Instructions for Tresiba Flextach solution for injection 100 U/ml cartridge inserted into a 3 ml syringe pen No. 5
Composition
active ingredient: insulin degludec;
1 ml of solution contains 100 U of insulin degludec* (equivalent to 3.66 mg of insulin degludec).
1 pre-filled pen contains 3 ml, equivalent to 300 U of insulin degludec.
*produced using rDNA technology in Saccharomyces cerevisiae;
excipients: glycerin, metacresol, phenol, zinc acetate dihydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear liquid, without turbidity, practically free of mechanical inclusions.
Pharmacotherapeutic group
Antidiabetic drugs. Long-acting insulins and analogues for injection. ATX code A10A E06.
Pharmacological properties
Mechanism of action
Insulin degludec binds specifically to the human insulin receptor and produces the same pharmacological effects as human insulin.
The blood sugar-lowering effect of insulin consists in promoting the absorption of glucose by tissues after insulin binds to receptors on muscle and fat cells, as well as in simultaneously inhibiting the release of glucose from the liver.
Pharmacodynamics.
Tresiba FlexTach is a basal insulin that forms a soluble multihexamer after subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the bloodstream, resulting in a smooth and sustained blood glucose-lowering effect. Over 24 hours, the blood glucose-lowering effect of Tresiba FlexTach when administered once daily, unlike insulin glargine, is evenly distributed between the first and second 12 hours (AUCWh,0-12h, PW / AUCWh, total PW = 0.5).
The duration of action of Tresiba FlexTach is more than 42 hours within the therapeutic dose range.
Equilibrium concentration in the blood is achieved after 2-3 days of taking the drug.
The glucose-lowering effect of insulin degludec at steady-state is characterized by a fourfold reduction in the daily variability, as determined by the coefficient of variation (CV), the reduction in glucose levels over 0-24 hours (AUCWh, τ, PW) and 2-24 hours (AUCWh2-24h, PW) compared to insulin glargine.
The overall glucose-lowering effect of Tresiba FlexTach increases linearly with increasing dose. The mean glucose-lowering effect of Tresiba FlexTach 100 U/ml and Tresiba FlexTach 200 U/ml is comparable when administered at the same dose.
No differences in the pharmacodynamic effect of the drug were found in young and elderly adult patients.
Clinical efficacy and safety
Eleven multinational, controlled, randomised, open-label, to-target clinical trials of 26 weeks and 52 weeks duration were conducted with Tresiba FlexTach, involving a total of 4,275 patients (1,102 patients with type 1 diabetes and 3,173 patients with type 2 diabetes).
The effect of the drug was tested in patients with type 1 diabetes, in patients who had not previously used insulin (initiation of insulin in patients with type 2 diabetes) and in patients who had previously used insulin (intensification of insulin therapy in patients with type 2 diabetes), with a fixed and flexible dosing regimen. It was confirmed that the reduction in HbA1c (from the beginning to the end of the trial) was non-inferior in all trials against all comparators (insulin detemir and insulin glargine). While the improvement in HbA1c was non-inferior compared to other insulin products, the effect of Tresiba FlexTach in reducing HbA1c compared to sitagliptin was statistically significantly greater.
In a prospectively planned meta-analysis of seven confirmatory trials with a “target-target” design in patients with type 1 and type 2 diabetes, Tresiba FlexTach demonstrated fewer emergency treatment-confirmed hypoglycemia (when used in type 2 diabetes) and fewer confirmed nocturnal hypoglycemia compared with insulin glargine (used as directed). The reduction in hypoglycemia was achieved at lower mean fasting plasma glucose levels with Tresiba FlexTach compared with insulin glargine.
There are no data on the development of clinically significant insulin antibodies during long-term treatment with Tresiba FlexTach.
Pharmacokinetics.
Absorption.
After subcutaneous injection, soluble and stable multihexamers of insulin degludec create a depot of insulin in the subcutaneous tissue. Insulin degludec monomers gradually dissociate from the multihexamers, resulting in a slow and steady release of insulin degludec into the bloodstream.
The 24-hour glucose-lowering effect of Tresiba FlexTach when administered once daily, in contrast to insulin glargine, was evenly distributed between the first and second 12 hours (AUCWh,0-12h, PW / AUCWh, total PW = 0.5).
Distribution
The affinity of insulin degludec for human plasma albumin is > 99%.
Metabolism
The degradation of insulin degludec is similar to that of human insulin; none of the metabolites formed have biological activity.
Breeding
After subcutaneous administration, the elimination half-life is determined by the rate of absorption from the subcutaneous tissue. The elimination half-life of Tresiba FlexTach is approximately 25 hours, regardless of dose.
Linearity
Dose proportionality in overall exposure is observed after subcutaneous administration in the therapeutic dose range. In a direct comparison, bioequivalence requirements were met for Tresiba FlexTach 100 U/mL and Tresiba FlexTach 200 U/mL (based on AUC IDeg, τ, PN and Cmax, IDeg, PN).
Sex
No differences in the pharmacokinetic properties of the drug were found depending on gender.
Elderly patients, race, renal and hepatic insufficiency
No differences in the pharmacokinetics of insulin degludec were found between elderly and young adult patients, between patients of different races, and between healthy subjects and patients with renal or hepatic impairment.
Indication
Treatment of diabetes in adults.
Contraindication
Hypersensitivity to insulin degludec or to any of the excipients included in the formulation.
Interaction with other medicinal products and other types of interactions
As is known, a number of medications affect glucose metabolism.
Drugs that may reduce insulin requirements
Oral hypoglycemic agents (OHAs), GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOIs), beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, and sulfonamides.
Drugs that may increase insulin requirements
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
β-blockers may mask the symptoms of hypoglycemia.
Octreotide/lanreotide may either decrease or increase insulin requirements.
Alcohol may enhance or reduce the hypoglycemic effect of insulin.
Application features.
Hypoglycemia
Skipping a meal or unexpected intense physical activity can lead to hypoglycemia.
Hypoglycemia can occur if the insulin dose is too high relative to insulin requirements.
Patients whose blood glucose control has improved significantly with intensive insulin therapy may experience a change in their usual warning symptoms of hypoglycemia, and should be warned about this in advance. The usual warning symptoms may disappear in patients with long-standing diabetes.
Concomitant diseases, especially infections and fever, usually increase the patient's insulin requirements. Concomitant diseases of the kidneys, liver, or diseases of the adrenal, pituitary, or thyroid glands may necessitate adjustment of the insulin dose.
As with other basal insulins, the prolonged action of Tresiba FlexTach may delay recovery of blood glucose levels after hypoglycemia.
Hyperglycemia
Administration of rapid-acting insulin is recommended in cases of significant hyperglycemia.
Inappropriate dosing or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and diabetic ketoacidosis. In addition, concomitant diseases, especially infections, may lead to hyperglycemia and thus to increased insulin requirements.
The first symptoms of hyperglycemia usually develop gradually, over a period of hours or days. They include thirst, frequent urination, nausea, vomiting, drowsiness, flushing and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone on the exhaled breath. In type 1 diabetes, untreated hyperglycemia leads to diabetic ketoacidosis, which is fatal.
Transferring a patient from another type of insulin
Transferring a patient to another type or brand of insulin or to insulin from another manufacturer should be done under strict medical supervision and may require adjustment of the insulin dose.
Combination of pioglitazone with insulin preparations
Cases of congestive heart failure have been reported with pioglitazone in combination with insulin, particularly in patients with risk factors for the development of congestive heart failure. This should be considered when prescribing treatment with the combination of pioglitazone and Tresiba FlexTach. When these drugs are used in combination, patients should be monitored for symptoms of congestive heart failure, weight gain and edema. In the event of any deterioration in cardiac function, pioglitazone treatment should be discontinued.
Intensification of insulin therapy with a sharp improvement in glycemic control may temporarily exacerbate diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
Preventing accidental errors
Patients should always check insulin labels before each injection to avoid accidentally mixing Tresiba FlexTach with other insulin products.
Patients should visually check the number of units dialed on the dose counter of the pen. Blind patients or patients with poor vision should seek help from another person who has good vision and knows how to use the insulin delivery device.
Production of antibodies to insulin
Insulin administration may result in the production of insulin antibodies. In rare cases, the presence of such antibodies may require adjustment of the insulin dose to overcome the tendency to hyperglycemia or hypoglycemia.
Use during pregnancy or breastfeeding
Pregnancy
There is no clinical experience with Tresiba FlexTach in pregnant women.
Animal reproduction studies have not revealed any differences in embryotoxicity and teratogenicity between insulin degludec and human insulin.
In general, increased blood glucose control and monitoring of pregnant women with diabetes are recommended during pregnancy and when planning a pregnancy. Insulin requirements usually decrease in the first trimester and increase during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy levels.
Breast-feeding
There is no clinical experience with Tresiba FlexTach during breastfeeding. In animals, insulin degludec is excreted in breast milk, and its concentration in milk was lower than in plasma.
It is not known whether insulin degludec is excreted in human milk. Metabolic adverse effects in breastfed newborns/infants are not expected.
Fertility
Animal reproductive studies with insulin degludec have not revealed any adverse effects on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
The patient's reactions and ability to concentrate may be impaired during hypoglycemia. This may be a risk factor, for example, when driving a car or operating machinery.
Patients should take precautions to prevent hypoglycemia before driving. This is especially important for patients who have reduced or absent warning signs of hypoglycemia or who have frequent episodes of hypoglycemia. In such circumstances, the advisability of driving should be considered.
Method of administration and doses
Dosage
Tresiba FlexTach is an ultra-long-acting basal insulin preparation for subcutaneous injection once a day at any time of the day, preferably at the same time.
The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) of insulin degludec is equal to 1 international unit (IU) of human insulin, 1 unit of insulin glargine, or 1 unit of insulin detemir.
In patients with type 2 diabetes, the drug can be administered alone or in combination with oral hypoglycemic agents or in combination with bolus insulin.
In patients with type 1 diabetes, the drug is used in combination with short/rapid-acting insulin to cover the need for insulin during meals.
The dosage of Tresiba FlexTach is determined according to the individual patient's needs. It is recommended to optimize glycemic control by adjusting the insulin dose depending on the fasting plasma glucose level.
As with other insulin preparations, dose adjustment may also be necessary when the patient's physical activity or usual diet changes, or when there are concomitant diseases.
The required dose is determined by the units of action. The Tresiba FlexTach 100 U/ml pen allows you to administer a dose from 1 to 80 units per injection in increments of 1 unit.
The dose counter shows the number of units regardless of the strength; the dose should not be recalculated when transferring a patient to a new strength of medication.
Flexibility in choosing the time of drug administration
In cases where administration at the same time of day is not possible, administration at a different time is possible, but an interval of at least 8 hours between injections must always be maintained.
Patients who forget to take a dose are advised to take it as soon as they remember and then return to their usual once-daily dosing schedule.
Start of application
Patients with type 2 diabetes
The recommended initial dose is 10 units once daily with subsequent individual dose adjustment.
Patients with type 1 diabetes
The drug should be used once a day in combination with insulin, which is used to cover mealtime insulin needs, with subsequent individual dose adjustment.
Close monitoring of blood glucose levels is recommended during the transition to Tresiba FlexTach and during the first weeks of treatment. Adjustment of the dose and timing of short-/rapid-acting insulin or other glucose-lowering agents may be necessary.
Patients with type 2 diabetes
For patients receiving basal, basal-bolus insulin therapy or using premixed insulins or self-mixing insulins, the transition to Tresiba FlexTach can be carried out in a one-to-one ratio from the previous basal insulin dose with subsequent individual dose adjustment.
Patients with type 1 diabetes
For most patients with type 1 diabetes, switching from basal insulin to Tresiba FlexTach can be done in a one-to-one ratio from the previous basal insulin dose with subsequent individual dose adjustment. For patients with type 1 diabetes, switching from basal insulin (when used in a twice daily regimen) or with HbA1c < 8.0%, the dose of Tresiba FlexTach should be calculated on an individual basis. Dose reductions should be individualized based on glycemic response.
Special populations
Elderly patients (≥ 65 years)
The drug can be used in elderly patients. More careful monitoring of blood glucose levels should be carried out and the dose should be adjusted individually (see section "Pharmacokinetics").
Liver and kidney dysfunction
Tresiba FlexTach can be used in patients with impaired hepatic and renal function. Closer monitoring of blood glucose levels and dose adjustment should be performed individually (see section 5.2).
Drug administration
Tresiba FlexTach is administered subcutaneously only, by injection in the anterior abdominal wall, upper arm or thigh. To reduce the risk of lipodystrophy, injection sites should always be rotated within the same area.
The drug cannot be administered:
– intravenously, as this may lead to the development of severe hypoglycemia;
– intramuscularly, as this may lead to changes in the rate of absorption;
– in an insulin infusion pump.
Tresiba FlexTach is supplied in a pre-filled pen (the “FlexTach”) designed to be used with NovoFine® or NovoTwist® injection needles up to 8 mm in length. The pre-filled pen delivers 1 to 80 units of insulin in increments of 1 unit.
Patient instructions for using Tresiba FlexTach
Before using the Tresiba FlexTouch pen, you must read these instructions carefully.
Do not use the syringe pen without instruction from a doctor or nurse.
First check the label to see that the pen contains Tresiba FlexTach 100 U/mL, then look at the illustrations below to get information about the different parts of the pen and the needle.
Blind patients or patients with poor vision who cannot visually check the number of units dialed on the dose counter of the pen should not use the pen without the help of another person. Ask for help from another person who has good vision and knows how to use the insulin delivery device.
The pre-filled pen contains 300 U of insulin. The Tresiba FlexTach 100 U/mL pen delivers doses from 1 to 80 units per injection in increments of 1 unit.
Tresiba FlexTouch is intended for use with NovoFine® or NovoTwist® injection needles up to 8 mm in length. Needles are not included in the package.
! Important information.
Please read these instructions carefully as they are important for the safe use of the pen.
Tresiba FlexTouch - pre-filled syringe pen (“FlexTouch”) and needle (sample).
1. Preparing the Tresiba FlexTouch pen for injection
Check the insulin name and strength on the label of your pen to make sure it contains Tresiba FlexTach 100 U/ml. This is especially important if you are using more than one type of insulin. Fig. A. Remove the cap from the pen. | |
| Fig. B. Make sure the insulin in the pen is clear and colorless. Look through the insulin cartridge: if the insulin looks cloudy, do not use the pen. | |
| Fig. C. Take a new needle and remove the paper membrane from it. | |
| Fig. D. Screw the needle onto the pen. Turn the needle until it is snug. | |
| Fig. E. Remove the large outer needle cap. Do not throw it away: you will need it after the injection to safely remove the needle from the pen. | |
| Fig. F. Remove the inner needle cap and throw it away: if you try to put it back on, you could accidentally inject yourself. A drop of insulin may appear at the tip of the needle. This is normal, but you should still perform an insulin flow test. | |
! Always use a new needle for each injection to prevent blocked needles, infection, or incorrect insulin dosing.
! Never use a bent or damaged needle.
2. Checking insulin flow
Always check the insulin flow before injecting. This will help ensure that the full dose of the drug has been administered.
Fig. A. Turn the dose selector to set 2 units. Make sure the dose counter shows 2.
|
| Fig. B. Holding the pen vertically with the needle pointing upwards, gently tap the cartridge with your finger several times to collect any air bubbles at the top of the cartridge. | |
Fig. C. Press and hold the dose button until the dose counter returns to “0”. The “0” mark should line up with the dose indicator. A drop of insulin should appear at the tip of the needle. | |
A small air bubble may remain at the tip of the needle, but it will not be introduced during the injection.
If a drop of insulin does not appear, repeat the step-by-step test (Fig. A to Fig. C) up to 6 times. If a drop of insulin does not appear again, change the needle and repeat steps Fig. A to Fig. C one more time.
If a drop of insulin still does not appear, throw away this pen and get a new one.
! Always make sure that a drop of insulin appears at the tip of the needle before injecting the drug. If a drop does not appear, insulin should not be injected, even if the dose counter is rotating.
3. Setting the dose
Fig. A. Before injection, make sure the dose counter is set to “0.” The “0” mark should line up with the dose pointer. Turn the dose selector to set the dose required for administration as prescribed by your doctor. The set dose can be adjusted both upwards and downwards by turning the dose selector in the appropriate direction. The syringe pen provides a single dose of up to 80 units. | |
The dose selector changes the number of units of insulin. Only the counter and dose pointer show how many units have been selected for delivery.
You can dial up to 80 units for one injection. If the pen contains less than 80 units of insulin, the dose counter will stop at the number of units remaining.
The dose selector clicks differently when turned to decrease/increase the dose or when more units are selected than are left in the pen. Do not count the clicks of the pen when selecting the insulin dose.
! Always use the dose counter and pointer to check the number of units set before injecting the medicine.
Do not count the clicks of the syringe pen to set the dose.
Do not use the insulin level scale, which only shows approximately how much insulin is left in the pen.
4. Insulin administration
Fig. A. Insert the needle under the skin. Follow the injection technique that your doctor or nurse has taught you. Make sure you can see the dose counter. Do not touch the dose counter with your fingers: this may stop the insulin delivery. Press and hold the dose button until the dose counter returns to “0”. The “0” should line up with the dose pointers and you may hear a click. The needle should be kept under the skin for at least 6 seconds. This ensures that the full dose of the drug is administered. | |
Fig. B. Remove the needle from the skin at a right angle. If there is any bleeding at the injection site, apply light pressure to the area with a cotton swab. Do not rub the injection site. | |
Sometimes you may see a drop of insulin at the tip of the needle after the injection. This is acceptable and does not affect the dosage in any way.
! Always watch the dose counter to monitor the number of units injected.
The dose counter shows the exact number of units.
Do not count the clicks of the pen to determine the number of units.
5. Removing the needle after injection
| Fig. A. On a flat surface, carefully cover the needle with the large outer cap without touching the needle or the outer cap. | |
Fig. B. Once the needle is closed, gently push the outer cap down until it stops, then unscrew the needle.
| |
| Fig. C. After each use, put the cap on the pen to protect the medicine from light. | |
Always remove the needle after each injection to ensure a painless injection and to prevent a blocked needle. Insulin cannot be injected if the needle is blocked.
Dispose of the used pen without the needle as instructed by your doctor, nurse, pharmacist, or local authorities.
! To avoid accidental needle stick injury, never put the inner cap back on once it has been removed.
! Always remove the needle after each injection to prevent needle blockage, infection, or insulin leakage or incorrect dosing.
6. Determining the amount of insulin in the syringe pen
| Fig. A. The insulin level scale only shows approximately how much insulin is left in the pen. | |
Fig. B. To determine how much insulin is left in the pen, use the dose counter: turn the dose selector until the dose counter stops. If the dose counter shows 80, there are at least 80 units of insulin left in the pen. If the dose counter shows less than 80, the number of units corresponds to the amount of insulin left in the pen. If you need to inject a larger dose of insulin than the units remaining in the pen, you can inject part of the missing dose with a second pen. | |
! Calculate the dose carefully when using two pens. If in doubt, it is better to inject the full dose from a new pen.
! Other important information:
· Always keep the pen with you.
· Always carry a spare pen and new needles in case your pen is damaged or lost.
· Always keep the pen and needles out of the reach of other people, especially children.
· The needles and the Tresiba FlexTouch pen are for individual use only.
· Caregivers should handle used needles with great care to avoid injury and infection.
Rules for the care and handling of the syringe pen:
· Do not leave the pen in the machine to prevent the drug from overheating or cooling.
· Prevent the pen from coming into contact with dust, dirt or liquid.
· Do not wash, wet or oil the pen. If necessary, the Tresiba FlexTouch pen can be cleaned by wiping it with a damp cloth and a mild detergent.
· Prevent the pen from being dropped. Do not knock the pen on a hard surface. If the pen is dropped or if you suspect a problem, attach a new needle and check the insulin flow before injecting.
· Do not attempt to refill the pen. If it is empty, it must be discarded.
· Do not attempt to repair the pen or take it apart.
Children.
The efficacy and safety of Tresiba FlexTach in children (under 18 years of age) have not been studied. There are no dosage recommendations for children, so the drug should not be used in children.
Overdose
Although a specific concept of overdose has not been formulated for insulin, hypoglycemia of varying severity may develop after its administration if doses that are too high compared to the patient's needs are used.
· Mild hypoglycemia can be treated with oral glucose or sugar-containing foods. Therefore, diabetics are advised to always carry glucose-containing foods with them.
In case of severe hypoglycemia, when the patient is unconscious, glucagon should be administered subcutaneously or intramuscularly (0.5 - 1.0 mg) by trained personnel. Glucose can be administered intravenously by a healthcare professional. Glucose should also be administered intravenously if the patient does not respond to glucagon within 10-15 minutes.
After the patient regains consciousness, he should take oral carbohydrates to prevent recurrence of hypoglycemia.
Adverse reactions
The most common adverse reaction reported during treatment is hypoglycemia (see “Description of selected adverse reactions”).
The following is a list of adverse reactions based on clinical trial data, classified by frequency and MedDRA system organ class. The frequency of these reactions has been classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
On the part of the immune system: rarely - hypersensitivity reactions, urticaria.
Nutritional and metabolic disorders: very common – hypoglycemia.
Skin and subcutaneous tissue disorders: uncommon – lipodystrophy.
General disorders and administration site conditions: Common: injection site reactions; uncommon: peripheral oedema.
Description of selected adverse reactions
On the part of the immune system
Allergic reactions may occur when using insulin preparations. Immediate-type allergic reactions to insulin or excipients can be life-threatening.
When using Tresiba FlexTach, urticaria and hypersensitivity reactions, manifested by swelling of the tongue and lips, diarrhea, nausea, fatigue and itching, are rarely observed.
Hypoglycemia
Hypoglycemia can occur when the insulin dose is significantly higher than the patient's insulin requirement. Severe hypoglycemia can lead to loss of consciousness and/or seizures, followed by temporary or permanent brain damage and even death. Symptoms of hypoglycemia usually come on suddenly. They include cold sweat, pale, cool skin, fatigue, nervousness or tremor, anxiety, unusual tiredness or weakness, confusion, difficulty concentrating, drowsiness, excessive hunger, blurred vision, headache, nausea, and rapid heartbeat.
Lipodystrophy
Lipodystrophy, including lipohypertrophy and lipoatrophy, may develop at injection sites. Constantly rotating injection sites within the same area of the body will reduce the risk of these reactions.
Injection site reactions
Skin reactions including hematoma, pain, bleeding, erythema, nodules, swelling, discoloration, itching, warmth, and induration at the injection site may occur at the injection site with Tresiba FlexTach. These reactions are usually mild and transient and resolve with continued treatment.
According to clinical studies, the frequency, type and severity of adverse reactions observed in elderly patients and patients with impaired renal and hepatic function do not differ from those in the general population.
Expiration date
2.5 years.
Storage conditions
Store in a refrigerator at 2-8°C (not too close to the freezer). Do not freeze. Keep the pen cap on to protect from sunlight.
The pen should not be stored in the refrigerator after first use. Store for 8 weeks at a temperature not exceeding 30°C. After each injection, the pen should be recapped in order to protect from light.
Keep out of reach of children.
Incompatibility.
The addition of various substances to Tresiba FlexTach may lead to degradation of insulin degludec.
Tresiba FlexTach should not be added to infusion solutions or mixed with any other drug.
Packaging
The pre-filled, multidose, disposable pen contains a 3 ml cartridge made of glass (type 1) and closed on one side with a halobutyl rubber plunger and on the other side with a halobutyl/polyisoprene rubber disc. The pen is made of polypropylene. 1 or 5 pens in a cardboard box.
Vacation category
According to the recipe.
Producer
Novo Nordisk A/S, Denmark.
Location.
Novo Allé, DK-2880 Bagsvaerd, Denmark. Tel. + 45 4444 8888 / Novo Allé, DK-2880 Bagsvaerd, Denmark. Tel. + 45 4444 8888.
