NovoRapid® Penfill® (NovoRapid® Penfill®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInsulin aspartInsulin aspart
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  • NovoRapid® Penfill®
    solution PC in / in 
    Novo Nordisk A / S     Denmark
  • NovoRapid® FlexPen®
    solution in / in PC 
    Novo Nordisk A / S     Denmark
    • Dosage form: & nbspsolution for intravenous and subcutaneous administration
    Composition:

    In 1 ml of the drug contains:

    active substance: insulin aspart 100 ED (3.5 mg);

    Excipients: glycerol 16 mg, phenol 1.5 mg, metacresol 1.72 mg, zinc chloride 19.6 μg, sodium chloride 0.58 mg, sodium hydrogen phosphate dihydrate 1.25 mg, sodium hydroxide 2 M about 2.2 mg, hydrochloric acid 2 M about 1.7 mg, water for injection up to 1 ml.

    One cartridge contains 3 ml of a solution equivalent to 300 units.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin analog
    ATX: & nbsp

    A.10.A.B.05   Insulin aspart

    Pharmacodynamics:

    Insulin aspart - an analog of human short-acting insulin, produced by the method of biotechnology of recombinant DNA using a strain Saccharomyces cerevisiae, in which the amino acid proline at position B28 is substituted for aspartic acid.

    Interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes,synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). Reduction of blood glucose is due to increased intracellular transport, increased digestion, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of production of glucose by the liver, etc.

    Substitution of amino acid proline in position B28 for aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in a solution of normal insulin. Concerning insulin aspart much more quickly absorbed from the subcutaneous fat and starts to act faster than soluble human insulin. Insulin aspart stronger reduces blood glucose in the first 4 hours after ingestion than soluble human insulin. The duration of action of insulin aspart after subcutaneous administration is shorter than that of soluble human insulin.

    After subcutaneous administration, the drug starts within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after the injection. The duration of the drug is 3-5 hours.Clinical studies involving patients with type 1 diabetes mellitus demonstrated a reduced risk of nocturnal hypoglycemia with insulin aspart compared to soluble human insulin. The risk of diurnal hypoglycemia did not increase reliably.

    Insulin aspart is an equipotential soluble human insulin based on the molarity index.

    Adults. Clinical trials involving patients with type 1 diabetes mellitus exhibit a lower postprandial blood glucose concentration when insulin is administered aspart as compared to soluble human insulin.

    Elderly. A randomized, double-blind, cross-over study of the pharmacokinetics and pharmacodynamics (PK / PD) of insulin aspart and soluble human insulin in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age 70 years) was performed. The relative differences in the pharmacodynamic properties between insulin aspart and human insulin in elderly patients were similar to those in healthy volunteers and in younger patients with diabetes mellitus.

    Children and teens. The use of insulin aspart in children showed similar results from long-term glycemic control when compared to soluble human insulin.

    A clinical study using soluble human insulin before meals and insulin aspart after meals was performed in young children (26 patients aged 2 to 6 years); as well as a FC / PD single dose study was conducted in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children was similar to that of adult patients.

    Pregnancy. Clinical studies of the relative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes mellitus (322 examined pregnant women, 157 received insulin aspart, 165 - human insulin) did not reveal any negative effects of insulin aspart during pregnancy or fetus / newborn health.

    Additional clinical studies in 27 women with gestational diabetes who receive insulin aspart and human insulin (insulin aspart received 14 women, human insulin - 13) testify to the comparability of safety profiles, along with a significant improvement in glucose control after meals in the treatment of insulin aspart.

    Pharmacokinetics:

    After subcutaneous injection of insulin aspart the time to reach the maximum concentration (tmax) in blood plasma is on average 2 times less than after the administration of soluble human insulin. The maximum concentration in the blood plasma (Cmax) on the average is 492 ± 256 pmol / l and is achieved 40 minutes after subcutaneous administration of a dose of 0.15 U / kg of body weight to patients with type 1 diabetes mellitus. The concentration of insulin returns to the baseline level 4-6 hours after the administration of the drug. The absorption rate is somewhat lower in patients with type 2 diabetes, which results in a lower maximum concentration (352 ± 240 pmol / L) and a later tmax (60 minutes). The intra-individual variability for tmax is significantly lower when using insulin aspart compared to soluble human insulin, whereas the indicated variability in CmOh for insulin aspart more.

    Pharmacokinetics in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes mellitus. Absorption of insulin aspart is rapid in both age groups, with tmax, similar to that of adults. However, there are differences CmOh in two age groups, which emphasizes the importance of individual dosing of the drug.

    The elderly. The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years old, mean age 70 years) type 2 diabetes mellitus were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients there was a decrease in the rate of absorption, which led to a slowdown tmax (82 (variability: 60-120) minutes), whereas CmOh was the same as that observed in younger patients with type 2 diabetes and slightly less than in patients with type 1 diabetes.

    Lack of liver function. A study was conducted pharmacokinetics with the introduction of a single dose of insulin aspart in 24 patients whose liver function is in the range from normal to severe form of disorder. In persons with impaired liver function, the rate of absorption of insulin aspart was reduced and more unstable, resulting in a slowdown with approximately 50 minutes in individuals with normal liver function to about 85 minutes in individuals with impaired liver function of moderate to severe severity. The area under the concentration-time curve, the maximum concentration in the plasma and the overall clearance of the drug (AUC, FROMmOh and CL/F) were similar in individuals with reduced and normal liver function.

    Lack of kidney function. A study was conducted pharmacokinetics of insulin aspart in 18 patients whose renal function ranged from normal to severe form of disorder. There was no clear effect of creatinine clearance on AUC, Cmax, tmax insulin aspart. Data were limited to indicators for people with impaired renal function of medium and severe form. Persons with renal insufficiency requiring dialysis were not included in the study.

    Preclinical safety data

    During preclinical trials, there was no evidence of any hazard to humans, based on general pharmacological safety studies, re-use toxicity, genotoxicity, and reproductive toxicity.

    In the tests in vitro, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on cell growth,The nature of the behavior of insulin aspart is very similar to that of human insulin. The results of the studies also showed that the dissociation of the binding of insulin aspart with the insulin receptor is equivalent to that of human insulin.

    Indications:

    Diabetes mellitus in adults, adolescents and children over 2 years.

    Contraindications:

    Increased individual sensitivity to insulin aspart or any of the components of the drug.

    It is not recommended to use NovoRapid® Penphill® in children under 2 years of age, clinical studies in children younger than 2 years have not been conducted.

    Pregnancy and lactation:

    NovoRapid® Penfill® can be administered during pregnancy.

    The data of two randomized controlled clinical trials (157 + 14 examined pregnant women) did not reveal any adverse effects of insulin aspart during pregnancy or fetus / newborn health compared to human insulin (see section "Pharmacological properties"). It is recommended to carefully monitor blood glucose levels and monitor pregnant women with diabetes mellitus (type 1 diabetes, type 2 diabetes or gestational diabetes), throughout pregnancy and during the period of possible pregnancy.The need for insulin, as a rule, decreases in the first trimester and gradually rises in the II and III trimesters of pregnancy. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

    In the period of breastfeeding, NovoRapid® Penfill® can be used since The introduction of insulin to a woman during lactation does not pose a threat to the child. However, it may be necessary to adjust the dose of the drug.

    Dosing and Administration:

    NovoRapid® Penfill® is a quick-acting insulin analog.

    The dose of NovoRapid® Penfill® is determined by the doctor individually according to the patient's needs. Usually the drug is used in combination with insulin preparations of medium duration or long-term action, which are administered at least 1 time per day. To achieve optimal glycemic control, it is recommended to regularly measure the concentration of glucose in the blood and adjust the dose of insulin. Usually, the individual daily requirement for insulin in adults and children is 0.5 to 1 unit / kg of body weight. When the drug is administered before meals,the need for insulin can be provided with NovoRapid® Penfill® by 50-70%, the remaining need for insulin is provided by prolonged-action insulin.

    Increasing the physical activity of the patient, changing the habitual diet or co-morbidities can lead to the need for dose adjustment. NovoRapid® Penfill® has a faster start and a shorter duration of action than soluble human insulin.

    Due to a faster onset of action, Novorapid® Penfill® should be administered, usually just before meals, if necessary, can be administered shortly after meals. Due to the shorter duration of action compared to human insulin, the risk of developing nocturnal hypoglycemia in patients receiving NovoRapid® Penphyl® is lower.

    Special patient groups

    As with the use of other insulin preparations, in elderly patients and patients with renal or hepatic impairment more closely monitor the concentration of glucose in the blood and adjust the dose of insulin aspart individually.

    Children and teens

    Use NovoRapid® Penfill® instead of soluble human insulin in children is preferable when a rapid onset of action of the drug is needed, for example, when it is difficult for a child to observe the necessary time interval between injection and ingestion.

    Translation from other insulin preparations

    When transferring a patient from other insulin preparations to NovoRapid® Penfill®, a dose adjustment of NovoRapid® Penfill® and basal insulin may be required.

    NovoRapid® Penfill® is injected subcutaneously into the anterior abdominal wall, thigh, shoulder, deltoid or gluteal region. Injection sites within the same body site should be changed regularly to reduce the risk of developing lipodystrophy. As with all insulin preparations, subcutaneous injection into the anterior abdominal wall provides faster absorption than when injected elsewhere. The duration of action depends on the dose, place of administration, intensity of blood flow, temperature and level of physical activity. However, a faster onset of action than soluble human insulin persists regardless of the localization of the injection site.

    NovoRapid® can be used for long-term subcutaneous insulin infusions (CPII) in insulin pumps designed for insulin infusions. PPII should be made in the anterior abdominal wall. Place infusions should be periodically changed.

    When using an insulin pump for infusion, NovoRapid® should not be mixed with other types of insulin. Patients using FPII should be fully trained in the use of the pump, the appropriate reservoir and the piping system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual that accompanies the infusion set.

    Patients receiving NovoRapid® with PSI should have additional insulin available in case of breakage of the infusion system.

    Intravenous administration

    If necessary, NovoRapid® may be administered intravenously, but only by qualified medical personnel.

    For intravenous administration, infusion systems with NovoRapid ® 100 U / ml preparation with concentrations from 0.05 U / ml to 1 U / ml of insulin aspart in 0.9% sodium chloride solution are used; 5% dextrose solution or 10% dextrose solution containing 40 mmol / L potassium chloride, using polypropylene infusion containers.These solutions are stable at room temperature for 24 hours.

    Despite stability for some time, a certain amount of insulin is initially absorbed by the material of the infusion system. During insulin infusions, it is necessary to constantly monitor the concentration of blood glucose.

    Side effects:

    Adverse reactions observed in patients using the drug NovoRapid® Penfill® are mainly due to the pharmacological effect of insulin.

    The most common adverse reaction is hypoglycemia. The incidence of side effects varies depending on the patient population, dosage regimen and glycemic control (see section below).

    At the initial stage of insulin therapy, refractive disorders, edema and reactions at the injection site (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur. These symptoms are usually transient. Rapid improvement in glycemic control can lead to a state of "acute pain neuropathy," which is usually reversible.Intensification of insulin therapy with a sharp improvement in carbohydrate metabolism control may lead to a temporary deterioration in the state of diabetic retinopathy, while a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

    The list of adverse reactions is presented in the table.

    All of the adverse reactions presented below, based on data from clinical trials, are grouped according to the frequency of development according to MedDRA and organ systems. The incidence of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥1 / 1,000 to <1/100); rarely (≥1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000) and unknown (impossible to estimate based on available data).

    Immune system disorders

    Infrequent - hives, skin rashes, skin rashes

    Very rarely - anaphylactic reactions *

    Disorders from the metabolism and nutrition

    Very often - hypoglycemia *

    Disturbances from the nervous system

    Rarely - peripheral neuropathy ("acute pain neuropathy")

    Disturbances on the part of the organ of sight

    Infrequent refractive disorders

    Infrequently - diabetic retinopathy

    Disturbances from the skin and subcutaneous tissues

    Infrequent - lipodystrophy *

    General disorders and disorders at the site of administration

    Infrequently - reactions in places of administration

    Infrequent - swelling

    *Cm. "Description of individual adverse reactions"

    Description of individual adverse reactions:

    Anaphylactic reactions

    Very rare reactions of generalized hypersensitivity (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heart rate, lowering of blood pressure), which are potentially life-threatening, have been noted.

    Hypoglycaemia

    Hypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a lethal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include "cold sweat", pale skin, increased fatigue, nervousness or tremor,anxiety, unusual fatigue or weakness, disorientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea and heart palpitations.

    Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen, and glycemic control. Clinical studies showed no difference in the overall incidence of episodes of hypoglycemia between patients receiving insulin aspart therapy and patients using human insulin preparations.

    Lipodystrophy

    There were reports of infrequent cases of development of lipodystrophy. Lipodystrophy can develop at the site of injection.

    Overdose:

    A certain dose required for an insulin overdose has not been established, but hypoglycemia can develop gradually if too high doses are administered in relation to the patient's need.

    - Light hypoglycemia the patient can eliminate himself by taking glucose or sugar-containing foods. Therefore, patients with diabetes are encouraged to constantly carry a sugar-containing products.

    - In case of severe hypoglycemia, when the patient is unconscious, should be administered from 0.5 mg to 1 mg glucagon intramuscularly or subcutaneously (can be administered by a trained person) or intravenously glucose solution (dextrose) (may be administered only by a medical professional). It is also necessary to introduce intravenous dextrose in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After restoration of consciousness, the patient is recommended to take a carbohydrate-rich food to prevent the recurrence of hypoglycemia.

    Interaction:

    There are a number of drugs that affect the need for insulin.

    Hypoglycemic action of insulin increases oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

    Hypoglycemic action of insulin weakens oral contraceptives, glucocorticosteroids,thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

    Beta-blockers can mask symptoms of hypoglycemia.

    Octreotide / lanreotide can both increase and decrease the need for insulin.

    Alcohol can both enhance and reduce the hypoglycemic effect of insulin.

    Incompatibility

    Some drugs, for example, containing thiol or sulphite groups, when added to NovoRapid® Penfill® can cause destruction of insulin aspart. The drug NovoRapid® Penfill® should not be mixed with other drugs. The exception is isophane-insulin and solutions for infusions, described in the section "Method of administration and dose".

    Special instructions:

    Before a long trip associated with the change of time zones, the patient should consult with his attending physician, as changing the time zone means that the patient must take food and inject insulin at another time.

    Hyperglycaemia

    Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis. Typically, the symptoms of hyperglycemia appear gradually, within a few hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, and the appearance of an odor of acetone in the exhaled air. Without proper treatment, hyperglycemia can lead to death.

    Hypoglycaemia

    Skipping meals, unplanned increased physical activity or too high a dose of insulin in relation to the patient's need may lead to hypoglycemia.

    After compensating for carbohydrate metabolism, for example, with intensified insulin therapy, the symptoms typical for them, precursors of hypoglycemia, can change in patients, which patients should be informed about.

    Common symptoms-precursors can disappear with prolonged course of diabetes.

    A consequence of the pharmacodynamic characteristics of short-acting insulin analogs is that,that the development of hypoglycemia in their use can begin earlier than when using soluble human insulin.

    Since NovoRapid® Penfill® should be used in direct connection with food intake, it should be taken into account the high rate of onset of the drug effect in the treatment of patients who have comorbid diseases or who take medications that slow food intake. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, adrenal, pituitary or thyroid gland disorders.

    When transferring the patient to other types of insulin, early symptoms-precursors of hypoglycemia may become less pronounced, compared with those with the previous type of insulin.

    Transfer of a patient from other insulin preparations

    Transfer of the patient to a new type of insulin or an insulin preparation of another manufacturer must be carried out under strict medical supervision.When changing the concentration, type, manufacturer and species (human insulin, animal insulin, human insulin analog) insulin preparations and / or manufacturing method, a dose change or an increase in injection frequency may be required compared to the previously used insulin preparations. If it is necessary to adjust the dose, it can be done already at the first administration of the drug or during the first weeks or months of treatment.

    Reactions at the site of administration

    As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, hives, inflammation, bruising, swelling and itching. Regular injection site changes in the same anatomical area can reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel NovoRapid® Penfill®.

    The simultaneous use of drugs of the thiazolidinedione group and insulin preparations

    Cases of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for developing chronic heart failure.This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

    Precautions for use

    NovoRapid® Penfill® and needles are for personal use only. Do not refill the Penfill® cartridge. NovoRapid® Penfill® can not be use if it has ceased to be transparent and colorless, or if it has been frozen. Inform the patient of the need to discard the needle after each injection.

    NovoRapid® can be used in insulin pumps (see "Method of administration and dose"). Pipes, the inner surface of which is made of polyethylene or polyolefin, have been checked and found suitable for use in pumps.

    In emergency cases (hospitalization, failure of the insulin delivery device) NovoRapid® for administration to the patient can be removed from the cartridge using an insulin syringe U100.

    Instructions for patients on the use of NovoRapid® Penfill®

    Do not use NovoRapid® Penfill®:

    - In case of allergy (hypersensitivity) to insulin aspart or any other component of NovoRapid®.

    - If you have begins hypoglycemia (low blood sugar).

    - If the cartridge or insulin delivery system with the cartridge installed is dropped, or the cartridge is damaged or crushed.

    - If the storage conditions of the preparation have been violated or it was frozen.

    - If insulin has ceased to be transparent and colorless.

    Before using NovoRapid® Penfill®:

    - Check the label to make sure, that the correct type of insulin is selected.

    - Always check cartridge, including a rubber piston. Do not use the cartridge if it has visible damage, or if there is a gap between the piston and the white strip on the cartridge. For further instructions, refer to the instructions for using the insulin delivery system.

    - Always use a new needle for each injection to prevent infection.

    - NovoRapid® Penfill® and needles are for personal use only.

    Mode of application

    NovoRapid® is intended for subcutaneous injections or prolonged infusions in the insulin pump system (PPII). NovoRapid® can also be administered intravenously under the strict supervision of a physician. Never administer insulin intramuscularly.

    Each time, change the injection site within the anatomical area. This will help reduce the risk of seals and ulcers at the injection site. It is best to inject the drug into the front abdominal wall, shoulder or front surface of the thigh. Insulin will act faster if it is injected into the anterior abdominal wall. Regularly measure the concentration of glucose in the blood.

    How to make an injection

    - Insulin should be injected under the skin. Use the injection technique recommended by your doctor or nurse, follow the instructions for administering insulin given in the manual for the insulin delivery device.

    - Hold the needle under the skin not less than 6 seconds. Hold the start button down until the needle is removed from under the skin.This will ensure the introduction of a full dose of the drug and prevent the ingress of blood into the needle or cartridge with insulin.

    - After each injection be sure to remove and discard the needle. Otherwise, it is possible to drain liquid from the cartridge, which can lead to an incorrect dosage of insulin.

    Do not fill the cartridge with insulin again.

    NovoRapid® Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® or NovoTvist® needles.

    If Novorapid® Penfill® and other insulin are used simultaneously in the Penfill® cartridge, two separate injection systems for insulin administration, one for each type of insulin, should be used.

    As a precaution, always carry a spare insulin delivery system in case you lose or damage your NovoRapid® Penfill®.

    Effect on the ability to drive transp. cf. and fur:

    The ability of patients to focus and respond to the reaction may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are particularly necessary (for example, when driving a vehicle or working with machinery and mechanisms).Patients should be advised to take measures to prevent the development of hypoglycemia in the management of transport and facilities and work with mechanisms. This is especially important for patients with a lack or decrease in the severity of symptoms-precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

    Form release / dosage:

    Solution for subcutaneous and intravenous administration, 100 units / ml.

    Packaging:

    3 ml in cartridges of glass 1 of hydrolytic class, sealed with discs of brombutyl rubber / polyisoprene on one side and pistons of bromobutyl rubber on the other.

    5 cartridges per blister of PVC / aluminum foil.

    1 blister with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze.

    Store the cartridges in a cardboard box to protect them from light.

    NovoRapid® Penfill® should be protected from excessive heat and light.

    For opened cartridges: do not store in the refrigerator. Store at a temperature not exceeding 30 ° C. Use within 4 weeks.

    Keep out of the reach of children.

    Shelf life:

    30 months.

    Do not use after the date indicated on the label of the cartridge and the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012703 / 01
    Date of registration:02.12.2009
    The owner of the registration certificate:Novo Nordisk A / SNovo Nordisk A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspNOVO NORDISK TOVNOVO NORDISK TOVDenmark
    Information update date: & nbsp24.10.2015
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