Dinatrop - instructions for use, dose, side effects, contraindications

Active substanceSomatropinSomatropin

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Dosage form: & nbsplyophosphate for the preparation of a solution for subcutaneous administration

Composition:

Composition of lyophilizate:

Active substance: somatropine 1.33 mg (4 IU).

Excipients: mannitol 20 mg, glycine 0.7 mg, sodium dihydrogen phosphate

1.5 mg, sodium chloride, 0.5 mg.

Composition of lyophilizate:

Active substance: somatropine 3.33 mg (UME).

Excipients: mannitol 40 mg, glycine 1.4 mg, sodium dihydrogen phosphate

1.5 mg, sodium chloride, 0.5 mg.

Composition of lyophilizate:

Active substance: somatropine 5.33 mg (UME).

Excipients: mannitol 60 mg, glycine 2.1 mg, sodium dihydrogen phosphate

1.5 mg, sodium chloride, 0.5 mg.

Composition of lyophilizate:

Active substance: somatropin 6.67 mg (20 IU).

Excipients: mannitol 73 mg, glycine 2.6 mg, sodium dihydrogen phosphate 1.5 mg, sodium chloride 0.5 mg.

Solvent composition per 1 ampoule: Solvent: water for injection 1 ml.

Description:

Lyophilizate: mass or powder white or white with a yellowish tinge. Solvent: colorless, transparent, odorless liquid.

Pharmacotherapeutic group:growth hormone

ATX: & nbsp

H.01.A.C Somatropin and its analogues

H.01.A.C.01 Somatropin

Pharmacodynamics:

Pharmacodynamics. Dinatrop® is a genetically engineered growth 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. Helps normalize body structure by increasing muscle mass and reducing body fat. In patients with growth hormone deficiency and osteoporosis, substitution therapy leads to normalization of 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:

Pharmacokinetics. Absorption of somatropin after subcutaneous administration is 80%, the maximum concentration in blood plasma is achieved in 3-6 hours. Penetrates into well-perfused organs. Metabolized in the kidneys and liver. The volume of distribution of somatropin is 0.49-2.11 l / kg. It is excreted by the kidneys and with bile (including 0.1% unchanged). The half-life after subcutaneous administration is 3-5 hours.

Indications:

Indications for use

Growth retardation in children due to inadequate growth hormone secretion, gonadal dis- ability (Shereshevsky-Turner syndrome), chronic renal failure (renal function decrease by more than 50%) in the prepubertal period.

In adults with confirmed congenital or acquired growth hormone deficiency as a substitute therapy.

Contraindications:

Hypersensitivity, malignant neoplasms, active brain tumors, urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure),pregnancy and lactation (during the period of treatment it is necessary to refuse breastfeeding).

Carefully:

Diabetes mellitus, intracranial hypertension, hypothyroidism.

Dosing and Administration:

Dinatrop® is administered subcutaneously, slowly, once a day, usually at night. It is necessary to change the injection site to prevent the development of lipoatrophy.

Dissolve the contents of the vial is recommended in 1 ml of the supplied solvent, based on the calculated dose. To do this, take the solvent with a syringe and inject it into the vial with the drug through a stopper. Gently shake until the contents of the vial are completely dissolved. Sharp shaking is unacceptable. The prepared solution is stored in the vial for no more than two weeks at a temperature of 2 ° C to 8 ° C.

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 secretion of growth hormone, a dose of 25-35 μg / kg / day (0.07-0.1 IU / kg / day) is recommended, which corresponds to 0.7-1 mg / m2 / day (2-3 IU / m2 / 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.

In Shereshevsky-Turner syndrome, in chronic kidney failure in children accompanied by growth retardation, a dose of 50 μg / kg / day (0.14 IU / kg / day) is recommended that corresponds to 1.4 mg / m2 / day (4.3 IU / m2 / 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 0.15-0.3 mg / day (corresponding to 0.45-0.9 IU / day), followed by an increase, depending on the effect. When the dose is titrated, the level of insulin-like growth factor I (IGF-I) in the blood serum can be used as a control parameter. The maintenance dose is selected individually, but does not exceed, as a rule, 1 mg / day, which corresponds to 3 IU / day. Elderly, lower doses are recommended.

Side effects:

Increased intracranial pressure (headache, nausea, vomiting, visual impairment), decreased thyroid function, hyperglycemia, leukemoid reactions, epiphiseolysis of the femoral head, fluid retention with development of peripheral edema, arthralgia, myalgia, tunnel syndrome.Symptoms are, as a rule, transitory, dose-dependent, may require a dose reduction.

Allergic reactions: skin rash, itching.

Rarely - the formation of antibodies to the drug with a decrease in its effectiveness.

Local reactions: hyperemia, swelling, pain, itching, lipoatrophy at the injection site.

Attention! The following side effects are 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), acceleration of the growth of the previously existing nevus (malignancy is possible), progressive Contents scoliosis (in patients with overgrowth), elevated levels of inorganic phosphate in the blood, paratireoid- Nogo hormone and alkaline phosphatase activity.

Overdose:

Acute overdose can lead first to hypoglycemia, 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.

Interaction:

Glucocorticosteroids reduce 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.

Special instructions:

Against the background of treatment with Dinatrop®, correction of doses of hypoglycemic drugs in diabetic patients may be required, manifestation of latent hypothyroidism may occur, and in patients receiving thyroxine, signs of hyperthyroidism may appear. During treatment, it is necessary to monitor the condition of the fundus, especially with symptoms of intracranial hypertension. Edema of the optic nerve requires withdrawal of the drug.Detection of lameness on the background of somatropin therapy requires careful observation. It is necessary to change the places of hypodermic injections in connection with the possibility of lipoatrophy development.

Form release / dosage:

Lyophilizate for the preparation of a solution for subcutaneous administration 4 ME, 10 ME, 16 ME, 20 ME.

Packaging:

Lyophilizate for the preparation of a solution for subcutaneous administration 4 ME, 10 ME, 16 ME, 20 ME.

Lyophilizate: 4 ME, 10 ME, 16 ME or 20 ME per bottle of neutral glass. Solvent: 1 ml per ampoule of neutral glass with a color mark (dot).

1 bottle with lyophilizate complete with 1 ampoule with a solvent and 1 disposable syringe with a volume of 1 ml in a plastic substrate. The substrate, together with the instruction for use, is placed in a pack of cardboard (1 set). For 5 sets per pack cardboard.

10 packs of cardboard in a group package (cardboard box), 4, 6, 8, 10 group packages are placed in a foam plastic container with ice and placed in a cardboard box.

50 vials with lyophilizate complete with 50 ampoules with a solvent in the foam substrate. The substrate, together with instructions for use in a pack of cardboard, 4, 6, 8, 10 packs of cardboard is placed in a container with ice and placed in a box of cardboard (for inpatient).

25 bottles with lyophilizate in a plastic substrate. The substrate, together with instructions for use in a pack of cardboard, 40 packs of cardboard is placed in a foam plastic container with ice and ice and placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of 2 ° C to 8 ° C. Do not freeze. The prepared solution should be stored at a temperature of 2 ° C to 8 ° C for 2 weeks. Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:PL-000517

Date of registration:01.03.2011

Expiration Date:01.03.2016

The owner of the registration certificate:Dinamik Development Laboratory Laboratories Co., Ltd.Dinamik Development Laboratory Laboratories Co., Ltd. Unknown

Manufacturer: & nbsp

DAROU PAKHSH PHARMACEUTICAL MFG. COMPANY Iran

Information update date: & nbsp16/08/2015

Illustrated instructions

Instructions

Dinatrop® (Dynatrope®)