Humatrope ® (somatropin (rDNA ursprung) för injektion)

För fullständig produktresumé för Humatrope® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Humatrope® (somatropin): Dosering och administreringssätt

Doseringen är individuell

Posology

The dosage and administration schedule should be personalised for each individual; however, for:

Growth hormone deficient paediatric patients

The recommended dosage is 0.025-0.035mg/kg of body weight per day by subcutaneous injection. This is the equivalent to approximately 0.7-1.0mg/m2 body surface area per day.

Growth hormone deficient adult patients

The recommended starting dose is 0.15-0.30mg/day. A lower starting dose may be necessary in older and obese patients.

This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-I concentrations. Total daily dose usually does not exceed 1mg.

IGF-I concentrations should be maintained below the upper limit of the age-specific normal range.

The minimum effective dose should be used and dose requirements may decline with increasing age.

Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen therapy are under-treated while men are over-treated.

The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.

Patients with Turner Syndrome

The recommended dosage is 0.045-0.050mg/kg of body weight per day, given as a subcutaneous injection, to be administered preferably in the evening. This is equivalent to approximately 1.4mg/m2 per day.

Prepubertal paediatric patients with Chronic Renal Insufficiency

The recommended dosage is 0.045-0.050mg/kg of body weight per day, given as a subcutaneous injection.

Paediatric patients with SHOX deficiency

The recommended dosage is 0.045-0.050mg/kg of body weight per day, given as a subcutaneous injection.

Paediatric patients born Small for Gestational Age (SGA)

The recommended dose is 0.035mg/kg of body weight per day (equivalent to 1mg/m2 body surface area per day) given as a subcutaneous injection, until final height is reached. Treatment should be discontinued after the first year of treatment, if the height velocity SDS is below +1.0 SDS. Treatment should be discontinued if height velocity is < 2cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of epiphyseal growth plates.

Method of Administration

Humatrope is administered by subcutaneous injection after reconstitution

The subcutaneous injection sites should be varied in order to avoid lipoatrophy.

Reference

Humatrope Summary of Product Characteristics

Datum fӧr senaste ӧversyn 2019 M02 01

Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss