.
For mild hypoglycemia, oral glucose or sugary food can be used for treatment. Therefore, it is recommended that diabetics carry candy or sugary foods, such as biscuits, with them.
For severe hypoglycemia, when the patient has lost consciousness, trained personnel can inject glucagon (0.5- 1.0 mg) or medical staff can inject glucose intravenously. If the patient does not respond to glucagon within 10- 15 minutes, glucose must be given intravenously immediately.
After the patient regains consciousness, it is recommended to take carbohydrates orally to avoid recurrence.
standard
Per milliliter 100 unit.
3 ml each.
parcel
5 sticks per box
term of validity
The product is valid for two years.
store
Unused products should be refrigerated at 2-8? C put it in the refrigerator (not too close to the freezer) and don't freeze it.
Do not store this product in the refrigerator when using it. After use, it can be stored at room temperature (no more than 30? C) Store for 4 weeks.
Cover the pen cap when not in use and keep it away from light.
Keep it out of the reach of children.
The expiration date is marked on the box. Don't use expired drugs.
Release date?
Registration number of imported drugs
Registration number of imported drugs: S20020032
Production enterprise
Company name: Novo Nordisk Denmark
novo nordisk
Production address: baggs Wald DK-2880 Novo Alle.
Tel: 0045 4444 8888
Fax: 0045 4443 8 1 18
Company consultation telephone number:
800 8 10 2299 (free)
0 10 6505 8787
Fax: 0 10 6505 6668
NovoRapid？ ，Flexpen？ ，NovoFine？ And; Novo Horizonte？ , special fee? And promises and needles? It is a registered trademark of Novo Nordisk Denmark.
2004
novo nordisk
No.2880 Wald, baggs, Denmark
Instructions for use of insulin aspart 30 injection
Novo Horizonte？ 30 special fee?
NovoMix？ 30 Flexpen？
(100 unit/ml x 3 ml)
Drug name
Generic name: insulin aspart 30 injection
Product name: Novo Horizonte? 30 special fee? (NovoMix？ 30 Flexpen？ )
English name: insulin aspart 30 injection
Hanyu Pinyin: A quick three-stone pig tongue leaf in the doorway.
The main components of this product and its chemical name are: this product contains 30% soluble insulin aspart and 70% protamine insulin aspart, and its active component is insulin aspart (proline at position B28 of human insulin amino acid chain is replaced by biotechnology aspartic acid). 1U (unit) is equivalent to 0.035mg of anhydrous insulin aspart without salt.
Other ingredients: mannitol, phenol, m-cresol, zinc chloride, sodium chloride, disodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid and water for injection.
This product is an insulin injection pen with a pre-filled refill. The supplement contains a biphasic suspension consisting of insulin aspart (a fast-acting human insulin analogue) and insulin aspart protamine (a medium-acting human insulin analogue).
This product is a unique insulin injection pen, and the injection dosage can be selected by adjusting the dial scale, as well as a Novozyme needle with a length of less than 8 mm. Use together. Nuohe needle? The box is marked with, indicating that the needle is a short hat needle.
Character; Role; letter
This product is a white cloud suspension.
Pharmacology and toxicology
The hypoglycemic effect of insulin is achieved by combining its molecules with insulin receptors on muscle and fat cells, promoting the absorption and utilization of glucose by cells and inhibiting the output of glucose by liver.
In insulin aspart, aspartic acid replaces proline at position B28 of human insulin amino acid chain, which reduces the tendency of the soluble part of the product to form hexamer, which is the trend of soluble human insulin. 30% of this product is composed of soluble insulin aspart, which takes effect faster than soluble human insulin in biphasic (premixed) human insulin. The other 70% is protamine aspartic insulin, which is similar to intermediate human insulin and takes a long time to absorb.
pharmacokinetics
This product is biphasic (premixed) human insulin. It contains 30% soluble insulin aspart. Compared with conventional soluble human insulin, this part of insulin aspart takes effect quickly, so it can be administered closer to before meals (0- 10 minutes before meals). The other 70% is protamine aspartic insulin, similar to Zhongxiao Yu insulin. After subcutaneous injection of this product, it takes effect within 10-20 minutes, the strongest time is between 1-4 hours after injection, and the duration of action can reach 24 hours.
A 3-month clinical trial of 1 and type 2 diabetes showed that the product had the same effect as biphasic (premixed) human insulin 30R in glycated hemoglobin control. In terms of drug dosage, insulin aspart is equivalent to human insulin.
The maximum serum insulin concentration of this product is 50% higher than that of biphasic (premixed) human insulin 30R on average. The average time to reach the maximum concentration of this product is half that of biphasic (premixed) human insulin 30R. The subcutaneous injection of this product in healthy people is 0.20 units per kilogram of body weight. After about 60 minutes of injection, it reaches the maximum concentration of blood insulin, with an average of140 32 pmol/L. The average half-life of this product is 8-9 hours, which reflects the absorption rate of protamine binding part. The serum insulin level returned to the basic value 15- 18 hours after subcutaneous injection. For patients with type 2 diabetes, after taking this product, the blood insulin concentration reaches the maximum after about 95 minutes, and will remain above the basic level for more than 14 hours. At present, the pharmacokinetics of this product has not been studied in the elderly, children and patients with liver and kidney damage.
indicate
Can be used for treating diabetes.
dosage
The dosage of this product varies from person to person and should be decided by the doctor according to the patient's condition. This product takes effect faster than biphasic (premixed) human insulin, so it should be injected immediately before meals. It can be taken immediately after meals if necessary.
The demand for insulin is usually 0.5- 1.0 unit per kilogram of body weight per day, which can be totally or partially derived from this product. For patients with insulin resistance (such as obesity), their daily needs will be higher; For patients with residual endogenous insulin secretion, the daily requirement can be less.
Good metabolic control of diabetic patients can delay the occurrence and progress of late complications of diabetes. Therefore, it is suggested to strengthen metabolic control, including blood sugar level monitoring.
When patients increase physical activity or change their daily diet, insulin dosage should be adjusted. Exercise immediately after meals increases the risk of hypoglycemia.
This product is injected subcutaneously, and the site can be thigh or abdominal wall. If it is convenient, you can also choose the hip or deltoid area. The injection point should rotate in the same injection area. Like all insulin, dosage, injection point, blood flow, temperature and exercise will affect its action time. The effects of different injection points on the absorption of this product have not been studied.
When renal function or liver function is insufficient, patients usually need less insulin.
This product is not allowed to be injected intravenously.
Matters needing attention in using this product
Do not use this product if it is not a uniform white mist suspension after rolling or shaking up and down between palms. Do not use it if there are lumps in the refill, or white solid particles are stuck on the bottom of the refill or on the bottle wall, which are frosty.
In order to prevent cross infection, this product is only for one person.
Pull out the needle after each injection, otherwise the liquid medicine will leak from the needle when the temperature changes, and the insulin concentration will also change accordingly.
This product cannot be refilled.
This product cannot be used for insulin pump.
counteraction
Hypoglycemia is more common in the adverse reactions of patients treated with insulin. Symptoms of hypoglycemia often appear suddenly, including cold sweat, pale and cold skin, fatigue, nervousness or tremor, anxiety, abnormal fatigue or weakness, emotional disorder, inattention, lethargy, excessive hunger, abnormal vision, headache, nausea and palpitation. Severe hypoglycemia can lead to loss of consciousness and/or convulsion, temporary or permanent brain function damage, and even death.
Edema and ametropia may appear in the initial stage of insulin treatment, but most of these phenomena are transient.
During insulin treatment, local allergic reactions (such as redness, swelling, itching, etc.) may occur at the injection point. These reactions are usually temporary and will disappear on their own in the process of continuing treatment.
Systemic allergic reactions are rare and may be life-threatening.
If the injection point at the injection site is not rotated properly, fat atrophy may occur at the injection site.
taboo
The following patients are disabled:
hypoglycemia
Allergic to insulin aspart or any component in this product.
Matters needing attention
When the insulin injection dose is insufficient or the treatment is interrupted, it will cause hyperglycemia and diabetic ketoacidosis (especially 1 diabetic patients). Usually, the initial symptoms of hyperglycemia gradually appear in about a few hours to a few days. Symptoms include thirst, frequent urination, nausea, vomiting, lethargy, dry and red skin, dry mouth, loss of appetite and acetone breath. If left untreated, high blood sugar may lead to death.
Patients with significantly improved blood sugar control (such as patients receiving intensive insulin therapy) will have some changes in the symptoms of hypoglycemia, so patients should be reminded.
The injection time of this product should be closely related to the meal time, that is, immediately before meals. This product takes effect quickly, so it is necessary to consider the complications of patients and whether the combination of drugs can delay the absorption of food.
With diseases, especially infections, patients usually need more insulin.
Miseating meals or engaging in unplanned high-intensity physical activity may lead to hypoglycemia.
Compared with biphasic (premixed) human insulin, this product significantly reduced postprandial blood sugar and kept it until 6 hours after injection. Although there is no significant difference in the incidence of hypoglycemia between the two groups, it is still recommended to adjust the insulin dosage and/or diet according to individual circumstances.
The process of patients switching to different brands and types of insulin preparations must be carried out under strict medical monitoring. Changes in the following aspects may lead to changes in dosage: insulin specification, brand, type, type (animal, human insulin or insulin analogue) and/or production process. After switching from other insulin to this product, the patient may need to change the original dose.
If the dosage needs to be adjusted, it should be adjusted at the time of first administration or within weeks or months after starting treatment.
Insulin suspension should not be used for insulin pump.
Influence on driving and mechanical operation ability
Hypoglycemia may damage patients' attention and reaction ability. If these abilities are damaged, it will cause danger (such as driving and operating machinery).
Patients should be specially reminded to avoid hypoglycemia reaction when driving, especially those patients whose symptoms of hypoglycemia are not obvious or lacking, and those who have had hypoglycemia frequently in the past. Under the above circumstances, the first thing to consider is whether the patient can operate safely.
Medication for pregnant and lactating women
The clinical experience of this product in pregnant women is limited.
Animal experiments have not found any difference between insulin aspart and human insulin in embryo toxicity and teratogenicity.
It is suggested that blood sugar control and monitoring should be strengthened for pregnant women with diabetes during the whole pregnancy and planned pregnancy. The demand for insulin in early pregnancy usually decreases; It gradually increases in the second and third trimester of pregnancy. After delivery, the insulin demand quickly returned to the pre-pregnancy level.
There are no restrictions on the use of this product by lactating women. The use of insulin by nursing mothers will not harm the baby. However, the dosage of this product may need to be adjusted accordingly.
Children's medication
This product has not been studied in children under 18 years old. Please follow the doctor's advice.
Medication for elderly patients
Please follow the doctor's advice.
drug interaction
Many drugs are known to affect glucose metabolism.
Drugs that may reduce insulin demand:
Oral hypoglycemic agents (OHAs), octreotide, monoamine oxidase (MAO) inhibitors, nonselective? Adrenaline blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, ethanol, anabolic steroids and thiamine preparations.
Drugs that may increase insulin demand:
Oral contraceptives, thiazide diuretics, glucocorticoids, thyroid hormones, sympathetic stimulants and danazol. ? -Blockers can mask the symptoms of hypoglycemia. Alcohol can aggravate and prolong the hypoglycemic effect of insulin.
excessive
There is no special definition of insulin overdose. However, when insulin is excessive, hypoglycemia will occur in different degrees:
A for mild hypoglycemia reaction, oral glucose or sugary food can be used for treatment. Therefore, it is recommended that diabetics take candy, candy, biscuits or sugary juice with them.
B. For severe hypoglycemia, when the patient has lost consciousness, glucagon (0.5- 1.0mg) can be injected into muscle or subcutaneously by professionally trained personnel, or glucose can be injected intravenously by medical personnel. If the patient does not respond to glucagon within 10- 15 minutes, glucose must be given intravenously immediately. After the patient regains consciousness, it is recommended to take carbohydrates orally to avoid recurrence.
Incompatibility (of drugs)
Adding other drugs to insulin may lead to the degradation of insulin (such as drugs containing sulfhydryl or sulfite).
This product cannot be used for intravenous infusion.
The specification is per milliliter 100 unit. 3 ml each.
5 pieces per box, per box 1 piece.
term of validity
The product is valid for 24 months.
store
Unused products should be refrigerated at 2-8? C put it in the refrigerator (not too close to the freezer) and don't freeze it.
When using this product, do not put it in the refrigerator. After use, it can be stored at room temperature (no more than 30? C) Store for 4 weeks, after which it must be discarded.
Do not use this product if it is not a uniform white mist suspension after shaking.
Cover the pen cap when not in use and keep it away from light.
Keep it out of the reach of children.
The box is marked with the expiration date. Don't use expired drugs.
Release date?
Registration number of imported drugs
Registration number of imported drugs:
Production enterprise
Company name: Novo Nordisk Denmark
novo nordisk
Production address: baggs Wald DK-2880 Novo Alle.
Tel: 0045 4444 8888
Fax: 0045 4443 8 1 18
Company consultation telephone number:
800 8 10 2299 (free)
0 10 6505 8787
Fax: 0 10 6505 6668
NovoMix？ ，Flexpen？ ，NovoFine？ And; Novo Horizonte？ , special fee? And promises and needles? It is a registered trademark of Novo Nordisk Denmark.
2004
novo nordisk
2880 Wald, baggs?