Composition, form of production and packaging
Liofilizate for the preparation of a solution for p / c injection in the form of powder or a porous mass of white or almost white color.
1 f. 1 ml of finished r-ra
somatropine 8 mg * 5.83 mg *
[PRING] sucrose, phosphoric acid, sodium hydroxide.
Solvent: 0.3% solution of metacresol in water d / and (1.37 ml).
Flasks of colorless glass with a volume of 3 ml (1) complete with a solvent (cartridges 1 pc.), Device for the preparation of a solution "Klik.izi" (case, sterile transitional cannula) (1 pc.) - plastic pallets (1) - cardboard boxes .
Vials of colorless glass in volume of 3 ml (5) complete with a solvent (cartridges 5 pcs.), Device for solution "Klik.izi" (case, sterile transitional cannula) (5 pcs.) - plastic pallets (1) - cardboard boxes .
* 1 mg corresponds to 3 IU.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Recombinant somatotropic hormone obtained by genetic engineering using the mammalian cell line. Identical in its composition and action to the pituitary hormone human growth - somatropin (single-chain polypeptide, consisting of 191 amino acid residues). It has anabolic and anti-catabolic properties, affecting not only growth, but also metabolic processes.
Influencing the epiphysis of the tubular bones, stimulates the growth of the bones of the skeleton. Regulates protein metabolism, stimulates the transport of amino acids into the cell and protein synthesis.
PHARMACOKINETICS
Pharmacokinetics in doses not exceeding 2.67 mg (8 IU) is linear, at higher doses linearity is disrupted without any clinical manifestations.
Suction and distribution
Absolute bioavailability with n / to the introduction is 70-90%. C max is observed after 4 hours and returns to the initial level 24 hours after the administration. After intravenous administration, V d is 7 l / kg, the total clearance is 15 l / h.
Cumulation is not observed.
Metabolism and excretion
Metabolized in the kidneys and liver. It is excreted with bile. T 1/2 is 2-4 hours.
INDICATIONS
- growth retardation in children due to insufficiency of growth hormone;
- growth retardation in girls with gonadal dysgenesis (Shereshevsky-Turner syndrome);
- stunting in children in the prepubertal period due to chronic renal insufficiency;
- growth retardation in children aged 4 and older with intrauterine growth retardation;
- confirmed congenital or acquired growth hormone deficiency in adults (as a substitute therapy).
DOSING MODE
The drug should be used under the regular supervision of a doctor who has sufficient experience in diagnosing and treating patients with growth hormone deficiency or with Shereshevsky-Turner syndrome.
The preparation Cisen В® in vials containing 8 mg (24 ME) of somatropin, is intended for multiple sc administration.
The dosing schedule is determined individually for each patient, taking into account the surface area of ​​the body (m 2 ) and body weight (kg).
Saizen В® is recommended to be administered in the evening.
Children with growth retardation caused by a deficiency of growth hormone secretion , the drug is prescribed SC in a dose of 0.7-1 mg / m 2 / day or 0.025-0.035 mg / kg / day.
If the growth in girls with gonadal dysgenesis (Shereshevsky-Turner syndrome) is impaired, the drug is given SC at a dose of 1.4 mg / m 2 / day or 0.045-0.05 mg / kg / day. If a girl simultaneously takes non-androgenic anabolic steroids, the intensity of growth can be increased.
When growth retardation in children in the prepubertal period caused by chronic renal failure, the drug is prescribed SC at a dose of 1.4 mg / m 2 / day or 0.045-0.05 mg / kg / day.
With growth retardation in children 4 years and older with intrauterine growth retardation in history, the dose for SC administration is 1 mg / m 2 / day or 0.035 mg / kg / day.
Treatment is discontinued after the patient's growth reaches values ​​corresponding to the growth of an adult human or after infection of the epiphyseal growth zones.
Adult therapy is recommended to begin with a sc administration of the drug at a low dose of 0.15-0.3 mg / day. The dose should be increased strictly under the supervision of the doctor. The recommended final dose usually does not exceed 1 mg / day. In general, small doses are effective. In elderly patients, the dose should be reduced.
Rules for the preparation of solution for injection and drug administration
To prepare a solution for injection, the contents of the vial are dissolved in the attached bacteriostatic solvent, which contains 0.3% solution of metacresol in water for injection, using the "Click." Device. The prepared solution, intended for injections, must be transparent and contain no visible particles. When visible particles are present in the solution, the application is not allowed. The prepared solution contains 8 mg of Sizen В® preparation (5.83 mg / ml).
Patients should receive detailed instructions on how to properly perform the procedure for dilution of the drug. You should carefully read the instructions for using the device "Click." If necessary, patients should consult a doctor, nurse or pharmacist.
It is necessary to make sure that the device for the preparation of the "Click." Solution is collected, to check the presence of the bottle with the preparation Sizen В® , a sterile transitional cannula, a cartridge with a solvent. Check the presence and integrity of the control visible signs on the "Click." And on the cap. If they are broken, then the device is not to be used, the patient must return it to the pharmacist or the treating doctor.
The preparation of the solution and the sc administration are carried out under aseptic and antiseptic conditions.
To prepare the solution of the drug should be guided by a colored insert embedded in the package with pictures illustrating the procedure for preparing the solution using the device "Click.".
1. Place the device to mix the "Click." Vertically on a flat surface with the bottle down and cap up.
2. Press the cap all the way down (the control visible sign on the "Click." Will now be broken).
3. Turn the cap slowly clockwise until the green indicator moves to the vertical window.
4. Continue slowly pressing on the cap until all the solvent has passed from the cartridge to the vial (the control visible sign on the cap will now be broken). It is very important to press the cap slowly to prevent the formation of bubbles. It is necessary to make sure that all the solvent has moved into the vial.
5. Dissolve the powder in the solvent with gentle circular motions. It is forbidden to sharply shake "Klik.izi", tk. foam or bubbles may form. It is necessary to allow the solution to settle until the powder completely dissolves.
6. Turn over the "Click." (Flacon up). Pull the cap down to the stop and then pull slowly until the solution completely moves back into the cartridge. It is necessary to make sure that not more than 1-2 drops of solution remain in the vial.
If more than 1-2 drops of solution remain in the vial, then slowly push on the cap again until the solution goes back into the vial. Then re-transfer the solution to the cartridge as described above.
Remove air trapped in the cartridge by slowly pressing the cap.
Do not pull the cap too fast. the air can enter the cartridge.
7. Hold the "Click." In the position with the bottle up, unscrew the cap and remove it. While holding the "Click." In the same position, you should remove the cartridge with the prepared solution from "Click.".
8. Carefully remove the outer label from the cartridge. Write the date of preparation of the solution on the internal label of the cartridge.
"Click." Should be disposed of in accordance with accepted rules.
The cartridge containing the prepared Sisen В® solution is ready for use with injectors that inject the drug. The injectors are supplied separately and a separate instruction is attached to them.
Injections should be made in different parts of the body. Do not administer the drug to places where swelling, tight knots, dents, or pain has occurred; The patient should report all symptoms to the doctor or other health care provider. At the injection site, the skin should be washed with soap.
If a dose is missed or an excessive dose of CysenВ® is administered, the patient should notify the physician about this, because minor changes in the recommended dose may be required to compensate for the disorder. The introduction of an excessive dose will lead to a change in the glucose level in the blood, with the appearance of a shiver and dizziness. If the patient receives a very high dose for a certain period of time, this will cause excessive growth of bones, mainly the bones of the hands, feet and jaws.
SIDE EFFECT
Local reactions: sometimes - tenderness, hyperemia, swelling, itching.
Very rarely: the formation of antibodies to somatropin.
Rarely: benign intracranial hypertension (severe headache, nausea, vomiting).
Possible: Epiphysiolysis of the head of the femur. In adult patients with 10% replacement hormone replacement, fluid retention with peripheral edema, joint pain, muscle pain, paresthesia (appeared at the beginning of therapy and usually disappeared during treatment). In adults with growth hormone deficiency diagnosed in childhood, fewer side effects are observed compared to those who have a deficiency of growth hormone in adulthood.
The following side effects have been described in the literature with the use of somatropin (however, they have not been observed to date with the use of the preparation Cysen В® ): weakness, fatigue, gynecomastia, edema of the optic nerve (usually observed during the first 8 weeks of treatment, most often in patients with Shereshevsky-Turner syndrome); pancreatitis (abdominal pain, nausea, vomiting); otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome); subluxation of the hip in children (limping, pain in the thigh and knee); leukemoid reactions, acceleration of growth of the previously existing nevus (malignancy is possible); progression of scoliosis (in patients with excessively rapid growth).
On the part of laboratory indicators: an increase in the content in the blood of inorganic phosphate, parathyroid hormone and activity of alkaline phosphatase.
Allergic reactions: skin rash, itching.
Most patients tolerate drug therapy well. Patients or parents of the child should inform the doctor of the occurrence of the above or any other side effects.
CONTRAINDICATIONS
- signs of active malignant neoplasm (antitumor therapy should be completed before the application begins);
- Pregnancy;
- lactation (breastfeeding);
- Hypersensitivity to somatropin, to any other component of the drug, or to m-cresol (part of the solvent).
With caution apply the drug for diabetes, intracranial hypertension, hypothyroidism.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy, tk. At present, there is insufficient data on the safety of the use of growth hormone during this period.
If you need to use the drug Saizen В® during lactation, breastfeeding should be discontinued. There is evidence of a possible release of somatropin with breast milk.
APPLICATION FOR FUNCTIONS OF THE LIVER
The defeat of the femur often occurs in children with impaired endocrine system or kidney. In chronic kidney failure, the child should be examined regularly for bone damage. Before starting treatment, a radiograph of the femur should be made. Patients should be cautioned that if lameness or pain in the femoral or knee joints occurs during treatment with Cisen, they should immediately consult a doctor.
Children with chronic kidney failure should stop treatment for the time of kidney transplantation.
With growth retardation in children in the prepubescent period caused by chronic renal failure, the recommended dose for the SC is 1.4 mg / m 2 / day or 0.045-0.05 mg / kg / day.
APPLICATION FOR CHILDREN
It is used in children according to the indications according to the dosing regimen.
APPLICATION IN ELDERLY PATIENTS
Patients over 60 years of age who undergo long-term therapy with Saizen В® should be closely monitored, since the experience of using the drug in elderly patients is insufficient.
SPECIAL INSTRUCTIONS
Treatment with Saizen В® should be carried out under the constant supervision of a doctor who has experience in the diagnosis and treatment of patients with growth hormone deficiency.
After a while after the introduction of the preparation Sizen В®, it is possible to reduce the concentration of glucose in the blood, which can be accompanied by a brief tremor or dizziness. During the next 2-4 hours the concentration of glucose in the blood can increase. Since the treatment with growth hormone can cause a violation of glucose tolerance, it is necessary to regularly monitor blood glucose levels. With diabetes or a hereditary predisposition to this disease requires careful medical control in the process of using the drug Saizen В® and, if necessary, correction of hypoglycemic therapy.
During treatment with Sizen В® , hypothyroidism may develop, therefore, functional tests of the thyroid gland should be performed periodically. With the development of hypothyroidism during the course of treatment with growth hormone, it is necessary to prescribe substitution therapy with drugs of thyroid hormones.
If a child has an anamnesis of a brain tumor, it is necessary to regularly check for relapse. Currently, there is no evidence of an increased likelihood of recurrence of neoplasms in the background of treatment with Saizen В® .
Some children with growth hormone deficiency developed leukemia (regardless of whether they received growth hormone or not), i.e. with this disease there is an increased risk of developing leukemia compared with children without growth hormone deficiency. The causal relationship between the use of growth hormone and these phenomena has not been established.
When a strong or relapsing headache, visual impairment, nausea and / or vomiting occur against the background of the drug, eye fundus examination (fundoscopy) should be performed to detect edema of the optic nerve disc. When confirming the edema, one should assume the presence of benign intracranial hypertension. In this case, it is necessary to stop the use of growth hormone, in the future it is possible to resume the use of the drug. If the symptoms of intracranial hypertension recur, SayenВ® should be discarded.
The defeat of the femur often occurs in children with impaired endocrine system or kidney. In chronic kidney failure, the child should be examined regularly for bone damage. Before starting treatment, a radiograph of the femur should be made. Patients should be cautioned that if lameness or pain in the femoral or knee joints occurs during treatment with Cisen, they should immediately consult a doctor.
Children with chronic kidney failure should stop treatment for the time of kidney transplantation.
In children diagnosed with growth retardation due to intrauterine growth retardation, other causes of growth retardation should be excluded before treatment begins.Before this treatment, this category of patients should be fasting to determine the level of insulin and glucose in the blood serum and carry out these studies annually.In the presence of diabetes, treatment with Sisen В® is not recommended.
In children diagnosed with growth retardation as a result of intrauterine growth retardation before treatment and then twice a year it is recommended to determine the level of insulin-like growth factor I. The final growth of children with this diagnosis will not be achieved if the treatment with SisenВ® is discontinued until the final growth is achieved.
The introduction of the drug in the same place for a long time can cause damage to this area of ​​the skin. It is important to constantly change the place of administration of the drug. HGH should not be used in the case of urgent conditions.
Patients over 60 years of age who undergo long-term therapy with Saizen В® should be closely monitored, since the experience of using the drug in elderly patients is insufficient.
Impact on the ability to drive vehicles and manage mechanisms
Sizen В® does not affect the ability to drive vehicles and work with machinery.
OVERDOSE
There are no reports of acute overdose cases.
Symptoms: when applying a dose that exceeds recommended, hypoglycemia is possible. With prolonged overdose, signs and symptoms characteristic of excess growth hormone - active growth of bone tissue, especially of the hands, feet and jaws, as well as the development of hypothyroidism, a decrease in cortisol in the blood may appear.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
Simultaneous application of GCS can suppress growth and, thus, inhibit the effect of Cysen В® . The effectiveness of the drug (with respect to final growth) may also be affected by concomitant therapy with other hormonal drugs (eg, gonadotropin, anabolic steroids, estrogens and thyroid hormones).
Currently, drugs that are incompatible with the preparation Cysen В® are not known.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in reach of children at a temperature not higher than 25 В° C in its original packaging. Shelf life - 3 years.
The reconstituted solution should be stored at 2 В° to 8 В° C for up to 28 days; Do not freeze.
