Aktrapid HM

Aktrapid HM – insulin human short action.

Form of release and structure

Dosage form – solution for injections: colourless, transparent liquid (in glass bottles on 10 ml, in a pack a cardboard 1 bottle).

Contains in 1 ml of solution:

• Active ingredient: insulin soluble (human genetically engineered) – 100 IU (international units) that corresponds to 3,5 mg of anhydrous human insulin;
• Additional components: water for injections, metacresol, глицерол, zinc chloride, Acidum hydrochloricum and/or sodium hydroxide.

Indications to use

Aktrapid HM – drug for treatment of a diabetes mellitus, including the medical emergencies which are followed by disturbance of glycemic control.

Contraindications

• Hypoglycemia;
• Hypersensitivity to any component of drug.

Route of administration and dosage

Aktrapid NM enter intravenously (in/in) or subcutaneously (п / to) in 30 min. prior to food or reception of the light meal containing carbohydrates.

The doctor selects a daily dose of drug individually depending on needs of the patient, usually it varies within 0,3-1 ME/kg. The daily need for insulin can be lower at patients with residual endogenous products of insulin and above – at patients with insulin resistance (for example, at obesity or during puberty).

To patients with renal failures or a liver the dose Aktrapida NM is reduced.

After achievement of optimum control of a glycemia of a complication of a diabetes mellitus are usually shown later therefore it is necessary to aim to optimize metabolic control, in particular, carefully tracing glucose level in blood.

If necessary Aktrapid NM can be appointed in a combination with insulin of the prolonged action.

Intravenously only the medical specialist has to administer the drug. For this purpose use the infusional systems containing human insulin in concentration of 0,05-1 ME/ml in such infusion solutions, as sodium chloride of 0,9%, Dextrosums of 5% and 10% including potassium chloride in concentration of 40 mmol/l. In system for intravenous administration use polypropylene infusional bags. In the course of infusion it is necessary to control glucose level in blood.

Subcutaneously means is entered usually into the area of a front abdominal wall, it is also possible to do injections in a rump, area of a hip or deltoid muscle of a shoulder. In the first case more bystry absorption in comparison with other injection sites is reached.

Administration of drug pleated of skin reduces risk of hit of solution in a muscle.

To prevent development of lipodystrophies, it is recommended to alternate places of injections within anatomic area.

It is necessary to administer the drug п / to only by means of insulin syringes on which the scale for dosage measurement in terms of action is applied. Bottles are intended for individual use.

Before introduction Aktrapida NM it is necessary to check the label to be convinced of a right choice like insulin, and also to disinfect a rubber stopper by means of a cotton plug.

It is forbidden to apply Aktrapid NM in the following cases:

• Transparency loss, solution discoloration;
• Storage without observance of the specified conditions, solution freezing;
• Use in insulin pumps;
• Lack of a protective cover of a bottle or its leaky corking.

The equipment of an injection when using only Aktrapida NM:

1. To gather in the syringe air in the quantity corresponding to a necessary dose of insulin;
2. To enter air into a bottle with drug, for this purpose to puncture with a needle a rubber stopper and to press the piston;
3. To turn a bottle upside down;
4. To gather the necessary dose of insulin in the syringe;
5. To take out a needle from a bottle;
6. To remove air from the syringe;
7. To check correctness of the gathered drug dose;
8. At once to make an injection.

The equipment of an injection when using Aktrapida NM in a combination with insulin of long action:

1. To take for a drive a bottle with the insulin of long action (ILA) between palms until solution becomes evenly muddy and white;
2. To gather in the syringe in air in the quantity corresponding to IDD dose, to enter it into the corresponding bottle and to take out a needle;
3. To gather in the syringe air in the quantity corresponding to a dose Aktrapida NM and to enter air into the corresponding bottle;
4. Without taking out the syringe, to turn a bottle upside down and to gather the necessary dose Aktrapida NM, to take out a needle and to remove air from the syringe, to check correctness of the gathered dose;
5. To enter a needle into a bottle with IDD;
6. To turn a bottle upside down and to gather the necessary dose of IDD;
7. To remove a needle from a bottle and air from the syringe, to check correctness of the gathered dose;
8. At once to make an injection of the gathered mix of insulin short and
   long action.

Insulin of short and long action always should be gathered in the sequence described above.

Rules of administration of drug:

1. Two fingers to take a skin fold;
2. To enter a needle into the fold basis at an angle approximately 45º and to enter insulin under skin;
3. Within 6 seconds not to take out a needle to be convinced of full introduction of a dose.

Side effects

The most frequent side effect of drug is the hypoglycemia which develops when the insulin dose considerably exceeds need of the patient for it. At a heavy hypoglycemia there can be spasms and/or a loss of consciousness, dysfunction of a brain and even death is possible.

Other possible undesirable reactions:

• From immune system: infrequently (> 1/1000, <1/100) – rash, urticaria; very seldom (<1/10000, including separate spontaneous cases) – anaphylactic reactions, the generalized hypersensitivity posing a threat for the patient's life (generalized skin rash, perspiration, an itch, a Quincke's disease, disturbances from bodies of digestive tract, a lowering of arterial pressure, tachycardia, a syncope/loss of consciousness);
• From a nervous system: very seldom – peripheral neuropathy;
• From an organ of sight: infrequently – disturbances of a refraction (usually arise in an initiation of treatment and have, as a rule, reversible character); very seldom – a diabetic retinopathy;
• From hypodermic fabrics and skin: infrequently – a lipodystrophy in the place of an injection (in those cases if the drug is constantly administered to the same area);
• Local reactions in the place of an injection: a swelling, erubescence, morbidity, an itch, formation of a hematoma (these reactions usually have passing character and disappear at therapy continuation).

Special instructions

In case of incorrectly picked up dose or at drug withdrawal there is a risk of development of a hyperglycemia, especially at patients with a diabetes mellitus of the I type. The first symptoms of this complication are usually shown gradually, within several hours or days: nausea, the expressed drowsiness, dryness in a mouth, vomiting, the dry and reddened skin, appetite loss, thirst, an acetone smell from a mouth, the increased release of urine.

If not to treat a hyperglycemia at patients with a diabetes mellitus of the I type, development of life-threatening diabetic ketoacidosis is possible. At considerable improvement of glycemic control (for example, due to the intensified insulin therapy) usual symptoms harbingers of a hypoglycemia can change what it is necessary to warn patients about. It is necessary to consider that harbingers of a hypoglycemia can become less expressed at patients who are transferred from one type of insulin on another.

Patients who plan a travel with crossing of time zones should consult with the doctor concerning the scheme of use Aktrapida NM as they should change time of meal and administration of drug.

In case of change of a type of insulin (human, animal or an analog of human), its type, biological activity, the company manufacturer and/or a method of production change of the mode of a drug dosing can be required. For this reason transfer of patients into other type of insulin or insulin made by other pharmacological company has to be carried out under careful control of the doctor.

In need of correction of a dose it is possible to make it both at introduction of the first dose, and in the first weeks/months of therapy.

The need for insulin usually increases at patients with associated diseases, especially with feverish states and infections.

At the admission of food or an unplanned heavy exercise stress the hypoglycemia can develop.

Aktrapid NM it is forbidden to use for the long hypodermic insulin infusions (LHII) in insulin pumps as it is impossible to foretell what amount of insulin is absorbed by infusional system.

The metacresol which is a part of drug can cause allergic reactions.

Insulin does not get through a placental barrier therefore there are no restrictions on its use during pregnancy. Bol of, if at the pregnant woman not to treat a diabetes mellitus, there is a danger to a fruit. Considering it, therapy of a disease during pregnancy should be continued. However the women including planning pregnancy have to be under constant medical observation with more strengthened control of level of glucose in blood as the hyperglycemia and a hypoglycemia which can develop at incorrectly picked up insulin dose increase risk of formation of malformations of a fruit and its pre-natal death. At the same time it is necessary to consider that in the I trimester of pregnancy the need for insulin usually decreases, and in II and III – gradually increases. After the delivery the need for insulin quickly is returned to that level which was before pregnancy.

Similarly there are no restrictions to use Aktrapida NM during breastfeeding as drug does not constitute danger to the child. However dose adjustment of insulin and/or a diet can be required by the woman.

The hyperglycemia and hypoglycemia can break the speed of reactions, and ability of the patient with a diabetes mellitus to concentration of attention that is dangerous in cases when these reactions are necessary, for example, during the driving of the car or work with mechanisms. Patients should recommend to undertake measures for the prevention of development of a hyperglycemia/hypoglycemia. It is especially important for the people suffering from frequent episodes of a hypoglycemia at which are absent or symptoms harbingers of the developing hypoglycemia are expressed slightly. In these cases expediency of performance of potentially dangerous types of activity is estimated.

Medicinal interaction

Hypoglycemic effect of insulin angiotensin-converting enzyme inhibitors, monoamine oxidase inhibitors, anabolic steroids, non-selective beta adrenoblockers, karboangidraza inhibitors, lithium drugs, peroral hypoglycemic drugs, tetracyclines, sulfonamides, cyclophosphamide, theophylline, фенфлурамин, кетоконазол strengthen, Clofibratum, Mebendazolum, Bromocriptinum, a pyridoxine, the drugs containing ethanol.

Hypoglycemic effect of insulin thyroid hormones, oral contraceptives, tricyclic antidepressants, blockers of calcium channels, sympathomimetics, thiazide diuretics, glucocorticosteroids, morphine, diazoxide, Phenytoinum, даназол weaken, heparin, a clonidine, nicotine.

Salicylates, Reserpinum, ланреотид, октреотид can both weaken, and to strengthen action Aktrapida NM.

At the same time applied beta adrenoblockers can mask symptoms of a hypoglycemia and complicate its elimination.

Alcohol can strengthen and extend hypoglycemic action Aktrapida NM.

Some drugs (for example, the containing sulfites or thiols) at addition to solution of insulin can cause its degradation therefore Aktrapid NM it is possible to combine only with those medicines with which it as it is authentically established, we will combine.

Terms and storage conditions

To store in the unavailable to children, protected from impact of a sunlight and heat place, in a cardboard pack at a temperature of 2-8 ºС (in the refrigerator, it is not too close to the freezer). Not to freeze.

Period of validity – 30 months.

The opened bottle can be stored within 6 weeks at a temperature up to 25 ºС, in a cardboard pack (for protection against light). It is not recommended to store the opened bottle in the refrigerator.

The prepared solution for intravenous administration keeps stability within 24 hours at the room temperature.