Miacalcic, 100 me 1 ml 5 pcs

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

The structure of all calcitonins is represented by a single chain of 32 amino acids and a ring of 7 amino acid residues at the N-end, the sequence of which varies from species to species. Because salmon calcitonin has a higher affinity for receptors (compared to mammalian calcitonins), its effects are greatest in both potency and duration.

Inhibiting osteoclast activity through action on specific receptors, salmon calcitonin significantly reduces the rate of bone metabolism to normal levels in conditions with increased resorption rates, such as osteoporosis.
In both animals and humans, Miacalcic has been shown to have analgesic activity in pain of bone origin, which appears to be due to a direct effect on the CNS.

After a single use of Miacalcic in humans there is a clinically significant biological response with increased urinary excretion of calcium, phosphorus and sodium (due to decreased tubular reabsorption) and decreased excretion of hydroxyproline.

Long-term (over 5 years) use of Miacalcic results in significant and sustained reduction of levels of biochemical markers of bone metabolism, such as serum C-telopeptides (sCTX) and bone alkaline phosphatase isoenzymes.
The use of Miacalcic leads to a statistically significant increase (by 1-2%) of bone mineral density in the lumbar vertebrae, which is already determined in the first year of treatment and persists up to 5 years. Miacalcic provides maintenance of mineral density in the femur.

The use of Miacalcic at a dose of 200 IU/day leads to a statistically and clinically significant reduction (by 36%) in the risk of developing new vertebral fractures in the group of patients who received Miacalcic (in combination with vitamin D and calcium preparations) compared to the group of patients who received placebo (in combination with the same preparations).

In addition, the group treated with Miacalcic (in combination with vitamin D and calcium preparations) compared to the group treated with placebo (in combination with the same preparations) showed a 35% reduction in the frequency of multiple vertebral fractures.
Calcitonin reduces gastric and exocrine pancreatic secretion.

Indications

– treatment of postmenopausal osteoporosis;
– bone pain associated with osteolysis and/or osteopenia;
– Paget’s bone disease (deforming osteitis);
– neurodystrophic diseases (synonyms: algodystrophy or Zudeck’s atrophy) due to various etiological and predisposing factors, such as posttraumatic painful osteoporosis, reflex dystrophy, brachial scapular syndrome, causalgia, and drug-induced neurotrophic disorders.

Active ingredient

Composition

1 ml of solution contains:

Active ingredient:

Synthetic salmon calcitonin 100 ME.

Associates:

acetic acid;

sodium acetate trihydrate;

sodium chloride;

water for injection.

How to take, the dosage

Subcutaneously, intramuscularly, intravenously.

Osteoporosis. The drug is administered p/cm or intravenously in a daily dose of 50 or 100 ME daily or every other day (depending on the disease severity). In order to prevent progressive bone mass loss simultaneously with the use of Miacalcic® administration of adequate doses of calcium and vitamin D is recommended.

Bone pain associated with osteolysis and/or osteopenia. The daily dose is 100-200 ME daily. The drug is administered intravenously, dropwise (in saline) or p/u or i/m in several injections – until satisfactory clinical effect is achieved. The dose should be adjusted taking into account the patient’s response to treatment.

It may take several days to achieve a complete analgesic effect. In long-term therapy, the initial daily dose is usually reduced and/or the interval between doses is increased.

Paget’s disease. P/V or IM at a daily dose of 100 ME daily or every other day. The treatment duration is at least 3 months; it can be longer if necessary. The dose should be adjusted according to the patient’s response to treatment.

Hypercalcaemia. Emergency treatment of hypercalcemic crisis. Because IV infusion is the most effective route of administration, it should be preferred for treatment of emergencies and other severe conditions.

Miacalcic® is administered by IV drip for at least 6 hours at a daily dose of 5-10 IU/kg in 500 ml of physiological solution. Slow IV drip infusion is also possible, in which the daily dose should be divided into 2-4 injections during the day.

Long-term treatment in chronic hypercalcemia. Daily p/k or v/m in a daily dose of 5-10 IU/kg once or in 2 injections. Dosage regimen should be adjusted according to the patient’s clinical condition and biochemical parameters. If the volume of necessary dose of Miacalcic® exceeds 2 ml it is preferable to make injections in m/m which should be made in different sites.

The neurodystrophic diseases. Early diagnosis is extremely important. Treatment should be started as soon as the diagnosis is confirmed. P / k or v / m in a daily dose of 100 ME for 2-4 weeks. It is possible to continue treatment with 100 ME every other day for up to 6 weeks, depending on the patient’s progress.

Acute pancreatitis. Miacalcic® is used as part of combined conservative treatment. It is administered by IV drip in a dose of 300 ME (in saline solution) for 24 h up to 6 consecutive days.

Interaction

When using calcitonin together with lithium preparations, the plasma concentration of lithium may decrease. Thus, when concomitant administration of Miacalcic and lithium preparations, it may be necessary to adjust the dose of the latter.

Special Instructions

The physician or nurse should give detailed instructions to patients who self-inject the drug subcutaneously.

Before using the drug Miacalcic® the condition of the ampoule and the solution should be visually checked. The ampoule of the drug should not be damaged, the solution should be clear, colorless and without any foreign substances. After a single use of Miacalcic® the unused drug solution remaining in the ampoule should be disposed. Before subcutaneous or intramuscular administration the Miacalcic® solution should be warmed up to room temperature. During long-term use of Miacalcic® patients may develop antibodies to calcitonin; however, this phenomenon usually does not affect the clinical efficacy. The “slipping away” phenomenon, observed mainly in patients with Paget’s disease receiving Miacalcic® for a long time, is probably due to saturation of the binding sites rather than to the formation of antibodies. After a break in treatment the therapeutic effect of Miacalcic® is restored.

In Paget’s disease as well as in other chronic diseases with increased bone metabolism the duration of treatment with Miacalcic® must be from several months to several years. During treatment, blood ALP concentration and urinary excretion of hydroxyproline are reduced, and often normalized. However, it should be borne in mind that in some cases after the initial decrease, these values may rise again. In these cases, in deciding whether to cancel treatment or when to resume it, the doctor should be guided by the clinical picture. One or more months after treatment withdrawal bone metabolism disorders may reoccur, in this case new treatment with Miacalcic® will be required.

As salmon calcitonin is a peptide, there is a possibility of systemic allergic reactions. There have been reports of allergic reactions, including isolated cases of anaphylactic shock, that have occurred in patients receiving Miacalcic®. If hypersensitivity of a patient to salmon calcitonin is suspected skin tests should be performed prior to the beginning of treatment using diluted sterile solution of Miacalcic® preparation.

Miacalcic® solution for injection contains almost no sodium (less than 23 mg).

Impact on ability to drive vehicles and operate machinery. The effect of the drug Miacalcic® on the ability to drive vehicles and operate mechanisms has not been studied. Some side effects of the drug, such as dizziness and visual disturbances may impair the ability to drive a vehicle and to perform potentially dangerous activities requiring increased concentration and rapid psychomotor reaction.

Note. During long-term therapy it is possible formation of antibodies to calcitonin, but as a rule it does not influence the clinical effectiveness. The phenomenon of habituation, which is observed mainly in patients with Paget’s disease receiving long-term therapy, may be a consequence of saturation of binding sites and obviously has no relation to the formation of antibodies. The therapeutic effect of Miacalcic® recovers after a break in treatment.

Contraindications

Sensitivity to synthetic salmon calcitonin and other components of the drug.

Side effects

Immune system disorders: rare – hypersensitivity; very rare – anaphylactic or anaphylactoid reactions, anaphylactic shock.

Nervous system disorders: often – headache, dizziness.

Sensory organs: often – taste disorders; sometimes – visual disturbances.

Cardiovascular system: often – hot flashes; sometimes – arterial hypertension.

Gastrointestinal disorders: often – nausea, abdominal pain, diarrhea; sometimes – vomiting.

Skin and subcutaneous tissue: rarely – generalized rash.

Skeletal and muscular system and connective tissue: often – arthralgia; sometimes – pain in bones and muscles

Perior urinary system: rarely – polyuria.

As to the body in general and local reactions: often – increased fatigue; sometimes – flu-like syndrome, facial, peripheral and generalized edema; rarely – chills, reactions at the site of administration of the drug, itching.

Respiratory system disorders: very often – nasal cavity pain, congestion, nasal mucous edema, sneezing, rhinitis, dry nasal cavity, allergic rhinitis, erythema of the nasal mucosa, irritation, unpleasant odor, formation of exoriations in the nasal cavity; frequently – nasal bleeding, sinusitis, ulcerative rhinitis, pharyngitis; sometimes – cough.

Overdose

Symptoms: Nausea, vomiting, hot flashes, and dizziness are dose-dependent with parenteral administration of Miacalcic®. Therefore, similar phenomena may be expected in case of overdose of Miacalcic® administered intranasally. However, there are reports of cases in which Miacalcic® nasal spray was administered in a dose of up to 1600 ME once and in a dose of 800 ME per day for 3 days and no serious adverse events were observed. Occasional cases of overdose have been reported. In overdose, hypocalcemia with symptoms such as paresthesias, muscle twitching are possible.

The treatment: symptomatic; in case of hypocalcemia – administration of calcium gluconate.

Pregnancy use

In experimental studies the drug Miacalcic had no embryotoxic and teratogenic effects and did not penetrate through the placental barrier.

But there is no clinical data about the safety of the drug Miacalcic during pregnancy. In this regard, the drug should not be used in women during pregnancy.

It is unknown whether salmon calcitonin penetrates into human breast milk, therefore it is recommended to avoid breastfeeding during the therapy with the drug.