Genotropin GoQuick Pen 12mg (36IU)
- Genotropin GoQuick Pen 12mg (36IU)
- Alcohol swab
- BD Ultra Fine Pen Needles
- Medical cooling container (2-8 degrees temperature)
Active material: Somatropin
CCF: Recombinant growth hormone
Manufacturer: PFIZER MFG. BELGIUM N.V. (Belgium)
The drug growth hormone. It represents synthesized by recombinant techniques somatropin, identical to human growth hormone. Children with lack of endogenous growth hormone, and Prader-Willi syndrome somatropin increases and accelerates the linear growth of the skeleton. As in adults, and children somatropin maintains a normal body structure, stimulating muscle growth and promoting the mobilization of fat. Especially sensitive to somatropin visceral adipose tissue. In addition to stimulation of lipolysis, somatropin decreases the entry of triglycerides in fat depots. Besides, drug affects fat, carbohydrate and water-salt metabolism. Somatropin stimulates LDL receptors in the liver, and acts on lipid and lipoprotein profile in serum. Generally, assignment somatropin patients with growth hormone deficiency reduces the concentration of LDL cholesterol and apolipoprotein B in serum. Also, there may be a reduction in total cholesterol. Somatropin increases insulin levels, However, fasting glucose levels normally not changed. Children with hypopituitarism may experience fasting hypoglycemia, docked in patients receiving the drug. Somatropin restores plasma volume and tissue fluid, reduced with a lack of growth hormone; promotes sodium retention, potassium and phosphorus. Somatropin stimulates the bone metabolism. In patients with growth hormone deficiency and osteoporosis somatropin prolonged treatment leads to a recovery of the mineral composition and bone density. Somatropin treatment increases muscle strength and physical endurance. Somatropin also increases cardiac output, but the mechanism of this effect is not yet known. A role it may play in a decrease in peripheral vascular resistance. In patients with growth hormone deficiency may be a decrease in mental abilities and changes in mental status. Somatropin increases vitality, It improves memory and affects the balance of neurotransmitters in the brain.
Absorption and distribution
As in healthy persons, and in patients with growth hormone deficiency absorbed approximately 80% n / a entered Genotropin®. When p / injection dose 0.1 IU / kg body weight Cmax is 13-35 ng / ml achieved after 3-6 no. Vd is 0.5-2.1 l / kg.
Metabolism and excretion
Biotransformiroetsa kidney and liver. Average T1/2 after the on / in the Genotropin® in patients with growth hormone deficiency is about 0.4 no. When s / to the introduction of the drug T1/2 reaches 2-3 no. The observed difference, probably, associated with a slower absorption of the drug in n / a injection. About 0.1% administered drug in unchanged form excreted in the bile.
Pharmacokinetics in special clinical situations
The absolute bioavailability of Genotropin® when s / to the same in males and females.
Side effects, caused by fluid retention: adult (>1% and <10%) – peripheral edema, pastoznost lower extremities, artralgii, myalgia and paraesthesia. These effects usually are mild or moderate, It occurs during the first months of treatment and decrease spontaneously or after dose reduction. The frequency of these side effects was dose-dependent Genotropin®, the age of patients and, perhaps, inversely proportional to the age, in which an insufficiency of growth hormone. In children, these side effects are rare (>0.1% and <1%). CNS: rarely (>0.01% and <0.1%) – benign intracranial hypertension, may develop swelling of the optic nerve. On the part of the endocrine system: rarely (>0.01% and <0.1%) – development of diabetes mellitus type 2. Also revealed a decrease in serum cortisol. The clinical significance of this phenomenon appears to be limited. On the part of the musculoskeletal system: dislocation and subluxation of the femoral head, soprovozhdaющiesя prihramыvaniem, pain in the hip and knee; in patients with Prader-Willi syndrome may develop scoliosis (tk. Genotropin® It enhances the growth rate); rarely – myositis, which may be caused by the action of m-cresol preservative, which is part of Genotropin®.
Allergic reactions: skin rash and itching.
Local reactions: at the injection site (>1% and <10%) – rash, itch, soreness, numbness, hyperemia, swelling, lipoatrophy.
Other: in a few cases (<0.01%) – The development of leukemia in children, however, the incidence of leukemia is not different from that in children without growth hormone deficiency.
- Symptoms of tumor growth, including the uncontrolled growth of benign intracranial tumor (antitumor therapy should be completed prior to initiation of treatment Genotropin®);
- Critical condition, urgently develop in patients as a result of open-heart surgery or abdominal, multiple trauma and acute respiratory distress;
- Severe obesity (the ratio of body weight / height exceeds 200%) or severe respiratory disorders in patients with Prader-Willi syndrome;
- The closure of epiphyseal growth zones of long bones;
- Hypersensitivity to any component of the drug.
FROM caution should be prescribed for patients with diabetes, intracranial hypertension, gipotireoze.
PREGNANCY AND LACTATION
Clinical experience with Genotropin® during pregnancy is limited. Therefore, during pregnancy should clearly assess the need for the appointment of the drug and the potential risk, associated with this. During normal pregnancy levels of pituitary growth hormone significantly reduced after 20 of the week, being replaced almost entirely by placental 30 week, and therefore the need for continued replacement therapy Genotropin® in the III trimester of pregnancy is unlikely. Experimental studies animals did not reveal any adverse effects on the fetus, from which however should not be, that similar results will be obtained when applying Genotropin® human. Reliable information about the excretion of growth hormone in breast milk are absent, but in any case, absorption of intact protein from the gastrointestinal tract of the child is extremely unlikely.
Cases of overdose Genotropin® unknown. Symptoms: in acute overdose possible hypoglycemia, and then hyperglycemia. Long-term overdose could occur known symptoms of excess human growth hormone (akromegalija, gigantizm). Treatment: removal of the drug, simptomaticheskaya therapy.
GCS at joint application reduces the stimulating effect of Genotropin® on the growth process. With simultaneous use of Genotropin® with thyroxin mild hyperthyroidism may develop.
CONDITIONS OF SUPPLY OF PHARMACIES
The drug is released under the prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 °C. Shelf life – 3 year. The finished solution can be stored in the refrigerator (at a temperature of from 2 ° to 8 °C) during 4 weeks. Avoid freezing or cartridge, no ready solution.