Myacalcic® (Miacalcic®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCalcitoninCalcitonin
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    • Dosage form: & nbspinjection
    Composition:

    1 ml (1 ampoule) of solution for injection contains:

    active substance: salmon calcitonin synthetic 100 ME;

    Excipients: glacial acetic acid 0.002 g, sodium acetate trihydrate 0.020 g, sodium chloride 0.0075 g, water for injection up to 1 ml.

    Description:Transparent colorless solution.
    Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
    ATX: & nbsp

    H.05.B.A   Calcitonin preparations

    H.05.B.A.01   Salmon calcitonin synthetic

    Pharmacodynamics:

    The hormone produced by C-cells of the thyroid gland is antagonist parathyroid hormone and with it participates in the regulation of calcium metabolism in the body.

    The structure of all calcitonins is represented by one chain of 32 amino acids and a ring of 7 amino acid residues at N-the end, the sequence of which is not the same for different species. Because the calcitonin Salmon has a higher affinity for receptors (compared with mammalian calcitonins), its effect is expressed to the greatest extent by force,both in terms of duration and duration.

    Suppressing the activity of osteoclasts due to action on specific receptors, calcitonin salmon significantly reduces the rate of bone tissue exchange to normal levels in conditions with an increased rate of resorption, for example, in osteoporosis.

    Both in animals and in humans it was shown that Miakaltsik has analgesic activity in bone pains, which, apparently, is due to a direct effect on the central nervous system.

    Already after a single application of Miakaltsik, a clinically significant biological response is observed in man, which is manifested by increased urinary excretion of calcium, phosphorus and sodium (due to a decrease in tubular reabsorption) and decreased excretion of hydroxyproline. Prolonged parenteral use of Mycatalc leads to a significant decrease in the level of biochemical markers of bone metabolism, such as pyridinoline and bone isoenzymes of alkaline phosphatase.

    Calcitonin reduces gastric and exocrine pancreatic secretion. These properties Miakaltsik determine its effectiveness in the treatment of acute pancreatitis.

    Pharmacokinetics:

    Bioavailability of salmon calcitonin is about 70% for both intramuscular and subcutaneous injection. The maximum concentration of the drug in the plasma is reached within 1 hour, and with subcutaneous injection - for about 23 minutes. The apparent volume of distribution is 0115-0.3 l / kg. Binding to plasma proteins - 30-40%. Up to 95% of calcitonin and its metabolites are excreted in urine, with only 2% in unchanged form. The half-life of the drug is about 1 hour with intramuscular injection and 1-1.5 hours with subcutaneous.

    Indications:

    - Prevention of acute bone loss due to immobilization.

    - Paget's disease (with inefficiency or intolerance of alternative therapies).

    - Hypercalcemia, caused by oncological diseases.

    Contraindications:Hypersensitivity to synthetic salmon calcitonin or any other component of the drug.
    Pregnancy and lactation:

    In experimental studies, the preparation Miakaltsik® did not exert embryotoxic and teratogenic effects.

    There are no data on the safety of Miacalcic® during pregnancy, and therefore the drug should not be used during this period.

    It is not known whether the calcitonin salmon in breast milk, so during the period of drug therapy it is recommended to abandon breastfeeding.

    Dosing and Administration:

    All indications

    The ampoule solution can be used for subcutaneous and intramuscular injections, as well as for intravenous infusions, but is not suitable for intravenous bolus administration. In connection with the increased risk of developing malignant tumors with prolonged therapy with Miakaltsik® (see the section "With care" and "Special instructions"), for each of the indications, it is necessary to maximally limit both the duration of treatment and the dose of the drug to the minimum effective. The drug may be administered only for the above indicated indications.

    Prevention of acute bone loss due to immobilization.

    The daily dose is 100-200 IU daily. The drug is administered intravenously (IV) dropwise (in physiological solution) or SCI or IM in a few injections - until a satisfactory clinical effect is achieved. The dose should be adjusted taking into account the patient's response to treatment.

    To achieve a complete analgesic effect, it may take several days.In long-term therapy, the initial daily dose is usually reduced and / or the interval between administrations is increased. The recommended duration of therapy is 2 weeks (maximum - 4 weeks).

    Paget's disease. P / to or in / m in a daily dose of 100 IU daily or every other day. The duration of treatment depends on the form of the disease and the patient's response to treatment, but should not exceed 3 months (longer duration or periodic administration is allowed with a favorable benefit ratio to the possible risk of use). The dose should be adjusted taking into account the patient's response to treatment.

    Hypercalcemia

    Emergency treatment of hypercalcemic crisis. Since IV infusion is the most effective mode of administration, it should be given preference for treatment of urgent and other severe conditions.

    Miakaltsik® is injected intravenously / drip for a minimum of 6 hours, at a daily dose of 5-10 IU / kg body weight in 500 ml of saline. It is also possible in / in a jet slow injection, in which the daily dose should be divided into 2-4 injections during the day.

    Treatment for chronic hypercalcemia. The duration of treatment should not exceed 4 weeks. Daily sc or to / m in a daily dose of 5-10 IU / kg once or in 2 injections. The dosage regimen should be adjusted taking into account the dynamics of the patient's clinical state and biochemical parameters. If the volume of the required dose of Miakaltsik® is more than 2 ml, then I / m injections should be preferred, which should be carried out in different places.

    Use in children

    The experience of parenteral administration of Miakaltsik® in children is limited, and therefore it is not possible to give recommendations for this age group.

    Use in patients aged 65 years and individual patient groups

    Extensive experience with the use of the injectable solution of Miakaltsik® in elderly patients indicates that in this age group there was no impairment of drug tolerance or the need to change the dosage regimen. The same applies to patients with impaired renal or hepatic function, although studies specifically for these groups of patients have not been conducted.

    Side effects:

    There have been reports of such undesirable effects as nausea, vomiting, dizziness, minor flushes of blood to the face, accompanied by a feeling of warmth, arthralgia.Nausea, vomiting, dizziness and hot flashes depend on the dose and are more likely to occur with intravenous than with intramuscular or subcutaneous injection. Against the background of the use of the drug Miakaltsik ® possible development of polyuria and chills, which usually disappear on their own, and only in some cases require a temporary reduction in the dose of the drug.

    The incidence of adverse events possibly associated with the use of the drug is estimated as follows: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1 000), very rarely (<1 / 10,000), including individual reports, the frequency is unknown (since reports of AEs were obtained voluntarily from a population of uncertain size during post-marketing studies and when applied drug in clinical practice, frequency estimation is not possible).

    Disorders from the metabolism and nutrition: the frequency of hypocalcemia is unknown.

    Immune system disorders: rarely - hypersensitivity; very rarely - anaphylactic or anaphylactoid reactions, anaphylactic shock.

    Impaired nervous system: often - headache, dizziness, taste disorders; frequency is unknown - tremor.

    Disorders from the side of the organ of vision: infrequently - visual disturbances.

    Vascular disorders: often - tides; infrequently - increased blood pressure.

    Disorders from the digestive system: often - nausea, abdominal pain, diarrhea; infrequently - vomiting.

    Disturbances from the skin and subcutaneous tissue: rarely - generalized rash; frequency unknown - hives.

    Disturbances from the musculoskeletal and connective tissue: often - arthralgia; infrequently - pain in the bones and muscles.

    Disorders from the kidneys and urinary tract: rarely - polyuria.

    General disorders and disorders at the site of administration: often - increased fatigue; infrequently - flu-like syndrome, facial edema, peripheral and generalized edema; rarely - chills, reactions at the injection site, itching.

    A meta-analysis of randomized, controlled trials in patients with osteoarthritis and osteoporosis has shown that the long-term use of calcitonin is associated with a small but statistically significant increase in the incidence of malignant neoplasms compared with placebo. The mechanism of development of this phenomenon is not established.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    In case of an overdose of parenterally administered Miakaltsik, nausea and vomiting were observed, dizziness and hot flashes were also possible. No serious block reactions due to overdose have been reported to date. Treatment is symptomatic.

    In case of an overdose, hypocalcemia may develop with symptoms such as paresthesia, muscle twitching. Treatment: administration of calcium gluconate.

    Interaction:

    When calcitonin is used together with lithium preparations, a decrease in the plasma concentration of lithium is possible. Thus, with simultaneous administration of Miakaltsik and lithium preparations, there is a need to adjust the dose of the latter.

    Special instructions:

    A doctor or nurse should instruct the patients in detail who independently make themselves hypodermic injections of the drug.

    Treatment should be as short as possible with the use of minimal effective doses of the drug.

    Before using Miakaltsik®, you should visually check the condition of the ampoule and solution. The ampoule of the drug should not be damaged, the solution - transparent, colorless and without foreign inclusions.After a single use of Miakaltsik®, the unused solution of the drug remaining in the ampoule should be disposed of. Before subcutaneous or intramuscular injection, the solution of Miakaltsik® should be heated to room temperature.

    A meta-analysis of randomized controlled trials in patients with osteoarthritis and osteoporosis has shown that prolonged use of calcitonin is associated with a small but statistically significant increase in the incidence of malignant neoplasm compared with placebo (see "Side effect" section). An increase in the absolute incidence of malignant neoplasms in patients who received calcitonin during the 6-

    12 months of therapy, compared with placebo, which ranged from 0.7% to 2.36%. The mechanism of this phenomenon is not established. Patients in these studies received calcitonin orally or intranasally, which, however, does not exclude an increase in the risk of malignant growth in patients who receive the product Miakaltsik® subcutaneously, intramuscularly or intravenously.In this regard, before starting therapy with Miakaltsik®, you need to assess the benefits and risks of using it.

    With prolonged use of the drug Miakaltsik ® in patients can form antibodies to calcitonin; However, this phenomenon usually does not affect clinical efficacy. The phenomenon of "escaping", observed mainly in patients with Paget's disease, receiving Mikaltsik® for a long time, is probably due to saturation of binding sites, rather than the formation of antibodies. After a break in treatment, the therapeutic effect of Miakaltsik® is restored.

    Against the background of treatment, the concentration of alkaline phosphatase in the blood and the excretion of hydroxyproline in the urine are reduced, and often normalized. However, it should be borne in mind that in some cases, after the initial decline, the values ​​of these indicators may again rise. In these cases, when deciding whether to cancel the treatment or the time of its resumption, the doctor should be guided by the clinical picture.

    One or several months after discontinuation of treatment, metabolic disorders of bone tissue may reappear; in this case, a new course of treatment with Mikaltsik® will be required.

    Because the calcitonin Salmon is a peptide, there is a possibility of occurrence of systemic allergic reactions. There have been reports of allergic reactions, including isolated cases of anaphylactic shock, which occurred in patients receiving Mycalcic®. If a patient is susceptible to increased sensitivity to salmon calcitonin, skin tests should be performed prior to treatment, using a diluted sterile drug solution Miakaltsik®.

    Miakaltsik®, solution for injection, practically does not contain sodium (less than 23 mg).

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

    The effect of Miakaltsik® on the ability to drive vehicles and work with mechanisms has not been studied.

    Some of the side effects of the drug, such as dizziness and visual disturbances, can adversely affect the ability to drive and perform potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

    Form release / dosage:Solution for injection 100 IU / ml.
    Packaging:In ampoules. 5 1 ml ampoules with a break point or a fracture ring, together with instructions for use in a cardboard bundle.
    Storage conditions:

    At a temperature of 2-8 ° C. Do not freeze.

    When opening the ampoule, the solution contained in it should be used immediately, since it contains no preservatives.

    The drug should be stored out of the reach of children.

    List B.

    Shelf life:

    5 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N008824
    Date of registration:17.05.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC
    Information update date: & nbsp12.05.2018
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