Gensulin R

Gensulin R

Manufacturer:

SciGen

Distributor:

Cosma Medical
Full Prescribing Info
Contents
Human insulin (soluble, recombinant DNA origin).
Description
Active substance of Gensulin preparation is human recombinant Insulin (100 IU/mL).
All GENSULIN preparations contain adequate amount of water for injections, water is the solvent and basis of the preparations.
pH of all the insulin preparations is 7.0-7.6.
Each injection contains 100 IU/mL of human recombinant insulin.
Action
Pharmacology: 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 resolved in the digestive tract and therefore the insulin preparations are administered in injections.
Human insulin preparations GENSULIN come in the following forms: Solution-GENSULIN R, its therapeutic action starts within 30 minutes and it reaches maximum effect 1-3 hours after the administration; the hypoglycaemic effect of the preparations continues up to 8 hours and depends on the administered dose.
Isophane suspension, GENSULIN N; its therapeutic action starts within 1 hour after the administration, reaches its maximum effect between 3rd and 10th hour (according to the dose) and continuous up to 24 hours.
Diphasic isophane suspensions-mixtures GENSULIN M10, M20, M30, M40, M50 that therapeutic action starts within 30 minutes after administration, maximum effect-between 2nd and 8th hour and the hypoglycaemic effect continues up to 24 hours and depends on the administered dose.
In healthy humans about 5% of insulin is bound with blood proteins. Insulin was also detected in cerebro-spinal fluid where its concentration constituted around 25% of total insulin concentration in blood serum.
Insulin is metabolised in liver and kidneys. Some quantities of insulin are metabolised in muscles and fat tissue. Insulin is identically metabolised in healthy and diabetic humans. It is eliminated through kidneys. Minute quantities of insulin are eliminated with bile. The half-life of insulin is circa 4 minutes. Liver and kidneys impairment may delay insulin elimination.
In elderly patients insulin elimination is slower and its hypoglycaemic effect is prolonged.
Indications/Uses
Diabetes mellitus treatment in patients who require insulin.
Gestational diabetes mellitus.
Dosage/Direction for Use
There are many known and practised schemes of human insulin treatment. A physician must choose and individually adjust a treatment to a patient, according to the requirements. Basing on the insulin concentration in a patient's blood a physician adjusts, a proper insulin dose and an insulin preparation. The patient mustn't apply any other insulin preparation except the one recommended by the physician. The patient shouldn't mix a prescribed by physician insulin with another preparation if the physician did not recommend it. Before use, the patient should always check on the label the name and a code of the insulin in the vial 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.
Administration: MODE OF USE: GENSULIN preparations are for subcutaneous injection, and the preparation GENSULIN R can also be injected intravenously. Only in exceptional circumstances the GENSULIN preparations may be administered intramuscularly.
Gensulin R is generally administered 15-30 minutes before a meal.
Gensulin R: The solution should be colourless and transparent. It should be water-like in the look and consistency. The patient shouldn't apply the preparation if the solution is clouded, seems dense and coloured.
Administration of GENSULIN preparations with syringes: Only especially designed syringes with insulin concentration marked on them can be used for insulin administration. When the patient is lacking disposable syringes and needles, the patient may apply multiple use ones but must sterilize them each time before the injection. It is recommended to use syringes of one type by the same producer. The patient must always check if a syringe has been graduated in accordance with the applied concentration of the insulin preparation.
Mode of preparation: Remove the safety tear-off lid on the vial.
Rub the vial plug with alcohol solution. Do not take it out.
Take into the syringe equal to the administered insulin volume of air.
Inject the air into the vial by puncturing the gum plug of the vial with the needle.
Turn the vial with the syringe upside down.
Make sure the point of the needle is in the insulin.
Withdraw into the syringe proper amount of insulin solution. Remove the air bubbles from the syringe by pumping them back into the vial.
Double check the recommended dose and take the needle out of the vial.
Disinfect the injection site on the skin.
With one hand stabilise the skin by pulling it or by pinching a large skin surface in order to form a skin crease.
Take the syringe in the other hand and hold it like a pencil. Shoot the needle straight into the skin (90° angle). Make sure the needle is properly shot and placed in the fat layer under the skin and not in the deeper layers of the skin (in very thin people it may be necessary to shoot the needle on the different from the square angle).
In order to inject insulin the patient must push the piston to the very end of the syringe within less than 5 seconds.
Hold the alcohol damped cotton close to the needle and take the needle out from the skin. Press the cotton for a few seconds on the injection site. Do not rub it.
It is recommended to change the puncture site with each injection in order to avoid tissue damages. The succeeding puncture site should be at least 1-2 cm away from the previous one.
MIXING GENSULIN R SOLUTION WITH GENSULIN N SUSPENSION OR MIXTURES (M10, M20, M30, M40, M50): Only the physician can decide about mixing Gensulin R with the suspension or mixtures. When preparing a mixture, the patient should always introduce a short time-effect insulin first into a syringe, that is Gensulin R. The patient should carry out the injection in the same way as described above.
INSULIN IN CARTRIDGES: Some Gensulin preparations are produced in cartridges which may be applied with multiple-use pen injectors.
In order to operate the injector (load the cartridge, insert the needle, carry out the injection) the patient must strictly observe the producer's instructions.
The patient should not use injectors by different procedures. In emergencies the patient may use the cartridge insulin in a normal insulin syringe and proceed as described above (in accordance with the insulin concentration and dose).
Overdosage
When the patient overdose insulin hypoglycaemia symptoms arrive which include: Intense hunger, anxiety, apathy, trembling, sweating, vomiting. In mild hypoglycaemia it is enough to have sweet beverages or carbohydrate-rich food. It is advisable to rest. The patients should carry with them sugar cubes, glucose or sweets. It is not advisable to have chocolate that contains fat, which delay glucose absorption. Severe hypoglycaemia may lead to convulsions and loss of consciousness, or death. If a patient is in coma it is necessary to administrate glucose into the vein.
When it comes to overdose of insulin hypoglycaemia may develop with hypokalaemia (a drop in potassium concentration in blood) with the succeeding myopathy.
Contraindications
Hypoglycaemia.
Hypersensitivity to insulin or any of its excipients.
Special Precautions
Only a physician can change an insulin dose or recommend to mix insulin preparations or to exchange one preparation for another.
Patients should inform a physician if they developed any earlier manifestations of allergy to any insulin preparations, as well as other drugs, food, preservatives or dyes.
In patients who developed generalised reaction to insulin skin tests should be conducted before the commencement of treatment with a new preparation.
During the insulin treatment glucose concentration in serum and urine, glycated haemoglobulin (HbA1) and fructosamine concentrations in blood should be monitored.
Patients should learn how to check themselves their glucose concentration in urine and blood by using simple tests (e.g. stripe tests). In case it is not accurate they should promptly notify their physician.
In different patients symptoms of a drop of glucose concentration in blood (hypoglycaemia) may occur at different times with different strength. Patients then should learn how lo recognise the characteristic for them hypoglycaemia symptoms. If such symptoms occur frequently, even with mild intensity, they should contact their physician 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 hypoglycaemia). Some patients may not feel the early hypoglycaemia symptoms after the human insulin administration as intensely as after animal insulin.
Also in patients with long-lasting diabetes or diabetic neuropathy, or ones who parallely apply β-adrenolytical drugs and reached to balance their glucose level in blood, the early signs of hypoglycaemia may also be weaker. Both hyperglycaemia and hypoglycaemia when not treated may lead to loss of consciousness, coma or death.
Patients should regularly visit their physicians, mostly at the commencement of insulin treatment.
It is very important to keep to regular and dietetic meals.
The need of insulin lowers with a bigger physical effort; a more intense exercise of the muscle that insulin has been injected in accelerates the hypoglycaemia development (e.g. insulin injection into a thigh before a run).
Patients who intend to change at least two time zones should consult a physician to change the timing of insulin administration. During a flight insulin should be storaged in a hand-baggage not in a baggage hatch (insulin can't get frozen).
The need of insulin may be altered by: High fever, severe infection (it may considerably increase the insulin need), emotional stress, sicknesses and disturbances of digestive tract with nausea, vomit, diarrhoea, low stomach discharge, absorption disturbances. Such conditions always require a consultation with a physician. Glucose concentration in blood and urine should be then frequently controlled, and if the results are not correct, it is absolutely obligatory to consult a physician. The recommended doses of insulin and regular meals should be observed. Even medicines 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 physician.
With kidneys failure the insulin elimination is reduced and its action lime is longer.
Patients with diabetes due to pancreas diseases or diabetes that co-exists with Addison's disease require very small doses of insulin.
In pituitary, adrenal or thyroid gland disturbances the organism requirements of insulin may alter.
Long-term insulin taking may generate an insulin resistance effect (see Adverse Reactions); in case insulin resistance effect occurs bigger doses of insulin should be administered.
Effect on the Ability of Driving and Operating Machinery: The influence of correct insulin doses administration on the ability of driving vehicles has not been examined. It may be handicapped by hyperglycaemia that causes disturbances of the central nervous system with the following symptoms: Headaches, anxiety, double seeing, disorders of association and distance evaluation. At the commencement of insulin treatment, change of insulin preparation, during the stress or excessive physical effort-when considerable differences of glucose concentration in blood occur, disorders in ability of driving and operating machinery may happen.
It is recommended to control the glucose concentration in blood during long journeys.
Use In Pregnancy & Lactation
Pregnancy: In diabetic women requires insulin application. The accurate glucose level maintenance in pregnancy is extremely important as hyperglycaemia in pregnant women may badly harm the fetus. 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 trimesters, generally by 75% of the before pregnancy dose.
Just after delivery the insulin requirement rapidly falls again.
Lactation: It is acceptable to breast-feed during the insulin treatment, considering this hormone is resolved in the digestive tract. During lactation period the need of insulin is lower than before pregnancy and it gets equalised to the original level after 6-9 months.
Adverse Reactions
All signs that worry a patient should be reported to a physician. If severe hypoglycaemia or hyperglycaemia and ketoacidosis symptoms occur, an immediate medical help is necessary.
The most frequent adverse effects in insulin treatment include: Hypoglycaemia (drop in glucose concentration in blood).
Symptoms of hypoglycaemia are: Over-sweating, dizziness, trembling, sensation of hunger, anxiety, tingling sensation in hands, feet and lips or tongue, concentration disturbances, sleepiness, sleep disturbances, loss of self-control, mydriasis, visual disorders, speech disturbances, depression, irritability. Symptoms of acute hypoglycaemia are: Disorientation, unconsciousness, convulsions.
Hyperglycaemia (increase of glucose concentration in blood): In patients suffering from type one diabetes prolonged hyperglycaemia 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 lypodystrophy (atrophy or over-growth of fat tissue in the area of puncture), allergy to insulin, insulin resistance.
Drug Interactions
GENSULIN preparations should not be mixed with animal insulin and biosynthetic insulin produced by other manufacturers. Many frequently used drugs (for example some antihypertensive drugs, cardiac drugs, drugs lowering the level of lipids in serum, thyroid replacement drugs, epilepsy treatment drugs, salicylates, antibacterial drugs, orally taken contraceptives) may affect the insulin action and the efficiency of insulin therapy.
Therefore patients should always inform their physician about constantly or temporally taken drugs. They should ask for advice a doctor or a pharmacist about over-the-counter available drugs. A drug that has never been taken before should always be consulted with a physician. A physician's patients are consulting for other than diabetes reason should always be informed about the insulin therapy.
Drugs and substances strengthening insulin action: Beta-blockers, chloroquine, ACE inhibitors, MAO inhibitors (antidepressants), methyldopa, clonidine, pentamidine, salicylates, anabolic steroids, cyclophosphamide, sulphonamide antibiotics, tetracyclines, antibacterial quinolones and ethyl alcohol.
Drugs reducing insulin action: Diltiazem, dobutamine, estrogens (also orally taken contraceptive pills), phenothiazine, phenytoine, thyroid hormones, heparin, calcitonin, corticosteroids, antiviral drugs applied in HIV infections, niacin, and diuretic thiazides.
Storage
Gensulin preparations can be stored for two years in the temperature 2-8°C. Do not freeze them. Once the vials have been open the preparations can be stored for 28 days in the temperature up to 25°C. Insulin should not be used after the expiry date.
Gensulin preparations must be protected from light.
ATC Classification
A10AB01 - insulin (human) ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Inj (vial) 100 IU/mL x 10 mL. Inj (cartridge) 100 IU/mL x 3 mL x 5's.
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