Somatin – instructions, price in pharmacies, analogues Tabletki.ua

Somatin – instruction, price in pharmacies, analogues | Tabletki.ua

Somatin – complete information on the drug: official instructions, price in the nearest pharmacies for Somatin, a list of analogues. Indications for use, method of administration, side effects, contraindications, pregnancy. Average price UAH 176.69. Reported prices 92 pharmacies.

active substance: somatropin;

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1 vial of the drug contains human recombinant somatropin 1.3 mg (4 IU) or 2.6 mg (8 IU);

excipients: mannitol, glycine, sodium dihydrogen phosphate, disodium phosphate;

solvent: metacresol, water for injection.

Dosage form. Lyophilisate for solution for injection complete with solvent.

Basic physical and chemical properties: preparation – white or almost white powder; solvent – transparent colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Hormones of the anterior pituitary gland and their analogues. Somatropin and somatropin agonists. Somatropin. ATX code H01A C01.

Pharmacological properties Pharmacodynamics.

Somatropin is a strong metabolic hormone that plays an important role in the metabolism of lipids, carbohydrates and proteins. In children with endogenous growth hormone deficiency, somatropin accelerates linear skeletal growth and growth rate. In both adults and children, somatropin maintains a normal body structure by increasing nitrogen absorption, accelerating skeletal muscle growth and mobilizing body fat. Visceral adipose tissue is especially sensitive to somatropin. In addition to stimulating lipolysis, somatropin reduces the supply of triglycerides to fat depots. Concentrations of IGF-1 (insulin-like growth factor, type 1) and IGFBP-3 (binding protein insulin-like growth factor, type 3) in blood serum increase under the influence of somatropin.

Lipid metabolism. Somatropin stimulates the low density lipoprotein (LDL) cholesterol receptors in the liver and affects the serum lipid and lipoprotein profile. In general, the use of somatropin in patients with growth hormone deficiency leads to a decrease in the concentration of LDL and apolipoprotein B..

Metabolism of carbohydrates. Somatropin increases insulin levels, but fasting glucose usually does not change. Children with hypopituitarism may have fasting hypoglycemia. Somatropin inverts this state.

Water-salt exchange. Growth hormone deficiency is associated with a decrease in blood plasma and tissue fluid volumes. Both clen 40 of these indicators grow rapidly after treatment with somatropin. Somatropin promotes the retention of sodium, potassium and phosphorus in the body.

Bone metabolism. Somatropin stimulates skeletal bone tissue renewal. In patients with growth hormone deficiency and osteoporosis, long-term treatment with somatropin leads to an increase in the mineral composition and bone density in the supporting areas..

Physical performance. Long-term treatment with somatropin increases muscle strength and physical endurance. Somatropin also increases cardiac output, but the mechanism of this effect has not yet been elucidated. A decrease in peripheral vascular resistance may play a role in this..

Safety data for long-term use of the drug are still limited..

Pharmacokinetics.

Absorption. The absolute bioavailability of somatropin administered subcutaneously is approximately 80%. The maximum concentration in the blood is reached after 3-6 hours.

Excretion. After subcutaneous application, the elimination half-life can be up to 2-3 hours..

Subpopulations. The bioavailability of somatropin after subcutaneous administration is the same in males and females.

Information on the pharmacokinetics of somatropin in elderly patients, children, patients of various races and in patients with impaired renal and liver function or heart failure is absent or incomplete.

Clinical characteristics.

Indications Children

hormone deficiency

Growth impairment with insufficient secretion of growth hormone (growth hormone deficiency (GHR);

Growth impairment associated with Shereshevsky-Turner syndrome or chronic renal failure.

Growth impairment (the standard deviation (SD) of the current height is less than –2.5 and the standard deviation of genetically determined height is less than tips and tricks to turinabol in uk your hidden bodybuilding –1) in children with low growth below the age norm, born with a weight and / or body length of less than –2 standard deviations that could not reach the age-specific growth rate (the value of the standard deviation of the growth rate is less than 0 during the last year) before they reach 4 years or more.

Growth disorders in Prader-Willi syndrome, in order to improve the growth and structure of the body. The diagnosis of Prader-Willi syndrome should be confirmed by appropriate genetic tests.

Adults

Replacement therapy for adults with severe growth hormone deficiency.

Growth hormone deficiency in adulthood. Patients with severe growth hormone deficiency associated with multiple hormonal deficiencies due to known pathology of the hypothalamus or pituitary gland, as well as patients who have a deficiency of at least one of the pituitary hormones, with the exception of prolactin Such patients should undergo an appropriate dynamic test to establish the presence or absence of growth hormone deficiency..

For patients with growth factor deficiency during childhood (as a result of congenital, genetic, acquired or idiopathic causes), the ability to produce growth hormone should be re-evaluated after the end of longitudinal growth. For patients with a high likelihood of persistent GHD, such as congenital or secondary GHD due to hypothalamic-pituitary disease or stroke, insulin-like growth factor (IGF-I) ISO < –2 без лечения гормоном роста в течение не менее 4 недель должна считаться достаточным основанием для диагностики ДГР. Для всех остальных пациентов достаточно проведения анализа ИРФ-I и одного теста стимуляции гормона роста.

Contraindications Hypersensitivity to the active substance or to any excipient.

Somatropin is forbidden to prescribe if there are any signs of tumor activity. Intracranial tumors must be inactive, and anticancer therapy must be completed before starting growth hormone therapy. If there are any signs of tumor growth, treatment should be discontinued.

SOMATIN should not be used to stimulate growth in children with closed epiphyseal growth zones.

Treatment with SOMATIN is contraindicated in patients who are in acute critical condition as a result of complications of open-heart surgery, abdominal surgery, as a result of multiple trauma, acute respiratory failure or other similar conditions (for information on patients receiving substitution treatment, see the section “Features applications “).

Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Somatropin is contraindicated in children with Prader-Willi syndrome, severe obesity or severe respiratory tract disorders.

In children with chronic kidney disease, somatropin treatment should be discontinued with kidney transplant.

Interaction with other medicinal products and other forms of interaction.

Simultaneous use with glucocorticosteroids (GCS) can suppress the stimulating effect of somatropin preparations on the growth rate. Therefore, it is necessary to carefully monitor the growth of patients receiving GCS treatment in order to be able to assess the potential effect of glucocorticoid use on growth..

Growth hormone reduces the conversion of cortisone to cortisol and may reveal previously undiagnosed central hypoadrenalism or make low-dose glucocorticoids ineffective in replacement therapy.

Somatropin is an inducer of the activity of cytochrome P450 (CYP), which can lead to a decrease in plasma concentration and, accordingly, to a decrease in the effectiveness of drugs that are metabolized with the participation of cytochrome CYP3A, such as sex hormones, corticosteroids, cyclosporine and anticonvulsants.

For additional information on diabetes mellitus and thyroid dysfunction, see the section “Peculiarities of use”, and for oral estrogen replacement therapy – in the section “Method of administration and dosage”.

Application features The diagnosis, initiation of therapy with SOMATIN and follow-up should be carried out by qualified doctors with experience in the diagnosis and treatment of patients in accordance with the indications for use..

Myositis is a very rare side effect that can be caused by the preservative metacresol in the drug. In the case of myalgia or increased pain at the injection site, myositis should be suspected. When it is confirmed, a form of somatropin preparation that does not contain metacresol should be used.

Do not exceed the maximum recommended daily dose (see section “Dosage and Administration”).

Insulin sensitivity

Somatropin can reduce insulin sensitivity. For patients with diabetes mellitus, after starting therapy with somatropin, a dose adjustment of insulin may be required. During therapy with somatropin, the condition of patients with diabetes mellitus, glucose intolerance or additional risk factors for the development of diabetes should be monitored. In rare cases, somatropin therapy can cause significant glucose intolerance that meets the diagnostic criteria for type 2 diabetes.

The risk of developing diabetes mellitus during treatment with somatropin is higher in patients with other risk factors for type 2 diabetes, such as obesity, a family history of diabetes mellitus, steroid treatment, or previously reduced glucose tolerance. In patients with existing diabetes mellitus, the dosage of antidiabetic therapy may require adjustment after prescribing somatropin therapy.

Thyroid function

Growth hormone accelerates the peripheral conversion of T4 to T3, which can lead to a decrease in serum T4 concentration and an increase in serum T3 concentration. While peripheral concentrations of thyroid hormones remain normal in most healthy volunteers, hypothyroidism is theoretically possible in patients with subclinical hypothyroidism. Therefore, all patients should be monitored for thyroid function. Patients with hypopituitarism receiving standard substitution therapy should carefully monitor the potential effect of growth hormone therapy on thyroid function..

In the case of secondary growth hormone deficiency due to treatment of malignant diseases, it is recommended to pay attention to signs of recurrence of malignant neoplasm. For persons with previous malignant neoplasm in childhood, an increased risk of developing a secondary neoplasm has been reported in patients treated with somatropin after a primary neoplasm. Most often, such secondary neoplasms in patients who received radiation treatment in the head region for a primary neoplasm were intracranial tumors, in particular meningiomas.

In patients with endocrine disorders, in particular those with growth hormone deficiency, dislocations of the femoral head may occur more often than in the general population. Children limping during somatropin therapy should be clinically evaluated.

Hypoadrenalism

Treatment with somatropin can lead to inhibition of 11βHSD-1 and a decrease in serum cortisol concentration. In patients who received somatropin, previously not diagnosed central (secondary) hypoadrenalism can be detected, and they may need to replace the GCS. In addition, patients receiving glucocorticoids as replacement therapy for previously diagnosed hypoadrenalism may require an increase in maintenance or loading doses after starting treatment with somatropin..

Application with oral estrogens

If a woman taking somatropin starts oral estrogen therapy, then the dose of somatropin may need to be increased to maintain serum IGF-1 levels within the age range. Conversely, if a woman on somatropin stops oral estrogen therapy, then the dose of somatropin may need to be reduced to avoid excess growth hormone and / or side effects.

Benign intracranial hypertension

In the event of severe or frequent headache, visual impairment, nausea and / or vomiting, an ophthalmoscopy is recommended to check for papilledema. If the presence of edema of the optic nerve head is confirmed, the diagnosis of benign intracranial hypertension should be considered and, if necessary, the treatment with growth hormone should be discontinued. Currently, there is insufficient information on the basis of which it is possible to formulate recommendations regarding the continuation of growth hormone therapy for patients after the elimination of intracranial hypertension. After resuming growth hormone therapy, close monitoring should be carried out for the appearance of symptoms of intracranial hypertension.

Leukemia

Cases of leukemia have been reported in a small number of growth hormone deficient patients, some of whom received somatropin therapy. However, there is no evidence of an increased incidence of leukemia in patients receiving growth hormone and not prone to this disease..

Antibodies

A small proportion of patients may develop antibodies to SOMATIN. These antibodies are characterized by weak binding capacity and do not affect the growth rate. Any patient with a poor response to treatment (which cannot be explained by other reasons) should be tested for antibodies to somatropin.

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Elderly patients

Experience with patients over 80 years of age is limited. Elderly patients may be more sensitive to the action of the drug, and therefore more prone to the development of adverse reactions.

Acute critical conditions

Since there is no information on the safety of HGH replacement therapy in acutely critical patients, for this situation, the benefits of continuing treatment should be weighed against the potential risks..

For all patients who have experienced a different or similar acute critical condition, it is necessary to compare the expected benefits of treatment with SOMATIN and the potential risk.

Pancreatitis

There are isolated cases of pancreatitis in children and adults treated with somatropin, with some evidence of a higher risk in children than in adults. There is evidence that girls with Shereshevsky-Turner syndrome are at greater risk than other children treated with somatropin. Any patient undergoing treatment with somatropin, especially children with progressive persistent severe abdominal pain, should be considered for pancreatitis..

Prader-Willi syndrome

In patients with Prader-Willi syndrome, treatment should always be combined with a low-calorie diet.

Lethal effects have been reported associated with the use of growth hormone in children with Prader-Willi syndrome who had one or more risk factors: severe obesity (patients with a weight-for-height ratio greater than 200%), a history of respiratory failure or sleep apnea. sleep time or unidentified respiratory infection. Patients with one or more of these factors may be at increased risk.

Prader-Willi syndrome

Patients with Prader-Willi syndrome should be monitored for signs of upper airway obstruction, sleep apnea, or respiratory infections before starting somatropin treatment.

If, when assessing the patency of the upper respiratory tract, data on the presence of pathology are obtained, the child should be referred to an otolaryngologist for treatment and elimination of the respiratory disorder before starting treatment with growth hormone.

Sleep apnea should be monitored prior to initiating growth hormone therapy using standard polysomnography or night oximetry and monitored if it develops.

If, during treatment with somatropin, patients develop symptoms of upper airway obstruction (including the appearance and increase of snoring), treatment should be interrupted and a new examination of the ENT organs should be performed.

If sleep apnea is possible, all patients with Prader-Willi syndrome should be monitored.

Patients should be screened for signs of respiratory infections that should be diagnosed as early as possible and actively treated.

All patients with Prader-Willi syndrome should also closely monitor body weight before and during treatment with growth hormone..

Scoliosis is common in patients with Prader-Willi syndrome. In some children, due to the rapid growth, scoliosis may progress. Signs of scoliosis should be monitored during treatment.

The experience of long-term use of growth hormone for the treatment of adults and patients with Prader-Willi syndrome is limited.

Children short from birth

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Before starting treatment for low-born children born with a growth less than the norm for their gestational age, the possibility of the influence of other medical reasons or treatments on impaired growth should be excluded.

It is recommended that fasting insulin and glucose levels be determined and repeated annually before starting treatment for low-birth-born babies born less than normal for their gestational age. Patients at high risk of diabetes mellitus (eg, family history of diabetes mellitus, obesity, severe insulin resistance, acanthosis nigricans) should have an oral glucose tolerance test. If diabetes is diagnosed, growth hormone should not be used..

It is recommended to measure IGF-1 levels and repeat this study twice a year before starting treatment in babies born short of birth who are less than normal for their gestational age. If, after repeated measurement, the standard deviation of IGF-1 levels exceeds +2 VCO in comparison with the age norm and puberty, then the IGF-1 / IFRSB-3 ratio should be taken into account to decide whether a dose adjustment is necessary..

Experience with treatment just prior to puberty for low-birth-weight babies is limited. Therefore, it is not recommended to start treatment just before the onset of puberty. Limited experience in treating patients with Silver-Russell syndrome.

Gains gained from treating low-birth-born babies with growth hormone may be lost if treatment is stopped before they reach full growth.

Chronic renal failure

In the case of chronic renal failure, renal function should be below 50% of normal before starting treatment. To confirm signs of growth abnormalities, growth should be monitored for a year before starting therapy. During this period, conservative treatment of renal dysfunction (including control of acidosis, hyperparathyroidism and nutrition) should be initiated and carried out during therapy with growth hormone. Treatment should be discontinued in case of kidney transplant.

To date, there are no data on the achievement of final growth in patients with chronic renal impairment, for which somatropin was used.

Neoplasms

Patients with existing tumors or growth hormone deficiency resulting from intracranial lesions should be regularly examined for progression or recurrence of the underlying pathological process. In children, there was no connection between somatropin replacement therapy and tumor recurrence of the central nervous system (CNS) or the emergence of new extracranial tumors. However, among surviving children with cancer, an increased risk of a second tumor has been reported in patients receiving somatropin after treatment for the first tumor. Intracranial tumors, in particular meningiomas, are the most common secondary neoplasms in patients treated with radiation to the head during treatment of the first neoplasm.

It is not known if there is an association between somatropin replacement therapy and tumor recurrence of the central nervous system in adult patients.

Patients should be closely monitored for any malignant transformation of skin lesions..

Hypopituitarism

Substitution therapy should be closely monitored in hypopituitarism patients treated with somatropin.

Dislocation of the femoral head in children

Dislocation of the femoral head is more common in patients with endocrine disorders (including GHD and Shereshevsky-Turner syndrome) or in fast-growing patients. Any pediatric patient who begins to limp or complain of pain in the hip or knee joint during somatropin therapy should be carefully evaluated.

Otitis media and cardiovascular disorders in patients with Shereshevsky-Turner syndrome

Patients with Shereshevsky-Turner syndrome should be carefully evaluated for the occurrence of otitis media and other ear disorders, as these patients have an increased risk of developing such diseases and hearing disorders. Treatment with somatropin may increase the risk of otitis media in patients with Shereshevsky-Turner syndrome. In addition, in patients with Shereshevsky-Turner syndrome, the state of the cardiovascular system should be carefully monitored, since such patients have an increased risk of cardiovascular diseases, such as stroke, aneurysm / aortic dissection, hypertension.

Systemic and local reactions

When somatropin is injected subcutaneously in the same place for a long time, tissue atrophy may occur..

As with any protein, local or systemic allergic reactions can occur. Parents / patients should be informed that such reactions are possible and in case of allergic reactions, prompt medical attention is needed.

Changes in laboratory parameters

With somatropin therapy, serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH), and insulin-like growth factor (IGF-I) may increase.

Application during pregnancy or lactation There are no clinical studies of the use of somatropin preparations during pregnancy. Therefore, preparations containing somatropin are not recommended for pregnant women and women of reproductive age who do not use contraception.

Clinical studies of the use of somatropin preparations during breastfeeding have not been conducted. It is not known whether somatropin passes into breast milk, but absorption of intact protein from the infant’s gastrointestinal tract is extremely unlikely. Somatropin preparations should be used with caution in women who are breastfeeding.

The ability to influence the reaction rate when driving motor transport or other mechanisms.

SOMATIN does not affect the reaction rate when driving or driving other mechanisms.

Dosage and administration The diagnosis, initiation of therapy with SOMATIN and follow-up should be carried out by qualified doctors with experience in diagnosing and treating patients in accordance with the indications for use..

The dosage and regimen of use should be selected individually, taking into account the severity of growth hormone deficiency, the weight or surface area of ​​the patient’s body, the effectiveness in the course of therapy.

The injection should be performed subcutaneously, slowly, usually in the evening, and change the injection site to prevent lipoatrophy.

Growth retardation due to insufficient secretion of growth hormone in children. The usual recommended dose is 0.025-0.035 mg / kg of body weight (0.07-0.1 IU / kg) per day or 0.7-1.0 mg / m2 of body surface area (2.1-3.0 IU / m2) per day. Treatment begins as early as possible and continues until the growth rate decreases the definitive guide to stanozolol steroid build a with treatment to 2 cm / year or less, until the growth zones are closed, socially acceptable growth is achieved (for girls, 155–160 cm, for boys, 165–170 cm) or reaching bone age in girls 14–15 years old, in boys – 16–17 years old.

If growth hormone deficiency occurs in childhood and persists in adolescence, treatment should be continued until full somatic development (that is, body structure, bone mass) is achieved. To monitor the achievement of normal peak bone mass is defined as T> –1 (standardization to mean peak bone mass of an adult as measured by gender and ethnicity dual energy X-ray absorptiometry), which is one of the therapeutic goals during the transition period.

Prader-Willi syndrome, for the purpose of improving height and physique in children. Usually prescribed at 0.035 mg / kg of body weight per day or 1.0 mg / m2 of body surface area. The daily dose of 2.7 mg should not be exceeded. SOMATIN should not be used in children with a growth rate of less than 1 cm per year and at the age when the epiphyseal growth zones begin to close.

Growth retardation due to Shereshevsky-Turner syndrome. The recommended dose is 0.045-0.05 mg / kg body weight (0.14 IU / kg) or 1.4 mg / m2 (4.3 IU / m2) body surface area per day.

Growth retardation in patients with chronic renal failure. The recommended dose is 0.045–0.05 mg / kg of body weight (0.14 IU / kg) or 1.4 mg / m2 (4.3 IU / m2) of body surface area per day. Insufficient growth rates may require a higher dose. Dose adjustments may be required after 6 months of treatment.

Growth retardation in short children from birth. Usually the recommended dose is 0.035 mg / kg body weight per day (1 mg / m2 body surface per day) until final growth is achieved.

Treatment should be discontinued after the first year if the standard deviation of the growth rate is less than +1. Treatment should be discontinued if the growth rate is less than 2 cm per year and (if necessary, confirmation) bone age is more than 14 years for girls or more than 16 years for boys, corresponding to the age of closure of growth zones in the epiphyses of bones.

Dosage recommendations for children