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

  • Name:

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

  • Company:
    info
  • Active Ingredients:

    Somatropin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/20

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Summary of Product Characteristics last updated on medicines.ie: 18/2/2020

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Novo Nordisk Limited

Novo Nordisk Limited

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Medicine Name Levemir Penfill (Insulin detemir) 100 units/ml solution for injection in cartridge Active Ingredients insulin detemir
Medicine Name Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 15 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 5 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 10 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 15 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 5 mg/1.5 ml, solution for injection in cartridge Active Ingredients Somatropin
Medicine Name Novofem film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
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1 - 0 of 40 items.Total: Infinity pages

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 18 February 2020 SmPC

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 PIL

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 PIL

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 SmPC

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 PIL

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 July 2019 SmPC

Reasons for updating

  • New SmPC 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