Humatrope ® (somatropin (rDNA ursprung) för injektion)

För fullständig produktresumé för Humatrope® se FASS.

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Humatrope® (somatropin): Biverkningar

Sammanfattning av säkerhetsprofilen för somatropin

The following table of undesirable effects and frequencies is based on clinical trial and post-marketing spontaneous reports.

Immune system disorders

Hypersensitivity to solvent (metacresol/glycerol): 1%-10%.

Hypersensitivity to the active substance: Frequency not known (cannot be estimated from the available data).

Endocrine disorders

Hypothyroidism: 1%-10%.

Reproductive system and breast disorders

Gynaecomastia: <0.01% paediatrics; 0.1%-1% adults.

Metabolism and nutrition disorders

Mild hyperglycaemia: 1% paediatrics; 1%-10% adults.

Type 2 diabetes mellitus: 0.1 % - 1 % paediatrics; adult cases were reported spontaneously with unknown frequency.

Insulin resistance.

Nervous system disorders

Benign intracranial hypertension: 0.01%-0.1%.

Headache: >10% adults.

Insomnia: <0.01% paediatrics; 1%-10% adults.

Paraesthesia: 0.01%-0.1% paediatrics; 1%-10% adults.

Carpal tunnel syndrome: 1%-10% adults.

Vascular disorders

Hypertension: <0.01% paediatrics; 1%-10% adults.

Respiratory, thoracic and mediastinal disorders

Dyspnoea: 1%-10% adults.

Sleep apnoea: 1%-10% adults.

Musculoskeletal and connective tissue disorders

Localised muscle pain (myalgia): 1%-10% adults; 0.01%-0.1% paediatrics.

Joint pain and disorder (arthralgia): >10% adults.

Progression of scoliosis: 1 %-10 % paediatrics.

General disorders and administration site conditions

Weakness: 0.1%-1%.

Injection site pain (reaction): 1%-10%.

Oedema (local and generalised): 1%-10% paediatrics; 10% adults.


Glucosuria: <0.01% paediatrics; 0.01%-0.1% adults.

Paediatric patients

In clinical trials with growth hormone deficient patients, approximately 2% of the patients developed antibodies to growth hormone. In trials in Turner syndrome, where higher doses were used, up to 8% of patients developed antibodies to growth hormone. The binding capacity of these antibodies was low and growth rate was not affected adversely. Testing for antibodies to growth hormone should be carried out in any patient who fails to respond to therapy.

A mild and transient oedema was observed early during the course of treatment.

Leukaemia has been reported in a small number of children who have been treated with growth hormone. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.

Adult patients

In patients with adult onset growth hormone deficiency, oedema, muscle pain and joint pain and disorder, were reported early in therapy and tended to be transient.

Adult patients treated with growth hormone, following diagnosis of growth hormone deficiency in childhood, reported side-effects less frequently than those with adult onset growth hormone deficiency.


Humatrope Summary of Product Characteristics.

Datum fӧr senaste ӧversyn February 01, 2019

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