Active substanceSomatropinSomatropin
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  • Dosage form: & nbsphypodermic solution
    Composition:
    In 1 cartridge (1.5 ml) contains:
    Active substance: somatropin (biosynthetic human growth hormone) - 5 mg (3.3 mg / ml), 10 mg (6.7 mg / ml) or 15 mg (10 mg / ml);
    Excipients: mannitol, histidine, poloxamer 188, phenol and water for injections.

    Description:colorless transparent liquid
    Pharmacotherapeutic group:growth hormone
    ATX: & nbsp

    H.01.A.C   Somatropin and its analogues

    H.01.A.C.01   Somatropin

    Pharmacodynamics:
    Norditropin® Simplex® stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes.
    Somatropin, replenishing the deficiency of endogenous growth hormone, contributes to the normalization of body structure by increasing muscle mass and reducing body fat.
    Most effects of somatropin are realized through insulin-like growth factor I (IRF-1), which is produced in all cells of the body (mainly by liver cells). More than 90% of IGF-1 is associated with proteins (IRFSB), of which the most important is IRFSB-3.
    Somatropin enhances the restructuring of bone tissue, which is manifested by an increase in the activity of biochemical bone markers in plasma. In adults, during the first months of treatment, due to more pronounced bone resorption, a decrease in its mass is observed, but with continued treatment, the mass of bone tissue increases.

    Pharmacokinetics:
    Pharmacokinetics. Intravenous infusions of the drug Norditropin (33 ng / kg / min for 3 hours) 9 patients with growth hormone deficiency gave the following results: the half-life of blood serum was 21.1 ± 1.7 min, the metabolic clearance rate was 2.33 + 0 , 58 ml / kg / min, and the volume of distribution was 67.6 ± 14.6 ml / kg.

    Indications:
    Children:
    growth retardation due to insufficiency of growth hormone;
    growth retardation in girls with gonadal dysgenesis (Shereshevsky-
    Turner);
    - growth retardation in children in the prepubertal period, caused by chronic
    renal insufficiency (CRF).
    Adults: Confirmed congenital or acquired deficiency
    growth hormone (as a substitute therapy).

    Contraindications:
    Hypersensitivity to any of the components of the drug.
    Signs of active malignant neoplasm (at the beginning of treatment, the intracranial tumor should be inactive and antitumor therapy completed).
    Urgent status (including conditions after operations on the heart, the abdomen, acute respiratory insufficiency, multiple trauma resulting from accidents).
    Proliferative and pre-proliferative diabetic retinopathy.
    Willy-Prader's syndrome in case of severe obesity and respiratory disorders.
    Pregnancy and lactation.
    In children with chronic renal insufficiency, treatment with Norditropin should be interrupted during kidney transplantation.

    Carefully:
    diabetes mellitus, cerebrospinal hypertension,
    gipoterioz.

    Pregnancy and lactation:
    AT
    Currently, there is insufficient data on the safety of the use of somatropin during pregnancy, and therefore the use Norditropin Simleks during pregnancy is not recommended. There are data on the possible secretion of somatropin with breast milk.If you need to use the drug Norditropin Simplex during breastfeeding, breast-feeding should be discontinued.

    Dosing and Administration:
    The dose is selected individually. It is usually recommended to do one subcutaneous injection of the drug at night. To prevent the development of lipoatrophy, it is necessary to change the injection site. The procedure for administering the drug is described in the instructions for the NordiPen® syringe pen.
    Patients should be reminded of the need to wash their hands with soap and / or a disinfectant before using Norditropin Simplex. Never shake the cartridge with Norditropin Simplex strongly.
    Recommendations for dosing the drug are given below.
    Children:
    Insufficient growth hormone: 25-35 μg / kg / day or 0.7-1 mg / m2 / day.
    Shereshevsky-Turner Syndrome and chronic renal failure: 50 mcg / kg / day or 1.4 mg / m 2 / day.
    Adults:
    Substitution therapy. It is recommended to begin treatment with the use of low doses of the drug: 0.1-0.3 mg / day and gradually increase the dose every month until the dose that is necessary for a particular patient is achieved.As a control parameter for titrating the dose, the level of serum IGF-1 can be used
    blood. As the patient's age increases, the need for growth hormone decreases.
    The maintenance dose of the drug is selected individually, but rarely exceeds 1 mg / day (corresponding to 3 IU / day).

    Side effects:
    Side effects in children are rare or very rare.
    Children can be observed:
    Peripheral edema due to fluid retention
    Hyperemia, itching and pain at the injection site
    Headache
    Muscle and joint pain
    Skin rash
    Adults may experience the following side effects:
    Wrist canal syndrome (tingling, numbness, or perhaps pain, mainly in the fingers due to compression of the nerve endings)
    Headache
    Muscle and joint regurgitation
    Peripheral edema due to fluid retention
    Hyperemia, itching and pain at the injection site
    In rare cases, the following undesirable events may occur:
    Formation of antibodies to growth factor
    Increased intracranial pressure.
    In very rare cases, a hypersensitivity reaction may develop.
    Attention! The following side effects are described in the literature when the preparation is administered somatropin, however, they were not observed on the present day when using the drug Norditropin Simplex: weakness, fatigue, epiphysis of the head of the femur, gynecomastia, edema of the optic nerve (usually observed during the first 8 weeks of treatment, most often in patients with Shereshevsky-Turner syndrome ), pancreatitis (abdominal pain, nausea, vomiting), otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome), subluxation of the hip in children (limping, pain in the thigh and knee), gynecomastia, leukemia reactions, accelerations the growth of the previously existing nevus (malignancy is possible), the progression of scoliosis (in patients with excessively rapid growth), an increase in the content of inorganic phosphate, parathyroid hormone and alkaline phosphatase activity in the blood.

    Overdose:
    Acute overdose can lead initially to hypoglycemia and. in the subsequent, to hyperglycemia. Such reduced levels of glucose were determined only biochemically without the clinical symptoms of hypoglycemia.With prolonged overdose, signs and symptoms characteristic of excess human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the level of cortisol in the serum may appear. Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:
    Concomitant glucocorticosteroid therapy can suppress growth and, thus, inhibit the growth effect of the drug Norditropin Simplex. The effectiveness of the drug (in terms of final growth) may also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.

    Special instructions:
    Do not use the drug Norditropin Simplex, if the solution has ceased to be colorless and transparent.
    Before use, make sure the cartridge is intact (for example, in the absence of cracks). Do not use the cartridge in the presence of any damage or cracks.
    A specialist in the field of growth pathology should regularly monitor the condition of children receiving Norditropin Simplex.The treatment with Norditropin Simplex should always be started by a doctor who has special knowledge in the field of growth hormone deficiency and its treatment. This also applies to the treatment of growth retardation in the Shereshevsky-Turner syndrome and CRF.
    Dysplasia in children with CRF should be accurately established before treatment with Norditropin Simplex is started by monitoring growth on optimal CRF therapy for one year. During therapy with the drug Norditropin Simplex, one should continue conservative treatment of uremia with traditional medicines and, if necessary, with dialysis.
    During treatment Norditropin Simplex CRF patients renal function should be monitored for its pronounced decrease or improve the glomerular filtration rate (which may mean hyperfiltration).
    The effect of somatropin on carbohydrate metabolism has been established, so patients should also be examined for glucose tolerance impairment.
    In patients receiving insulin treatment, with the appointment of the drug Norditropin Simplex, it may be necessary to adjust its dose.
    When treated with the drug Norditropin Simplex, the level of serum thyroxine may decrease due to increased peripheral deiodination of T4 in T3. In patients with progressive pathology of the pituitary gland, hypothyroidism may develop. Patients with Shereshevsky-Turner syndrome have an increased risk of developing primary hypothyroidism associated with anthyroiditis antibodies. Since hypothyroidism is an obstacle to an adequate rosive effect when treated with the drug Norditropin Simplex, patients receiving this therapy should regularly examine the thyroid function and conduct replacement therapy with thyroid hormones when it is detected.
    With secondary growth hormone deficiency due to the presence of intracranial neoplasm, regular patient examinations should be performed to identify signs of progression or recurrence
    primary disease. A small number of patients with growth hormone deficiency, some of whom were treated with somatropin, reported on the development of leukemia. Based on current data, it seems unlikely that the treatment with somatropin was the cause.In patients with complete remission of tumors or malignant diseases, growth hormone therapy was not associated with an increased rate of relapse. Nevertheless, after the start of Norditropin Simplex treatment, patients who achieved complete remission of malignant diseases should be carefully monitored for their relapse.
    In patients with endocrine diseases, subluxation of the femoral head may be more common, and Legg-Calvet-Perthes disease may be more common in low-growth patients. These diseases can be manifested by lameness or pain in the femoral or knee joint. Doctors and patients should be warned about this.
    In the presence of severe or repeated headaches, visual impairment, nausea and / or vomiting, it is recommended that the eye fundus (fundoscopy) be inspected to detect edema of the optic nerve disc. If the edema is confirmed, it is necessary to assume the presence of benign intracranial hypertension and, if this diagnosis is correct, treatment with growth hormone should be canceled. Currently, there is insufficient data to guide only the clinical criteria for deciding patients with intracranial hypertension in the resolution stage.When resuming treatment with growth hormone, careful monitoring of the symptoms of intracranial hypertension is necessary.
    Adult drug Norditropin Simplex is prescribed for insufficiency of growth hormone, which developed in childhood and confirmed again during two provocative tests, as well as with a significant decrease in the production of growth hormone in the established disease of the hypothalamic-pituitary region (deficiency of another hormone other than prolactin), confirmed during two provocative tests after the initiation of adequate substitution treatment for the deficiency of any other hormone.
    Adults with growth hormone deficiency undergoing substitution therapy with Norditropin Simplex should be under the supervision of an endocrinologist with experience in the treatment of pituitary diseases.
    Adult growth hormone deficiency persists throughout life and requires appropriate treatment, but currently experience in treating patients older than 60 years, as well as the results of therapy lasting more than 5 years, are insufficient.

    Effect on the ability to drive transp. cf. and fur:does not render
    Form release / dosage:
    . A solution for subcutaneous administration of 5 mg, 10 mg, 15 mg.in cartridges of 1.5 ml. 1 cartridge in the blister. For 1 blister, along with the instructions for use, they are placed in a cardboard box.

    Packaging:
    • (1) - cartridges (1) - packings
    Storage conditions:
    List B.
    For a dosage of 5 mg / 1.5 ml and 10 mg-1.5 ml: at a temperature of 2 ° C to 8 ° C (in
    refrigerator), in a cardboard pack or NordiPen syringe pen during use. After opening, store for 4 weeks at a temperature of 2 ° C to 8 ° C (in the refrigerator) or for 3 weeks at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.
    For a dosage of 15mg / 1.5ml: at a temperature of 2 ° C to 8 ° C (in the refrigerator), in a cardboard pack or NordiPen syringe pen during use. After opening, store for 4 weeks at a temperature of 2 ° C to 8 ° C (in the refrigerator). Do not freeze
    Shelf life:. 2 years. Do not use after the expiration date indicated on the package
    Terms of leave from pharmacies:On prescription
    Registration number:П N013373 / 01
    Date of registration:15.09.2006
    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: & nbsp16.08.2015
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