Osteover (Osteover)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCalcitoninCalcitonin
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  • Osteover
    solution w / m d / infusion PC 
    VEROPHARM SA     Russia
    • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    active substance: calcitonin (salmon) - 100 ME;

    Excipients: Acetic Acidic Acid, Sodium Acetate Trihydrate, Sodium Chloride, Water for Injection.

    Description:

    Transparent colorless solution with a faint smell of acetic acid.

    Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
    ATX: & nbsp

    H.05.B.A   Calcitonin preparations

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

    Pharmacodynamics:

    Calcitonin - a hormone produced by C-cells of the thyroid gland, is an antagonist of parathyroid hormone and together 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 per 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 to mammalian calcitonins), its effect is expressed to the greatest extent both in strength and duration. Calcitonin reduces the resorption of bone tissue, promotes the transition of calcium ions (Ca2 +) and phosphates from the blood to the bone tissue, reduces the activity of osteoclasts and their number, reduces the content of Ca2 + ions in the serum, increases the activity of osteoblasts. Providing direct action on the kidneys, reduces tubular reabsorption of Ca2 + ions, sodium (Na+) and phosphorus.

    Suppresses gastric secretion and exocrine pancreatic function.

    With pains of bone origin has an analgesic effect, which, apparently, is due to a direct effect on the central nervous system.

    Pharmacokinetics:

    Bioavailability of salmon calcitonin with intramuscular or subcutaneous injection is about 70%. The time to reach the maximum concentration is 1 hour. The apparent volume of distribution is 0.15-0.3 l / kg. The connection with plasma proteins is 30-40%. Up to 95% of calcitonin and its metabolites are excreted by the kidneys, and only 2% - in unchanged form. The half-life is 70 to 90 minutes.

    Indications:

    - Osteoporosis:

    - Primary osteoporosis - postmenopausal osteoporosis (both early and late stages); senile osteoporosis in women and men;
    - secondary osteoporosis, in particular caused by therapy with glucocorticosteroids or immobilization.

    - Bone pain associated with osteolysis and / or osteopenia.

    - Paget's disease (deforming osteitis).

    - Hypercalcemia and hypercalcemic crisis, caused by the following factors:

    - osteolysis caused by malignant tumors (cancer of the breast, lungs, kidneys, myeloma, etc.)
    - Hyperparathyroidism, immobilization, hypervitaminosis     D
    both for relief of urgent conditions and for long-term treatment of chronic conditions - until the effect of specific therapy of the underlying disease appears.

    - Neurodystrophic diseases (synonyms: algoneurodystrophy, Zudeck's atrophy), caused by various etiological and predisposing factors, such as posttraumatic pain osteoporosis, reflex degeneration, humerus syndrome, causalgia, drug neurotrophic disorders.

    - Acute pancreatitis (as part of combination therapy).

    Contraindications:

    - Hypersensitivity to synthetic salmon calcitonin or any other component of the drug.

    - Children's age (experience with children is limited).

    Pregnancy and lactation:

    Since clinical studies in women during pregnancy have not been conducted, use calcitonin in this category of patients should not be.

    It is not known whether calcitonin with human breast milk, so if you need to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    The drug is administered intravenously (IV), intramuscularly (IM) and subcutaneously (SC).

    Osteoporosis. The drug is administered sc or in / m in a daily dose of 50 or 100 ME daily or every other day (depending on the severity of the disease).

    In order to prevent progressive loss of bone mass at the same time with the application of Osteovera, it is recommended that adequate doses of calcium and vitamin D.

    Bone pain associated with osteolysis and / or osteopenia. The daily dose is 100-200 ME daily. The drug is administered iv in a drop (in saline) or p / c or in / m 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.

    Paget's disease. P / to or in / m in a daily dose of 100 ME daily or every other day.

    The duration of treatment is at least 3 months; if necessary, it can be more. The dose should be adjusted taking into account the patient's response to treatment.

    Hypercalcemia.

    Hypercalcemic crisis. In / in the 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.

    Long-term treatment for chronic hypercalcemia. Daily n/ k or IM in a daily dose of 5-10 IU / kg once or in 2 administrations. 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 Osteover is greater than 2 ml, then I / m injections should be preferred, which should be carried out at different locations.

    Neurodystrophic diseases. P / to or in / m in a daily dose of 100 ME within 2-4 weeks. Possible continuation of treatment with the introduction of 100 ME every other day for up to 6 weeks, depending on the dynamics of the patient's condition.

    Acute pancreatitis. As part of a combined conservative treatment. Enter in / in a drip in a dose of 300 ME (in physiological saline) for 24 hours up to 6 consecutive days.

    Side effects:

    Allergic reactions: anaphylactic and anaphylactoid reactions, anaphylactic shock.

    From the side of the nervous system: headache, dizziness, taste disorders.

    From the senses: a blurred vision.

    From the CCC: "hot flashes" of blood, increased blood pressure.

    On the part of the digestive system: nausea, abdominal pain, diarrhea, vomiting.

    From the skin: a generalized rash.

    From the musculoskeletal system: arthralgia, oslagia, myalgia.

    Other: polyuria, fatigue, flu-like syndrome, facial edema, peripheral and generalized edema, chills, reactions at the injection site, itching.

    Overdose:

    Symptoms: nausea, vomiting, dizziness and hot flashes, development hypocalcemia with such symptoms as paresthesia, muscle twitching.

    Treatment: symptomatic; with the development of hypocalcemia, calcium gluconate is recommended.

    Interaction:

    No cases of drug interaction with calcitonin have been reported.

    Special instructions:

    With long-term use of salmon calcitonin, antibodies can form in patients, which, as a rule, does not affect clinical efficacy. The formation of resistance to treatment is observed mainly in patients with Paget's disease receiving calcitonin long, and may be the result of saturation of receptor binding sites, and not the formation of antibodies; The therapeutic effect of calcitonin is restored after a break in treatment.

    In the case of Paget's disease, the activity of alkaline phosphatase (ACF) in the blood serum (decrease in osteogenesis) and a decrease in urinary excretion of hydroxylol and pa (reflecting a decrease in bone resorption, in particular, collagen splitting) are noted in the treatment with calcitonin. The most pronounced decrease in the values ​​of these indicators, reflecting the positive effect of treatment, is observed after 6-24 months permanent treatment. However, in some cases, after an initial decrease in these indicators, there is an increase, which may require discontinuation of treatment. Control of the activity of AF in the blood serum and daily excretion in urine hydroxyproline should be carried out before treatment, regularly in the first 3 months and every 3-6 months during long-term treatment.

    In the course of therapy of patients with hypercalcemia, a systematic control of Ca2 + concentration in serum is shown.

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

    There is no data on the effect of calcitonin on the ability to drive vehicles and work with other mechanisms. Calcitonin can cause dizziness, therefore it is recommended to be cautious when driving vehicles and when engaging in other activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Solution for injection 100 IU / ml.
    Packaging:

    1 ml in ampoules of light-protective glass. 5 ampoules in a box or a pack of cardboard. 5 ampoules in the outline of the cell. 1 contour pack in a pack of cardboard. In the box or bundle, insert the instructions for use and the opener for opening ampoules or the ampoule scarifier. When using ampoules with incisions or a fracture ring, a scarifier ampoule or a knife for opening ampoules is not inserted.

    Storage conditions:

    List B. In the dark place at a temperature of 2 to 8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002402/10
    Date of registration:24.03.2010
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.09.2015
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