Miakaltsik

Miakaltsik – the medicine influencing phosphorus-calcium exchange and applied at treatment of osteoporosis.

Form of release and structure

Miakaltsik release in two dosage forms:

• Solution for injections: colourless, transparent (in ampoules on 1 ml, on 5 ampoules in a cardboard pack);
• Spray nasal: colourless, transparent, inodorous (in bottles (bottles) on 2 ml (14 doses), on 1 or 2 bottles in a cardboard pack).

For injections is a part of 1 ml of solution:

• Active ingredient: a synthetic calcitonin of a salmon – 100 ME * (the international units);
• Auxiliary components: acetic acid, trihydrate sodium acetate, sodium chloride, water for injections.

Nasal is a part of 1 ml of spray:

• Active ingredient: a synthetic calcitonin of a salmon – 200 ME *;
• Auxiliary components: chloride a benzalkoniya, sodium chloride, Acidum hydrochloricum, water purified.

* 1 ME there correspond about 0,2 mkg of active ingredient.

Indications to use

• The ostealgias connected with an osteopeniya and/or ossifluence;
• The neurodystrophic diseases (are shown in the form of an algoneyrodistrofiya, Zudek's atrophy) caused by various contributing and etiological factors including medicinal neurotrophic disturbances, posttraumatic painful osteoporosis, reflex dystrophy, kauzalgiya, a humeroscapular syndrome;
• Deforming osteit (Pedzhet's disease);
• Postmenopauzny osteoporosis (early and late stages).

In addition injection solution of Miakaltsik is appointed at treatment of the following diseases / states:

• The Giperkaltsiyemichesky crisis and hypercalcemia caused by such factors as: the ossifluence (a multiple myeloma, a carcinoma of lungs, a mammary gland, kidneys) caused by malignant tumors, an immobilization, a hyperparathyreosis, intoxication vitamin D (for stopping of medical emergencies and long therapy of a chronic hypercalcemia – until the effect of specific treatment of the main disease is shown);
• Primary osteoporosis: senile osteoporosis at men and women;
• The secondary osteoporosis connected with performing therapy by glucocorticoids or an immobilization;
• Acute pancreatitis (along with other medicines).

Contraindications

Contraindication to Miakaltsik's use is hypersensitivity to drug components.

Due to the lack of necessary data pregnant women should not use drug. In the period of a lactation it is recommended to interrupt breastfeeding.

Miakaltsik in any dosage form do not appoint to children due to the lack of sufficient data about safety and efficiency of its use for this age group.

Route of administration and dosage

Solution for injections:
Miakaltsik enter subcutaneously, intramusculary and intravenously.

The mode of dosing is defined by indications:

• Osteoporosis: subcutaneously or intramusculary; a daily dose – 50 or 100 ME, daily or every other day (is defined by disease severity). For prevention of progressive loss of bone weight together with Miakaltsik purpose of adequate doses of vitamin D and calcium is recommended;
• The ostealgias connected with an osteopeniya and/or ossifluence: intravenously, kapelno (in normal saline solution), subcutaneously or intramusculary; a daily dose – 100-200 ME in several introductions, daily. Therapy is carried out to achievement of satisfactory clinical effect. Carrying out dose adjustment taking into account reaction of the patient to therapy is possible. To reach full analgetic effect several days can be required. When performing long treatment usually reduce an initial daily dose and/or increase a break between introductions;
• Pedzhet's disease: subcutaneously or intramusculary; a daily dose – 100 ME, daily or every other day. Course duration – is not less than 3 months, in cases of need more long therapy is possible. Carry sometimes out dose adjustment taking into account reaction of the patient to treatment;
• Giperkaltsiyemichesky crisis (urgent treatment): intravenously kapelno for at least 6 hours; a daily dose – 5-10 ME/kg in 500 ml of normal saline solution. Also perhaps intravenous jet slow administration, in this case a daily dose are divided into 2-4 introductions;
• Chronic hypercalcemia (long therapy): subcutaneously or intramusculary; a daily dose – 5-10 ME/kg, once or in 2 introductions. The scheme of use of Miakaltsik needs to be adjusted taking into account dynamics of biochemical indicators and a clinical condition of the patient. If the daily dose is more than 2 ml, intramuscular use of drug is more preferable, solution needs to be entered into different places;
• Neurodystrophic diseases: subcutaneously or intramusculary; a daily dose – 100 ME, course duration – 2-4 weeks. Depending on dynamics of a condition of the patient further Miakaltsik it is possible to enter every other day in the same dose for no more than 1,5 months. Therapy is recommended to be begun right after confirmation of the diagnosis;
• Acute pancreatitis (along with other drugs): intravenously kapelno; a daily dose – 300 ME (in normal saline solution), daily for no more than 6 days.

Spray nasal:
Miakaltsik apply intranazalno, it is more preferable – serially in one and other nasal course.

The mode of dosing is defined by indications:

• Osteoporosis: a daily dose – 200 ME. For prevention of progressive loss of bone weight along with performing therapy use of adequate doses of vitamin D and calcium is recommended. As a rule, prolonged treatment;
• The ostealgias connected with an osteopeniya and/or ossifluence: a daily dose 200-400 ME, in 1 (200 ME) or several introductions (higher doses), daily. The correcting of the scheme of use of Miakaltsik taking into account individual needs of the patient is possible. At long therapy the dose decline or increase in an interval between administrations of drug is possible;
• Pedzhet's disease; a daily dose – 200 ME, increase to 400 ME (in several introductions), daily is sometimes possible. Therapy duration – is not less than 3 months (if necessary it can be increased up to several years). The correcting of the scheme of use of drug taking into account individual needs of the patient is possible. During therapy essential reduction of concentration of an alkaline phosphatase in blood and excretion of hydroxyproline with urine, in certain cases – to normal values can be noted. Sometimes values of these indicators after initial decrease can increase again. The question of cancellation or continuation of therapy is solved the doctor individually. If in one or several months after the end of therapy of disturbance of metabolism of a bone tissue arise again, carrying out a repeated course can be required;
• Neurodystrophic diseases: an initial daily dose – 200 ME (in one introduction), daily for 2-4 weeks. In need of further drug is used every other day in the same dose by no more than 6 weeks (depends on dynamics of a condition of the patient). Therapy needs to be begun right after confirmation of the diagnosis.

Elderly patients and patients with reduced function of kidneys or a liver should not adjust the mode of dosing of Miakaltsik in any dosage form.

The bottle with spray nasal never should be stirred up as at the same time in solution vials of air can be formed that can lead to the wrong dosing.

At the first use the bottle needs to be held strictly in vertical position. To squeeze out air from a tubule, it is necessary to press 3 times on the piston. After that color of a window of the counter of doses will be replaced with red on green that means readiness of the device for work. After each use the figure in a window of the counter of doses changes. The bottle contains 14 doses, thanks to the provided solution rest, possibly receiving 2 more additional doses.

At spray use the tip of a bottle has to be located on one line with the nasal course. It will allow to provide more hypodispersion of drug.

To warn a solution effluence, after a vspryskivaniye it is necessary to make several vigorous breaths a nose. It is not recommended to clean a nose right after Miakaltsik's introduction. At purpose of 2 doses, they are entered into the different nasal courses.

It is impossible to try to increase a sprayer opening by means of a needle or other sharp objects as it can lead to disturbance of operation of the portioning device.

Side effects

During use of all dosage forms of Miakaltsik there were messages on development of such undesirable actions as dizziness, vomiting, nausea, arthralgias, the insignificant rushes of blood to the person which are followed by feeling of heat. Dispepsichesky frustration, inflows and dizziness depend on the applied dose, at intravenous administration of drug they develop more often than at hypodermic or intramuscular. Also during therapy there can be a polyuria and a fever which, as a rule, pass independently and only in certain cases demand temporary decrease in a dose of Miakaltsik.

Frequency of development of the side effects which are perhaps connected with performing therapy is estimated as follows (≥1/10 – very often; ≥1/100, <1/10 – часто; ≥1/1000, <1/100 – иногда; ≥1/10 000, <1/1000, включая отдельные сообщения – редко):

• Nervous system: often – dizziness, a headache;
• Cardiovascular system: often – inflows; sometimes – arterial hypertension;
• Immune system: seldom – hypersensitivity; very seldom – an acute anaphylaxis, anaphylactoid or anaphylactic reactions;
• Digestive tract: often – dispepsichesky frustration (in the form of an abdominal pain, nausea, diarrhea); sometimes – vomiting;
• Urinary system: seldom – a polyuria;
• Skeletal and muscular system and connecting fabric: often – arthralgias; sometimes – muscle and bones pain;
• Skin and hypodermic cellulose: seldom – generalized rash;
• Sense bodys: often – flavoring disturbances; sometimes – visual disturbances;
• Organism in general and local reactions: often – increased fatigue; sometimes – face edemas, a grippopodobny syndrome, generalized and peripheral hypostases; seldom – reactions in a solution injection site, a fever, an itch.

At Miakaltsik's use in the form of spray nasal disturbances in addition can develop from respiratory tracts: very often – the unpleasant smell, developments of stagnation, morbidity in a nasal cavity, swelled mucous a nose, rhinitis, sneezing, dryness in a nasal cavity, an erythema mucous a nose, allergic rhinitis, irritation, formation of excoriations in a nasal cavity; often – sinusitis, nasal bleedings, pharyngitis, ulcer rhinitis; sometimes – cough.

Special instructions

The ampoule with injection solution should not be damaged, solution has to be colourless, transparent, without foreign inclusions. Solution, unused after single use, in an ampoule needs to be utilized. Before intramuscular and hypodermic introduction Miakaltsik's solution needs to be heated to room temperature.

At long therapy at patients antibodies to a calcitonin can be formed that, as a rule, does not influence clinical performance. Most often the phenomenon of "uskolzaniye" is observed at Pedzhet's disease, after a break in therapy the therapeutic effect is usually recovered.

The calcitonin of a salmon belongs to peptides therefore there is a probability of development of system allergic reactions. At suspicion on hypersensitivity of the patient to active agent prior to performing therapy it is necessary to carry out skin tests with use of divorced sterile solution of drug.

Injection solution practically does not contain sodium (less than 23 mg).

During therapy it is necessary to consider a possibility of development of some side effects of drug (visual disturbances, dizziness) which are negatively influencing ability to drive the car and performance of potentially dangerous types of the works demanding the increased concentration of attention and bystry psychomotor reactions.

Medicinal interaction

At Miakaltsik's use along with drugs of lithium decrease in plasma concentration of lithium is possible that can result in need of correction of doses of these drugs.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 2-8 °C, not to freeze.

Period of validity:

• Spray nasal – 3 years;
• Injection solution – 5 years.

After opening of a bottle with spray nasal, drug can be used for 4 weeks on condition of its storage at the room temperature, avoiding sharp temperature differences.