Insulatdd medicine 100iu/ml Novo Nordisk treat diabetes (10ml)

Dosage form Bottle x 10ml
Specifications Human insulin

Ingredient

Thành phần cho 10ml

Composition information	Content
Human insulin	1000UI

Uses

indications

10 ml insulatdd drugs are indicated in the following cases:

Treatment of diabetes.

Pharmacology

Medical therapy group: drugs used in diabetes. Insulin and substances similar to injection insulin, intermediate effects, insulin (people).

The effect of reducing insulin blood glucose is caused by making it easier to absorb glucose after insulin attaches to receptors on muscle and fat cells, while inhibiting the production of glucose from the liver. Insulatdd 10 ml is an intermediate -acting insulin.

The effect begins within 11/2 hours, achieving maximum efficiency within 4 - 12 hours and the whole time is about 24 hours.

Clinical safety data

Pre -clinical data shows that there is no special risk for people based on regular studies on safety pharmacological, toxicity with reminders, gene toxicity, cancer, toxicity for reproduction.

Dynamic pharmacokinetics

in the blood, insulin has a half -minute half -life. Therefore, the data on the time of time 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 2 - 18 hours.

Distribution

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

Metabolism

Insulin people are reported by insulin protease or enzyme with insulin variable and possibly due to Isomerase protein. Some cutting positions (hydrolysis) on human insulin molecules have been proposed; After cutting, no metabolites are formed.

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). The tests show that T1/2 is about 5 - 10 hours.

Before taking Insulatdd medicine 100iu/ml Novo Nordisk treat diabetes (10ml)

How to use

Use subcutaneously. Insulin mixture is never intravenously.

Insulatdd 10 ml is used under the skin into the thigh area. If convenient, abdominal wall, buttock or Delta muscle area can also be injected.

subcutaneous injection into the thigh area makes the absorption slowly and less change than other injection sites.

Injected into skin folds that are pinched to minimize the risk of indefinite intramuscular injection. Holding needles under the skin for at least 6 seconds to ensure the entire dose of insulin has been injected. Should always change the injection site in the same injection area to reduce the risk of fat disorder.

Insulatdd 10 ml is used with insulin syringes with the corresponding unit.

Insulatdd 10 ml is closed in the box with a detailed manual for the patient to follow.

Dosage

insulatdd 10 ml is an intermediate -acting insulin, can be used alone or in combination with fast -acting 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 - 1.0 IU/kg/day. The daily insulin demand may be higher in insulin resistant patients (for example, during 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.

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

Severe hypoglycemia, when the patient is unconscious, can be treated with intramuscular injection or subcutaneous injection of Glucagon (0.5 to 1 mg) 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 you forget 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 an insulatdd 10 ml, you may experience unwanted effects (ADR).

Summary of safety data

The most commonly reported side effect during treatment is hypoglycemia. In clinical trials and in the process of use on the market, the frequency of hypoglycemia changes according to the patient group, the dosage regime and the level of blood sugar control.

At the beginning of insulin treatment, there may be abnormalities in refractive, edema and response at the injection site (pain, redness, urticaria, inflammation, bruising, swelling and itching at the injection site). These reactions are often temporary. The rapid improvement of blood glucose control may be associated with acute neuropathy, which can be recovered. Enhanced insulin therapy with sudden improvement in blood sugar control may be associated with diabetic retinopathy temporarily worse, while improving long -term blood sugar control reduces the risk of progression of diabetic retinopathy.

List of side effects

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

immune system disorders

Uncommon: urticaria, rash.*

Very common: hypoglycemia.

Very rare: peripheral neuropathy (neuropathy).

Very rare: refractive disorders.*

Less: Fatty disorder.*

Uncommon: reaction at the injection site.

Describe selective side effects

Anaphylactic reaction:

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

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

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

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Insulatdd medicine 10 ml contraindicated in the following cases:

Hypersensitivity to active ingredients or any excipients of the drug.

Caution 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 non -treatment hyperglycemia will lead to diabetes metonic acidosis, which is likely to be fatal.

Hypoglycemia may occur if insulin dose is too high compared to insulin needs. Skipping a meal or physical 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 may be lost in patients with diabetes for a long time.

When transferring patients to use another type of insulin or other insulin brands need to be performed under tight medical supervision. Changes in concentration, brand (manufacturer), type, origin (human insulin, substance similar to insulin) and/or production methods can lead to the need for dose changes.

Patients who are transferred to insulatdd 10 ml 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 insulatdd 10 ml, 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 pain, redness, urticaria, inflammation, bruising, swelling and itching. Continuous changes in the injection site in a certain injection area can help reduce or prevent these reactions. The above reactions often pass in a few days to a few weeks. In some rare cases, the reaction at the injection site may require stopping using insulatdd 10 ml.

Before traveling to the place of time zone, patients should consult a doctor, because this means that patients have to inject insulin and use meals at other times.

Do not use insulin in the insulin transmission pump.

Special prudence when canceling and other operations

Do not use insulin preparations have been frozen.

After carrying the 10 ml insulatdd bottle out of the refrigerator, it is recommended to bring the bottle to the room temperature before mixing insulin as it has been instructed for the first use.

Do not use insulin mixture if the mixture is not uniformly white after mixing.

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 recognize the 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 then increase in the middle and the last 3 months of pregnancy. After birth, insulin demand often returns to the values as before pregnancy.

The period of breastfeeding

There is no restriction on the treatment with InsulatVDD 10 ml during breastfeeding.

Insulin treatment for breastfeeding mothers is not at risk for babies. However, it may be necessary to adjust the dose of insulatdd 10 ml, diet or both.

Drug interaction

combining thiazolidinedione and insulin drugs

There have been reports on cases of congestion heart failure when using Thiazolidinedione combined with insulin, especially in patients with risk factors for 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. Must stop using thiazolidinedione if any heart worsening symptoms occur.

Interaction with other drugs and other types of interactions

Some drugs are known to interact with glucose metabolism.

The following substances can reduce the patient's insulin needs

Oral diabetes treatment, Monoamine oxidase inhibitors (MAOI), unsatisfactory beta blockers, angiotensin (ACE), Salicylate, Salicylate and Sulphonamide.

The following substances can increase the patient's insulin demand

Oral contraceptives, thiazide, glucocorticoids, thyroid hormones, 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.

Cavalry

Do not put insulin in the transmission.

Storage

Store in the refrigerator (2 ° C - 8 ° C). To far from the cooling unit. Do not freeze.

Keep the vial in the carton box to avoid light.

Insulatdd 10ml of jars must be avoided to avoid excessive heat or light.

After the first opening or carrying out: not in the refrigerator.

When using, the expiry date is 6 weeks when storing less than 25 ° C or 4 weeks when stored below 30 ° C.

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