Omnitrope^® (Solution) Instructions for Use

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Novartis Pharmaceutical Manufacturing GmbH (Austria)

ATC Code

H01AC01 (Somatropin)

Active Substance

Somatropin (Rec.INN)

Dosage Forms

	Omnitrope®	Solution for subcutaneous administration 3.3 mg/1 ml: cartridges 1.5 ml 1, 5 or 10 pcs.
		Solution for subcutaneous administration 6.7 mg/1 ml: cartridges 1.5 ml 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration transparent or slightly opalescent, colorless.

Excipients : sodium hydrogen phosphate heptahydrate – 1.33 mg, sodium dihydrogen phosphate dihydrate – 1.57 mg, poloxamer – 3 mg, benzyl alcohol (preservative) – 13.5 mg, mannitol – 52.51 mg, phosphoric acid – q.s. to pH 6.2±0.2, sodium hydroxide – q.s. to pH 6.2±0.2, water for injections – up to 1.5 ml.

1.5 ml – cartridges (1) – plastic contour packaging (1) – cardboard boxes.
1.5 ml – cartridges (5) – plastic contour packaging (1) – cardboard boxes.
1.5 ml – cartridges (10) – plastic contour packaging (1) – cardboard boxes.

Solution for subcutaneous administration transparent or slightly opalescent, colorless.

Excipients : sodium hydrogen phosphate heptahydrate – 1.7 mg, sodium dihydrogen phosphate dihydrate – 1.35 mg, poloxamer – 3 mg, phenol (preservative) – 4.5 mg, glycine – 27.75 mg, phosphoric acid – q.s. to pH 6.2±0.2, sodium hydroxide – q.s. to pH 6.2±0.2, water for injections – up to 1.5 ml.

1.5 ml – cartridges (1) – plastic contour packaging (1) – cardboard boxes.
1.5 ml – cartridges (5) – plastic contour packaging (1) – cardboard boxes.
1.5 ml – cartridges (10) – plastic contour packaging (1) – cardboard boxes.

Clinical-Pharmacological Group

Recombinant somatropin

Pharmacotherapeutic Group

Somatotropic hormone

Pharmacological Action

A recombinant growth hormone, identical in composition and effects to the human pituitary growth hormone.

It is a polypeptide containing 191 amino acids. The biological activity is approximately 3 IU/mg.

It stimulates skeletal growth and body weight gain; stimulates the transport of amino acids into the cell, accelerating intracellular protein synthesis and thus exhibiting an anabolic effect.

It causes retention of nitrogen, mineral salts (calcium, phosphorus, sodium) and fluid in the body. It increases blood glucose levels.

Pharmacokinetics

After subcutaneous administration, systemic absorption is 80%. C_max in plasma is reached in 3-6 hours and is 13-35 ng/ml. It is metabolized in the liver.

T_1/2 is 2-3 hours. It is excreted through the intestines.

Indications

Growth hormone deficiency in the body (pituitary dwarfism); chronic renal failure in children, accompanied by growth retardation; Shereshevsky-Turner syndrome.

ICD codes

Dosage Regimen

Determine the dosage individually based on the patient’s body weight and clinical indication.

Administer the solution by subcutaneous injection once daily.

For the treatment of growth hormone deficiency, the typical dose is 0.07 to 0.1 IU per kg body weight daily.

In some clinical situations, administer a dose of 0.14 to 0.2 IU per kg body weight every other day.

Use the appropriate cartridge strength (3.3 mg/ml or 6.7 mg/ml) to accurately measure the prescribed dose.

Rotate injection sites daily to prevent lipoatrophy.

Adjust the dose based on clinical response and serum IGF-I concentrations.

Regularly monitor growth velocity and bone age in pediatric patients.

Discontinue therapy once epiphyseal fusion is complete.

Adverse Reactions

From the endocrine system hyperglycemia, increased symptoms of hypothyroidism.

Allergic reactions skin rash, itching, increased titer of antibodies to somatropin.

Other headache, edema.

Local reactions pain, redness at the injection site.

Contraindications

Malignant neoplasms, pregnancy, lactation period, hypersensitivity to somatropin.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Special Precautions

Do not use in patients with completed bone growth process.

Use with caution in patients with diabetes mellitus (control of blood sugar levels is required and, if necessary, an increase in the insulin dose).

Insufficient thyroid function may reduce the effectiveness of somatropin. In case of development of a hypothyroid condition, thyroid hormones should be administered.

Drug Interactions

With simultaneous use with glucocorticosteroids, the effectiveness of somatropin decreases.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.