Expiration date: 05/2025

The composition and form of issue:

Solution for subcutaneous and intravenous injection. 1 ml contains:

insulin aspart 100 U

1 IU corresponds to 0,035 mg salt-free anhydrous insulin aspart 

excipients: glycerin (glycerol) phenol metacresol zinc chloride sodium chloride sodium hydrogen phosphate dihydrate sodium hydroxide 2M or hydrochloric acid 2M for injection 

for 3 ml glass cartridges Penfill in blister packs of 5 cartridges in cardboard pack 1 blister.

Description pharmaceutical form:

Clear, colorless solution.

Feature:

Insulin aspart — insulin analogue of short action, obtained by biotechnology, in which the amino acid Proline in position B28 replaced by aspartic acid.

Pharmacological action:

The mechanism of the hypoglycemic action of insulin aspart is that the molecules contribute to the uptake of glucose by binding to insulin receptors on muscle and fat cells and simultaneously suppressing glucose production by the liver.

Pharmacokinetics:

The substitution of Proline at position B28 on the aspartic acid reduces the tendency of the molecules to the formation of hexamers, which is observed in a solution of regular insulin, and the drug is much faster absorbed from the subcutaneous fat than the solution of human insulin. The time to reach Cmax, on average, two times less than that of a solution of human insulin. Cmax achieved after 40 min, return to baseline within 4-6 h.

Description pharmacological action:

Novorapid Penfill starts to operate much faster than human insulin solution, and stronger lowers the level of glucose in the first 4 hours after a meal. Duration of action after p/to the introduction of shorter than the solution of human insulin. Effect develops through 10-20 minutes after s/to the introduction in the region of the abdominal wall, reaches its maximum after 1-3 hours and lasts 3-5 hours

Indications:

Diabetes.

Contraindications:

Hypersensitivity, hypoglycaemia.

Application of pregnancy and breast-feeding:

Experience of clinical application of the drug Novorapid Penfill in pregnancy is limited. Restrictions on the use of insulin aspart nursing mothers not, but you may need a dose adjustment.

Side effects:

Hypoglycemia, sometimes transient edema and refractive error, local allergic reactions (redness, swelling and itching at the injection site) in rare cases, generalized hypersensitivity reaction (potentially life threatening) may develop lipodystrophy at the injection site (if the patient is long does not change the injection site).

Drug interactions:

MAO inhibitors, nonselective beta-blockers, ACE inhibitors, salicylates, anabolic steroids, oral hypoglycemic agents, octreotide, sulfonamides, alcohol can reduce the need for insulin, oral contraceptives, corticosteroids, thyroid hormones, sympathomimetics and danazol is to increase the need for insulin.

Method of application and dose:

P/K, V/V. Novorapid Penfill has a more rapid onset and shorter duration of action than soluble human insulin. Due to the more rapid onset of action, Novorapid Penfill should be administered, generally before meals, and if you want to enter shortly after eating.

The dose is determined individually in each case, on the basis of the level of glucose in the blood. Usually Novorapid Penfill used in combination with drugs insulin average duration or long-acting, which is administered at least 1 time a day.

Usually the total daily insulin requirement is 0.5–1 U/kg of body weight. When the drug is administered before a meal, insulin requirements may be provided by the drug Novorapid Penfill 50-70%, the remaining need for insulin provided by insulin of the prolonged action.

Temperature of insulin must correspond to room. Novorapid Penfill is injected subcutaneously in the anterior abdominal wall, hip, shoulder or buttocks. Injection sites within the same area of the body need to be regularly changed.

As with any other insulin preparations, the duration of action of Novorapid Penfill is dependent on dose, site of injection, intensity of flow, temperature and level of physical activity.

Subcutaneous administration into the abdominal wall ensures a faster absorption than administration in other places. However, a more rapid onset of action compared to soluble human insulin is maintained regardless of the location of the injection site.

If necessary, Novorapid Penfill may be administered in/in, but only qualified medical personnel. For I/V administration used the infusion system with the drug Novorapid Penfill® 100 U/ml with a concentration of from 0.05 to 1 U/ml insulin aspart in 0.9% sodium chloride solution 5 or 10% dextrose solution containing 40 mmol/l potassium chloride, using polypropylene containers for infusion. These solutions are stable at room temperature for 24 h During infusion of insulin needed to control blood glucose levels.

Novorapid Penfill® can also be used for continuous subcutaneous insulin infusion (PII) in insulin pumps designed for infusion of insulin. PII should be made in the abdominal wall. Places of the infusion should be changed periodically. When using an insulin pump for infusion Novorapid Penfill must not be mixed with other types of insulin. Patients using PII should be trained to use the pump, the relevant reservoir and tubing for the pump. Infusion set (tubing and catheter) should be replaced in accordance with the user manual attached to the infusion set. Patients receiving Novorapid Penfill use PII need to have extra insulin for use in case of failure of the infusion system.

Overdose:

Symptoms: hypoglycemia (cold sweat, palpitations, tremor, hunger, excitement, irritability, paleness, headache, drowsiness, lack of movement, impaired speech and vision, depression). Severe hypoglycemia can lead to impaired function of the brain and coma.

Treatment: sugar, or glucose inside (if the patient is conscious), n/a, I/m glucagon (at a dose of 0.5–1 mg) or/in — glucose. In addition, in intravenous glucose is necessary in cases where via 10-15 min after injection of glucagon, the patient does not regain consciousness. After regaining consciousness that oral carbohydrates to prevent relapse of hypoglycemia.

Precautions:

Insufficient dose or interrupt treatment, especially in insulin-dependent diabetes mellitus (type 1) can lead to hyperglycaemia and diabetic ketoacidosis.

Experience of clinical application in children under 6 years there. Novorapid should be used in children instead of the usual short-acting insulin only in those cases where a quick onset of action can have the best effect — for example, if the child is difficult to observe the required interval between injections and reception food.

Comorbidities, particularly infection, usually increase, and damage kidneys or liver — reduce the need for insulin. A patient on a new type or brand of insulin should be implemented under strict medical supervision. When using the drug Novorapid Penfill may require more injections a day or change dose, as compared to those using conventional insulin preparations. If there is a need for dose adjustment, it can occur already at the first introduction or in the first few weeks or months after the transfer. After compensation of carbohydrate metabolism in patients can change their typical symptoms-signs of hypoglycemia, what should inform their. Skipping meals or unplanned exercise may lead to hypoglycaemia. With extreme caution during the drivers of vehicles and people skills relate to the high concentration of attention, because they may develop hypoglycemia, particularly in patients with mild or no symptoms with signs of hypoglycemia or frequent episodes of its. In such cases, you should seriously consider whether it is desirable for the patient to drive a car. Smart Penfill is solely for personal use. After injection for a minimum of 6 needle should remain under the skin for full doses.

Special instructions:

You should not use this medicine if the solution has ceased to be colorless and transparent.

Storage conditions:

Do not freeze. Used cartridge at room temperature not above 30 °C is not more than 4 weeks after the start of use should not be stored in the refrigerator.