Tresiba-200 Units-ml-pre-filled -FlexTouch

  • Name:

    Tresiba-200 Units-ml-pre-filled -FlexTouch

  • Company:
    info
  • Active Ingredients:

    Insulin degludec

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/07/18

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2018

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Novo Nordisk Limited

Novo Nordisk Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Activelle Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Actrapid 100 international units/ml, Solution for injection in a vial Active Ingredients Human Insulin
Medicine Name Estrofem 2mg Active Ingredients Estradiol Hemihydrate
Medicine Name Fiasp 100 units-mL solution for injection in Cartridge Penfill Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in pre-filled FlexTouch pen Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in vial Active Ingredients Insulin aspart
Medicine Name GlucaGen HypoKit 1 mg powder and solvent for solution for injection Active Ingredients Glucagon hydrochloride
Medicine Name Insulatard 10 ml Vial Active Ingredients Human Insulin
Medicine Name Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Insulatard Penfill Active Ingredients Human Insulin
Medicine Name Insulatard, Insulatard Penfill, Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Kliogest 2 mg/1 mg film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Levemir FlexPen (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
Medicine Name Levemir InnoLet (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
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
Medicine Name NovoMix 30 FlexPen Active Ingredients Insulin aspart
Medicine Name NovoMix 30 Penfill Active Ingredients Insulin aspart
Medicine Name NovoNorm 0.5 mg, 1 mg and 2 mg tablets Active Ingredients Repaglinide
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 20 November 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

update to section 6.5: word "stopper" replaced with "laminate rubber sheet"

update to section 10: date of revision of the text changed to 11/2018

Updated on 16 July 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.5: Addition of a new pack size : "5 (without needles)"

Section 8: addition of new MA number: EU/1/12/807/016

section 10: update of revision date to 07/2018

Updated on 16 July 2018 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 1 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2018 PIL

Reasons for updating

  • Change to section 3 - dose and frequency

Updated on 22 November 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.2
addition of:

Tresiba must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).


Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).

section 4.4
addition of:

To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen.

In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).

section 5.1
addition of Cardiovascular evaluation sub-section.

section 6.6
addition of:A  new needle must always be attached before each use. Needles must not be re-used. The patient should discard the needle after each injection.

 

In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

Tresiba in a pre-filled pen is available in two strengths. “Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.

Tresiba 100 units/mL packaging and label are light green.


Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.

section 9
Date of latest renewal: 21 September 2017

Section 10
10/2017

section 9Date of latest renewal: 21 September 2017Section 1010/2017

section 9Date of latest renewal: 21 September 2017Section 1010/2017

section 9Date of latest renewal: 21 September 2017Section 1010/2017

Updated on 22 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 November 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 3 October 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of black triangle

Updated on 2 October 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

For Tresiba, the inverted black triangle has been removed.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

 

4.2     Posology and method of administration

 

Posology

This medicinal product medicine resiba i is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.

 

The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) of insulin degludec corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.

 

In patients with type 2 diabetes mellitus, Tresiba this medicinal product medicine can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see section 5.1).

 

As with all insulin products, aAdjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

 

Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre‑filled pen

 

Tresiba is available in two strengths. For both, the needed dose is dialled in units. The dose steps, however, differ between the two strengths of the medicinal productmedicineTresiba.

 

Paediatric population

There is no clinical experience with the use of this medicinal product medicine in children below the age of 1 year. This medicinal product medicineresiba can be used in adolescents and children from the age of 1 year (see section 5.1).

 

Method of administration

Tresiba is for sSubcutaneous use only.

 

Tresiba  i must not be administered intravenously as it may result in severe hypoglycaemia.

This medicinal productresiba must not be administered intramuscularly as it may change the absorption.

This medicinal productresiba must not be used in insulin infusion pumps.

 

4.4       Special warnings and precautions for use

Sodium

 

This medicinal preoduct contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

 

4.5     Interaction with other medicinal products and other forms of interaction

Oral antidiabetic medicinal products, GLP‑1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta‑blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphfonamides.

 

4.7     Effects on ability to drive and use machines

This medicinal product medicine has no or negligible influence on the ability to drive and use machines.,

 

 

10.     DATE OF REVISION OF THE TEXT

 

09/2017

 



Updated on 24 May 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

3. How to use Tresiba

 

Under Flexibility in dosing time.

 

Sentence has been added:

There is no experience with flexibility in dosing time of Tresiba in children and adolescents.

 

5.1 Clinical data included to include data from SWITCH trials.

 

10. This leaflet was last revised in: 04/2017

Updated on 19 May 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 15 May 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2      Posology and method of administration

Flexibility in dosing time

 

Sentence and text added:

There is no clinical experience with flexibility in dosing time of Tresiba in children and adolescents.”

 

Patients with type 2 diabetes mellitus

Paragraph/text in bold added:

 

During transfer from other insulins; in type 2 diabetes (text added)

taking once-daily basal, basal-bolus, premix or self-mixed insulin therapy changing the basal insulin to Tresiba® can be done unit-to-unit, based on the previous basal insulin component;

 

A dose reduction of 20% based on the previous basal insulin dose followed by individual dosage adjustments should be considered when

- transferring to Tresiba from twice-daily basal insulin

- transferring to Tresiba from insulin glargine (300 units/mL)

 

Patients with type 1 diabetes mellitus

Paragraph changed per bold.

For patients with type 1 diabetes a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response.

 

Sentence deleted:

For patients with type 1 diabetes transferring from twice-daily basal insulin or having HbA1c < 8.0% at the time of transfer, the dose of Tresiba needs to be determined on an individual basis. Dose reduction needs to be considered followed by individual dosage adjustment based on the glycaemic response.

 

5.1      Pharmacodynamic properties

Section updated to include data from clinical trials.

 

10.      DATE OF REVISION OF THE TEXT

 

Revised 04/2017

Updated on 31 December 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 December 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided