Active substanceInsulin biphasic [human genetic engineering]Insulin biphasic [human genetic engineering]
Dosage form: & nbspsubcutaneous suspension
Composition:

In 1 ml of the drug contains:

active substance: Human Genetically Engineered Insulin 100 ME;

Excipients: glycerol, protamine sulfate (in terms of protamine base), sodium dihydrogen phosphate, zinc oxide, metarecoline, phenol, water for injection.

Description:

A suspension of white color. When standing, the slurry settles to form a white precipitate. The supernatant is clear, colorless or almost colorless. The precipitate is easily resuspended by gentle shaking.

Pharmacotherapeutic group:A hypoglycemic agent is a combination of insulin of short and medium duration
ATX: & nbsp

A.10.A.C   Insulins and their analogues of average duration of action

Pharmacodynamics:

Biosulin® 30/70 is a human insulin obtained using recombinant DNA technology. It is a combination of insulin of short and medium duration of action in a ratio of 30:70.

Interacts with a specific receptor cytoplasmic outer cell membrane to form insulin-receptor complex stimulates intracellular processes, in m. H. Synthesis of some key enzymes (hexokinase, pyruvate kinase, glycogen and others.).

Reduction of glucose in the blood due to an increase of intracellular transport, absorption and assimilation tissue enhancement, stimulation of lipogenesis, glikogenogeneza decreased hepatic glucose rate and other products.

The duration of action of insulin formulations is mainly due to absorption rate, which depends on several factors (e.g., dose, method and place of introduction), and therefore the action of insulin profile is subject to considerable variations as different people, and at the same rights.

Activity profile after subcutaneous injection (approximate figures): onset of action after 30 minutes, the maximum effect - in the range between 6 and 12 hours, duration - 18-24 hours.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed in tissues unevenly; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications:

Diabetes.

Contraindications:

Increased individual sensitivity to insulin or any of the components of the drug.

Hypoglycemia.

Dosing and Administration:

Biosulin ® 30/70 is intended for subcutaneous administration.

The dose of the drug is determined by the doctor individually in each case, based on the level of glucose in the blood. On average, the daily dose of the drug ranges from 0.5 IU / kg to 1 IU / kg body weight (depending on the individual characteristics of the patient and blood glucose level).

The temperature of the insulin should be appropriate at room temperature.

Biosulin ® 30/70 is usually injected subcutaneously into the thigh. Injections can also be made in the anterior abdominal wall, buttock or the area of ​​the deltoid muscle of the shoulder. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy.

Side effects:

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, excitement, paresthesia in the mouth, headache). Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: rarely - skin rash, angioedema; extremely rare - anaphylactic shock.

Local reactions: hyperemia, puffiness and itching at the injection site, with prolonged use - lipodystrophy at the injection site.

Other: edema, transient refractive disorders (usually at the beginning of therapy).
Overdose:

Overdose may develop hypoglycemia.

Treatment: an easy hypoglycemia patient can eliminate himself by taking sugar inside or carbohydrate-rich foods. Therefore, patients with diabetes are encouraged to always carry sugar, sweets, cookies or sweet fruit juice.

In severe cases, if the patient lost consciousness, intravenously injected 40% solution of dextrose; intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Interaction:

There are a number of drugs that affect the need for insulin.

Hypoglycemic action of insulin enhances oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

Hypoglycemic action of insulin weakens oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of the drug are possible.

Special instructions:

Do not use Biosulin ® 30/70, if after shaking the suspension does not turn white and evenly cloudy.

On the background of insulin therapy, continuous monitoring of blood glucose levels is necessary.

Causes hypoglycemia In addition to an overdose of insulin, there may be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), injection site change, and interaction with other drugs.

Incorrect dosing or breaks in the administration of insulin, especially in patients with type 1 diabetes, can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, over a period of several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, odor of acetone in the exhaled air. If not treated, hyperglycemia in type 1 diabetes can lead to the development of life-threatening diabetic ketoacidosis. The dose of insulin must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and kidney dysfunction and diabetes mellitus in persons over 65 years of age.

Correction of the dose of insulin may also be required if the patient increases the intensity of physical activity or changes the habitual diet.

Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

The transition from one type of insulin to another should be carried out under the control of blood glucose.

The drug lowers tolerance to alcohol.

Due to the possibility of precipitation in some catheters, the use of the drug in insulin pumps is not recommended.

Instructions to be given to the patient

The technique of injection with the use of insulin in vials

If the patient uses only one type of insulin

1. Disinfect the rubber membrane on the vial.

2. Put the air in the syringe in the amount corresponding to the required dose of insulin. Insert air into the vial with insulin.

3. Turn the bottle with the syringe upside down and type the desired dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check the correctness of the dose of insulin.

4. Immediately inject.

If the patient needs to mix two types of insulin

1. Disinfect the rubber membranes on the vials.

2. Just before the set, take a bottle of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy.

3. Type in the syringe air in an amount corresponding to the dose of "turbid" insulin. Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.

4. Type in the syringe air in an amount corresponding to a dose of insulin of short action ("transparent"). Insert air into the bottle with "transparent" insulin. Turn the bottle with the syringe upside down and type the desired dose of "transparent" insulin. Remove the needle and remove air from the syringe. Check the correctness of the dialed dose.

5. Insert the needle into the bottle with a "cloudy" insulin, flip the bottle with the syringe upside down and type the desired dose of insulin. Remove air from the syringe and check the correctness of the dialed dose. Immediately inject the dialed mixture of insulin.

6. Always take the insulin in the same sequence described above.

The technique of injection with the use of insulin in cartridges

The cartridge with the preparation Biosulin ® 30/70 is intended for use only with the syringe handle Biosulin ® Pen.The patient should be warned about the need to carefully follow the instructions in the instructions for using the syringe pen for insulin administration.

Before use, make sure that there are no damages (for example, cracks) on the cartridge with Biosulin® 30/70. Do not use the cartridge if there are any visible damage. After the cartridge is inserted into the syringe pen, a colored strip should be visible through the cartridge holder window.

Before placing the cartridge in the syringe pen, turn the cartridge up and down so that the glass ball moves from end to end of the cartridge. This procedure should be repeated at least 10 times, until all the liquid becomes white and evenly turbid. Immediately after this, an injection must be made.

If the cartridge is already inside the pen syringe, turn it with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.

After the injection, the needle should remain under the skin for a minimum of 6 seconds. Keep the button depressed until the needle is completely removed from the skin, thus ensuring the correct dose administration and limiting the possibility of blood or lymph flow into the needle or the insulin cartridge.

The cartridge with the preparation Biosulin® 30/70 is intended only for individual use and can not be refilled.

Injection procedure

- With two fingers, take the fold of the skin, insert the needle into the base of the fold at an angle of about 45 ° and insert insulin under the skin.

- After the injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely.

- If blood is removed from the needle after the needle is removed, gently press the injection site with your finger.

- It is necessary to change the injection site.

Effect on the ability to drive transp. cf. and fur:

In connection with the primary appointment of insulin, a change in its type or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a car or to manage various mechanisms, as well as engaging in other potentially dangerous activities requiring increased attention and speed of mental and motor reactions.

Form release / dosage:

Suspension for subcutaneous administration, 100 IU / ml.

Packaging:

To 10 ml in a bottle of colorless neutral glass (type I USP), sealed with a rubber stopper with an aluminum run-off and a plastic lid.

1 bottle per cardboard pack together with instructions for use.

3 ml per colorless neutral glass cartridge for use with the Biosulin® Pen syringe pen.

5 cartridges per blister AL / PVC.

1 blister in a cardboard box, along with instructions for use.

Storage conditions:

Store in a dark place at a temperature of 2 to 8 ° C.

Do not freeze.

Use the opened vial with insulin to store at room temperature (not above 25 ° C) for 6 weeks, the used opened cartridge - for 4 weeks.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:LSR-005204/08
Date of registration:03.07.2008
Expiration Date:Unlimited
The owner of the registration certificate:PHARMSTANDART-UFIM VITAMIN FACTORY, OJSC PHARMSTANDART-UFIM VITAMIN FACTORY, OJSC Russia
Manufacturer: & nbsp
Representation: & nbspPHARMSTANDART-Ufa-VITA, JSCPHARMSTANDART-Ufa-VITA, JSC
Information update date: & nbsp12.02.2017
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