Bula do remedy Somatrop

the package insert of the medicine Somatrop. Active principles Human Somatropin Recombinant. Sale under medical prescription.

what For?

SOMATROP is indicated in the treatment of dwarfism in patients with epiphysis open; in the treatment of delayed growth due to the secretion decreased or absent growth hormone (Somatropin) endogenous or Turner Syndrome.

Contraindications

When should I not use?

. Known hypersensitivity to the hormone somatrópico and/or to the components of the formula;
. In case of growth retardation, SOMATROP should not be used in patients with epiphysis consolidated;
. SOMATROP should not be used when there is any evidence of tumor;
. Craniofaringioma and other neoplasms intracranial and extracranianas;
. In the presence of disease, tumor activity, therapy with SOMATROP should be discontinued.

Dosage

How to use?

paediatrics – the exclusive use of intramuscular and/or subcutaneous tissue

Side Effects

What are the evils that can cause me?

. Adverse effects were observed in less than 1% of patients treated with human growth hormone recombinant, mostly in the form of reactions transient at the site of injection (swelling, slight and transient pain and inflammation).

. Water retention with oedema peripheral was observed.

. During therapy with SOMATROP have been reported rare cases of rash and itching.

. Have been identified some cases of leukemia in patients treated with Growth Hormone, which could be slightly more frequent than those observed in patients without deficiency of the hormone, however, the definite association between the growth hormone and leukemia cannot be established due to the concurrence of many other external factors.

. Some patients may develop hypothyroidism during treatment with SOMATROP, but must submit them to the regular controls of thyroid function.

. Have you observed any cases of dislocation of the epiphysis that require a careful assessment of the appearance of symptoms of claudication in a patient treaty.

. Other reactions rare: headache, muscular weakness, hyperglycemia, light glicosúria, edema, leukemia, insulin resistance, pain in the hip and/or knees.

Warnings and Precautions

what should I know before using?

Warning: This medicine may induce a positive reaction in tests for doping control.

. The treatment with SOMATROP should be done only by doctors experienced in the diagnosis and management of the patient with deficiency of the growth hormone (dysfunction of growth).

. The diagnosis of Turner Syndrome should be duly established with a cariotipagem.

. It is advisable that the hormone treatment is integrated by a suitable intake caloric and amino acids.

. In the case of subcutaneous administration, it is advisable to vary the location of application in order to avoid the possible occurrence of lipodystrophy location.

. In the case of the treatment of patients with neoplasms and intra-and extracranianas in remission, we recommend an attentive and constant control on the part of the doctor.

. Patients with growth deficit secondary to neoplastic lesions intracranial should be monitored more frequently to avoid possible progression or recurrence of malignancy.

. It is advisable to maintain constant control of patients with psoriasis.

. Therapy with SOMATROP may be associated, in the initial period with the development of hypoglycemia.

. The growth hormone may induce a state of insulin resistance; for this reason, patients should be constantly monitored as to blood glucose, for evaluation of any signs of glucose intolerance. Regular testing of the urine for research glicosúria must be performed in all patients.

. Patients with diabetes mellitus may require adjustments in their therapy antidiabética.

. Therapy with glucocorticoids may inhibit the growth induced by GH. Patients with deficit of concomitant ACTH should be maintained under substitute treatment with glucocorticoids in doses adequate to prevent the inhibitory effect of the growth.

. Some patients may develop hypothyroidism during treatment with growth hormone. Therefore, it should be carried out periodic evaluation of thyroid function and the treatment of replacement, if that is the case, in order to avoid reduction in the efficiency of the hormone somatrópico.

. The treatment should continue while the patient is responding until the patient acquires the stature of a mature adult, or until the epiphyses to close.

Note: there are Not yet results available on the effectiveness of long-term use of growth hormone in Turner Syndrome and the treatment should be performed under strict medical control.

. The production of antibodies against the growth hormone was observed in a small proportion of patients (2%). In general, these antibodies have a low binding ability, and its appearance does not have clinical significance.

either way, if the growth is not observed with the use of
SOMATROP, it is suggested the investigation of these antibodies in the patient.

Overdose

what to do if someone use a larger amount than is recommended?

A superdose acute can lead to a hypoglycemia initial and, subsequently, hyperglycemia. superdose for long periods of time can result in signs and symptoms of acromegaly consistent with the known effects of excess human growth hormone.

“warning: this product is a new drug and although research carried out have indicated the efficacy and safety when properly indicated, can occur adverse reactions unpredictable, not yet described or known. in the case of a suspected adverse reaction, the doctor should be notified.”

Introduction

Powder liófilo injected with 4 iu of somatropin. box with 1 vial-ampoule of lyophilisate and 1 ampoule with diluent of 1 ml.

Drug Interactions

. Hormones anabolic steroids, androgens, estrogens and/or thyroid hormones may accelerate the closure of epiphyses bone.- Concomitant use with hormones adrenocorticóides, glicocorticódes, ACTH and corticosteroids, especially in the use of chronic, decreases the effectiveness of the therapy of growth hormone.

. Glucocorticoids can inhibit the effect of the SOMATROP about the growth.

. Growth Hormone may trigger insulin resistance in diabetics, for this reason, we advise a constant monitoring of blood sugar levels.

. In the case of the deficit of concomitant ACTH , the treatment possible with glucocorticoids should be adjusted to avoid its inhibitory effect on the growth.

Sales

Sale prescription

Introduction

SOMATROP
somatropin recombinant human
4 UI
Powder Liófilo Injectable

Pregnancy and Lactation

there are No sufficient data on the use of growth hormone during pregnancy and lactation. It is not recommended that the product be used in pregnant or nursing women.

CARCINOGENESIS, MUTAGÊNESE AND IMPAIRMENT OF FERTILITY
Studies of carcinogenicity were not performed with SOMATROP. No potential carcinogenic effects was observed in a battery of tests including the Ames test, the induction of genetic mutation in cells mammary (L5178Y) in vitro and in cells intact from the bone marrow of mice.

there are No studies that prove if the reproductive capacity is altered by the administration of SOMATROP.

Compositions

Each bottle-ampoule of lyophilized of SOMATROP 4 IU contains:
somatropin recombinant human …. 4 UI
Excipients q. s. p. …. 1
bottle-light bulb
(glycine, dibasic anhydrous sodium phosphate monobasic anhydrous sodium)
Each ampoule with diluent contains:
Sterile water for Injection q. s. p. …. 1.0 ml

Patient Info

Care storage: The product should be stored in the refrigerator (between 2ºC and 8ºC) until the date of their maturity and protected from light. After reconstitution, the product should be kept refrigerated (between 2ºC and 8ºC) and used within 7 days.

Period of validity: provided that they are subject to the care, storage, SOMATROP features expiration date of 24 months. Do not use product after the expiration of the term of validity.

the expected Action of the drug: The product is indicated in dwarfism or a deficiency in growth resulting from the secretion decreased or lack of growth hormone (Somatropin) endogenous or Turner Syndrome.

Only the physician should determine the time of correct treatment for each specific case.

Pregnancy and lactation: Inform your doctor the occurrence of pregnancy during treatment or after its termination.

it is Not recommended that the product be used in women who are pregnant or breastfeeding.

Care in the interruption of the treatment: The treatment must be followed as requested by the doctor. Do not stop treatment without the knowledge of your doctor.

adverse Reactions: If you have any reactions to unpleasant, such as allergy, look for your doctor immediately.

“ALL MEDICINE SHOULD BE KEPT OUT of the REACH OF CHILDREN.”
Concomitant ingestion with other substances: Informar your doctor if it is necessary the simultaneous use of other medications.

Care in the administration: reconstitute the medicine with water for injection before use. Make rotation motion smooth until its complete dissolution. Do not agitate the solution during the preparation. SOMATROP should be administered by intramuscular or subcutaneous.

Contra-indications and precautions: The product is contraindicated to patients who have known hypersensitivity to Somatropin and/or to other components of the formula.

In the case of growth retardation, SOMATROP should not be used in patients with epiphysis consolidated; SOMATROP should not be used when there is any evidence of tumor; in craniopharyngiomas and other tumors, intracranial and extracranianas. In the presence of disease, tumor activity, therapy with SOMATROP should be discontinued.

Care should be taken when SOMATROP is administered to patients with diabetes mellitus.

“do NOT TAKE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR. IT CAN BE DANGEROUS TO YOUR HEALTH.”

Action Mode

The Recombinant Human Growth Hormone, SOMATROP (somatropin), is a product sterile and highly purified, obtained through genetic engineering. It is a protein composed of 191 amino acids, with a molecular weight of 22,124 daltons, fully identical to the hGH secreted by the human pituitary gland.

SOMATROP is produced by a recombinant DNA technology using a strain of Escherichia coli, which secretes the hormone as a protein to the space periplásmico (between the cell wall and the plasma membrane of the bacterial). The careful breakdown of the cell wall, keeping intact the inner membrane, allows to separate the Human Growth Hormone of the majority of proteins in bacterial, getting to a Human Growth Hormone of high purity.

LINEAR GROWTH – THE hormone somatrópico, based on the mediation of the somatomedin, induces the development of somatic and bone growth. The human Somatropin increases the synthesis of proteins and amino acids at cellular level, with consequent nitrogen retention and stimulates the growth of areas of cartilage of the long bones. This retention of nitrogen was demonstrated by the reduction of urinary excretion and low serum and urinary urea.

CELL GROWTH – Treatment with growth hormone results in an increase in the number and size of muscle cells skeletal.

PROTEIN METABOLISM – linear growth is facilitated in part by increased protein synthesis in the cell. With the therapy with SOMATROP occurs retention of nitrogen, which can be demonstrated by a decrease in nitrogen excretion of urinary nitrogen (urea) in serum.

the METABOLISM OF CARBOHYDRATES – Has an effect diabetogênico assigned to peripheral insulin resistance, with its consequent overproduction. Children with hipopituitarismo have sometimes episodes of hypoglycemia in the fasting, which tend to improve with treatment with the growth hormone. On the other hand, the employment of high doses of growth hormone can change your glucose tolerance.

LIPID METABOLISM – THE initial administration of SOMATROP the patients with the deficiency in growth hormone production results in a mobilization of fat, with a reduction of the fat deposits and with the increase in fatty acids circulating.

the METABOLISM OF MINERALS – growth hormone promotes the retention of sodium, potassium and phosphorus. The calcium in serum is not significantly changed by the treatment with growth hormone. Serum concentrations of inorganic phosphate are increased in patients after therapy with growth hormone.

the METABOLISM OF CONNECTIVE TISSUE – growth hormone stimulates the synthesis of chondroitin sulfate and collagen, as well as the urinary excretion of hidroxiprolina.

PHARMACOKINETIC – THE solution has a pH of approximately 6.7. When administered subcutaneously its absorption is 80%. Undergoes biotransformation in liver intense (around 90%). The maximum plasma concentration is reached 5 hours after its administration. Its half-life is about 3 to 5 hours. It is eliminated via the biliary and renal, almost all in the form of metabolites.

Quantities detectable in the drug remain after 72 hours.

Dosage and Form of Administration

The dose should be individually determined and should only be established by the attending physician. In general, it is recommended that the dose of 0,50-0,70 IU/kg/week or approximately 12 IU/m2/week divided into 6-7 injections subcutaneous or 2-3 intramuscular injections. In the case of subcutaneous administration, it should vary the application site to prevent the occurrence of lipoatrophy.

In Turner Syndrome, the recommended dose of 1.0 IU/Kg body weight/week or 30 IU/m2/week, administered by subcutaneous injection.

Alternatively, the dosage weekly can be divided into daily doses equal.

The product should be stored in the refrigerator (between 2ºC and 8ºC) until the date of their maturity and protected from light. After reconstitution, the solution of SOMATROP should be kept in the refrigerator and must be used within 7 days. Should not be frozen.

Laboratory

Biosintética Farmacêutica Ltda.

SAC: 0800-7016900

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Attention: the remedy of The earth is a space character only, with issues related to health and well-being, The information here disclosed shall not be used as a substitute for a doctor’s prescription for the treatment of any disease.