Update of SPC to reflect re-name of needle-free device from "ZOMAJET VISION X" to " ZomaJet 10".

Section 4.4:

New sentence:

“Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment (see section 4.5)”

Section 4.5

New sentence:

 “Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).”

Change to product name: 'in pre-filled syringe' removed

Section 1: 'in pre-filled syringe' removed

Section 3: 'in pre-filled syringe' removed

Section 4.3:

Deleted  "Any evidence of active malignant tumours. Intracranial neoplasm must be inactive and antitumour therapy should be completed prior to institution of therapy."

New text added:  "Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.”

Section 4.4:

Deleted text:

“In all patients developing other or similar acute critical illness, the possible benefit of treatment with growth hormone must be weighed against the possible risk involved.”

New text added:

“The maximum recommended daily dose should not be exceeded (see section 4.2).”

“In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.”

“Although rare, pancreatitis should be considered in somatropin-treated patients, especially children who develop abdominal pain.”

Section 4.8:

Sentence added under the undesirable effects table: “Pancreatitis has been reported post-marketing during GH therapy (frequency unknown).”

Section 6.6:

Reference to pre-filled syringe removed

Change to product name: 'in pre-filled syringe' removed

Section 1: 'in pre-filled syringe' removed

Section 3: 'in pre-filled syringe' removed

Section 4.3:

Deleted  "Any evidence of active malignant tumours. Intracranial neoplasm must be inactive and antitumour therapy should be completed prior to institution of therapy."

New text added:  "Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.”

Section 4.4:

Deleted text:

“In all patients developing other or similar acute critical illness, the possible benefit of treatment with growth hormone must be weighed against the possible risk involved.”

New text added:

“The maximum recommended daily dose should not be exceeded (see section 4.2).”

“In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.”

“Although rare, pancreatitis should be considered in somatropin-treated patients, especially children who develop abdominal pain.”

Section 4.8:

Sentence added under the undesirable effects table: “Pancreatitis has been reported post-marketing during GH therapy (frequency unknown).”

Section 6.6:

Reference to pre-filled syringe removed

Section 4.3: Text rephrased. Sentence added:  

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

Section 4.4: Text updated and statements added:

-          At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.

-          However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.

-          As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin. The binding capacity of these antibodies is low and there is no effect on growth rate.  Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.

-          Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask insipiens hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.

-          Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin containing product therapy is initiated. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Zomacton should also be used with caution in patients with a family history predisposing for the disease.

-          In patients with growth hormone deficiency secondary to an intra-cranial lesion, frequent monitoring for progression or recurrence of the underlying disease process is advised.

Section 4.5: Text rephrased.

Section 4.6: Text updated to:

For Zomacton, no clinical data on exposed pregnancies are available. There is no data from the use of Zomacton during pregnancy in animals. (See section Preclinical safety data 5.3)

Therefore, Zomacton is not recommended during pregnancy and in woman of childbearing potential not using contraception.

There have been no clinical studies conducted with somatropin containing products in breast-feeding women. It is not known whether somatropin is excreted in human milk. Therefore caution should be exercised when somatropin containing products are administered to breast-feeding women.

 Section 4.8:  full section update. Adverse events updated – see SPC for full details.

Section 4.3: Text rephrased. Sentence added:  

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

Section 4.4: Text updated and statements added:

-          At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.

-          However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.

-          As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin. The binding capacity of these antibodies is low and there is no effect on growth rate.  Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.

-          Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask insipiens hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.

-          Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin containing product therapy is initiated. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Zomacton should also be used with caution in patients with a family history predisposing for the disease.

-          In patients with growth hormone deficiency secondary to an intra-cranial lesion, frequent monitoring for progression or recurrence of the underlying disease process is advised.

Section 4.5: Text rephrased.

Section 4.6: Text updated to:

For Zomacton, no clinical data on exposed pregnancies are available. There is no data from the use of Zomacton during pregnancy in animals. (See section Preclinical safety data 5.3)

Therefore, Zomacton is not recommended during pregnancy and in woman of childbearing potential not using contraception.

There have been no clinical studies conducted with somatropin containing products in breast-feeding women. It is not known whether somatropin is excreted in human milk. Therefore caution should be exercised when somatropin containing products are administered to breast-feeding women.

 Section 4.8:  full section update. Adverse events updated – see SPC for full details.