Biosulin N, 100 IU/ml, suspension for subcutaneous administration, 10 ml, 1 pc.
Instructions to be given to the patient
Injection technique when using insulin in vials
Do not use Biosulin® N if, when mixing the contents of the bottle according to the instructions for use, the insulin does not become uniformly white and cloudy.
Do not use Biosulin® N if it contains flakes after mixing.
Do not use Biosulin® N if hard white particles are stuck to the bottom or walls of the bottle, creating a “frost pattern” effect.
If the patient is using only one type of insulin
1. Disinfect the rubber membrane of the bottle.
2. Fill the syringe with air in a volume corresponding to the required dose of insulin. Inject air into the insulin vial.
3. Turn the bottle with the syringe upside down and draw the required dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check that your insulin dose is correct.
4. Inject immediately.
If a patient needs to mix two types of insulin
1. Disinfect the rubber membranes of the bottles.
2. Immediately before drawing, roll the vial of long-acting insulin (“cloudy”) between your palms until the insulin becomes uniformly white and cloudy.
3. Fill the syringe with air in a volume corresponding to the dose of “cloudy” insulin. Inject air into the vial with “cloudy” insulin and remove the needle from the vial (“do not draw cloudy” insulin at this stage yet).
4. Fill the syringe with air in a volume corresponding to the dose of short-acting (“transparent”) insulin. Inject air into the vial of clear insulin. Turn the bottle with the syringe upside down and draw the required dose of “transparent” insulin. Remove the needle and remove air from the syringe. Check the correct dose.
5. Insert the needle into the vial with “cloudy” insulin, turn the vial with the syringe upside down and draw the required dose of insulin. Remove air from the syringe and check that the dose is correct. Inject the collected insulin mixture immediately.
6. Always draw insulins in the same sequence described above.
Injection technique when using insulin cartridges
The cartridge with the drug Biosulin® N is intended for use with the BiomaticPen® syringe pen. The patient should be warned about the need to carefully follow the instructions in the instructions for using the syringe pen for administering insulin.
Before use, make sure that there is no damage (for example, cracks) on the cartridge with Biosulin® N. Do not use the cartridge if there is any visible damage. Do not use Biosulin® N if, when mixing the contents of the cartridge according to the instructions for use, the insulin does not become uniformly white and cloudy.
Do not use Biosulin® N if it contains flakes after mixing. Do not use Biosulin® N if hard white particles are stuck to the bottom or walls of the cartridge, creating a “frost pattern” effect.
After the cartridge is inserted into the pen, a colored stripe should be visible through the window of the cartridge holder.
Before placing the cartridge into the pen, you should 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 uniformly cloudy. Immediately after this you need to give an injection.
If the cartridge is already inside the pen, you should turn it with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.
After injection, the needle should remain under the skin for at least 6 seconds. You should keep the button pressed until the needle is completely removed from under the skin, thus ensuring the correct dose is administered and limiting the possibility of blood or lymph getting into the needle or into the insulin cartridge.
The cartridge with Biosulin® N is intended for individual use only and cannot be refilled.
Injection procedure
Use two fingers to gather a fold of skin, insert the needle into the base of the fold at an angle of about 45° and inject insulin under the skin.
After injection, the needle should remain under the needle for at least 6 seconds to ensure that the insulin is completely injected.
If blood appears at the injection site after removing the needle, lightly press the injection site with a swab moistened with a disinfectant solution (for example, alcohol).
It is necessary to change injection sites.
INSTRUCTIONS FOR INJECTION OF THE MEDICINE Biosulin® N, suspension for subcutaneous administration 100 IU/ml USING A SYRINGE PEN BiomaticPen®2
(single use for multiple injections)
Appearance and parts of the BiomaticPen®2 syringe pen
1 — cap, 2 — body, 3 — dosage indicator window, 4 — dose setting ring, 5 — start button
Before use, make sure that there is no damage (for example, cracks) on the cartridge with Biosulin® N. Do not use a pen with a cartridge if there is any visible damage. Do not use the drug if, when mixing the contents of the cartridge according to the instructions for use, the insulin does not become uniformly white and cloudy.
Do not use a syringe pen with Biosulin® N if there are flakes in the cartridge after mixing. Do not use a syringe pen with Biosulin® N if hard white particles are stuck to the bottom or walls of the cartridge, creating a “frosty pattern” effect.
Ensuring asepsis during injection
Before giving the injection, you must wash your hands. It is very important that your hands and all equipment needed for injection are clean. Select the injection site. Wipe the skin at the injection site with an alcohol wipe only after the insulin dose has been set in the syringe pen. Before injection, allow the alcohol to dry at the injection site.
| Preparation |
| 1. Before using the BiomaticPen®2 syringe pen with Biosulin® N for the first time, roll the syringe pen between your palms 10 times. Then turn the syringe pen up and down 10 times so that the glass ball moves from end to end of the cartridge (position 1–2). These manipulations must be repeated until the suspension becomes uniformly white and cloudy. Immediately after this you need to give an injection. Before each injection: Turn the pen up and down 10 times so that the glass ball moves from end to end of the cartridge (position 1-2). Repeat this manipulation until the suspension becomes uniformly white and cloudy. Immediately after this you need to give an injection |
| Attaching a needle to a syringe pen |
| 2. Before use, remove the protective cap from the syringe pen. Disinfect the rubber membrane of the cartridge using an alcohol wipe or medical swab soaked in alcohol to prevent the entry of microorganisms. |
| 3. Remove the protective film from the outer protective cap of the needle. Attention! For each injection, use a new, sterile pen needle (with the protective film intact)! Read the instructions for using the pen needle! |
| 4. Carefully and tightly screw the needle onto the threads of the cartridge holder tip until it stops. |
| 5. Remove the outer needle protective cap and save it for removal and disposal of the used needle. |
| 6. Remove and discard the inner needle protective cap. Attention! The needle of the syringe pen is sterile! Don't touch her! Use a new needle for each injection to prevent infection. To avoid accidental needle sticks, never put the inner cap back on the needle. |
| Preparing a syringe pen for injection |
| 7. Turn the dose setting ring clockwise to set the test dose to 2 units. |
| 8. Install the BiomaticPen®2 syringe pen with the working end up and gently tap the cartridge holder so that all the air contained in the cartridge rises to the top. |
| 9. While holding the pen with the needle up, press the start button all the way. The dosage indicator will return to zero (position “0”). |
| 10. A few drops of the drug should appear at the end of the needle. If this does not happen, the operation (steps 7–9) should be repeated. If no drops appear, use a new needle (the needle may become clogged). Attention! To ensure that the dose is complete, you should always check that a drop of liquid comes out of the needle before each dose. |
| Setting the required dose of the drug |
| 11. Make sure the dosage indicator is in the “0” position. Set the number of units required to inject the drug by turning the dose setting ring clockwise (see the table for converting the BiomaticPen®2 syringe pen dosage indicator readings into the drug dose). The dose can be adjusted by rotating the dose setting ring in any direction until the correct dose is set against the dosage indicator. Attention! When rotating the dose setting ring, be careful not to accidentally press the start button to avoid releasing the dose of the drug. Safety limiter. The dose of the drug, which is installed on the BiomaticPen®2 syringe pen, can be limited by the amount remaining in the cartridge. If the amount of drug remaining in the cartridge is not sufficient for the required dose, the dose setting ring will not turn further in the clockwise direction. Throw away the pen or administer the remaining dose units and use a new pen to complete the required dose. |
| Carrying out the injection |
| 12. The injection of the drug should be carried out in accordance with the recommendations of the attending physician. To administer the set dose of the drug, press the start button all the way and hold it down throughout the entire administration process until the value “0” appears opposite the dosage indicator. A “0” value in the dosage indicator window means that you have administered your dose completely. Note: You can interrupt the injection of the drug by releasing the trigger button. The amount of drug that was not administered will be displayed in the dosage indicator window and can be additionally entered by pressing the start button again. |
| 13. After injection, the needle should remain under the skin for at least 6 seconds. You should keep the button pressed until the needle is completely removed from under the skin, thus ensuring the correct dose is administered and limiting the possibility of blood or lymph getting into the needle or into the insulin cartridge. Attention! Failure to follow these steps may result in the wrong dose being administered. If insulin continues to leak from the needle after an injection, hold the needle longer for subsequent injections. |
| 14. After removing the needle from under the skin, carefully place the outer protective cap on the needle of the syringe pen. |
| 15. Disconnect the needle by turning it counterclockwise and dispose of it properly. Attention! Strictly follow safety precautions to avoid accidental needlestick injury and possible transmission of infectious diseases. |
| 16. Close the syringe pen with the 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 sound and tactile signals:
— setting the required dose
When rotating the dose setting ring, a certain physical resistance is felt and clicks are heard as each dose unit is dialed.
- injection
The process of administering a drug from a BiomaticPen®2 syringe pen is accompanied by a sound signal (ratchet), which stops when the drug is completely introduced (to the value “0” in the dosage indicator window).
Rules for storage, use and disposal
The syringe pen is intended for individual use and cannot be used by several people.
Handle the BiomaticPen®2 syringe pen carefully.
Do not allow dust or moisture to get into the BiomaticPen®2 syringe pen.
After each use, close the syringe pen with the cap. Always keep the BiomaticPen®2 syringe pen in its individual packaging without a needle.
Store the BiomaticPen®2 syringe pen following the instructions for storing the medicinal product.
You can clean the BiomaticPen®2 syringe pen with a damp cloth. Do not use alcohol, solvents or other cleaning agents.
Never immerse the BiomaticPen®2 syringe pen in water, as this may damage it.
Warnings
Use the BiomaticPen®2 syringe pen only with pen-compatible needles recommended by your doctor.
Biosulin N should be used only as part of therapy prescribed by your doctor and in the dosage prescribed for you. Any changes should be made under the supervision of a physician.
If you have questions regarding needle length, consult your doctor or healthcare team.
Do not expose the BiomaticPen®2 syringe pen to extreme temperatures, do not leave it in direct sunlight or in the cold (for example, in the freezer). Keep the BiomaticPen®2 pen and pen needles out of the reach of children and others who are not familiar with proper handling techniques. In cases of unintentional administration of the drug or injury from a needle stick, you should immediately seek medical help!
Pen needles should only be used by one person to prevent the transmission of infectious diseases.
Use a new pen needle for each injection to ensure sterility. Remove the pen needle after injecting to prevent drug leakage, air ingress, and possible clogging of the pen needle. Dispose of used pen needles together with their protective cap, following the manufacturer's instructions, so that they do not cause harm to others.
Never use the BiomaticPen®2 syringe pen if you have any doubts about its correct operation.
Disposal rules
The BiomaticPen®2 syringe pen does not contain components that are hazardous to the environment and can be disposed of with normal household waste.
The used BiomaticPen®2 syringe pen should be disposed of only with the needle disconnected.
Table for converting the dosage indicator readings of the BiomaticPen®2 syringe pen into the dose of the drug Biosulin® N, suspension for subcutaneous administration 100 IU/ml:
| Dosage indicator indications | Dose of Biosulin® N, ME |
| 1. | 1. |
| 2. | 2. |
| 3. | 3. |
| 4. | 4. |
| 5. | 5. |
| 6. | 6. |
| 7. | 7. |
| 8. | 8. |
| 9. | 9. |
| 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. |
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Insulin Biosulin is human insulin , which is obtained using recombinant DNA . There are three types of bioinsulins : 30/40 (biphasic), medium-acting and short-acting soluble. All types of genetically engineered insulins interact with the cell membrane receptor and form a complex. It is he who stimulates intracellular processes and the synthesis of basic enzymes. A decrease in glucose content is associated with an increase in its absorption and assimilation.
Biosulin N has an average duration of action. Its action profile is subject to significant fluctuations even in the same person. With subcutaneous injection, the onset of action is observed after approximately 1-2 hours, after 5 and 12 hours the maximum effect is achieved, and the duration of action varies between 19-24 hours.
Biosulin R has a short action. When injected subcutaneously, it takes effect within 30 minutes, the maximum effect is within 2-4 hours, and the duration is 7-8 hours.
Pharmacokinetics
The onset of the effect of any insulin depends on the dose, site of administration, and concentration of the drug. Injected insulin is distributed unevenly throughout the tissues. Destroyed by insulinase in the kidneys and liver.
Barriers to insulin therapy and unmet needs: focus on hypoglycemia
Several barriers remain to the adoption of insulin and its optimal use in clinical practice, both at the patient and clinician level. The most common reasons for refusing to start insulin therapy in patients with type 2 diabetes are:
- fear of hypoglycemia,
- weight gain,
- discomfort associated with the need for regular blood tests,
- pain from injections,
- the opinion that insulin therapy is a complex and labor-intensive process.
Adherence to insulin therapy, however, is more influenced by factors such as health insurance structure and employment.
Fear of hypoglycemia not only influences the decision to initiate insulin therapy, but it may also compromise the adequacy of glycemic control.
It has been reported that most physicians would treat patients in a more aggressive manner without adequate glucose control if not for concerns about hypoglycemia.
Burden of hypoglycemia in patients with diabetes receiving insulin therapy
Hypoglycemia is a significant side effect of diabetes therapy, as it
- worsens the quality of life of patients.
Observational studies show that
- hypoglycemia occurs in 42.89 cases/patient-year with type 1 diabetes,
- 16.36 cases/patient-year in patients with type 2 diabetes receiving insulin therapy.
The incidence of severe hypoglycemia is approximately
- 1.15 cases/patient-year and can reach 3.2 cases/patient-year for type 1 diabetes;
- 0.7 cases/patient-year in patients with type 2 diabetes receiving insulin therapy.
Nocturnal hypoglycemia that occurs during sleep is especially dangerous because patients are unlikely to recognize the symptoms or wake up during the episode.
- The DCCT study reported that 43% and 55% of all hypoglycemic and severe hypoglycemic events, respectively, occurred during sleep.
- A large online survey conducted in the United States among 7,239 participants with type 2 diabetes (28.7% on insulin therapy) showed that hypoglycemia interfered with social activity,
- caused more absenteeism,
- decrease in overall labor productivity,
- negatively affected the overall quality of life.
- with losses ranging from U$ 15.26 to U$ 93.47
- 2108 respondents (32.8% with type 1 diabetes and 67.2% with type 2; 74.2% receiving insulin) reported that the frequency of hypoglycemic episodes significantly affected sleep and functional status the next day, 60.7% reported moderate to severe consequences .
- A longitudinal study of 16,667 older patients with type 2 diabetes (mean age 65 years; 35% receiving insulin) after 27 years showed an increased risk of dementia among patients with hypoglycemic episodes, with risk increasing as the number of hypoglycemic episodes increased.
The frequency of hypoglycemic episodes may lead patients to avoid taking medications, with significant reductions or even discontinuation of insulin doses after a hypoglycemic event, which negatively affects glycemic control.
Biosulin price, where to buy
You can buy Biosulin N at any pharmacy. The cost of 1 bottle of suspension 100 IU 10 ml is 500-510 rubles, 5 cartridges of 3 ml each can be purchased for 1046-1158 rubles.
- Online pharmacies in RussiaRussia
ZdravCity
- Biosulin n suspension.
for s/c input. 100 IU/ml 3ml No. 5 (cartridge + syringe pen) Pharmstandard-Ufavita Ufimsky vitamin plant OJSC RUB 1,406 order
Interaction
The effect of the drug is enhanced by: oral hypoglycemic agents, inhibitors of monoamine oxidase , carbonic anhydrase, angiotensin-converting enzyme , sulfonamides, non-selective beta-blockers , octreotide , bromocriptine , anabolic steroids, clofibrate , tetracyclines , ketoconazole , pyridoxine , cyclophosphamide , theophylline , hairdryer fluramine , lithium preparations, ethanol.
The effect of the drug is weakened by: glucocorticosteroids , oral contraceptives, heparin , thiazide diuretics, tricyclic antidepressants , danazol , clonidine , sympathomimetics, calcium channel blockers, morphine , phenytoin , diazoxide , nicotine . When using reserpine and salicylates, both a weakening and an increase in the effect are observed.
Overdose
Manifested by a hypoglycemic state: increased sweating, pallor, palpitations, hunger, tremor , paresthesia , agitation, headache . , hypoglycemic coma develops .
Treatment for mild hypoglycemia involves taking sugar, sweet tea, or carbohydrate foods (sweets, cookies, candy). In severe cases ( coma ), a 40% dextrose intravenously, and glucagon . After the patient regains consciousness, it is recommended to take carbohydrate foods.
Side effects
- increased sweating, pallor, headache , palpitations, hunger, tremor , paresthesia , agitation;
- hypoglycemic coma;
- Quincke's edema , skin rash, anaphylactic shock ;
- swelling;
- refractive errors;
- hyperemia at the injection site, lipodystrophy (with long-term use).
Reviews about Biosulin
The drug of choice in the treatment of patients with diabetes is genetically engineered human insulin, which is identical in chemical structure to human insulin. According to the International Diabetes Federation, these are the only insulins used throughout the world. Their advantage is their effectiveness and safety, and therefore the Ministry of Health of the Russian Federation recommends their use for the treatment of adolescents, children and pregnant women. The results of studies of such drugs showed that the content of liver enzymes, lipids, residual nitrogen, creatinine and urea remained within normal limits during their use. No one had any allergic reactions.
Another advantage (this applies to the long-acting drug) is that the protein protamine (the so-called NPH insulin ) is used as a prolongator, rather than zinc. NPH insulins can be mixed with short-acting drugs in the same syringe and this will not lead to a change in pharmacokinetics. Despite all the advantages, there are negative reviews and many patients prefer imported drugs ( Humalog , NovoRapid ).
- “... I’ve been injecting him for several months now. Everything is fine, but I think that there is nothing better than Humalog.”
- “... Grandmother on Biosuline. It’s possible to compensate for the sugar, but the vision decreases and the diabetic foot.”
- “... I’ve been on it for several days. Issued at the clinic. It got worse - sugar levels are over 20! Does not help!".
- “...Personally, Biosulin N does not help me, but Biosulin R works well.”
