Composition, form of production and packaging
Solution for s / c introduction is colorless or slightly colored, transparent or opalescent.
1 ml
human somatropine 15 IU (5 mg)
[PRING] sodium chloride, sodium citrate dihydrate, phenol, polysorbate 20, citric acid, water d / and.
3 ml - colorless glass cartridges (1) - packings contour mesh (1) - packs cardboard.
3 ml - colorless glass cartridges (5) - packings contour mesh (1) - packs cardboard.
3 ml - bottles of colorless glass with a capacity of 5 ml (1) - packs of cardboard.
3 ml - bottles of colorless glass with a capacity of 5 ml (5) - packaging contour mesh (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Somatotropic hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. Stimulates the growth of the bones of the skeleton, affecting the plate epiphysis tubular bones, bone metabolism in children. Helps normalize body structure by increasing muscle mass and reducing body fat.
In patients with growth hormone deficiency and osteoporosis, substitution therapy results in normalization of the mineral composition and bone density.
Increases the number and size of cells of muscles, liver, thymus gland, gonads, adrenals, thyroid gland. Stimulates the transport of amino acids into the cell and the synthesis of proteins, reduces the level of cholesterol, affecting the profile of lipids and lipoproteins. Suppresses the release of insulin. Promotes the retention of sodium, potassium and phosphorus. Increases body weight, muscle activity and physical endurance.
PHARMACOKINETICS
Suction
After sc administration, absorption of somatropin is 80%. C max in blood plasma is achieved in 3-6 hours.
Distribution
Penetrates into well perfused organs, especially the liver and kidneys. V d of somatropin - 0.49-2.11 l / kg.
Excretion
T 1/2 after the SC administration is 3-5 hours.
INDICATIONS
- growth retardation in children due to inadequate growth hormone secretion, with Shereshevsky-Turner syndrome, with chronic renal failure (decreased kidney function by more than 50%) in the prepubertal period;
- in adults with confirmed congenital or acquired pronounced growth hormone deficiency as a substitute therapy.
DOSING MODE
Rastan В® is administered sc, slowly, 1 time / day, usually at night. It is necessary to change the injection site to prevent the development of lipoatrophy.
Doses are selected individually, taking into account the severity of growth hormone deficiency, mass or body surface area, the effectiveness in the therapy process.
In children with insufficient growth hormone secretion , a dose of 25-35 Ојg / kg / day (0.07-0.1 IU / kg / day) is recommended, which corresponds to 0.7-1 mg / m 2 / day (2-3 IU / m 2 / day) . Treatment begins as early as possible and continues until puberty and / or until the bone growth zones are closed. It is possible to stop treatment when the desired result is achieved.
With the Shereshevsky-Turner syndrome , with chronic renal failure in children accompanied by growth retardation , a dose of 45-50 Ојg / kg / day (0.14 IU / kg) is recommended that corresponds to 1.4 mg / m 2 / day (4.3 IU / m 2 / day ). If the dynamics of growth is insufficient, a dose adjustment may be required.
With a deficiency of growth hormone in adults, the initial dose is 150-300 Ојg / day (corresponding to 0.45-0.9 IU / day), followed by an increase, depending on the effect. When titrating the dose, the level of insulin-like growth factor (IRP-1) in the blood serum can be used as a control parameter. The maintenance dose is selected individually, but, as a rule, it does not exceed 1 mg / day, which corresponds to 3 IU / day.
Older patients are recommended lower doses of the drug.
Injection technique with Rastan В® in vials
1. The rubber membrane of the vial should be disinfected with alcohol or other antiseptic to prevent microorganisms from entering the vial, which is especially important when carrying out multiple injections.
2. For injections, sterile syringes and needles should be used. The syringe should be of sufficient volume to take the right amount of the drug and to carry out the injection.
3. It is necessary to dial into the syringe air in a volume corresponding to the desired dose of the drug. Insert air into the vial.
4. Then turn the vial with the syringe upside down and draw the desired dose of the drug into the syringe. Remove the needle from the vial and remove air from the syringe. It is necessary to check the correctness of the dose set of the drug.
5. Immediately inject.
Injection technique with Rastan В® in cartridges
For injections of Rastan В® in cartridges, use the BiomatikPen В® syringe pen or any other syringe pen intended for use with Rastan В® cartridges. For the correct administration of Rastan В®, you must carefully follow the instructions in the instructions for use of the syringe pen.
1. Before using, make sure that there is no damage (for example, cracks) on the RastanВ® cartridge. Do not use the cartridge if there is any visible damage or change in the appearance of the solution (discoloration, transparency, the presence of sediment, etc.).
2. The rubber cap of the cartridge should be treated with alcohol or another antiseptic to prevent ingestion of microorganisms.
3. Install the cartridge in the syringe pen according to the instructions for using the syringe pen.
4. For each injection of Rastan В® in cartridges, a new sterile replaceable needle should be used.
5. After the injection, the needle should remain under the skin for a minimum of 10 seconds. It is necessary to hold the button down until the needle is completely removed from the skin, thus ensuring the correct dose administration and limiting the possibility of blood or lymph flow into the needle or the cartridge with the drug Rastan В® .
6. Cartridge with Rastan В® is intended for individual use only, it is not refillable.
For the introduction of a dose prescribed by the doctor, a table of recalculation of the indicator of the syringe-pen indicator in the dose of the drug should be used.
Table of transfer indicators indicator syringe-pen BiomatikPen В® in a dose of Rastan В® solution for p / c injection, cartridges 3 ml.
Indications of the indicator, K. Dose of the drug Rastan В® (mg)
1 0.05
2 0.10
3 0.15
4 0.20
5 0.25
6 0.30
7 0.35
8 0.40
9 0.45
10 0.50
11 0.55
12 0.60
13 0.65
14 0.70
15 0.75
16 0.80
17 0.85
18 0.90
19 0.95
20 1.00
21 1.05
22 1.10
23 1.15
24 1.20
25 1.25
26 1.30
27 1.35
28 1.40
29 1.45
30 1.50
31 1.55
32 1.60
33 1.65
34 1.70
36 1.75
36 1.80
37 1.85
38 1.90
39 1.95
40 2.00
41 2.05
42 2.10
43 2.15
44 2.20
45 2.25
46 2.30
47 2.35
48 2.40
49 2.45
50 2.50
51 2.55
52 2.60
53 2.65
54 2.70
55 2.75
56 2.80
57 2.85
58 2.90
59 2.95
60 3.00
SIDE EFFECT
From the side of the central nervous system: increased intracranial pressure (headache, nausea, vomiting, impaired vision).
On the part of the endocrine system: a decrease in thyroid function, hyperglycemia.
On the part of the hematopoiesis system: leukemoid reactions.
From the musculoskeletal system: epiphysis of the head of the femur.
From the side of metabolism: fluid retention with the development of peripheral edema.
The above-mentioned adverse reactions are, as a rule, transient, dose-dependent, a dose reduction may be required.
Allergic reactions: skin rash, itching.
Local reactions: soreness, numbness, hyperemia, swelling, lipotrophy at the injection site.
Side effects described in the literature with the use of somatropin: 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), gynecomastia, acceleration of the growth of the previously existing nevus (malignancy is possible), progression of scoliosis (in patients with overgrowth), elevated levels of inorganic phosphate in the blood, parathyroid hormone and alkaline phosphatase activity.
CONTRAINDICATIONS
- malignant neoplasms;
- Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);
- growth stimulation in patients with closed epiphyseal growth zones;
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
With caution should be used in diabetes, intracranial hypertension, hypothyroidism (including when carrying out thyroid hormone replacement therapy), with concomitant therapy with GCS, Prader-Willi syndrome.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
In children with insufficient growth hormone secretion , a dose of 25-35 Ојg / kg / day (0.07-0.1 IU / kg / day) is recommended, which corresponds to 0.7-1 mg / m 2 / day (2-3 IU / m 2 / day) . Treatment begins as early as possible and continues until puberty and / or until the bone growth zones are closed. It is possible to stop treatment when the desired result is achieved.
With the Shereshevsky-Turner syndrome , with chronic renal failure in children accompanied by growth retardation , a dose of 45-50 Ојg / kg / day (0.14 IU / kg) is recommended that corresponds to 1.4 mg / m 2 / day (4.3 IU / m 2 / day ). If the dynamics of growth is insufficient, a dose adjustment may be required.
APPLICATION IN ELDERLY PATIENTS
Older patients are recommended lower doses of the drug.
SPECIAL INSTRUCTIONS
Against the backdrop of Rastan's treatment, it may be necessary to correct the dose of hypoglycemic drugs in patients with diabetes mellitus, manifestation of latent hypothyroidism may occur, and in patients receiving levothyroxine sodium, symptoms of hyperthyroidism may appear.
During treatment, it is necessary to monitor the condition of the fundus, especially with symptoms of intracranial hypertension. With edema of the optic nerve, it is necessary to cancel the drug.
Detection of lameness on the background of somatropin therapy requires careful observation.
It is necessary to change the location of SC injections in connection with the possibility of developing lipoatrophy.
During the transplantation of the kidney, treatment with the drug should be discarded.
Impact on the ability to drive vehicles and manage mechanisms
If there are no symptoms of increased intracranial pressure (headache, nausea, vomiting, impaired vision), Rastan В® does not affect the ability to drive vehicles or engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: acute overdose can lead to hypoglycemia first, and then to hyperglycemia. With prolonged overdose, signs and symptoms characteristic of excess human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the level of cortisol in the serum can be noted.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
Somatropin increases the clearance of drugs metabolized by microsomal enzymes of the liver, especially sex hormones, glucocorticoids, anticonvulsants and cyclosporine.
GCS inhibits the stimulating effect of somatropin on growth processes.
The effectiveness of the drug (in terms of final growth) may also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
The used vial (cartridge) should be stored at a temperature of 2 В° to 8 В° C for 28 days.
