Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen

*
Pharmacy Only: Prescription
  • Company:

    Novo Nordisk Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 23 December 2022

File name

Norditropin FlexPro 10 mg PIL_Dec2022_clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Countries list updated (United Kingdom updated to United Kingdom (Northern Ireland))

Date of revision updated to 12/2022

Updated on 23 December 2022

File name

Norditropin FlexPro SmPC-IE-v6-Dec2022_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2:

'Somatropin' updated to 'somatropin' in 'somatropin (recombinant DNA origin produced in E-coli)'

Section 4.8 (table, Uncommon, Reproductive system and breast disorders):

'Gynecomastia' updated to 'Gynaecomastia'

Section 10:

Revision date updated to 12/2022.

Updated on 10 June 2021

File name

Norditropin FlexPro 10 mg PIL_May2021_clean.pdf

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

File name

Norditropin FlexPro SmPC-IE-v5-May2021_clean.pdf

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

File name

Norditropin Flexpro SmPC-IE-v4-May2021_clean.pdf

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

File name

Norditropin FlexPro 10mg PIL_Feb2021_clean.pdf

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 FlexPro 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 FlexPro.

 

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

File name

Norditropin Flexpro SmPC_v3_Noonan_clean.pdf

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 18 February 2020

File name

ie-pl-clean-flexpro 10mg_noonan_final.pdf

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 17 January 2020

File name

ie-pl-clean-flexpro 10 mg_approved.pdf

Reasons for updating

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

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 FlexPro, 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.”

 

Change to storage instructions

IFU:

Sentence added: “Do not freeze your pen or store it close to any cooling element, e.g. in a refrigerator.”

Updated on 17 January 2020

File name

Norditropin FlexPro SmPC_v2_clean.pdf

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 26 September 2019

File name

ie-pl-clean-flexpro 10 mg_02 2019.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision updated. No content change.

Updated on 31 July 2019

File name

ie-pl-clean-flexpro 10 mg_APR2018_medicines.pdf

Reasons for updating

  • New PIL for new product

Updated on 31 July 2019

File name

Norditropin Flexpro SmPC_ver 1_IE clean_Feb2018.pdf

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

Product launch