Norditropin SimpleXx

Active material: Somatropin
When ATH: H01AC01
CCF: An analogue of the growth hormone
ICD-10 codes (testimony): E23.0, N25.0, Q96, R62
When CSF: 15.06.01
Manufacturer: NOVO NORDISK A/S (Denmark)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

The solution for the p / to the introduction colorless, clear.

Excipients: mannitol, gistidin, poloxamer 188, phenol, hydrochloric acid or sodium hydroxide, water d / and.

1.5 ml – flint glass cartridges (1) – pen multidose disposable for multiple injections (1) – packs cardboard.

Pharmacological action

The drug growth hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. Somatropin, compensate for a deficiency of endogenous growth hormone, It contributes to the normalization of the body structure by increasing muscle mass and decrease body fat.

Most of the effects of growth hormone is realized through the insulin-like growth factor-I (IRF-I), is produced in all cells of the organism (preferably liver cells). More 90% IGF-I is associated with proteins (IRFSB), of which the most important 3-IRFSB.

Somatropin increases bone restructuring, It is shown by increased activity of biochemical bone markers in plasma. In adults, in the first months of treatment due to more pronounced bone resorption decrease its mass, but with continued treatment increases bone mass.

Pharmacokinetics

Pharmacokinetic parameters after / v infusion of growth hormone (33 ng / kg / min for 3 no) in 9 Patients with growth hormone deficiency: T_1/2 from blood serum was 21.1 ± 1.7 min, the rate of metabolic clearance was 2.33 ± 0.58 ml / kg / min, V_d made 67.6 ± 14.6 ml / kg.

Testimony

Children

- Stunting due to growth hormone deficiency;

- Growth retardation in girls with gonadal dysgenesis (Syndrome Shyeryeshyevskogo Ternera);

- Growth retardation in prepubertal children, due to chronic renal failure.

Adult

- Confirmation of congenital or acquired deficiency of growth hormone (as replacement therapy).

Adults drug Norditropin^® FlexPro^® prescribed for growth hormone deficiency, has developed in childhood and confirmed again in the course of two provocative tests, as well as a significant reduction of growth hormone during a disease of hypothalamic-pituitary region (failure of another hormone, except for prolactin), confirmed in two provocative tests after the start of adequate replacement therapy for any other hormone deficiency.

Dosage regimen

The drug is administered s / c 1 time / day at night. To prevent the development of lipoatrophy should change injection sites.

Babies at growth hormone deficiency administered at a dose of 25-35 ug / kg / day, corresponding 0.7-1 mg / m²/d.

At Turner's syndrome and chronic renal failure the drug is prescribed in a dose 50 ug / kg / day, corresponding 1.4 mg / m²/d.

At short stature in children, had prenatal growth retardation, the drug is prescribed in a dose 33-67 ug / kg / day, corresponding 1-2 mg / m²/d.

Adults as replacement therapy it is recommended to start treatment with the drug in low doses 0.1-0.3 mg / day and gradually increase the dose every month until the dose, required an individual patient.

As a benchmark when titrated doses can be used IGF-I levels in serum. With increasing age of the patient in need of growth hormone is reduced.

The maintenance dose is adjusted individually, but rarely exceeds 1 mg / day (corresponding 3 IU / day).

How to use the drug Norditropin^® FlexPro^®

Norditropin^® FlexPro^® a disposable, prefilled pen for repeated injections, consisting of a cartridge volume 1.5 ml, fixedly mounted in a plastic pen-injector. Bottom cartridge plastic cork stopper in the form of a plunger, and on top – Laminated plastic stopper in the form of a disc, sealed aluminum lid. Pen is designed for use with needles NovoFayn^®.

Preparations for the introduction of the drug. Pull to remove the cap and pen. Remove the protective cover from the needle NovoFayn^® privintitь igloo and the FlexPro^®. Remove the outer and inner needle caps. Put aside the outer needle cap, tk. he will need to use the post-injection.

In the course of normal use in the needle and cartridge with growth hormone may collect a small amount of air. To avoid the introduction of air and ensure proper dosing, should be kept NordiLet^® needle up. It gently tapped the injection pen NordiLet^® and ensure, all air bubbles are gathered at the top of the cartridge with the drug. Before each injection, remove air from the cartridge.

Derzha SimpleXx^® needle up, rotate the cartridge with a solution of the drug in a direction “clockwise” until, not yet established one click.

Continuing to hold the pen needle up, press a button to press to stop, while at the needle tip should appear a drop of drug solution. If it does not appear, then repeat the procedure, but not more 6 time. If a drop of drug solution does not come out of the needle, which indicates, that syringe pen is faulty and is not subject to further use.

faulty and no longer be used

To set the dose should again put the cap on the pen, setting “0” the pointer dose. The dose is set by clicking, therefore followed to establish the number of clicks according to the required dose. Norditropin device^® FlexPro^® It allows you to do by 1 to 29 clicks the dose for each injection, which is also accompanied by a click. Dose per click is 0.0667 mg (5 mg / 1.5 ml); 0.1333 (10 mg / 1.5 ml); 0.2 mg (15 mg / 1.5 ml). The packaging includes installation instructions, comprising conversion table dose (mg) in the appropriate number of clicks.

The procedure for the introduction of It consists of two stages: 1-Stage – subcutaneous needle; 2-Stage – Pressing for dose.

The patient must use a method of administration, recommended by your doctor.

After the injection needle should be left under the skin of at least 6 sec. The button should be held fully depressed until, until the needle is removed from the skin. This will ensure that the introduction of a full dose.

After injection should be put on the outer needle cap, unscrew the needle and, careful, throw it away. Again, put the cap on the pen so, the indicator pointed to dose “0”.

If you remove and eliminate needles medical staff, relatives and other persons, performing injections and patient care, We must comply with the general safety precautions, to eliminate the risk of inadvertent damage to the needle.

Subsequent injections. Always check, It takes you to press a button to its lowest position. If it is not, it is necessary to rotate the pen cap until, until the button is not pressed to be in the lowest position. You can then move on to the preparation and carrying out injection, as described above.

You can not rely on the sound of clicks to determine or confirm the required dose. Always check both scales, to verify the correctness of the set dose.

When using the drug Norditropin^® FlexPro^® it should be remembered, what:

- While, when the drug is not used, the lid should be kept tightly closed;

- For each injection should always use a new needle;

- Should not be left Norditropin^® FlexPro^® with a plastic needle, when not in use;

- You can use the growth hormone level indicator to estimate the number of remaining clicks of growth hormone, but you can not use the indicator to set the growth hormone dose;

- It is impossible to establish the dose, exceeding the number of remaining clicks;

- After the full use should be carefully throw Norditropin^® FlexPro^®, pre-releasing of the needle.

Patients should be reminded to wash their hands with soap and / or disinfectant before use Norditropin^® FlexPro^®. It should never be shaken vigorously Norditropin^® FlexPro^®.

Do not use Norditropin drug^® FlexPro^®, when the solution has ceased to be colorless and transparent as water.

It is necessary to avoid situations, that Norditropin^® FlexPro^® It may be damaged. Protect Norditropin^® FlexPro^® dust, dirt and direct sunlight. The outer surface of Norditropin^® FlexPro^® can be purified, wiping with cotton, moistened with alcohol. Do not immerse the pen in alcohol, do not wash or lubricate, tk. this may damage the mechanism.

Side effect

Children

Side effects in children are rare or very rare.

CNS: headache.

On the part of the musculoskeletal system: muscle and joint pain.

Dermatological reactions: skin rash.

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

Other: peripheral edema due to fluid retention.

Adult

From the central and peripheral nervous system: perhaps – carpal tunnel syndrome (pricking, numbness or, perhaps, pain, primarily in the fingers due to compression of nerves), headache; rarely – intracranial hypertension.

On the part of the musculoskeletal system: perhaps – stiff muscles and joints, muscle and joint pain.

Local reactions: perhaps – hyperemia, itching and pain at the injection site.

Other: perhaps – peripheral edema due to fluid retention, impaired glucose tolerance; rarely – forming antibodies to somatropin, increased activity of alkaline phosphatase in the blood; rarely – hypersensitivity reactions.

The following side effects are described in the literature when using the drug somatropin, but to date they have not been observed when using the drug Norditropin^® FlexPro^®: weakness, fatigue, epiphysiolysis femoral head, gynecomastia, papilledema (typically occurs during the first 8 weeks of treatment, most often in patients with Turner's syndrome), pancreatitis (abdominal pain, nausea, vomiting), otitis media, and hearing loss (in patients with Turner's syndrome), subluxation of the hip in children (lameness, pain in the hip and knee), gynecomastia, leukemoid reaction, accelerating the growth of pre-existing nevus (possible malignancy), progressirovanie scoliosis (in patients with overgrowth), increase the blood levels of inorganic phosphate and parathyroid hormone.

Contraindications

- Evidence of active malignancy (to the beginning of treatment intracranial tumor must be in an inactive state and anti-tumor therapy is completed);

- Urgent conditions (incl. states after cardiac surgery, abdomen, acute respiratory failure, multiple injuries in accidents);

- Proliferativnaya and preproliferativnaya diabeticheskaya retinopathy;

- Prader-Willi syndrome in the case of gross obesity and respiratory disorders;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

FROM caution should be prescribed for patients with diabetes, intracranial hypertension, gipotireoze.

In children with chronic kidney disease treatment with Norditropin^® FlexPro^® should be discontinued at renal transplantation.

Pregnancy and lactation

Currently, there are insufficient data on the safety of growth hormone during pregnancy, therefore, use of the drug Norditropin^® FlexPro^® contraindicated in pregnant women.

There is evidence of a possible secretion of growth hormone in breast milk. If necessary, use Norditropin^® FlexPro^® lactation breastfeeding should be discontinued.

Cautions

Home treatment with Norditropin^® FlexPro^® must always be performed by a doctor, with special expertise in the field of growth hormone insufficiency and its treatment. This also applies to the treatment of growth retardation in the Turner's syndrome and chronic renal failure, stunted children, had prenatal growth retardation. Specialist in the pathology of growth should regularly monitor the status of children, poluchaющih Norditropin^® FlexPro^®.

Violation of growth in children with chronic renal failure should be clearly established before the start of treatment with Norditropin^® FlexPro^® by monitoring growth on optimal treatment of chronic kidney disease within one year. During therapy with Norditropin^® FlexPro^® should continue conservative treatment of uremia traditional medicines and, if necessary, dializom. During treatment with Norditropin^® FlexPro^® patients with chronic renal failure should be monitored for renal function expressed its decrease or increase the level of glomerular filtration rate (which could mean hyperfiltration).

The effect of growth hormone on carbohydrate metabolism, therefore, patients should also be tested for impaired glucose tolerance.

Patients, treated with insulin, in the appointment of Norditropin^® FlexPro^® It may be necessary to correct the dose.

In the treatment of drug Norditropin^® FlexPro^® may decrease serum thyroxine due to the increased peripheral deiodination of T₄ in T₃. In patients with progressive pathology pituitary may develop hypothyroidism. Patients with Turner's syndrome have an increased risk of developing primary hypothyroidism, associated with antithyroid antibodies. Unnecessarily. Hypothyroidism is an impediment to adequate Rostov effect in the treatment of drug Norditropin^® FlexPro^®, patients, receiving this therapy, you should regularly inspect the function of the thyroid gland and carry thyroid hormone replacement therapy in the identification of its reduction.

In secondary growth hormone deficiency, due to the presence of intracranial tumors, should regularly carry out surveys of patients for signs of progression or recurrence of the primary disease.

A small number of patients with growth hormone deficiency, some of which were treated with somatropin, It reported on the development of leukemia. Based on current data, it seems unlikely, what somatropin treatment was the reason for this.

Patients with complete remission of tumors or malignant disease, growth hormone therapy was not associated with an increased frequency of relapses. Nonetheless, after the start of treatment with Norditropin^® FlexPro^®, Patients, attained a complete remission of malignant disease, should be carefully monitored for their recurrence.

In patients with endocrine disorders may be more common subluxation of the femoral head, and in patients of small stature often can develop Legg-Calve-Perthes. These diseases may appear limp or pain in the hip or knee. Physicians and patients should be warned about this.

If you have express or recurring headaches, impairment, nausea and / or vomiting is recommended to inspect the fundus (fundoscopy) to identify papilledema. If the swelling confirmed, We must assume the presence of benign intracranial hypertension, and if necessary, treatment with growth hormone should be discontinued. Currently, there are insufficient data, to be guided only by clinical criteria for making decisions about patients with intracranial hypertension in the resolution stage. With the resumption of growth hormone treatment requires careful monitoring for symptoms of intracranial hypertension.

Adult, suffering from growth hormone deficiency, undergoing replacement therapy Norditropin^® FlexPro^®, should be under the supervision of an endocrinologist, with experience in the treatment of diseases of the pituitary gland.

Growth hormone deficiency in adults persists throughout life and requires appropriate treatment, Currently, however, experience in patients older 60 years, and the results of therapy, continuing more 5 years, inadequate.

Effects on ability to drive vehicles and operate machinery

The drug has no effect on the ability to drive vehicles and operate machinery.

Overdose

Symptoms Acute overdose could be first of hypoglycemia, and then hyperglycemia. Such fluctuations in glucose concentrations were determined only biochemically without clinical manifestations. With long-term overdose may have signs and symptoms, characteristic of an excess of human growth hormone – acromegaly and / or gigantism, and hypothyroidism may occur and lowering serum cortisol.

Treatment: removal of the drug, simptomaticheskaya therapy.

Drug Interactions

Concomitant therapy corticosteroids can suppress growth and, thus, reduce the stimulating effect of the drug Norditropin^® FlexPro^® on the growth process.

The effectiveness of the drug Norditropin^® FlexPro^® (in respect of finite growth) It can also affect other hormones concomitant therapy, eg, gonadotropin, anabolic steroids, estrogens and thyroid hormones.

Conditions of supply of pharmacies

The drug prescription.

Conditions and terms

List B. The drug should be stored at 2 ° to 8 ° C (in a refrigerator) in carton; Do not freeze. Shelf life – 2 year.

After the first use Norditropin^® FlexPro^® a dosage 5 mg / ml and 1.5 10 mg / 1.5 ml to be stored for 4 weeks at a temperature of from 2 ° to 8 ° C. (in a refrigerator) or for 3 weeks at a temperature no higher than 25 ° C; Do not freeze.

After the first use Norditropin^® FlexPro^® a dosage 15 mg / 1.5 ml to be stored for 4 weeks at a temperature of from 2 ° to 8 ° C. (in a refrigerator); Do not freeze.

The drug should be stored out of reach of children.