Norditropin SimpleXx 15 mg/1.5 ml, solution for injection in cartridge

Product Information *

  • Company:

    Novo Nordisk Limited
  • Status:

    Updated
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 June 2021

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 

Text added:

Norditropin contains sodium

Norditropin contains less than 1 mmol sodium (23 mg) per 1.5 ml, that is to say essentially ‘sodium-free’.

 

Section 6

Date of revision updated to: 05/2021

Updated on 10 June 2021

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Specials warnings and precautions for use

Text added:

Excipients
Norditropin contains less than 1 mmol sodium (23 mg) per 1.5 ml, that is to say essentially ‘sodium-free’.

Updated on 28 May 2021

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Specials warnings and precautions for use

New text added:

Adults and Children
Pancreatitis
Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children.

 

Section 4.8 Undesirable effects

New text added to columns:

System organ classes

Reproductive system and breast disorders

Uncommon (≥ 1/1,000 to < 1/100)

In adults and children

Gynecomastia

 

Section 10. Date of revision of the text

Updated to: 05/2021

Updated on 28 May 2021

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - Warnings and precautions

New text added:

Norditropin SimpleXx may cause an inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if you or your child develops stomach ache after taking Norditropin SimpleXx.

 

Section 4 - Possible side effects

New text added regarding 'Breast enlargement (gynaecomastia) in the following sections:

Additional side effects in children

Uncommon (may affect up to 1 in 100 children)

- Breast enlargement (gynaecomastia)

 

Additional side effects in adults

Uncommon (may affect up to 1 in 100 children)

- Breast enlargement (gynaecomastia)

 

Section 6 - date of revision

Updated to: 02/2021

Updated on 18 February 2020

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - duration of treatment

Free text change information supplied by the pharmaceutical company

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

Updated on 18 February 2020

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 17 January 2020

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

 

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.”

Updated on 17 January 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

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."

Updated on 21 June 2019

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

PDF of SPC uploaded to replace Word document

Updated on 05 June 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 29 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes from previous version:

Update to section 4.4 and 4.5.

Updated on 16 October 2015

Reasons for updating

  • New PIL for new product

Updated on 16 October 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 13 November 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision

Updated on 07 March 2012

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 29 September 2011

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 07 March 2011

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 18 November 2009

Reasons for updating

  • Improved electronic presentation

Updated on 16 October 2009

Reasons for updating

  • New PIL for medicines.ie