ZOMACTON POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 4 MG [SIN14362P]

Product Info

ZOMACTON POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 4 MG

[SIN14362P]

THERAPEUTIC INDICATIONS
ZOMACTON® is indicated for:

• the long-term treatment of children who have growth failure due to inadequate secretion of growth hormone.

• the long-term treatment of growth retardation due to Turner’s Syndrome confirmed by chromosome analysis.

POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ZOMACTON® therapy should be initiated and monitored by physicians who are appropriately qualified and experienced in the management of patients with growth hormone deficiency.

The dosage and schedule of administration of ZOMACTON® should be individualised for each patient.

The duration of treatment, usually a period of several years, will depend on maximum achievable therapeutic benefit.

Growth Hormone Deficiency
Generally a dose of 0.17 – 0.23 mg/kg bodyweight (approximating to 4.9 mg/m² – 6.9 mg/m² body surface area) per week divided into 6 – 7 s.c. injections is recommended (corresponding to a daily injection of 0.02 – 0.03 mg/kg bodyweight or 0.7 – 1.0 mg/m² body surface area).

The total weekly dose of 0.27 mg/kg or 8 mg/m² body surface area should not be exceeded (corresponding to daily injections of up to about 0.04 mg/kg).

Turner’s Syndrome
Generally a dose of 0.33 mg/kg bodyweight (approximating to 9.86 mg/m² body surface area) per week divided into 6 – 7 s.c. injections are recommended (corresponding to daily injection of 0.05 mg/kg bodyweight or 1.40 – 1.63 mg/m² body surface area).

Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.

Patients with childhood onset Growth Hormone Deficiency should be re-evaluated for growth hormone secretory capacity after growth completion

Method of administration
The solution for injection should be administered subcutaneously. The injection site should be varied to prevent lipoatrophy.

For instructions for use and handling of the medicinal product, see section Instruction for use and handling and special precautions for disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The required dose of ZOMACTON® 4 mg is administered with an ordinary syringe.

CONTRAINDICATIONS
Hypersensitivity to somatropin or to any of the excipients.

ZOMACTON® must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumor therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.

ZOMACTON® should not be used for growth promotion in children with closed epiphysis.

Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar conditions should not be treated with ZOMACTON® (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In children with chronic renal disease, treatment with ZOMACTON® should be discontinued at renal transplantation.

ZOMACTON® 4 mg must not be given to premature babies or neonates as the solvent contains benzyl alcohol.