Section 4.1:

New indication added: “Growth failure due to Noonan syndrome”

Section 4.2:

New text added for new indication:

“Noonan syndrome:

0.066 mg/kg/day is the recommended dose, however in some cases 0.033 mg/kg/day may be sufficient (see section 5.1).

Treatment should be discontinued at the time of epiphyseal closure (see section 4.4).”

Section 4.4:

New text: “Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.”

Section updated to:

“Children treated with somatropin should be regularly assessed by a specialist in child growth. Somatropin treatment should always be instigated by a physician with special knowledge of growth hormone insufficiency and its treatment. This is true also for the management of Turner syndrome, chronic renal disease, and SGA and Noonan syndrome. Data of final adult height following the use of Norditropin are limited for children with Noonan Syndrome and are not available for children with chronic renal disease are not available.”

Section updated to:

“Scoliosis is known to be more frequent in some of the patient groups treated with somatropin for example Turner syndrome and Noonan syndrome.”

Section 5.1:

Clinical efficacy and safety:

Full section update to include data related to the Noonan syndrome indication – see SPC for full details.

Section 1:

New indication added:

“If they have Noonan syndrome (a genetic problem which may affect growth).”

Section 3:

New text added:

“Children with Noonan syndrome:

The usual dose is 0.066 mg per kg body weight per day, however your doctor may decide that 0.033 mg per kg body weight per day is sufficient”

Section updated:

“How long you will need treatment for

•          Children with growth failure because of Turner syndrome, kidney disease, SGA or Noonan syndrome: Your doctor will recommend you continue treatment until you stop growing”

Section 2, Warnings and Precautions:

Deleted:

”If you develop a limp or low-back pain as these could be signs of a curved spine (scoliosis)”

Added:

• An increase in sideways curvature of the spine (scoliosis) may progress in any child during rapid growth. During treatment with Norditropin SimpleXx, your doctor will check you (or your child) for signs of scoliosis.
• If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.

Section 5:

Sentence added: “Do not store close to any cooling elements.”

Section 4.4:

Scoliosis

Scoliosis is known to be more frequent in some of the patient groups treated with somatropin for example Turner syndrome. In addition, rapid growth may progress in any child can cause progression of scoliosis. during rapid growth. Signs of scoliosis should be monitored during treatment. However, Somatropin treatment has not been shown to increase the incidence or severity of scoliosis. Signs of scoliosis should be monitored during treatment.

Slipped capital femoral epiphysis

In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population. A patient treated with somatropin who develops a limp or complains of hip or knee pain should be evaluated by a physician.

Section 4.8

• Sentence deleted from 'Post-marketing experience' (text updated and presented in Section 4.4):

Slipped capital femoral epiphysis. Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders.

• HPRA reporting details condensed

Section 6.4

Sentence added: "Do not store close to any cooling elements."

PDF of SPC uploaded to replace Word document

Changes from previous verion:

Update to section 4.4 and 4.5.