Mixtard 30 Novo Nordisk injection mixture treatment for diabetes (10ml)

Dosage form Bottle x 10ml
Specifications Solube Fraction, Isophane Insulin Crystals

Ingredient

Thành phần cho 10ml

Composition information	Content
Solube Fraction	300iu
Isophane insulin crystals	700iu

Uses

Indications

Mixtard 30 is indicated in the following cases:

Treatment of diabetes . Insulin and analogues insulin injected, intermediate effect combined with fast effect, insulin (human). The effect of reducing insulin blood glucose is caused by making the absorption of glucose easier after insulin attaches to receptors on muscle and fat cells, while inhibiting the production of glucose from the liver.

Mixtard 30 is dual -acting insulin.

Starting to work within 12 hours, maximum efficiency within 2-8 hours and 24-hour effect time.

pharmacokinetics

In the blood, insulin has a half -minute selling time.

Therefore, the line of acting over time of the insulin preparation is determined only 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

Data on absorption is because the product is a mixture of insulin with fast and extended absorption. The highest concentration in the plasma of insulin works quickly achieved within 1.5 - 2.5 hours after subcutaneous injection.

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 the proposed human insulin molecule; After cutting, no metabolites are formed.

Elimination

The last half -life is determined by the absorption rate from the subcutaneous tissue. Therefore, the final half -life (T1/2) is a measure of the absorption rather than the excretion per second of insulin from plasma (insulin in blood t1/2 minutes). The tests show that T1/2 is about 5 - 10 hours.

Before taking Mixtard 30 Novo Nordisk injection mixture treatment for diabetes (10ml)

How to use

Use subcutaneously.

Insulin mixture is never intravenous.

Mixtard 30 is used in the skin into the thigh or abdominal wall. If convenient, the butta or Delta muscle area can also be injected.

Injecting subcutaneously into the abdominal wall ensures faster absorption at other injection sites.

Injected into skin folds that are pinched to minimize the risk of indefinite intramuscular injection. Hold 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 disorders.

Mixtard 30 vials are used with insulin syringes with the corresponding unit.

Mixtard 30 is closed in the box with a detailed manual for patients to follow.

Injection of mixtard 30 is a double -acting insulin. This is a two -phase formula including fast -acting insulin and prolonged acting insulin.

Preparable insulin products are usually used once or twice a day when it is necessary to have a quick starting effect with a longer -lasting effect.

Dosage

Dosage depends on the individual and is determined according to the patient's needs. Insulin needs of each individual usually from 0.3 to 1.0 IU/kg/day.

Daily insulin needs may be higher in insulin resistant patients (for example, during puberty or obesity) and lower in patients producing surplus endogenous insulin.

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

Dose adjustment

The accompanying disease, especially the infection and fever , often increases the patient's insulin demand. 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.

The adjustment of the dose may also be necessary when transferring 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 hypoglycemic stage, can be treated using oral glucose or sugar products. Therefore, patients with diabetes are advised to bring people with sugar products.

The severe hypoglycemia, when the patient is unconscious, can be treated with glucagon (0.5 to 1 mg) intramuscularly or subcutaneously injected by a person who has been instructed on how to inject, or using intravenous injection 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 mixtard 30, you may experience unwanted effects (ADR).

Summary of safety

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 neuria, which can be recovered.

Enhanced insulin therapy with sudden improvement in blood sugar control may be associated with diabetes, when the diabetes worsens temporarily, while the improvement. Long -term blood sugar control reduces the risk of progression of diabetes.

Side reactions

The side effects are listed below based on clinical test data and are classified according to the frequency and group of Meddra's organs.

Very common (≥ 1/10)

Metabolic and nutrient disorders: Hypoglycemia.

immune system disorders: rash urticaria , rash.

Nervous system disorders: Surgical neuropathy (neuropathy).

eye disorders: diabetes retinopathy.

Skin and lower tissue disorders: fat disorders.

Systemic disorders and injection status: reaction at the injection site.

Systemic disorders and injection status: reaction at the injection site, edema.

Very rare (

immune system disorders: Anaphylaxis.

Eye disorders: refractive disorders.

Describe selective side effects

Anaphylactic reaction

The appearance of body hypersensitivity reactions (including body rash, itching , sweating, gastrointestinal disorders , nerve angiema, shortness of breath, hitting chest drum, reducing blood pressure and consciousness) is very rare but capable of 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 can cause temporary or permanent brain failure or even death. Head , nausea and chest drums.

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

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Mixtard 30 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 a doctor.

This drug is only used by a doctor.

The treatment is not enough or not 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, urination, nausea, vomiting , drowsiness, red skin, dry mouth , loss of appetite as well as acetone smell.

In tip 1 diabetes, cases of untreated hyperglycemia will eventually lead to diabetic acid ceton infection, which is likely to be fatal.

Hypoglycemia

can 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 enhanced insulin therapy, there may be changes in the common warning symptoms of hypoglycemia and must be notified by the doctor.

The 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 brand, it must be performed under tight medical supervision. Changes in concentration, brand (manufacturer), type, origin ( human insulin , insulin analogue) and/or production methods can lead to the need to change the dose.

Patients who are transferred to mixtard® from another type of insulin may have 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 the mixtard 30 drug, 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 usually go for a few days to a few weeks. In rare cases, the response at the injection site may require stopping using mixtard®.

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.

Combining thiazolidinedione and insulin drugs

Cases of congestive heart failure when using thiazolidinedione combined with insulin have been reported, especially in patients with risk factors for congestive heart failure. This should be remembered if considering combining thiazolidinedione with insulin drugs.

If used combined, patients must monitor the signs and symptoms of congestive heart failure, weight gain and edema. Must stop using thiazolidinedione if any heart worsening symptoms occur.

The ability to drive and operate machinery

The patient's ability to concentrate and react 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 must be notified to take measures to prevent hypoglycemia while driving. This is especially important in patients who are difficult to identify whether or not to recognize the warning signs of hypoglycemia or in people who often have hypoglycemia. It is necessary to consider the suitability of 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 inadequate treatment of diabetes control, can increase the risk of defects and fetal deaths in the uterus.

Recommended to enhance blood glucose control and monitor pregnant women with diabetes during pregnancy and when intended to become pregnant.

The demand for insulin usually decreases in the first three months of pregnancy and then increase in the middle and the last three months of pregnancy. After birth, insulin demand often quickly returns to the values as before pregnancy.

Breastfeeding period

There is no restriction on the treatment with mixtard® during breastfeeding.

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

Medicinal interaction

Interacting with other drugs and 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, enzyme inhibitors (ACE), Salicylate, Steroids and Sulphonamide.

The following substances can increase the patient's insulin demand

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

Beta blockers can cover the symptoms of hypoglycemia and delay recovery. Octreotide / Lanreotide may increase or decrease insulin demand.

Alcohol may 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.

Mixtard 30 must be to avoid excessive heat or light.

Other drugs

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