Miacalcium injection 1 ml 5 ampoules
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Active ingredients
Calcitonin
Release form
Solution
Composition
Synthetic salmon calcitonin 100 IU *.
Pharmacological effect
The hormone produced by C-cells of the thyroid gland is an antagonist of parathyroid hormone and, together with it, participates in the regulation of calcium metabolism in the body. species. Since salmon calcitonin has a higher affinity for receptors (compared to mammalian calcitonin), its effect is most pronounced in both strength and duration. By suppressing osteoclast activity due to the effect on specific receptors, salmon calcitonin significantly reduces the rate of bone metabolism to normal levels in conditions with an increased rate of resorption, such as osteoporosis. In both animals and humans, it was shown that Miacalcium has analgesic activity with pain of bone origin, which, apparently, is due to a direct effect on the CNS. Already after a single use of Miacalcica in humans, a clinically significant biological response is observed, which is manifested by an increase in urinary excretion of calcium, phosphorus and sodium (due to a decrease in their tubular reabsorption ) and a decrease in the excretion of hydroxyproline. Prolonged parenteral use of Miacalcic leads to a significant decrease in the level of biochemical markers of bone metabolism, such as pyridinoline and bone isoenzymes of alkaline phosphatase. Calcitonin reduces gastric and exocrine pancreatic secretion. These properties of Miacalcic determine its effectiveness in the treatment of acute pancreatitis.
Pharmacokinetics
Absorption and distribution The bioavailability of calcitonin salmon used in the / m or s / c, is about 70% .Cmax in plasma is achieved within the first hour. The apparent Vd is 0.15-0.3 l / kg. Binding to plasma proteins - 30-40%. Metabolism and elimination: Up to 95% of calcitonin and its metabolites are excreted in the urine, with only 2% - unchanged. T1 / 2 is about 1 hour with i / m administration and 1-1.5 h - with s / c administration.
Indications
Treatment of postmenopausal osteoporosis. Bone pain associated with osteolysis and / or osteopenia. Pedzhet's disease (deforming osteitis). Neurodystrophic diseases (synonyms: algoneurodystrophy, Zudek atrophy) caused by various etiological and predisposing factors, which are used by a group of people that aren’t allynostomaticsysthe people, atopicoscopic syndrome, Zoodek atrophy, caused by various etiological and predisposing factors. humeroscapular syndrome, causalgia, medicinal neurotrophic disorders.
Contraindications
Hypersensitivity to synthetic salmon calcitonin or any other component of the drug.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Experimental studies have established that Miacalcic does not have embryotoxic and teratogenic effects. Does not penetrate the placental barrier. However, clinical data on the safety of the use of Miacalcik during pregnancy is not available. In this regard, it is not recommended to use the drug in pregnant women. It is not known whether calcitonin is excreted salmon from breast milk in humans, therefore, breastfeeding is not recommended during drug treatment.
Dosage and administration
The solution for injection is administered subcutaneously, intramuscularly or by continuous intravenous infusion. When self-administering the drug to the muscle or subcutaneously, the patient should be thoroughly instructed by medical staff. The treatment course, application features and doses of the drug are individual for each patient depending on the nature and severity of the disease, as well as the individual characteristics of each patient. In osteoporosis, it is usually prescribed in the form of subcutaneous or intramuscular injections of 50 or 100 IU every 24 or 48 hours. When using the drug in the form of a nasal spray, 200ME is prescribed 1 time per day. Long-term treatment, to prevent bone loss, it is necessary during the period of treatment with Miakalcik to prescribe calcium supplements and vitamin D. Osteolysis and / or osteopenia, which are accompanied by pain in the bones: usually prescribed as subcutaneous, intramuscular injections or intravenous infusions (infusion solution is prepared on isotonic solution of sodium chloride) in a daily dose of 100-200ME. The drug is used to improve the condition.When applying the nasal spray dose is 200-400ME per day. The dose to 200ME is administered in 1 dose, if the daily dose exceeds 200ME, then it is divided into several doses. If a long course of treatment is planned, it is necessary to adjust the initial dose or increase the intervals between injections. In case of deforming osteitis, it is administered subcutaneously or intramuscularly at 100 IU every 24 or 48 hours. When using the spray, it is prescribed in the initial dose of 200 or 400 ME, then continue therapy with the drug in the dose of 200 ME. The minimum course of treatment is 3 months. During the course of treatment, the dose of the drug may be changed depending on the effectiveness and tolerability of the drug. Some time after the drug is discontinued, the patient's condition may deteriorate again and then it is necessary to decide on a repeat course. In case of a hypercalcemic crisis, intravenous infusions are prescribed. Assign intravenously drip at 5-10ME / kg body weight, the dose is diluted in 500 ml of 0.9% sodium chloride, injected within 6 hours. An alternative to this method of administration is the jet injection of a daily dose, divided into several infusions. In chronic hypercalcemia, long-term treatment with Miacalcic is performed. Injected subcutaneously or intramuscularly at 5-10ME / kg body weight 1-2 times a day. If the required dose of the drug exceeds 200 ME, it is recommended to use the intramuscular route of administration of the drug, while it is desirable to alternate the muscles into which injections are made. When neurodystrophic diseases are usually administered intramuscularly or subcutaneously, 100 ME per day. The course of treatment is 2-4 weeks. If necessary, continue therapy with the drug is administered at 100 ME every 48 hours to 6 weeks of therapy. When using a nasal spray, 200ME is prescribed every 24 hours. The course of treatment is 2-4 weeks. If it is necessary to continue treatment with the drug, use ME 200 every 48 hours for up to 6 weeks of treatment. In acute pancreatitis, Miacalcium is used in complex treatment. It is usually administered intravenously in 300ME in 0.9% sodium chloride solution for up to 6 days in a row. It is not necessary to adjust the dose in the treatment of elderly patients, as well as with impaired liver and / or kidney function.
Side effects
It was reported on such undesirable effects as nausea, vomiting, dizziness, slight flushing of the face, accompanied by a sensation of heat, arthralgia. Nausea, vomiting, dizziness, and hot flashes are dose dependent and occur more often with intravenous than with intramuscular or subcutaneous administration.Against the background of Miacalcik, it is possible to develop polyuria and chills, which usually disappear on their own, and only in some cases require a temporary reduction in the dose of the drug. The incidence of adverse events, possibly associated with the use of the drug, is estimated as follows: very often (more than 1/10); often (more than 1/100, less than 1/10); sometimes (more than 1/1 000, less than 1/100); rarely (more than 1/10 000, less than 1/1 000), including individual messages. On the part of the immune system: rarely - hypersensitivity; very rarely anaphylactic or anaphylactoid reactions, anaphylactic shock; On the part of the nervous system: often - headache, dizziness, taste disturbances; From the senses: sometimes - visual disturbances. Since the cardiovascular system: often-tides; sometimes - arterial hypertension; On the part of the respiratory tract: very often soreness in the nasal cavity, congestion, swelling in the nasal mucosa, sneezing, rhinitis, dryness in the nasal cavity, allergic rhinitis, erythema of the nasal mucosa, irritation, unpleasant smell, formation of excoriation in the nasal cavity; often - nosebleeds, sinusitis, ulcerative rhinitis, pharyngitis; inb ^ yes - cough; On the part of the gastrointestinal tract: often - nausea, abdominal pain, diarrhea; sometimes vomit; From the skin and subcutaneous tissue: rarely - a generalized rash. From the musculoskeletal system and connective tissue: often - arthralgia; sometimes - pain in the bones and muscles; From the urinary system: rarely - polyuria. On the part of the organism as a whole, and local reactions: often - increased fatigue; sometimes flu-like syndrome, swelling of the face, peripheral and generalized edema, rarely - chills, reactions at the injection site, itching.
Overdose
Symptoms: nausea and vomiting, dizziness and flushing are also possible, hypocalcemia may develop with symptoms such as paresthesias, muscle twitching. No serious adverse reactions due to overdose have been reported to date. Treatment: symptomatic therapy is carried out, with the development of hypocalcemia, the introduction of calcium gluconate is recommended.
Interaction with other drugs
When using calcitonin together with lithium preparations, a decrease in the plasma concentration of lithium is possible.Thus, with the simultaneous appointment of Miacalcic and lithium preparations, it may be necessary to adjust the dose of the latter.
special instructions
The doctor or nurse should instruct patients in detail who independently make subcutaneous injections of the drug themselves. Before using Miacalcium, the state of the ampoule and solution should be visually monitored. Ampoule of the drug should not be damaged, the solution is clear, colorless and without foreign inclusions. After a single use of Miacalcica, the unused solution of the drug remaining in the ampoule should be disposed of. Before s / c or v / m administration, the Miacalcic solution should be heated to room temperature. With long-term use of Miacalcic, patients may produce antibodies to calcitonin; however, this phenomenon does not usually affect clinical efficacy. The phenomenon of escape, observed mainly in patients with Paget's disease, receiving Miacalcic for a long time, is probably due to saturation of binding sites, rather than 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 an increased level of bone tissue metabolism, the duration of treatment with Miacalcic should be from several months to several years. During treatment, the concentration of alkaline phosphatase in the blood and the excretion of hydroxyproline in the urine are reduced, and often normalized. However, it should be borne in mind that in some cases, after the initial decline, the values of these indicators may increase again. In these cases, when deciding whether to cancel treatment or about the time of its renewal, the physician should be guided by the clinical picture. One or several months after discontinuation of treatment, disorders of bone tissue metabolism may occur again; in this case, a new course of treatment with Miacalcic will be required. Since salmon is a peptide calcitonin, there is a possibility of systemic allergic reactions. There are reports of allergic reactions, including isolated cases of anaphylactic shock, which occurred in patients who received Miacalcium.If a patient is susceptible to calcitonin salmon prior to treatment, skin tests should be performed using diluted sterile Miacalcic solution. The solution for injection contains almost no sodium (less than 23 mg). Effect on ability to drive motor vehicles and control mechanisms ability to drive vehicles and work with mechanisms has not been studied. Some side effects of the drug, such as dizziness and visual impairment, can adversely affect the ability to drive and perform potentially hazardous activities that require increased concentration and psychomotor reactions.