Tresiba FlexTouch 200 Units/mL – (3x3ml)

Tresiba Penfill 100 units/ml in cartridge: Solution for injection (SC) at 100 units/ml (neutral, colourless, clear):  3 ml cartridge, box of 5. Tresiba FlexTouch 200 units/ml in pre-filled pen: Solution for injection (SC) at 200 units/ml (neutral, colourless, clear):  3 ml cartridge, contained in a disposable multidose pre-filled pen, box of 3 (without needle).

Tresiba Penfill 100 units/ml in cartridge:

Excipients: glycerol, metacresol, phenol, zinc acetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
1 ml of solution contains 100 units of insulin degludec (equivalent to 3.66 mg of insulin degludec).

Tresiba FlexTouch 200 units/ml in pre-filled pen:

Excipients: glycerol, metacresol, phenol, zinc acetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
1 ml of solution contains 200 units of insulin degludec (equivalent to 7.32 mg of insulin degludec).

^*   Produced in Saccharomyces cerevisiae by recombinant DNA technology.

Treatment of diabetes in adults, adolescents and children from the age of 1 year.

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Hypoglycemia:

Skipping a meal or engaging in significant unplanned exercise can lead to hypoglycemia.

Hypoglycemia may occur if the insulin dose is too high for the patient’s insulin needs ( see Interactions , Adverse reactions , Overdose ).

In children, insulin doses (particularly in a basal-bolus regimen) should be adjusted according to food intake and physical activity in order to reduce the risk of hypoglycemia.

Patients with markedly improved glycaemic control (e.g. on intensified insulin therapy) may experience a change in their usual warning signs of hypoglycaemia and should be alerted to this possibility. The usual warning signs may disappear in patients with long-standing diabetes.

Concomitant illnesses, particularly infections and feverish conditions, generally increase the patient’s insulin requirements. Concomitant diseases of the kidneys, liver, or adrenal, pituitary, or thyroid glands may require adjustment of the insulin dose.

As with other basal insulins, the prolonged effect of Tresiba may delay recovery from hypoglycemia.

Hyperglycemia:

Administration of rapid-acting insulin is recommended in situations of severe hyperglycemia.

Inadequate dosage and/or discontinuation of treatment in patients requiring insulin may result in hyperglycaemia and potentially diabetic ketoacidosis. In addition, concomitant diseases, particularly infections, may result in hyperglycaemia and thereby increase insulin requirements.

In general, the first symptoms of hyperglycemia appear gradually, over a few hours or days. These include a feeling of thirst, increased urination, nausea, vomiting, drowsiness, dry and red skin, dry mouth, loss of appetite and acetone odor to the breath. In type 1 diabetes, untreated hyperglycemic episodes can eventually lead to diabetic ketoacidosis, which can be fatal.

As a replacement for other insulins:

If the type, brand or manufacturer of insulin is changed, the patient will need to be monitored medically and a change in dosage may be necessary.

Skin and subcutaneous tissue disorders:

Patients should be instructed to rotate injection sites continuously to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsening of glycaemic control following insulin injections at sites with these reactions. A sudden change of injection site to an unaffected area has been reported to result in hypoglycaemia. Monitoring of blood glucose is recommended after changing the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.

Combination of pioglitazone and insulins:

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, particularly in patients with risk factors for heart failure. This should be taken into account if treatment with pioglitazone and Tresiba is considered. If such a combination is initiated, these patients should be monitored for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if worsening of symptoms of heart failure occurs.

Eye condition:

Intensification of insulin therapy with sudden improvement in glycemic control may be associated with transient worsening of diabetic retinopathy, whereas long-term improvement in glycemic control decreases the risk of progression of diabetic retinopathy.

Prevention of medication errors:

Patients should be instructed to always check the insulin label before each injection to avoid accidental confusion between the two strengths of Tresiba as well as with other insulins.

Patients should visually check the number of units selected on the pen’s dose counter. Therefore, in order to self-inject, patients must be able to read the pen’s dose counter. Patients who are blind or visually impaired should be instructed to always seek assistance from another person with good vision who is trained in the use of the insulin injection device.

To avoid dosing errors and possible overdose, patients and healthcare professionals should never use a syringe to withdraw medicine from the pre-filled pen cartridge.

In case of needle obstruction, patients should follow the instructions described in the instructions for use accompanying the package leaflet ( see Handling and disposal instructions ).

Anti-insulin antibodies:

Insulin administration may induce the formation of anti-insulin antibodies. In rare cases, the presence of anti-insulin antibodies may require adjustment of the insulin dose to correct a tendency to hyperglycemia or hypoglycemia.

Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Traceability:

In order to improve the traceability of biological medicines, the name and batch number of the administered product must be clearly recorded.

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Pregnancy:
The use of Tresiba in pregnant women with diabetes has been studied in one interventional trial ( see Pharmacodynamics ). A moderate amount of clinical trial and post-marketing data in pregnant women (over 400 pregnancies) do not indicate any malformation or foetal/neonatal toxicity. Animal reproduction studies have revealed no differences between insulin degludec and human insulin with respect to embryotoxicity and teratogenicity.

Treatment with Tresiba may be considered during pregnancy, if clinically needed.

In pregnant women with diabetes, it is generally recommended to intensify glycemic control and monitoring throughout pregnancy and when planning a pregnancy. Insulin requirements usually decrease during the first trimester and then increase during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy levels. Close monitoring of glycemic control is recommended and the insulin dose should be adjusted individually.

Breastfeeding:
There is no clinical experience regarding the use of Tresiba during lactation. In rats, insulin degludec was secreted into milk; the concentration in milk was lower than in plasma.

It is unknown whether insulin degludec is excreted in human milk. No metabolic effects are expected in breast-fed newborns/infants.

Fertility:
Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.

This medicinal product has no or negligible influence on the ability to drive and use machines. However, the patient’s ability to concentrate and react may be impaired in the event of hypoglycaemia. This could be a risk in situations where these abilities are essential (e.g. driving or using machines).
Patients should be advised to take precautions to avoid hypoglycaemia while driving. This is particularly important in patients who are unfamiliar with the warning signs of hypoglycaemia or who experience frequent hypoglycaemic episodes. In such circumstances, the ability to drive should be reassessed.

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For insulins, there is no specific definition of overdose. However, hypoglycemia can develop in successive stages if the patient receives more insulin than necessary:

• Mild hypoglycaemic episodes can be treated with oral administration of glucose or other sugary foods. Patients are therefore advised to carry food containing glucose with them at all times.
• Severe hypoglycaemic episodes, in which the patient is unable to self-treat, may be treated with glucagon or intravenous glucose administration by healthcare professionals. If the patient does not respond to glucagon within 10 to 15 minutes, intravenous glucose should be administered. Once the patient has regained consciousness, oral carbohydrate intake is recommended to prevent relapse.

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Non-clinical data from studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and reproductive toxicity revealed no concerns for human safety.

The ratio of mitogenic power to metabolic potential of insulin degludec is similar to that of human insulin.

This medicine should not be mixed with other medicines.

Substances mixed with Tresiba may cause insulin degludec to break down.

Tresiba should not be added to infusion fluids.

Shelf life: 30 months.

Before first use:

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Keep away from the cooling element.

Tresiba FlexTouch 200 units/ml, solution for injection in pre-filled pen: Keep the cap on the pen in order to protect from light.

Tresiba Penfill 100 units/ml, solution for injection in cartridge: Store the cartridges in the outer carton in order to protect from light.

After first use or kept on hand as a reserve:

The medicine can be stored for a maximum of 8 weeks. Store at a temperature not exceeding 30 °C.

Tresiba FlexTouch 200 units/ml solution for injection in pre-filled pen: Can be stored in a refrigerator (2°C – 8°C). Keep the cap on the pen in order to protect from light.

Tresiba Penfill 100 units/ml, solution for injection in cartridge: Do not store in a refrigerator. Store cartridges in the outer carton in order to protect from light.

This medicine is for single patient use only. The pre-filled pen should not be refilled.

Tresiba should not be used if the solution is not clear and colourless.

Tresiba should not be used if it has been frozen.

A new needle should always be attached before each use. Needles should not be reused. The patient should discard the needle after each injection.

In case of needle obstruction, patients should follow the instructions described in the instructions for use accompanying the package insert.

All waste must be disposed of in accordance with current regulations.

See the leaflet for detailed instructions for use.

Tresiba FlexTouch 200 units/ml, solution for injection in pre-filled pen: The concentration “Tresiba 200 units/ml” is clearly stated on the pen label and on the packaging.

Tresiba FlexTouch 200 units/ml, solution for injection in pre-filled pen:

The packaging and label of Tresiba 200 units/ml are striped dark green with a red frame highlighting the concentration.

The pre-filled pen is designed to be used with NovoFine or NovoTwist needles up to 8 mm in length.

It delivers from 2 to 160 units in increments of 2 units. The detailed instructions that accompany the pre-filled pen must be followed.

Tresiba Penfill 100 units/ml, solution for injection in cartridge:

The cartridge is designed for use with Novo Nordisk delivery systems (durable devices for repeated use not included in the package) and NovoFine or NovoTwist needles up to 8 mm in length. The detailed instructions accompanying the delivery system should be followed.

LIST II

Marketing Authorization Holder: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark.

Local representative: