ACTRAPID injection 100 IU/mL Novo treat diabetes (10ml)

Dosage form Bottle
Specifications Human insulin
Ingredient Novo Nordisk a/s

Ingredient

Composition information	Content
Human insulin	1000iu/ml

Uses

Indications

Actrapid HM 100IU is indicated in the following cases:

Treatment of diabetes. insulin and substances similar to injection insulin, fast effect, insulin (people).

Effectiveness reduces glucose easier after insulin binds to receptors on muscle cells and fat cells, while inhibiting the production of glucose from the liver.

A forest trial at an active care unit Hyperglycemia (blood glucose over 10mmol/l) in 204 diabetes patients undergoing surgery shows that blood sugar returns to normal level (blood glucose 4.4 - 6.1 mmol/l) due to Actropic intravenous injection has reduced the death rate of 42% compared to 4.6% compared to 4.6%).

Actrapid is a fast -acting insulin. The effect begins within 1/2 hours, achieves the maximum effect within 1.5 - 3.5 hours and the whole time is about 7 - 8 hours.

pharmacokinetics

In the blood, insulin has a half -minute half -life. Therefore, data on the effect of insulin preparations is only determined by its absorption characteristics. This process is affected by a few factors (such as insulin dose, injection, injection site, thickness of subcutaneous fat, diabetes). Therefore, insulin pharmacokinetics are affected by a significant change in each patient and between patients.

absorption

After subcutaneous injection, the highest concentration in plasma is achieved within 1.5 - 2.5 hours.

Distribution

Not strongly attached to plasma proteins, except for anti -insulin antibodies during the circulation (if any) have been observed.

Metabolism

human insulin is reported by insulin protease or enzyme with insulin varies and possibly due to Isulfide protein isomerase. Some cutting positions (hydrolysis) on the proposed insulin molecule; After cutting, there is no metabolism that is still in operation.

Elimination

Last half -life is determined by the rate of absorption from subcutaneous tissue. Therefore, the final half -life (T1/2) is a measure of absorption rather than the excretion per second of insulin from plasma (blood insulin with t1/2 minutes). Testing shows t 1/2, 2 - 5 hours.

Before taking ACTRAPID injection 100 IU/mL Novo treat diabetes (10ml)

How to use

actrapid HM is used injected under the skin. Always change the injection site in an injection area to reduce the risk of swelling or skin dents. The best places for you to inject are: the front of the waist (abdomen), buttocks, front of the thigh or the upper arm.

insulin will work faster if you inject in the area around the waist. ACTRAPID HM can also be used in special cases and performed by health workers.

How to inject Actrapid HM separately or mix with prolonged insulin.

Make sure you are using the right type of syringe with the corresponding unit division for insulin injections.

withdraw into the syringe an air with the dose of insulin you need.

Follow the instructions of doctors and nurses.

Insulin injection under the skin. Using injection techniques such as doctors or nurses guided.

Dosage

actrapid HM is a fast -acting insulin and can be used in combination with prolonged insulin products.

Dosage depends on each individual and is determined according to the needs of the patient. The insulin needs of each individual usually from 0.3 - 1.0iu/kg/day. Daily demand for insulin may be higher in insulin resistant patients (for example, puberty or obesity) and lower in patients producing surplus endogenous insulin.

Dose adjustment

The accompanying disease, especially infection and fever, often increases the patient's insulin needs. Included diseases in the kidneys, liver or diseases affect the adrenal glands, pituitary or thyroid glands may require changes in insulin dose. It may also be necessary to adjust the dose if the patient changes physical activity or normal diet. Adjusting the dose may also be necessary when converting patients from an insulin preparation to another type.

There should be a main meal or a snack containing carbohydrate within 30 minutes after each injection.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Mild hypoglycemic stage, can be treated using oral glucose or sugar products. Therefore, patients with diabetes are often advised to bring people with sugar products.

Severe hypoglycemia, when the patient is unconscious, can be treated with intramuscular injection or subcutaneously subcutaneously glucagon (0.5 to 1mg) by a person who has been instructed on how to inject, or using intravenous glucose by a medical staff. Intravenous glucose must be used, if the patient does not respond to glucagon within 10 - 15 minutes.

When the patient wakes up, the food contains carbohydrates to prevent recurrence.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using actrapid HM, you may experience unwanted effects (ADR).

The side effects are listed below based on clinical data and are classified according to the frequency and system groups of Meddra. The frequency groups are determined according to the following convention: very common (> = 1/10), common (> = 1/100 to = 1/1000 to = 1/10000 to Common - Hypoglycemia*

Skin disorders and subcutaneous tissue disorders Uncommon - Moisturizing dysplasia*

Anaphylactic reaction

The appearance of body hypersensitivity reactions (including body rash, itching, sweating, digestive disorders, nerve angiemas, shortness of breath, chest drum, loss of blood pressure and fainting/loss of consciousness) are rare but can be life -threatening.

Hypoglycemia

The most commonly reported side effect is hypoglycemia, which may occur if insulin dose is too high with insulin demand. Hypoglycemia can lead to unconsciousness or convulsions and may cause temporary or permanent brain failure or even death.

Symptoms of hypoglycemia often appear suddenly, may include cold sweat, pale and cold skin, fatigue, restlessness or tremor, feeling anxiety , tired or abnormal, confused, difficult to concentrate, drowsiness, intense hunger, vision change, headache , nausea and hit chest drums.

Fatty disorder

Fatty disorder is reported less, can occur in the injection site.

Instructions on how to handle ADR

Notify the doctor the unwanted effects encountered when using.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Actrapid HM drug is contraindicated in the following cases:

Hypersensitivity to active ingredients or any excipients of the drug.

Precautions when using

Read the instructions carefully before use. If you need more information, please consult your doctor.

This drug is only used by a doctor.

The treatment is not enough or non -continuous, especially in type 1 diabetes, which can lead to hyperglycemia.

Normally, the first symptoms of hyperglycemia appear slowly, lasting for several hours or days. These symptoms include thirst, many times, nausea, vomiting, drowsiness, red skin, dry mouth, loss of appetite as well as acetone smell. In Type 1 diabetes, cases of untreated hyperglycemia will lead to acetone acidic acidosis due to diabetes, likely to be fatal.

Hypoglycemia

Hypoglycemia may occur if insulin dose is too high compared to insulin needs. Skipping a meal or exercise, no plan that can lead to hypoglycemia. Patients with blood glucose control are improved, for example, due to positive insulin therapy, there may be changes in the common warning symptoms of hypoglycemia and should be notified by the doctor. Common warning symptoms can be lost in diabetes patients for a long time.

When transferring patients to use another type of insulin or other insulin brands should be performed under tight medical supervision. Changes in concentration, brand (manufacturer), type, origin (human insulin, substance similar to insulin) or production methods can lead to the need for dose changes. Patients who are transferred to actrapid HM from another type of insulin may need to increase some daily injections or change the dose of the insulin they have used earlier. If the adjustment is necessary when switching to the patient to use Actrapid HM, it can be done at the first dose or in the first few weeks or the first few months.

Like any other insulin therapy, there may be reactions at the injection site, including red pain, urticaria, inflammation, bruising, figs and itching. Continuous changes in the injection site in a certain injection area can help reduce or prevent these reactions. The above reactions usually go for a few days or weeks. In some rare cases, the response to the injection site may require stop use of HM.

Before traveling to other places, there is a difference in time zone, patients should consult a doctor because this means that patients have to inject insulin and use meals at other times.

Due to the risk of precipitation in some insulin pump pipes, do not use actrapid HM in insulin pumps to transmit insulin under the skin continuously.

Combining thiazolidinedione and insulin drugs

There have been reports on cases of congestion heart failure when using thiazolidinedione combined with insulin, especially in patients at risk of developing congestive heart failure. This should be remembered if considering the combination of thiazolidinedione with insulin drugs. If used in combination, patients must monitor the signs and symptoms of congestion, weight gain and edema. Yes, but use thiazodililylioneione if any heart worsens occur.

Special prudence when canceling and other operations

To use intravenous lines: The transmission system with actrapid® is at a concentration of 0.05iu/ml to 1.0iu/ml insulin in the infusion: 0.9% sodium chloride, 5% dextrose and 10% dextrose including 40mmol/l potassium chloride, using stable polypropylene bags at room temperature in 24 hours. Although stable over time, a certain amount of insulin will initially be absorbed into the material of the transmission bag. Need to monitor blood glucose during the transmission process.

Do not use insulin preparations have been frozen.

Do not use insulin solution if the solution is not transparent and colorless.

Do not use actrapid HM in insulin pumps to transmit insulin under the skin continuously.

The ability to drive and operate machinery

The patient's concentration and reaction ability may be impaired as a result of hypoglycemia. This can be dangerous in situations where these possibilities are of special importance (such as driving or operating machinery).

Patients should be reminded to be careful to avoid hypoglycemia while driving. This is especially important in patients who are reduced or not recognized as warning signs of hypoglycemia or in people who often have hypoglycemia. Consider driving in these cases.

Pregnancy

There is no restriction on the treatment of diabetes with insulin during pregnancy, because insulin does not pass the placenta.

Both hypoglycemia and hyperglycemia may occur in the case of incomplete treatment for diabetes control, which may increase the risk of defects and fetal deaths in the uterus. It is recommended to enhance blood glucose control and monitor pregnant women with diabetes during pregnancy and when intended to become pregnant.

Insulin demand usually decreases in the first 3 months of pregnancy and increases in the middle and the last 3 months of pregnancy. After birth, insulin demand often quickly returns to indicators as before pregnancy.

Breastfeeding period

There is no restriction on treatment with actrapid HM during breastfeeding.

Insulin treatment for breastfeeding mothers is not at risk for babies. However, it may be necessary to adjust the dose of actrapid HM, diet or both.

Drug interaction

Some drugs are known to interact with glucose metabolism.

The following substances can reduce the patient's insulin demand:

Drugs to treat oral diabetes, Monoamine oxidase inhibitors (MAOI), unsatisfactory beta blockers, angiotensin enzyme inhibitors (ACE), salicylate, homosexual steroids and sulfonamide .

The following substances can increase the patient's insulin demand:

Oral contraceptives, thiazide, glucocorticoid, thyroid hormone, substances that are similar to sympathetic nerve, growth hormone and Danazol.

Beta blockers can cover hypoglycemic symptoms and delay recovery.

Octreotide/Lanreotide may increase or decrease insulin demand. Alcohol can increase or decrease the hypoglycemic effect of insulin.

Storage

When using, do not leave Actrapid HM bottles in the refrigerator. Actrapid HM vials can be kept at room temperature (no more than 30oC) to 6 weeks after opening.

When not in use, it is recommended to store actrapid HM vials in the refrigerator at 2 ° C to 8 ° C (not too close to the freezer). Do not freeze.

Keep the vial in the carton box to avoid light.

actrapid HM must avoid excessive heat or light.

To be out of reach and vision of children.

Do not use overdue Actrapid HM stated on the label/carton box.

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