Do not use Biosulin ® P if it becomes cloudy, colored, or if solid particles are detected.
On the background of insulin therapy, a constant control of the concentration of glucose in the blood is necessary. In case of insufficient glycemic control or a tendency to episodes of hyper- or hypoglycemia, before making a decision to correct the dose of insulin, it is necessary to check the performance of the prescribed mode of insulin administration, to make sure that insulin is injected into the recommended area, to check the correctness of the injection technique and all other factors , which can affect the effect of insulin.
Since the simultaneous administration of a number of drugs (see the section "Interaction with other drugs") can weaken or intensify the hypoglycemic effect of the preparation Biosulin® P, it can not be taken with other drugs without special permission from the doctor.
Hypoglycemia occurs if the dose of insulin exceeds the need for it.
The risk of hypoglycemia is high at the beginning of treatment with insulin, when another insulin preparation, patients with low maintenance concentration of glucose in the blood. The causes of hypoglycemia, in addition to an overdose of insulin, can be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (violations of the liver and kidneys, hypofunction of the adrenal cortex, pituitary gland or thyroid gland) injections, as well as interaction with other drugs.
As with all insulins, special care should be taken and intensive monitoring of blood glucose concentrations in patients for whom hypoglycemic episodes may be of particular clinical importance is recommended,such as patients with severe stenosis of the coronary or cerebral arteries, as well as in patients with proliferative retinopathy, especially if they have not been photocoagulated, because they have the risk of transient amaurosis (complete blindness).
With the development of hypoglycemia, there are certain clinical signs and symptoms that should indicate to the patient or others on developing hypoglycemia. These include: increased sweating, skin moisture, tachycardia, heart rhythm disturbances, increased blood pressure, chest pains, tremors, anxiety, hunger, sleepiness, sleep disorders, feelings of fear, depression, irritability, unusual behavior, anxiety, paresthesia in the mouth and around the mouth, pallor of the skin, headache, impaired coordination of movements, as well as transient neurological disorders (speech and vision disorders, paralytic symptoms) and unusual sensations. With an increasing decrease in glucose concentration, the patient may lose self-control and even consciousness. In such cases, coldness and moisture of the skin can be observed, and convulsions may also appear.Therefore, every patient with diabetes who receives insulin should learn to recognize symptoms that are signs of developing hypoglycemia. The patient can adjust himself the observed decrease in blood glucose concentration by taking sugar or foods high in carbohydrates. To this end, the patient should always carry 20 g of glucose. In more severe hypoglycemia, injection of glucagon is indicated. After sufficient improvement, the patient should eat. If hypoglycemia can not be immediately remedied, then it is urgent to call a doctor. It is necessary to inform the doctor immediately about the development of hypoglycemia so that he makes a decision about the need to correct the dose of insulin.
Under certain circumstances, the symptoms of hypoglycemia may be mild or may be absent. Such situations occur in elderly patients, in the presence of lesions of the nervous system (neuropathy), with concomitant mental illnesses, concomitant therapy with other drugs (see section "Interaction with other drugs"), with low maintenance glucose concentration in the blood, with a change insulin.
Failure to follow a diet, insulin injection, an increased need for insulin as a result of infectious or other diseases, decreased physical activity may lead to increased blood glucose (hyperglycemia), possibly with an increase in the level of ketone bodies in the blood (ketoacidosis). 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 mellitus can lead to the development of life-threatening diabetic ketoacidosis. At the first symptoms of metabolic acidosis (thirst, frequent urination, loss of appetite, fatigue, dry skin, deep and rapid breathing, high concentrations of acetone and glucose in the urine), urgent medical intervention is necessary.
When a doctor changes (for example, during hospitalization for an accident, illness during a vacation), the patient should inform the doctor that he has diabetes mellitus.
In patients with renal insufficiency, the need for insulin may be reduced as a result of changes in its metabolism.
In patients with severe impairment of liver function, the need for insulin can also be reduced as a result of changes in its metabolism and a decrease in gluconeogenesis. 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 the concentration of glucose in the blood.
Cases of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for developing chronic heart failure.This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight and the presence of peripheral edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.
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.
INSTRUCTION FOR THE TECHNIQUE OF INJECTION OF MEDICINAL DRUGS
Biosulin® P solution for injection 100 IU / ml
USING THE SYRINGE-HANDLE BiomatikPen®2
(disposable for multiple injections)
Appearance and parts of the syringe-pen BiomatikPen®2 - see Fig. "Appearance and parts of the syringe-pen BiomatikPen®2"
Provision of aseptic injection
Before the injection, you should wash your hands. It is very important that the hands and all the necessary devices for injection be clean. Choose a place for injection.Wipe the skin at the injection site with an alcoholic napkin only after the insulin dose has been set in the syringe pen. Before injection, allow the alcohol to dry at the injection site.
Attaching the needle to the syringe pen
1. Before use, remove the protective cap from the syringe handle. Disinfect the rubber membrane of the cartridge with alcohol wipes or a medical tampon soaked in alcohol to prevent ingestion of microorganisms (see Figure 1).
2. Remove the protective film from the outer protective cap of the needle (see Figure 2).
Attention! For each injection, use a new, sterile needle for the pen-syringe (with an undamaged protective film)!
Read the instructions for using the needle for the syringe pen!
3. Carefully and tightly screw the needle onto the thread of the tip of the cartridge holder until it stops (see Figure 3).
4. Remove the outer protective cap of the needle and save it to remove and dispose of the used needle (see Figure 4).
5. Remove and dispose of the inner protective cap of the needle (see Figure 5).
Attention! The needle of the syringe-pen is sterile! Do not touch it!
For each injection, use a new needle to prevent infection.
To avoid accidental injections, never put the inner cap back on the needle.
Preparing the syringe pen for injection
6. Turn the dose setting ring clockwise, set the test dose to 2 units (see Figure 6).
7. Place the biomatic pen "BiomatikPen®2" with its working end up and gently tap on the cartridge holder so that all the air in the cartridge rises upward (see Figure 7).
8. Hold the needle with the needle up, press the start button all the way. The dosing indicator will return to zero (position "0") (see figure 8).
9. At the end of the needle should appear a few drops of the drug. If this does not happen, the operation (steps 6-8) should be repeated. If drops do not appear, use a new needle (needle clogging is possible) (see Figure 9).
Attention! In order for the dose to be complete, before every dose administration, it is always necessary to check the outlet of the liquid drop from the needle. Setting the required dose of the drug
10. Check that the dosing indicator is in the "0" position. Set the number of units needed for injecting the drug by turning the dose setting ring clockwise (see the table for transferring the indication of the dosage indicator of the BiomatikPen® 2 syringe to the dose of the drug).The dose can be adjusted by rotating the dose setting ring in any direction until the correct dose is established opposite the dosing indicator (see Figure 10).
Attention! When rotating the dose setting ring, be careful not to accidentally press the start button to avoid dosing the drug.
Secure Limiter
The dose of the drug, which is installed on the BiomatikPen® 2 syringe, can be limited by the amount left in the cartridge. If the remaining amount of the drug in the cartridge is not enough for the required dose, the dose setting ring will not rotate further in the clockwise direction. Discard the syringe pen or enter the remaining dose units and use a new syringe pen to complete the required dose.
Injection
11. Injection of the drug should be carried out in accordance with the recommendations of the attending physician.
For the introduction of the set dose of the drug, press the trigger button all the way and hold it for the entire duration of the injection until the value "0" appears opposite the dosage indicator. A value of "0" in the dosage indicator window means that you entered your dose completely (see Figure 11).
Note: You can interrupt the injection of the drug by releasing the start button.
The amount of the drug that has not been entered will be displayed in the dosage indicator window and can be additionally entered by pressing the start button again.
12. 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 and restricting the possibility of blood or lymph flow into the needle or the insulin cartridge (see Figure 12).
Attention!
Failure to follow these steps can lead to an incorrect dose. If the insulin continues to flow out of the needle after the injection, hold the needle in the skin for longer injections.
13. After removing the needle from under the skin, gently place the outer protective cap on the needle of the syringe handle (see Figure 13).
Disposing of the needle and storage of the syringe pen
14. Disconnect the needle by turning it anti-clockwise and dispose of it properly (see Figure 14).
Attention!
Strictly observe the precautions to avoid accidental injury from needle sticking and possible transmission of infectious diseases.
15. Close the syringe handle with a protective cap after each use, to prevent direct sunlight and dust from entering the cartridge.
Additional Information
Sound and tactile signals
During operation, the BiomaticPen®2 syringe pen produces the following audio and tactile signals:
- setting the required dose
When the dose setting ring is rotated, a certain physical resistance is felt and clicks are heard when each dose unit is dialed.
- injection
The process of administering the drug from the BiomatikPen® 2 syringe is accompanied by
is given by a sound signal (ratchet), which stops when the drug is completely inserted (to the value "O" in the dosage indicator window).
Rules for storage, use and disposal
The syringe pen is designed for individual use and can not be used by several persons.
Handle the BiomatikPen® 2 syringe handle carefully.
Do not allow dust and moisture to enter the BiomatikPen82 pen.
After each use, close the syringe pen with a cap. Always keep the BiomaticPen®2 syringe pen in its individual packaging without needles.
Store the BiomatikPen®2 syringe pen, following the instructions for storing the medicinal product.
Clean the BiomatikPen®2 syringe handle with a damp cloth. Do not use alcohol, solvents or other cleaning agents.
Never immerse the BiomatikPen®2 syringe in water as this may damage it.
Edit Warnings
Use the BiomaticPen®2 syringe pen with only needles that are compatible with the syringe pen that your doctor recommends.
The drug Biosulin® P should only be used as part of the therapy that is prescribed by your doctor and at the dosage prescribed for you. Any changes should be made under the supervision of a physician.
If you have questions about the length of the needle, consult your doctor or medical personnel.
Do not expose the BiomatikPen®2 syringe to extreme temperatures, do not leave it under direct sunlight or in the cold (for example, in the freezer).
Store the BiomaticPen®2 syringe pen, the needles for the syringe pen in an inaccessible place for children and others who are not familiar with the correct method of treatment. In cases of unintentional administration of the drug or the resulting injury from a needle prick, immediate medical attention should be sought!
Needle syringe-pens should be used by only one person to prevent transmission of infectious diseases.
Use a new syringe-needle needle for each injection to ensure sterility. Remove the needle of the syringe pen after injecting to prevent leakage of the drug, ingress of air and possible clogging of the needle of the syringe pen.
Dispose of the used syringe pen needles together with the protective cap attached to them, following the manufacturer's instructions so that they can not harm other people.
Never use the BiomatikPen® 2 syringe pen if you have doubts about its correct operation.
Disposal rules
The Syringe Pen BiomatikPen®2 does not contain any components that are hazardous to the environment, and can be disposed of with household garbage.
The used BiomatikPen®2 syringe handle must only be disposed of with a disconnected needle.
Table of transfer of indications of the dosage indicator of the syringe-pen BiomatikPen®2 to the dose of Biosulin® R, injection for 100 IU / ml:
| Dosing indication | The dose of Biosulin ® P, ME |
| 01 | 01 |
| 02 | 02 |
| 03 | 03 |
| 04 | 04 |
| 05 | 05 |
| 06 | 06 |
| 07 | 07 |
| 08 | 08 |
| 09 | 09 |
| 10 | 10 |
| 11 | 11 |
| 12 | 12 |
| 13 | 13 |
| 14 | 14 |
| 15 | 15 |
| 16 | 16 |
| 17 | 17 |
| 18 | 18 |
| 19 | 19 |
| 20 | 20 |
| 21 | 21 |
| 22 | 22 |
| 23 | 23 |
| 24 | 24 |
| 25 | 25 |
| 26 | 26 |
| 27 | 27 |
| 28 | 28 |
| 29 | 29 |
| 30 | 30 |
| 31 | 31 |
| 32 | 32 |
| 33 | 33 |
| 34 | 34 |
| 35 | 35 |
| 36 | 36 |
| 37 | 37 |
| 38 | 38 |
| 39 | 39 |
| 40 | 40 |
| 41 | 41 |
| 42 | 42 |
| 43 | 43 |
| 44 | 44 |
| 45 | 45 |
| 46 | 46 |
| 47 | 47 |
| 48 | 48 |
| 49 | 49 |
| 50 | 50 |
| 51 | 51 |
| 52 | 52 |
| 53 | 53 |
| 54 | 54 |
| 55 | 55 |
| 56 | 56 |
| 57 | 57 |
| 58 | 58 |
| 59 | 59 |
| 60 | 60 |
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 of the vial.
2. Put the air in the syringe in the volume 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 of 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 a volume 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. Put the air in the syringe in the volume corresponding to the 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 ® P is intended for use only with the syringe-handle BiomatikPen®2. 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 is no damage (for example, cracks) on the cartridge with Biosulin® P. 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.
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 and restricting the possibility of blood or lymph flow into the needle or the insulin cartridge.
The cartridge with the preparation Biosulin® P is intended only for individual use and can not be refilled.
Injection procedure
- With two fingers, take a skin fold, 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, after removing the needle, blood appears on the site of the injection, gently press the injection site with a swab moistened with a disinfectant solution (for example, alcohol).
- It is necessary to change the injection site.