Миакальцик®

General characteristics. Structure:

Active agent: synthetic calcitonin of a salmon 2200 ME
Excipients: a benzalkoniya chloride, sodium chloride, Acidum hydrochloricum (for regulation рН), the water purified.

Description: inodorous transparent colourless solution

Pharmacological properties:

Pharmacodynamics. The hormone produced by S-cells of a thyroid gland is an antagonist of parathyroid hormone and together with it participates in regulation of exchange of calcium in an organism.
The structure of all calcitonins is presented by one chain from 32 amino acids and a ring from 7 amino-acid remains on the N-end which sequence is not identical at different types. As the calcitonin of a salmon has higher affinity to receptors (in comparison with calcitonins of mammals), its action is expressed most both on force, and on duration.
Suppressing activity of osteoclasts due to impact on specific receptors, a calcitonin of a salmon significantly reduces the speed of exchange of a bone tissue to normal level at states with the raised resorption speed, for example, at osteoporosis.
Both at animals, and at the person it was shown that Miakaltsik has analgetic activity at pains of a bone origin which, apparently, is caused by immediate effect on the central nervous system.
After single use of Miakaltsik of nasal spray for the person clinically significant biological response which is shown by increase in excretion with urine of calcium, phosphorus and sodium (due to decrease in their canalicular reabsorption) and decrease in excretion of hydroxyproline is noted. At long (within 5 years!) Miakaltsik's use it is reached considerable and permanent decrease in level of biochemical markers of bone exchange, such as serumal S-telopeptidy (sCTX) and bone isoenzymes of an alkaline phosphatase.
Miakaltsik's use of nasal spray leads to statistically significant increase (for 1-2%) the mineral density of a bone in lumbar vertebrae which is defined on the first year of treatment and remains up to 5 years. Miakaltsik provides maintenance of mineral density in a femur.
Miakaltsik's use of nasal spray in a dose 200 ME in days leads to statistically and clinically significant decrease (for 36%) risk of development of new fractures of vertebras in group of the patients receiving Miakaltsik (in a combination with vitamin D drugs й calcium), in comparison with group of the patients receiving placebo (in a combination with the same drugs). Besides, in group of the patients treated by Miakaltsik (in a combination with drugs of vitamin D and calcium), in comparison with group of the patients receiving placebo (in a combination with the same drugs), decrease by 35% of frequency of multiple fractures of vertebrae is noted. The calcitonin reduces gastric and exocrine pancreatic secretion.

Pharmacokinetics. Bioavailability of Miakaltsik applied intranazalno makes 3-5% in relation to bioavailability of the drug used parenterally. Miakaltsik is quickly soaked up through a mucous membrane of a nose and its maximum concentration in plasma is reached within the first hour (on average about 10 minutes). The elimination half-life makes about 20 minutes. At repeated purposes of drug of cumulation it is noted. At uses of drug in the doses exceeding the recommended, its concentration in blood were higher (that was confirmed by increase in the area under a curve "concentration time" (AUC)), but relative bioavailability at the same time did not increase.
Definition of concentration of a calcitonin of a salmon in plasma, as well as concentration of other polypeptide hormones, is represented invaluable as on the level of concentration it is impossible to predict a therapeutic effectiveness of drug. Thus, Miakaltsik's activity should be estimated on clinical indicators of efficiency.
The calcitonin of a salmon does not get through a placental barrier at the person.

Indications to use:

- Treatment of post-menopausal osteoporosis.
- The ostealgias connected with ossifluence and/or an osteopeniya.
- Pedzhet's disease (deforming osteit).
- Neurodystrophic diseases (synonyms: an algoneyrodistrofiya, Zudek's atrophy), caused by various etiological and contributing factors, such as posttraumatic painful osteoporosis, reflex dystrophy, humeroscapular syndrome, kauzalgiya, medicinal neurotrophic disturbances.

Route of administration and doses:

Drug should be used intranazalno. Miakaltsik is recommended to make administration of nasal spray serially in one, in other nasal course.
For treatment of osteoporosis the recommended dose makes 200 ME in days. For the purpose of prevention of progressive loss of bone weight along with Miakaltsik's use of nasal spray purpose of adequate doses of calcium and vitamin D is recommended. Treatment should be carried out for a long time.
The ostealgias connected with ossifluence and/or an osteopeniya. The daily dose makes 200-400 ME daily. The daily dose, a component 200 ME, can be entered for 1 time. Higher doses should be divided into several introductions. The dose should be adjusted taking into account individual needs of the patient.
For achievement of full analgetic effect several days can be required. When performing long therapy the initial daily dose is usually reduced and/or increase an interval between introductions.
Pedzhet's disease. Drug appoint daily in a daily dose 200 ME. In certain cases in an initiation of treatment the dose 400 ME in days, appointed in several introductions can be required.
Duration of treatment makes at least 3 months; if necessary it can be more. The dose should be adjusted taking into account individual needs of the patient.
Note. At a disease Pedzheta has to make duration of treatment by Miakaltsik from several months to several years. Against the background of treatment essential decrease in concentration of an alkaline phosphatase in blood and excretion of hydroxyproline with urine, sometimes to normal values is noted. However, in some cases after initial decrease in value of these indicators can raise again. In these cases the doctor, being guided by a clinical picture, has to decide whether it is necessary to cancel treatment and when it can be renewed.
In one or several months after cancellation of treatment of disturbance of metabolism of a bone tissue can arise again; in this case carrying out a new course will be required.
Neurodystrophic diseases. Early diagnosis is extremely important. Treatment should be begun at once after confirmation of the diagnosis. Appoint on 200 ME/days (in one introduction) daily within 2-4 weeks. Perhaps additional appointment on 200 ME every other day during term up to 6 weeks depending on dynamics of a condition of the patient.
Use for children
Experience of use of Miakaltsik of nasal spray for children is limited in this connection it is not possible to make recommendations for this age group.
Use for patients of advanced age and separate groups of patients
Extensive experience of use of Miakaltsik of nasal spray for elderly patients demonstrates that in this age group deterioration, portability of drug or need to change the dosing mode is noted. The same concerns patients with depression of function of kidneys or a liver though researches especially for these groups of patients were not conducted.

Features of use:

As the calcitonin of a salmon is peptide, there is a probability of emergence of system allergic reactions. There are messages on allergic reactions, including separate cases of an acute anaphylaxis which took place at the patients receiving Miakaltsik nasal spray. At suspicion on hypersensitivity of the patient to a calcitonin of a salmon prior to treatment it is necessary to carry out by drug skin tests with use of the diluted sterile solution for injections, Miakaltsik.
Note. At long therapy antibody formation to a calcitonin is possible, however it, as a rule, does not influence clinical performance. The accustoming phenomenon which is observed generally at the patients with Pedzhet's disease receiving long therapy can be a consequence of saturation of places of binding and obviously has no relation to antibody formation. The therapeutic effect of Miakaltsik is recovered after a break in treatment.

Influence on ability to manage motor transport and to work with mechanisms
Miakaltsik's influence on ability to manage motor transport and to work with mechanisms was not studied. Some side effects of drug, such as dizziness, increased fatigue and visual disturbances, can negatively influence ability to drive the car and to carry out potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

It was reported about such undesirable effects as the nausea, vomiting, dizziness, insignificant rushes of blood to the person which are followed by a caumesthesia, arthralgias. Nausea, vomiting, dizziness and inflows depend on a dose and more often arise at intravenous, than at intramuscular or hypodermic introduction. Against the background of Miakaltsik's use development of a polyuria and fever which usually disappear independently is possible, and only in some cases demand a temporary dose decline of drug.
Frequency of development of the undesirable phenomena, perhaps connected using drug, is estimated as follows: very often (> 1/10); often (> 1/100, <1/10); sometimes (> 1/1 000, <1/100); seldom (> 1/10 000, <1/1 000), including separate messages.
From immune system: seldom - hypersensitivity; very seldom anaphylactic or anaphylactoid reactions, acute anaphylaxis;
From a nervous system: often - a headache, dizziness, flavoring disturbances;
From sense bodys: sometimes - visual disturbances.
From cardiovascular system: often - inflows; sometimes - arterial hypertension;
From respiratory tracts: very often - morbidity in a nasal cavity, developments of stagnation, hypostasis in mucous a nose, sneezing, rhinitis, dryness in a nasal cavity, allergic rhinitis, an erythema mucous a nose, irritation, an unpleasant smell, formation of excoriations in a nasal cavity; often - nasal bleedings, sinusitis, ulcer rhinitis, pharyngitis; инб^да - cough;
From digestive tract: often - nausea, an abdominal pain, diarrhea; sometimes - vomiting;
From skin and hypodermic cellulose: seldom - generalized rash.
From skeletal muscular system and connecting fabric: often - arthralgias; sometimes - an ostealgia and muscles;
From an urinary system: seldom - a polyuria.
From an organism in general and local reactions: often - increased fatigue; sometimes - a grippopodobny syndrome, face edemas, peripheral and generalized hypostases, it is rare - a fever, reactions in a drug injection site, an itch.

Interaction with other medicines:

At use of a calcitonin together with drugs of lithium decrease in plasma concentration of lithium is possible. Thus at co-administration of Miakaltsik and drugs of lithium there can be a need for dose adjustment of the last.

Contraindications:

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

Pregnancy and period of breastfeeding
In pilot studies Miakaltsik had no embriotoksichesky and teratogenic effect and did not get through a placental barrier.
However there are no clinical data on safety of use of Miakaltsik during pregnancy. In this regard drug should not be used at women during pregnancy.
It is unknown whether the calcitonin of a salmon gets into breast milk at the person therefore during therapy drug recommends to refuse feeding by a breast.

Overdose:

At parenteral use of Miakaltsik nausea, vomiting, inflows and dizziness have dozozavisimy character. Therefore at overdose of Miakaltsik applied intranazalno it is possible to expect the similar phenomena. However, there are messages on cases when Miakaltsik nasal spray was applied in a dose to 1600 ME once and in a dose 800 ME in days within 3 days, at the same time no serious undesirable phenomena were noted. There are messages on separate cases of overdose. Symptomatic treatment.
At overdose development of a hypocalcemia with such symptoms as paresthesias twitching of muscles is possible. Treatment: administration of calcium of a gluconate.

Storage conditions:

Prior to use to store in the refrigerator at 2-8 °C. Not to freeze.
Later began to store uses at a temperature below 25 °C within no more than 4 weeks (not to store in the refrigerator). For ensuring the correct spraying the bottle needs to be stored in vertical position.
To store in the place, unavailable to children. List B. Period of validity 3 years. Drug should not be used after expiry date.

Issue conditions:

According to the recipe

Packaging:

Spray a nasal 200 ME/dose of 2 ml in a bottle from colourless glass. One or two bottles with the screw-on spraying portioning device together with the application instruction in a cardboard pack.