Miakaltsik

Active material: Calcitonin
When ATH: H05BA01
CCF: Preparation, influencing the calcium and phosphorus metabolism, used to treat osteoporosis
ICD-10 codes (testimony): C34, C50, C64, C90.0, E21, E67.3, K85, M81.0, M81.2, M81.4, M81.8, M88, M89.0, M89.5
When CSF: 15.05.03.01
Manufacturer: NOVARTIS PHARMA AG (Switzerland)

Pharmaceutical form, composition and packaging

Solution for injection clear, colorless.

Excipients: acetic acid, sodium acetate trigidrate, sodium chloride, water d / and.

* 1 CU corresponds approximately 0.2 mcg of synthetic calcitonin salmon.

1 ml – ampoule (5) – packs cardboard.

Pharmacological action

Hormone, thyroid, It is an antagonist of the parathyroid hormone and together with it is involved in the regulation of calcium metabolism in the body.

The structure of all calcitonins is represented by one chain from 32 amino acids and a ring from 7 amino acid residues on the N-end, the sequence of which is not the same in different types. Since salmon calcitonin has a higher affinity to receptors (Compared to mammalian calcitonins), Its action is most expressed as in force, and by duration.

Suppressing the activity of osteoclasts due to the impact on specific receptors, Calcitonin salmon significantly reduces the rate of bone metabolism to the normal level with states with an increased resorption rate, For example at osteoporosis.

Like animals, So in a person was shown, What a myacalcic^® It has analgesic activity in pain of bone origin, that, apparently, due to the direct impact on the central nervous system.

After the one -time use of myacalcic^® A person has a clinically significant biological response, which is manifested by increased excretion with urine of calcium, phosphorus and sodium (due to a decrease in their luminous reabsorption) and a decrease in excretion of hydroxyproline. Long -term parenteral use of myacalcic^® leads to a significant decrease in the level of biochemical markers of bone exchange, such as pyridinolin and bone isoenzyme alkaline phosphatase.

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

Pharmacokinetics

Absorption and distribution

Bioavailability of salmon calcitonin, used in/m or p/c, is about 70%.

C_max Plasma is achieved during the first hour. In Кажущийся_d is 0.15-0.3 l / kg. Plasma protein binding - 30-40%.

Metabolism and excretion

To 95% Calcitonin and its metabolites are excreted in the urine, Moreover, only 2% – in unchanged form. T_1/2 is about 1 h with a/m introduction and 1-1.5 no – when s / to.

Testimony

- Osteoporosis: Primary osteoporosis – Postmenopaurus osteoporosis (how, So the late stages), Senile osteoporosis in women and men; Secondary osteoporosis, In particular, caused by glucocorticoids or immobilization;

- Bone pain, associated with osteolysis and / or osteopenia;

-Paget's disease of bone (deforming cools);

- hypercalcemia and hypercalcemic crisis, due to the following factors: Osteolis, caused by malignant tumors (breast carcinoma, light, kidney, Myeloma), giperparatireoz, immobilization, Intoxication by vitamin D, as for stopping emergency conditions, and for prolonged treatment of chronic conditions – until, until the effect of specific therapy of the underlying disease is manifested;

- Neurodistrophic diseases (synonyms: Algoneurodistrophy or Zudek disease), due to various etiological and predisposing factors, such as post -traumatic painful osteoporosis, Reflex dystrophy, shoulder -shoulder syndrome, Causalgia, Medicinal neurotrophic disorders;

- Acute pancreatitis (in a combination therapy).

Dosage regimen

At osteoporosis A prescribe the drug of the p/k or v/m in the daily dose 50 ME or 100 Cm daily or after a day (depending on the severity of the disease).

In order to prevent progressive bone loss, simultaneously with the use of myacalcic^® It is recommended to prescribe adequate doses of calcium and vitamin D.

At Bone pain, associated with osteoliasis and/or osteopenia, daily dose is 100-200 IU daily. The drug is introduced into / in the drip (in saline), p/k or v/m in several introductions – Until a satisfactory clinical effect. The dose should be corrected taking into account the patient's reaction to treatment.

To achieve a complete analgesic effect, it may take several days. During prolonged therapy, the initial daily dose is usually reduced and/or increased the interval between the introduction.

At Paget diseases A prescribe the drug of the p/k or v/m in the daily dose 100 Cm daily or after a day.

The duration of treatment is a minimum 3 of the month; If necessary, it can be more. The dose should be corrected taking into account the patient's reaction to treatment.

Emergency treatment of hypercalcemic crisis. Since in/in infusion is the most effective way to introduce, It is she who should give preference for the treatment of emergency and other serious conditions.

Miacalcik^® Introduce in/in drip for a minimum 6 h in a daily dose 5-10 IU/kg body weight in 500 ml saline. Possibly also in/in jet slow introduction, in which the daily dose should be divided into 2-4 Introduction during the day.

Long -term treatment for chronic hypercalcemia. Daily p/c or/m in the daily dose 5-10 Me/kg in 1 or in 2 introduction. The dosing mode should be corrected taking into account the dynamics of the clinical state of the patient and biochemical indicators. If the volume of the required dose of myacalcic^® more than 2 ml, then more preferably in/m injection, which should be carried out to different places.

At neurodistrophic diseases Early diagnosis is extremely important. Treatment should begin immediately after confirming the diagnosis.

The drug is administered to or/m in a daily dose 100 IU for 2-4 weeks. It is possible to continue treatment with the introduction of 100 IU, a day in a period before 6 weeks depending on the dynamics of the patient's condition.

At acute pancreatitis Miacalcik^® Apply as part of a combined conservative treatment. Introduced in/in drip in the dose 300 ME (in saline) during 24 h to 6 days in a row.

Experience in the use of the injection solution of myacalcic^® in children limited, In this connection, it is not possible to give recommendations for this age group.

Extensive experience in the use of the injection solution of myacalcic^® in elderly patients indicates, that in this age group there was no deterioration of the tolerance of the drug or the need to change the dosing regimen. The same applies to patients with a decrease in kidney or liver function, although studies specifically for these groups of patients were not conducted.

Side effect

Reported such undesirable effects, nausea, vomiting, dizziness, Minor flows of blood to the face, accompanied by a sensation of heat, arthralgia. Nausea, vomiting, dizziness and tides depend on the dose and more often occur at/in, than with/m or p/c the introduction. Against the background of the use of myacalcic^® the development of polyuria and chills is possible, which usually disappear independently, And only in some cases do they require a temporary reduction in the dose of the drug.

The incidence of adverse events, possibly associated with the use of the drug, is evaluated as follows:: Often (≥1/10); often (≥ 1/100, < 1/10); sometimes (≥ 1/1 000, < 1/100); rarely (≥ 1/10 000, < 1/1 000), including isolated reports.

From the nervous system: often – headache, dizziness, flavor violation.

From the senses: sometimes – visual impairment.

Cardio-vascular system: often – tides; sometimes – arterial hypertension.

From the digestive system: often – nausea, abdominal pain, diarrhea; sometimes – vomiting.

Dermatological reactions: rarely – generalized rash.

On the part of the musculoskeletal system: often – arthralgia; sometimes – Pain in bones and muscles.

From the urinary system: rarely – polyuria.

From the body as a whole and local reactions: often – fatigue; sometimes – flu-like symptoms, facial swelling, Peripheral and generalized edema; rarely – chills, reactions at the injection drug, itch.

Allergic reactions: rarely – hypersensitivity; rarely – anaphylactic or anaphylactoid reactions, anaphylactic shock.

Contraindications

- increased sensitivity to synthetic calcitonin salmon and other components of the drug.

Pregnancy and lactation

IN experimental studies found, What a myacalcic^® does not have an embryotoxic and teratogenic effect. Does not penetrate the placental barrier.

However, clinical data on the safety of mycalcic^® There is no pregnancy during pregnancy. In this regard, it is not recommended to use the drug in pregnant women.

Unknown, Whether Calcitonin salmon is distinguished with breast milk in humans, Therefore, during the treatment with the drug, breastfeeding is not recommended.

Cautions

A doctor or nurse must instead of patients, which independently make subcutaneous injections of the drug.

Before use of myacalcic^® the state of the ampoule and solution should visually control. The ampoule of the drug should not be damaged, The solution is transparent, colorless and without extraneous inclusions. After the one -time use of myacalcic^® The unused solution of the drug remaining in the ampoule should be disposed of. Before the p/c or/m introduction of a miacalcic solution^® It should be warmed to room temperature.

With prolonged use of myacalcic^® In patients, antibodies to calcitonin can form in patients; However, this phenomenon usually does not affect the clinical efficiency. Phenomenon “slipping”, observed mainly in patients with Pedget's disease, receiving myacalcic^® protractedly, Determined, probably, saturation of binding places, not the formation of antibodies. After a break in treatment, the therapeutic effect of myacalcic^® Restores.

With Pedget's disease, as well as with other chronic diseases with an increased bone metabolism level, the duration of treatment with mycalcic^® should be from several months to several years. Against the background of treatment, the concentration of the BCF in the blood and the excretion of hydroxyproline in the urine decrease, and often normalize. But, it should be understood, that in some cases, after the initial decrease in the values of these indicators, it may increase again. In these cases, Solving the issue of canceling treatment or the time of its renewal, The doctor should be guided by the clinical picture.

One or several months after the treatment of treatment of bone metabolism disorders may occur again; In this case, a new course of treatment with a myacalcic will be required^®.

Since salmon calcitonin is a peptide, There is a probability of systemic allergic reactions. There are reports of allergic reactions, including individual cases of anaphylactic shock, who took place in patients, those who receive a myacalcic^®. In case of suspicion of increased sensitivity of the patient to salmon calcitonin, skin tests should be carried out before treatment., using a diluted sterile miacalcic solution for this^®.

Solution for injection, practically does not contain sodium (less 23 mg).

Effects on ability to drive vehicles and management mechanisms

The influence of Miacalcic^® the ability to drive vehicles and work with mechanisms was not studied. Some side effects of the drug, such as dizziness and visual disorders, can negatively affect the ability to drive a car and perform potentially dangerous activities, requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: nausea and vomiting, Dizziness and tides are also possible, It is possible to develop hypocalcemia with symptoms such as paresthesia, clonus. About any serious adverse reactions, caused by an overdose, not yet reported.

Treatment: symptomatic therapy, With the development of hypokalcemia, it is recommended to introduce gluconate calcium.

Drug Interactions

With the use of calcitonin along with lithium preparations, a decrease in plasma concentration of lithium is possible. Thus, With the simultaneous prescription of myacalcic^® and lithium preparations may be necessary to correct the dose of the latter.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 5 years.

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