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Instructions

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Instruction for use: Norditropin SimpleXx

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ATX Code H01AC01 Somatropin

Active substance: Somatropin

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Nosological classification (ICD-10)

E30.0 Delay in puberty

Later sexual development, Sexual maturation later

E34.3 Low-growth [dwarfism], not elsewhere classified

Growth retardation, Growth retardation in children, Dwarfism, Nanism hypophyseal, Inadequate endogenous growth hormone, Growth Hormone Deficiency, Pituitary Nanism, Low height, Growth disorder, Disturbance of the growth process, Pituitary dwarfism, Disruption of endogenous hormone secretion with growth retardation, Growth disorders, Naniz disproportionate, Nanism associated with external factors

Q96 Turner Syndrome

Turner syndrome, Gonadal Dysgenesis, Mixed gonadal dysgenesis, Shereshevsky-Turner Syndrome

Composition and form of release

1 cartridge with 1.5 ml solution for subcutaneous injection contains somatropine 5, 10 or 15 mg; In carton pack 1 contour cell pack with 1 cartridge.

Characteristic

Cartridges 5, 10 and 15 mg are designed for use with NordiPen 5, Nordipen 10 and NordiPen 15 syringes, respectively.

pharmachologic effect

Pharmacological action - somatotropic.

Recombinant growth hormone. Stimulates growth and weight gain.

Indications

Growth retardation in children due to insufficiency of growth hormone or chronic renal failure (at prepubertal age), Shereshevsky-Turner syndrome (genetic disease in which normal growth can be disturbed).

Contraindications

Hypersensitivity, signs of active malignant tumor process, kidney transplant, pregnancy, breast-feeding.

pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects

Rarely, puffiness of the extremities (due to fluid retention), redness and itching at the injection site (a dose reduction may be required), development of antibodies to the drug, temporary increase in intracranial pressure (possible signs - headache, visual impairment, nausea or vomiting); Very rarely - pain in the hip or knee joint, lameness (may not result from the use of the drug, but be caused by Legg-Calve-Perthes disease or the head of the epiphysis of the femur).

Dosing and Administration

P / c using NordiPen 5, Nordipen 10 and NordiPen 15, just before bedtime, changing the injection site each time. If growth hormone deficiency is 25-35 μg / kg / day or 0.7-1 mg / m2 / day, with Shereshevsky-Turner syndrome and growth retardation in chronic renal failure, 50 μg / kg / day or 1 , 4 mg / m2 / day until the completion of the growth process. The dose should be adjusted depending on the individual response to treatment. If the injection is skipped accidentally, the next dose is administered as usual, and a double dose of the drug can not be used.

If the development of growth hormone is impaired, the drug is effective both in children and in older age.

Precautionary measures

The simultaneous use of glucocorticoids or sex steroid hormones can affect the final growth.

Patients with diabetes may require a change in the dose of insulin administered.

special instructions

To protect from light, it should be stored in a cardboard bundle or in a NordiPen 5, Nordipen 10 or NordiPen 15 (in use) syringe.

Do not use thawed or heat-affected solution, and also if the drug has ceased to be colorless and transparent.

From the beginning of use the drug can be stored in the refrigerator for 4 weeks at a temperature of 2-8°C.

Storage conditions

At a temperature of 2-8 ° C. After opening, store for 4 weeks at a temperature of 2-8 ° C or for 3 weeks at a temperature of no higher than 25 ° C (do not freeze).

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.

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