Tresiba 100 units/ml solution for injection in cartridge (Penfill)

Reference to the new Tresiba 100 units/mL FlexPen solution for injection in pre filled pen presentation has been included

Section 4.9: Reference to method of administration for glucagon has been removed

Reference to method of administration for glucagon has been removed. 

SPC uploaded for launch

PIL uploaded for product launch

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 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.

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

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

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

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

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 HbA_1c < 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

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 HbA_1c < 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