Norditropin^® (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

H01AC01 (Somatropin)

Active Substance

Somatropin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Recombinant somatropin

Pharmacotherapeutic Group

Somatotropic hormone

Pharmacological Action

Recombinant growth hormone, identical in composition and effects to human pituitary growth hormone. It is a polypeptide consisting of 191 amino acids. The biological activity is approximately 3 IU/mg.

It stimulates skeletal growth and increase in body weight; it 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%. The maximum plasma concentration (C_max) is reached in 3-6 hours and is 13-35 ng/ml. It is metabolized in the liver.

The elimination half-life (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.
Turner syndrome.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E23.0	Hypopituitarism
N18	Chronic kidney disease
Q96	Turner's syndrome

ICD-11 code	Indication
5A61.0	Hypopituitarism
GB61.Z	Chronic kidney disease, unspecified stage
LD50.0	Turner syndrome

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Establish the dosage regimen individually based on the patient’s condition and indication for use.

Administer subcutaneously at a dose of 0.07-0.1 IU/kg body weight once daily.

In some cases, administer a dose of 0.14-0.2 IU/kg body weight every other day.

Solution

It is established individually. Usually administered subcutaneously at 0.07-0.1 IU/kg once daily, and in some cases – at 0.14-0.2 IU/kg every other day.

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 (active).
Pregnancy and lactation period.
Hypersensitivity to somatropin or any component of the formulation.

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 and, if necessary, an increase in the insulin dose is required).

Insufficient thyroid function may reduce the effectiveness of somatropin. If a hypothyroid condition develops, thyroid hormones should be administered.

Drug Interactions

Concomitant use with glucocorticosteroids may decrease the effectiveness of somatropin.

Monitor for reduced therapeutic response and adjust therapy if necessary.

Overdose

Symptoms of overdose may include fluid retention, hyperglycemia, and initial hypoglycemia followed by persistent hyperglycemia.

Long-term overdose can lead to features consistent with acromegaly and gigantism.

Manage overdose by discontinuing therapy and providing symptomatic and supportive care.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Norditropin^® [Novo Nordisk A/S (Denmark)]
Solution for subcutaneous administration 10 mg/1.5 ml: cartridge in a pen-injector 1.5 ml

Marketing Authorization Holder

Novo Nordisk A/S (Denmark)

Dosage Form

Norditropin^®

Solution for subcutaneous administration 10 mg/1.5 ml: cartridge in a pen-injector 1.5 ml

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration colorless, transparent or slightly opalescent.

	1 ml	1 pen-injector (1.5 ml)
Somatropin (genetically engineered human growth hormone)	6.7 mg	10 mg

* 1 mg of somatropin corresponds to 3 IU (International Units) of somatropin.

Excipients : mannitol, histidine, poloxamer 188, phenol, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections.

1.5 ml – glass cartridges, sealed in multidose disposable pen-injectors for multiple injections (pre-filled pen-injectors) NordiFlex^® (1) – cardboard packs.

Norditropin^® Simplexx [Novo Nordisk A/S (Denmark)]
Solution for subcutaneous administration 5 mg/1.5 ml: cartridges 1 pc.
Solution for subcutaneous administration 10 mg/1.5 ml: cartridges 1 pc.
Solution for subcutaneous administration 15 mg/1.5 ml: cartridges 1 pc.

Marketing Authorization Holder

Novo Nordisk A/S (Denmark)

Dosage Forms

	Norditropin^® Simplexx^®	Solution for subcutaneous administration 5 mg/1.5 ml: cartridges 1 pc.
		Solution for subcutaneous administration 10 mg/1.5 ml: cartridges 1 pc.
		Solution for subcutaneous administration 15 mg/1.5 ml: cartridges 1 pc.

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration	1.5 ml (1 cartridge)
Somatropin	5 mg

1.5 ml – cartridges (1) – contour cell packaging (1) – cardboard packs.

Solution for subcutaneous administration	1.5 ml (1 cartridge)
Somatropin	10 mg

1.5 ml – cartridges (1) – contour cell packaging (1) – cardboard packs.

Solution for subcutaneous administration	1.5 ml (1 cartridge)
Somatropin	15 mg

1.5 ml – cartridges (1) – contour cell packaging (1) – cardboard packs.

Norditropin^® NordiLet [Novo Nordisk A/S (Denmark)]
Solution for subcutaneous administration 5 mg/1.5 ml: cartridge for pen-injector 1.5 ml 1 pc.
Solution for subcutaneous administration 10 mg/1.5 ml: cartridge in a pen-injector 1.5 ml 1 pc.
Solution for subcutaneous administration 15 mg/1.5 ml: cartridge in a pen injector 1.5 ml 1 pc.

Marketing Authorization Holder

Novo Nordisk A/S (Denmark)

Dosage Forms

	Norditropin^® NordiLet^®	Solution for subcutaneous administration 5 mg/1.5 ml: cartridge for pen-injector 1.5 ml 1 pc.
		Solution for subcutaneous administration 10 mg/1.5 ml: cartridge in a pen-injector 1.5 ml 1 pc.
		Solution for subcutaneous administration 15 mg/1.5 ml: cartridge in a pen injector 1.5 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for subcutaneous administration colorless, transparent.

	1 ml
Somatropin	3.3 mg

Excipients : mannitol – 40 mg, histidine – 0.68 mg, poloxamer 188 – 3 mg, phenol – 3 mg, hydrochloric acid or sodium hydroxide – q.s. (for pH adjustment), water for injections – up to 1 ml.

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

Solution for subcutaneous administration colorless, transparent.

	1 ml
Somatropin	6.7 mg

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

Solution for subcutaneous administration colorless, transparent.

	1 ml
Somatropin	10 mg

Excipients : mannitol – 39 mg, histidine – 1.1 mg, poloxamer 188 – 3 mg, phenol – 3 mg, hydrochloric acid or sodium hydroxide – q.s. (for pH adjustment), water for injections – up to 1 ml.

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