Миакальцик®

General characteristics. Structure:

Active agent: 1 ml of solution for injections includes 100 ME synthetic calcitonins of a salmon (1 ME there correspond 0,2 mkg medicinal to substance);
 
other components: ice acetic acid, acetate sodium trihydrate, sodium chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. Molecules of all calcitonins contain until 32 amino-acid rests in one polypeptide chain, and the sequence of the remains at different types different. The calcitonin of a salmon has higher relationship with receptors in comparison with synthetic calcitonins of mammals (including a synthetic calcitonin of the person) therefore Miakaltsik in the clinical relation is more active drug with a bigger duration of action.
 
The calcitonin - active agent of Miakaltsik - is one from major factors of regulation of mineral exchange and metabolism in a bone tissue. On the influence on bone weight is an antagonist of parathormone, at the same time the calcitonin influences both a bone tissue, and a calcium homeostasis. Miakaltsik significantly reduces a calcium exit from bones at states with the increased speed of a resorption and osteogenesis, such as osteoporosis, Pedzhet's disease, ossifluence at malignant new growths. Braking of activity of osteoclasts and, obviously, increase in education and activity of osteoblasts is noted. Miakaltsik suppresses ossifluence which leads to decrease patholologically in the raised calcium level in serum. Besides, drug increases release of calcium, phosphorus and sodium with urine due to decrease in their reabsorption in tubules. Thus concentration of calcium in serum does not decrease below norm.
 
Miakaltsik shows analgetic action, especially at pain of a bone origin. This effect has the central mechanism of action as in some sites of TsNS specific places binding of a calcitonin of a salmon are revealed.
 
Miakaltsik reduces gastric secretion and exocrine function of a pancreas. Its clinical performance is based on this actions at acute pancreatitis.
 
Pharmacokinetics. Miakaltsik's bioavailability makes about 70% both after intramuscular, and after a subcutaneous injection. The maximum concentration in blood is reached within 1 hour.
 
Linkng with proteins of plasma makes 30 - 40%. The imaginary volume of distribution makes 0,15 - 0,3 l/kg. To 95% of a calcitonin and its metabolites only 2% - in an invariable look are removed with urine, and. An elimination half-life - from 70 to 90 minutes.

Indications to use:

- Post-menopausal osteoporosis at early and late stages;
- senile osteoporosis;
- the secondary osteoporosis for example caused to treatments by glucocorticoids or an immobilization.
- An ostealgia, connected with ossifluence and/or остеопениею.
- Kistkova Pedzhet's disease (deforming osteit).
- The hypercalcemia and giperkaltsiyemichesky crisis, are caused by such factors: the ossifluence caused by malignant tumors (a carcinoma of a mammary gland, lungs, kidneys, a myeloma, etc.); a giperparatireodizm, an immobilization, intoxication vitamin D (both for stopping of medical emergencies, and for prolonged treatment of chronicities - until the effect of specific therapy of a basic disease is shown).
- Neurodystrophic diseases (synonimy: the algodistrofiya or Zudek's disease), are caused by different etiological and advantage factors, such as posttraumatic painful osteoporosis, reflex dystrophy, a syndrome "shoulder brush", a kauzalgiya, medicinal neurotrophic disturbance.
- Acute pancreatitis.

Route of administration and doses:

Osteoporosis. Subcutaneously or intramusculary in a daily dose of 50 - 100 ME daily or every other day (depending on disease severity). In a combination with reception adequate which answer potreba of an organism, doses of drugs of calcium and vitamin D - for prevention the progressing loss of bone weight.
 
Ostealgia, connected with ossifluence and/or остеопениею. The dose is established individually. Intravenously kapelno (at normal saline solution), subcutaneously or intramusculary in several introductions, in a daily dose of 100 - 200 ME daily - before achievement of side clinical effect.
 
Several days (can be necessary for achievement of full analgetic effect at any way of introduction). When performing long therapy the daily dose is ordinary reduced and/or increase an interval between introductions.
 
Pedzhet's disease. Subcutaneously or intramusculary in a daily dose 100 ME daily or every other day.
 
Treatment duration, irrespective of a way of introduction, makes at least 3 months; if necessary it can be bigger. The dose of drug is adjusted taking into account reaction of the patient to treatments.
 
Note. At Pedzhet's disease, and also at other chronic diseases with the raised metabolic rate of a bone tissue duration of treatment by Miakaltsik has to make from several months to several years. Against the background of treatment concentration of an alkaline phosphatase in blood and hydroxyproline excretion with urine decrease, and it is frequent and are normalized. However it must be kept in mind that in some cases after initial decrease value of these indicators can raise again. In these cases, resolving the issue concerning cancellation of treatment or time its resuming, the doctor has to be controlled a clinical picture. In one or several months after treatment cancellation disturbance of metabolism of a bone tissue can arise again; in this case carrying out a new course of treatment by Miakaltsik is necessary.

Hypercalcemia.

Neotlozhne of treatment of giperkaltsiyemichesky crisis. As intravenous infusion is most efficiently introductions, at medical and other serious conditions this way of introduction should prefer.
 
Intravenously kapelno (within at least 6th hour) in a daily dose of 5 - 10 ME/kg of body weight in 500 ml normal saline solution. Perhaps also in/in jet slow introductions (the daily dose should be divided into 2 - 4 introductions).
 
Long-term treatment at a chronic hypercalcemia. Subcutaneously or intramusculary in a daily dose of 5 - 10 ME/kg; frequency rate of introduction - 1 - 2 time a day. The mode of a dosage should be adjusted taking into account dynamics of a clinical condition of the patient and biochemical indicators. If the volume of Miakaltsik which is entered exceeds 2 ml, prefer vnutrimyshechnyy to injections which should be carried out to different places.

Neurodystrophic diseases. Early diagnosis and early an initiation of treatment is very important.
 
Subcutaneously or intramusculary in a daily dose 100 ME within 2 - 4 weeks. Further enter on 100 ME every other day of nearly 6 weeks, depending on dynamics of a condition of the patient.
 
Acute pancreatitis. Miakaltsik apply as a part of complex conservative treatment. Enter intravenously kapelno in a dose 300 ME (at normal saline solution) within 24 hours up to 6 days in a row.

Note. The doctor or the nurse have to instruct in details patients who independently do themselves subcutaneous injections of drug. At prolonged use of Miakaltsik at the patient antibodies to a calcitonin can be formed; however this phenomenon ordinary does not influence clinical performance. The phenomenon of "disappearance" which is observed sometimes at long therapy is caused probably to nasyshcheniye of places binding, but not to antibody formations. After a break in treatment the therapeutic effect of Miakaltsik renews.
 
Use for treatment of children. There are not enough data on long use of Miakaltsik for treatment of children. In this connection it is not possible to give recommendations for this age group.
 
Use for treatment at elderly people. Experience of use of injection solution of Miakaltsik for treatment of elderly people demonstrates about what in this age group is noted to deterioration in portability of drug or need to change the dosage mode. It concerns also patients with the lowered function of a liver or kidneys though researches especially for these groups of patients were not conducted.

The ways of introduction recommended at different indications are given in the table. 

Way of introduction	Hypodermic (p/sh)	Internally - muscular (in oil)	Intravenous jet (in/in p.)	Intravenous drop (in/in the territory)
Osteoporosis	x	x
Ostealgia	x	x		x
Pedzhet's disease	x	x
Hypercalcemia urgent introductions chronicity	x	x	x	x
Neurodystrophic diseases	x	x
Acute pancreatitis				x

 

Features of use:

As the calcitonin of a salmon represents peptide, system allergic reactions are possible. To patients who inclined to allergic reactions, prior to treatment it is necessary to carry out skin test.
 
Miakaltsik does not pass through a placental barrier at animals. Experience of use of Miakaltsik by pregnant women is absent. During treatment by Miakaltsik chest feeding is not recommended. There are data which demonstrate that the calcitonin gets into breast milk.
 
Influence on ability to drive the car and to work with mechanisms. There are no data about Miakaltsik's influence on ability of the patient to drive the car and to work with mechanisms. Miakaltsik can cause dizziness that can negatively affect ability of the patient to bystry reactions. The doctor has to warn the patient that in case of developing of dizziness he / she does not need to drive the car or to work with mechanisms.

Side effects:

The nausea, vomiting, dizziness, insignificant rushes of blood to the person which are followed by a caumesthesia, an arthralgia can be noted. These effects depend on a dose and it is most often noted at intravenous administration in comparison with intramuscular and hypodermic introduction. Seldom - a polyuria, a fever. These effects ordinary disappear independently, and the temporary dose decline only in some cases can be necessary.
 
Seldom Miakaltsik can cause development of reactions of hypersensitivity: as local (in a drug injection site), and generalized skin reactions. It was reported about development of reactions as anaphylactic which revealed tachycardia, arterial hypotension, a collapse.

Interaction with other medicines:

Interactions with a calcitonin of a salmon are not reported about cases medicinal.

Contraindications:

Hypersensitivity to a calcitonin of a salmon or other components of drug.

Overdose:

Nausea, vomiting, dizziness, rushes of blood to the person which arise at parenteral administration of Miakaltsik is dozozavisimy undesirable effects. At overdose of parenterally entered Miakaltsik nausea and vomiting were observed. About some serious side effects caused by overdoses it is not reported.
 
Treatment - symptomatic.

Issue conditions:

According to the recipe

Packaging:

To store at a temperature of 2 - 8 °C in the place, unavailable to children. After disclosure of an ampoule solution needs to be used immediately as it does not include preservatives. A period of validity - 5 years.