Lupinsulin 30:70

All Recombinant Human Insulin 70% Isophane Insulin 30% Soluble Insulin (Lupinsulin 30:70) preparations contains adequate amount of water for injection, water is the solvent and basis of the preparations. pH of all the insulin preparations is 6.9-7.8.

Pharmacology: Pharmacokinetics: Absorption and Fate: Insulin has no hypoglycemic effect when administered by mouth since it is inactivated in the gastrointestinal tract.
It is fairly, rapidly absorbed from SC tissue following injection and although the t_½ in blood is very short (being only a matter of minutes), the duration of action of most preparations is considerably longer due to their formulation. The rate of absorption from different anatomical sites may be different and may also be increased by exercise. The absorption of insulin after IM administration is more rapid than that following SC administration. Human insulin may be absorbed slightly faster from SC tissue than porcine or bovine insulin.
Resistant to Insulin: The term insulin resistance has traditionally been used to describe a state which the diabetic patient exhibits considerably increased insulin requirements. It is now used in a much wider sense and in for instance, also applied to patients in whom a subnormal biological response to insulin can be demonstrated, although many of these patients do not apparently present difficulties in their clinical management.
Insulin is a hormone produced in the specialized pancreas cells. It participates in carbohydrates, fat and protein metabolism, causing among others, glucose lowering in blood serum. Insulin deficiency in organism causes diabetes. The injected insulin acts identically as the organism produced hormone.
The administered orally insulin is totally inactivated in the digestive tract and therefore the insulin preparations are administered in injections. Human insulin preparation Lupinsulin come in the following forms: Lupinsulin (plain clear solution), its therapeutic action starts within 30 minutes after administration and it reaches maximum effect 1-3 hours after the administration; the hypoglycemic effect of the preparations continues up to 8 hours and depends on the administered dose.
Milky white - Biphasic isophane suspension: mixture of Lupinsulin that therapeutic action starts within 30 minutes after administration, maximum effect between 2^nd and 8^th hour and the hypoglycemic effect continues up to 24 hours and depends on the administered dose.
In the healthy human about 5% of insulin is bound with blood proteins. Insulin was also detected in cerebrospinal fluid where its concentration constituted around 25% of total insulin concentration in the blood. Insulin is metabolized in liver and kidney. Some quantities of insulin are metabolized in muscle and fat tissue. Insulin is identically metabolized in healthy and diabetic humans. It is eliminated through kidneys. Minute quantities of insulin are eliminated with bile. The half-life of insulin is 4 minutes. Liver and kidneys sicknesses may delay insulin elimination. In elderly patients insulin elimination is slower and its hypoglycemic effect is prolonged.

Diabetes mellitus treatment in patients who require insulin.

There are many known and practiced schemes of human insulin treatment. A doctor must choose and individually adjust a treatment to a patient, according to his requirements. Basing on the insulin concentration in a patient blood a doctor adjust a proper insulin dose and an insulin preparation. Patient must not apply any other insulin preparation except the one recommended by the doctor. The patient should not mix a prescribed by the doctor, insulin with another preparation if the doctor did not recommended it.
Before use, the patient should always check on the label the name and the a code of the insulin in the cartridge and make sure it is identical with the prescribed one. The patient should check the expiry date on the container. Do not apply after the expiry date.
Mode of Use: Lupinsulin preparations are for subcutaneous injection, and the preparation Lupinsulin can also be injected intravenously. Only in exceptional circumstances the Lupinsulin preparations may be administered intramuscularly. Lupinsulin is administered 15-30 minutes before a meal. During the preparation administration general hygiene rules should be observed: hands must be washed before the procedure and the injection site must be disinfected before administration.
Before the administration the cartridge containing insulin must be carefully watched.
Lupinsulin: The solution should be colorless and transparent. It should be water-like in the look and consistency. The patient should not apply the preparation, if the solution is cloudy, seems dense and/or colored. Suspension and mixture should be homogeneously opaque (Uniformly cloudy and milky). The cartridge should not be used it after mixing contain of both remains clear or there is a film of white substance on the bottom, there are white clusters floating, or solid, white particles remain stick to the walls making the preparation look frozen. The patient must especially careful not to introduce insulin in to a blood vessel during the injection.
Mixing Lupinsulin Solution with Suspension or Mixtures: Only the doctor can decide about mixing Lupinsulin with the suspension or mixtures. When preparing a mixture the patient should always introduce a short-time-effect insulin first into syringes. That is Lupinsulin. The patient should carry out the injection in the same way as described previously.
Insulin in Cartridges: Some Lupinsulin preparations are produced in cartridges which may be applied with multiple uses, pen injectors. In order to operate the injector (load the cartridge, insert the needle, carry out the injection) the patient must strictly observe the producers and follow the instructions. Suspension of Lupinsulin 30:70 should be mixed before every injection by mean of rotating up and down 10 times or rolling between both palms until homogeneous suspension appears. Rotation/Rolling should be continued until homogeneous cloudy or milky suspension appears. Content of cartridge can be mixed & fixed into pen. In emergency, the patient may use the cartridge insulin in a normal insulin syringe and proceed as explained by the doctor. (In accordance with the insulin concentration and dose).

When the patient overdose insulin, hypoglycemic symptoms arrive which include: Intense hunger, anxiety, apathy, trembling, sweating, vomiting. In mild hypoglycemia it is enough to have sweet beverages or carbohydrate-rich food. It is advisable to rest. The patient should carry with them sugar cubes, glucose or sweets. It is not advisable to have chocolate that contains fat, which delay glucose absorption. Severe hypoglycemia may lead to convulsion and loss of consciousness, or death. If a patient is in coma it is necessary to administer glucose into the vein. When it comes to overdose of insulin hypoglycemia may develop with hypokaelamia (a drop in potassium concentration in blood) with the succeeding myopathy. In acute hypoglycemia when patients are not able to take food they should be administered 1 mg of glycogen into the muscle and/or glucose intravenously.

Hypoglycemia. Hypersensitivity to insulin or any of its excipients.

Only a doctor can change an insulin dose or recommend to mix insulin preparations or to exchange one preparation for another.
Patient should inform a doctor if they develop any early manifestations of allergy to any insulin preparations, as well as other drugs, food, preservatives or dyes.
In patients who developed generalized reaction to insulin skin test should be conducted before the commencement of treatment with a new preparation.
During the insulin treatment glucose, HbA1 and fructosamine concentration in the blood serum and urine should be monitored.
Patients should learn how to check themselves their glucose concentration in urine and blood by using simple tests (e.g. Strip tests). In case it is not accurate they should promptly notify their doctor.
In different patients symptoms of a drop of glucose concentration in blood (hypoglycemia) may occur at different times with different strength. Patients then should learn how to recognize the characteristic for them hypoglycemic symptoms. If such symptoms occurs frequently, even with mild intensity, the patient should contact his/her doctor in order to change the insulin dose or diet.
Patients who change the animal insulin for human insulin may require a smaller dose of insulin (possibility of hypoglycemia). Some patients may not feel the early hypoglycemia symptoms after the human insulin administration as intensely as the animal insulin.
Also in patients with long lasting diabetes or diabetic neuropathy, or one who parallelly apply beta adrenolytical drugs and reached to balance their glucose level in blood, the early signs of hypoglycemia may also be weaker. Both hyperglycemia and hypoglycemia when not treated may lead to loss of consciousness, coma or death.
It is very important to keep to regular and diabetic meals.
The need of insulin lowers with a bigger physical effort; a more intensive exercise of the muscle insulin has been injected in intensive exercise of the muscle insulin has been injected in precipitates the hypoglycemia development (e.g. insulin injection in to a thigh before a run).
Patients who intend to change at least two time zones should consult a doctor to change the timing of insulin administration. During a flight insulin should be storage in hand-baggage not in the baggage hatch (insulin can get frozen).
The need for insulin may be altered by: high fever, severe infection (it may considerably increase the insulin need), emotional stress, sicknesses and disturbance of digestive tract with nausea, vomits, diarrhoea, low stomach discharge, absorption disturbances. Such conditions always require a consultation with a doctor. Glucose and if the results are correct, it is absolutely obligatory to consult a doctor. Recommended doses of insulin and regular meals should be observed.
Even medicine available over-the-counter (cold, fever, pain relief, appetite-reducing medicines) may alter the insulin need, therefore each time their application should be consulted with a doctor.
With kidneys failure the insulin elimination is reduced and its action time is longer.
Patients with diabetes due to pancreas sickness or diabetes that co-exist with Addison's sickness require very small doses of insulin.
In pituitary gland, suprarenal gland or thyroid gland disturbances the organism requirements of the insulin may alter.
Long-term insulin taking may generate an insulin resistance effect (see Adverse Reactions); in case insulin resistance effect occurs higher doses of insulin should be administered.
Effect on the ability of driving and operating machinery: The influence of the correct insulin dose administration on the ability of driving vehicle has not been examined. It may be handicapped by hyperglycemia that caused disturbances of the central nervous system with following symptoms: headaches, anxiety, double seeing, disorder of associations and distance evaluation. At the commencement of insulin treatment, change of insulin preparation, during stress or excessive physical effort-when considerable differences of glucose concentration in blood occur, disorder in ability of driving and operating machinery may happen. It is recommended to control the glucose concentration in blood during long journeys.

Pregnancy: Pregnancy in diabetic women requires insulin application. The accurate glucose level maintenance in pregnancy is extremely important as hyperglycemia in pregnant women may badly harm the foetus. In the first trimester of pregnancy the insulin requirement rapidly falls and it is necessary to reduce the insulin dose, which further on gradually growths in the second and third trimester, generally by 75% of the before pregnancy dose. Just after delivery the insulin requirement rapidly falls again.
There is no restriction on treatment of diabetes with insulin during pregnancy as insulin does not pass the placental barrier.
Breast-feeding: There is no reaction on treatment of diabetic with insulin during pregnancy, or insulin does not pass the placental barrier.
It is acceptable to breast-feed during the insulin treatment, considering this hormone is inactivated in the digestive tract. During lactation period the need of insulin is lower than before pregnancy and it gets equalized to the original level after 6-9 months.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Human insulin may cause hypoglycaemia (low blood sugar). The symptoms of low blood sugar include the following: tiredness, rapid heartbeat, nervousness or shakiness, feeling sick, headache, cold sweat.
Do not use Lupinsulin 30:70 if the patient thinks hypoglycaemia (low blood sugar) is starting. If the blood sugar is low, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as the doctor has advised the patient and have some rest.
This will often get the patient over mild hypoglycaemia or a minor insulin overdose. If the patient gets worse and the breathing is shallow and the skin gets pale, tell the doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If the patient does not respond to glucagon, he/she will have to go to hospital. Ask the doctor to tell the patient about glucagon.
Alcohol and some medicines can affect blood sugar levels.
Hyperglycaemia and diabetic ketoacidosis.
Hyperglycaemia (too much sugar in the blood) means that the body does not have enough insulin.
Hyperglycaemia can lead to diabetic ketoacidosis.
The symptoms include the following: feeling sleepy, no appetite, flushed face, fruity smell on the breath, thirst, feeling or being sick.
Severe symptoms are heavy breathing and a rapid pulse.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death.
The following additional adverse reactions have been identified: Systemic allergy is very rare. The symptoms are as follows: fall in blood pressure, rash over whole body, difficulty in breathing, wheezing, fast heart beat, sweating.
Local allergy is common. Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. Lipodystrophy (thickening or pitting of the skin) is uncommon.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of blood glucose.
The most frequent adverse effects in insulin treatment include: Hypoglycemia (drop in glucose concentration in blood).
Symptoms of hyperglycemia are: over sweating, dizziness, trembling, sensation of hunger, anxiety, tingling sensation in hand, feet and lips or tongue, concentration disturbances, sleepiness, sleep disturbances, loss of self control, mydriasis, visual disorder, speech disturbances, depression, impaired reaction.
Hyperglycemia (increase of glucose concentration in blood) in patients suffering from Type 1 diabetes prolonged hyperglycemia leads to ketoacidosis and diabetes coma, which is life-threatening. First ketoacidosis symptoms that gradually appear within hours, or even days, are sleepiness, reddening of the face, thirst, loss of appetite, acetone like smell of the breathed out by the ill air, increased amount of glucose and ketone bodies, fast breath and heart beat. Other adverse events that occasionally occur during biosynthetic insulin treatments are: post-insulin lipodystrophy (atrophy or over growth of fat tissue in the area of puncture), allergy to insulin, insulin resistance.

Lupinsulin preparations should not be mixed with animal insulin and biosynthetic insulin by other manufacturers. Many frequently used drugs (e.g. some blood pressure lowering drugs, cardiac drugs, drugs lowering the level of lipid in serum, thyroid treatment drugs, some contraceptives, epilepsy treatment drugs, salicylates, antibacterial drugs, orally taken contraceptives) may affect the insulin action and the efficiency of the insulin therapy. Therefore patients should always inform their doctors about constantly or temporarily taken drugs. They should ask for advice a doctor or pharmacist about the over-the-counter available drugs. A drug that has never been taken before should always be consulted with a doctor. A doctor to whom patients are consulting for other than diabetes reason, should always be informed about the insulin therapy.
Drugs and substances strengthening insulin action: Beta-blocker drugs, Chloroquine, Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors), MOA inhibitors (Antidepressants), Methyldopa, Clonidine, Penthamidine, Salicylates, Anabolic Steroids, Cyclophosphamide, Sulphonamides, Tetracyclines, Antibacterials Quinolones and Ethyl alcohol.
Drugs reducing insulin action: Diltiazem, Dobutamine, Estrogens (also orally taken contraceptive pills), Phenothiazines, Phenytoins, Thyroid Hormones, Heparin, Calcitonin, Corticosteroids, Anti-viral drugs applied in HIV infection, Niacin, and Diuretic Thiazides.

Injection Technique: Correct Syringe: The dose of insulin is always expressed in international units (IU). Please study the markings made on the insulin syringe carefully and understand the calculation of the dose in mL. Make sure that only a syringe calibrated to 40 and/or 100 IU/mL. The volume of insulin to be injected depends upon the dose required by the patient. Use a syringe marked for the insulin. If proper syringe is not used, it may lead to an error in the dosage. These may cause serious problems eg, blood glucose may become too low or too high.
Sterilization of Insulin Syringes: Do not share the syringe or needle with anyone else. Reusable syringe and needles must be sterilized before each injection. Separate the syringe, plunger (piston) and needle. Place them in water in a covered container.
Bring the water to boiling and continue to boil for at least 5 min. Allow it to cool completely. Disposable syringe and needle are used only once and then discard.
Preparing the Dose and Injection: Wash hands with soap and water.
Insert the plunger into the syringe; fix the needle with a slight twist. Push the plunger in and out several times to remove all the water that might have remained inside. The syringe is ready for use. However, this step is not necessary while using a sterile disposable syringe and a needle. Gently rotate the insulin vials several times to ensure that the contents are properly mixed. Insulin should have a uniform milky appearance. Do not use the insulin if anything unusual is detected in the appearance of the vial.
When using a new vial, remove the plastic protective cap on the stopper. However, do not remove the stopper.
Wipe the top of the vial with a spirit swab immediately before drawing insulin into the syringe and allow it to dry.
If the physician has advised the patient to mix different types of insulin, ensure to follow the same sequence for drawing insulin from the vials every time. The insulin mixture should be prepared just prior to injection.
Pull the plunger down to the required mark and draw air into the syringe equivalent to the volume of insulin to be withdrawn for administration. Push the needle through the rubber stopper into the vial and inject the air into the vial. Please note that it will be difficult to draw insulin into the syringe unless an equal volume or at least ½ of the required volume of air is injected into the vial. Ensure that the tip of the needle is in insulin and then invert the vial along with the needle and the syringe and draw the required dose of insulin.
Pull the needle out of the insulin vial. If there are any air bubbles in the syringe, hold the syringe vertical with the needle on top and gently tap the syringe. It will make the air bubbles move towards the needle. Remove the air bubble by pushing the plunger slowly. Check that the correct dose of insulin has been drawn into the syringe.
Other Information: The vials of insulin zinc, isophane insulin human and insulin human + isophane insulin human preparations should look uniformly milky after mixing. Do not use if the white material remains at the bottom of the vial after mixing. If anything unusual is noticed in the appearance of the vial of insulin or noticed that the insulin requirements are changing frequently, consult the physician immediately.

Lupinsulin preparation can be stored for two years at temperatures between 2°C-8°C. Do not freeze. Once the cartridge is opened, the preparation can be stored for 28 days at 25°C. Insulin should not be used after the expiry date. Lupinsulin preparation must be protected from light.

Insulin Preparations

A10AD01 - insulin (human) ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.

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