Norditropin NordiLet - instructions for use, dose, side effects, contraindications

Somatropin, replenishing the deficiency of endogenous growth hormone, contributes to the normalization of body structure by increasing muscle mass and reducing body fat.

Most of the effects of somatropin are realized through an insulin-like growth factor I (IGF-I), It is produced in all cells of the body (mainly by liver cells). More than 90% of the IRF-I is associated with proteins (IRFSB), of which the most important is IRFSB-3.

Somatropin enhances the restructuring of bone tissue, which is manifested by an increase in the activity of biochemical bone markers in plasma. In adults, during the first months of treatment, due to more pronounced bone resorption, a decrease in its mass is observed, but with continued treatment, the mass of bone tissue increases.

Pharmacokinetics:

Absorption of somatropin after subcutaneous administration is 80%. The maximum concentration in the blood plasma is reached after 3-6 hours. It penetrates into the well perfused organs, especially the liver and kidneys. The volume of distribution of somatropin is 0.49-2.11 l / kg. Metabolized first in the kidneys, also in the liver. The half-life after subcutaneous administration is 3-5 hours. It is excreted with bile (incl.0,1% - unchanged).

Indications:

Children:

Growth retardation due to insufficiency of growth hormone;

growth retardation in girls with gonadal dysgenesis (Shereshevsky-

Turner):

growth retardation in children in the prepubertal period, caused by chronic renal failure.

Adults: Confirmed congenital or acquired growth hormone deficiency (as replacement therapy).

Contraindications:

Hypersensitivity to any of the components of the drug.

Signs of active malignant neoplasm (at the beginning of treatment, the intracranial tumor should be inactive and antitumor therapy completed).

Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure).

Pregnancy and lactation.

Carefully:Carefully: diabetes mellitus, cerebrospinal hypertension, hypothyroidism.

Pregnancy and lactation:

Currently there is insufficient data on the safety of use of somatropin in pregnancy, and therefore Norditropin NordiLet during pregnancy can not be used.There are data on the possible secretion of somatropin with breast milk. If Norditropin NordiLet is needed during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:

Norditropin NordiLet is a hypodermic injection solution in cartridges in a multi-dose, single-use, pre-filled syringe pen for multiple injections intended for use with NovoFine® needles.

The dosage is set by clicking. Norditropin NordiLet allows you to do from 1 to 29 clicks of the dose setting for each injection, which is also followed by a click. The dose for each click is 0,0667 mg (5 mg / 1.5 ml); 0.1333 mg (10 mg / 1.5 mL); 0.2 mg (15 mg / 1.5 mL). The package contains an instruction containing a table of dose transfer (mg) in the appropriate number of clicks.

The dose of the drug is prescribed individually. It is usually recommended to do one subcutaneous injection at night. To prevent the development of lipoatrophy, injection sites should be changed. The procedure for the injection is set forth in the instructions for Norditropin NordiLet.Patients should be reminded of the need to wash their hands with soap and / or a disinfectant before using Norditropin NordiLet. You should never shake Norditropin NordiLet violently.

Recommendations for dosing the drug are given below.

For children: Growth Hormone Deficiency: 25-35 μg / kg / day (0.07-0.1 IU / kg / day), which corresponds to 0.7-1 mg / m²/ day (2-3 IU / m²/day).

Shereshevsky-Turner syndrome and chronic renal failure: 50 μg / kg / day (0.14 IU / kg / day), which corresponds to 1.4 mg / m²/ day (4.3 IU / m²/day).

Adults: Substitution therapy. It is recommended to begin treatment with the use of low doses of the drug: 0.15-0.3 mg / day (corresponding to 0.45-0.9 IU / day) and gradually increase the dose every month until the dose that is needed by a particular patient is achieved.

As a control indicator for titrating the dose, the level of IGF can be used-I in the blood serum. As the patient's age increases, the need for growth hormone decreases.

The maintenance dose of the drug is selected individually, but rarely exceeds 1 mg / day (corresponding to 3 IU / day).

Norditropin® NordiLet ™

Information on How to Administer Growth Hormone Introduction

Norditropin® NordiLet ™ is a multi-dose, single-use, pre-filled syringe pen for multiple injections containing a solution of human growth hormone for subcutaneous administration.

For each injection, you can set doses ranging from 1 to 29 clicks. Just set the dose and enter.

- Button for pressing
- Push button scale
- Dose indicator
- Growth Hormone Container
- Growth hormone level indicator
- Rubber membrane
- Screw cap cap of syringe pen
- Cap of pen syringe
- Needle Novofine®

Protective sticker
Needle
Internal needle cap
Outer needle cap

The dose you need will be determined by your doctor. The dose is set in mg. To administer the dose with NordiLet ™, it must be translated into a number of clicks.

To transfer the dose from mg to the number of clicks, you must use the translation table.

Always check that the Conversion Concentration Table corresponds to your NordiLet syringe. You should use the Norditropin NordiLet Translation Table 5 mg / 1.5 mL for Norditropin NordiLet syringe 5 mg / 1.5 mL; translation tableNorditropin NordiLet 10 mg / 1.5 mL for Nordicotropin NordiLet syringe 10 mg / 1.5 mL; Norditropin NordiLet Transfer Table 15 mg / 1.5 mL for Norditropin NordiLet syringe 15 mg / 1.5 mL.

First find your dose on the scale in mg in the translation table. Then find the equivalent number of clicks.

Norditropin® NordiLet ™ Transfer Table

5 mg / 1.5 mL

Interval in mg

From	Before	Clicking
Mg	Mg
0,01 -	0,09	1
0,10 -	0,16	2
0,17 -	0,22	3,,...
0,23 -	0,29	4
0,30 -	0,36	5
0,37 -	0,42	6
0,43 -	0,49	7

0,50 -	0,56	8
0,57 -	0,62	9
0,63 -	0,69	10
0,70 -	0,76	11
0,77 -	0,82	12
0,83 -	0,89	13
0,90 -	0,96	14
0,97 -	1,02	15
1,03 -	1,09	16
1,10 -	1,16	17
1,17 -	1,22	18
1,23 -	1,29	19
1,30 -	1,36	20
1,37 -	1,42	21
1,43 -	1,49	22
1,50 -	1,56	23 -
1,57 -	1,62	24
1,63 -	1,69	25
1,70 -	1,76	26
1,77 -	1,82	27
1,83 -	1,89	28
1,90 -	1,93	29

Example:

If your dose is 1.2 mg, the required number of clicks is 18.

Norditropin® NordiLet ™ Transfer Table

10 mg / 1	, 5 ml
Interval in mg
From	Before	Clicking
Mg	Mg
0,01 -	0,19	1
0,20 -	0,32	2 '>■
0,33 -	0,46	3
0,47 -	0,59	4
0,60 -	0,72	5
0,73 -	0,86	6
0,87 -	0,99	7
1,00 -	1,12	8
1,13 -	1,26	9
1,27 -	1,39	10
1,40 -	1,52	11
1,53 -	1,66	12
1,67 -	1,79	13
1,80 -	1,92	14
1,93 -	2,06	15
2,07 -	2,19	16
2,20 -	2,32	17
2,33 -	2,46	18
2,47 -	2,59	19
2,60 -	2,72	20

2,73 - 2,86

2,87 -	2,99	22
3,00 -	3,12	23
3,13 -	3,26	24
3,27 -	3,39	25
3,40 -	3,52	26
3,53 -	3,66	27
3,67 -	3,79	28
3,80 -	3,87	29

2,87 -	2,99	22
3,00 -	3,12	23
3,13 -	3,26	24
3,27 -	3,39	25
3,40 -	3,52	26
3,53 -	3,66	27
3,67 -	3,79	28
3,80 -	3,87	29

Example:

If your dose is 2.4 mg, the required number of clicks is 18

Translation Table Norditropin © NordiLet ™

15 mg / 1.5 ml
Interval in mg
From	Before	Clicking
Mg	Mg
0,01	- 0,29	1
0,30	- 0,49	2
0,50	- 0,69	3
0,70	- 0,89	4
0,90	- 1,09	"" 5
1,10	- 1,29	6
1,30	- 1,49	7
1,50	- 1,69	8
1,70	- 1,89	9
1,90	- 2,09	10
2,10	- 2,29	11
2,30	- 2,49	12
2,50	- 2,69	13
2,70	- 2,89	14
2,90	- 3,09	15
3,10	- 3,29	16
3,30	- 3,49	17
3,50	- 3,69	18
3,70	- 3,89	19
3,90	- 4,09	20
4,10	- 4,29	21
4,30	- 4,49	22 """
4,50	- 4,69	23
4,70	- 4,89	24
4,90	- 5,09	: 25

5,10 -

5,29

5,30 -

5,49

5,50 -

5,69

5,70 -

5,80

Example:

5,10 -	5,29	26
5,30 -	5,49	27
5,50 -	5,69	28
5,70 -	5,80	29
Example:

If your dose is 3.6 mg, the required number of clicks is 18.

1. Preparation of the NordiLet ™ syringe-pen for injection

A Remove the cap of the syringe pen

In Screw the needle

Remove the protective sticker from the NovoFine® needle and screw the needle onto the NordiLet. Remove the outer and inner needle caps. Set aside the outer cap of the needle, as it will be needed for use after the injection.

C Gently tap on the syringe pen

FROM

Before each injection, remove air:

During normal use, a small amount of air can be collected in the needle and container with the growth hormone. To avoid the introduction of air and to ensure proper dosing, keep NordiLet needle up. Gently tap with a finger on the NordiLet syringe and make sure that all the air bubbles are gathered in the top of the growth hormone container.

D Set one click on the scale

E Press the button

Hold the NordiLet needle up, turn the growth hormone container in the direction of the arrow shown in the figure until you insert one click.

Continuing to hold the needle up, press the button to push it all the way in, with a drop of growth hormone on the tip of the needle. If it does not appear, repeat the procedure no more than 6 times. If a drop of growth hormone still does not appear, the syringe pen is defective and can not be used.

If the syringe pen is defective, give it to your supplier in exchange for a new one.

2. Setting the dose

F Put on the cap of the pen syringe

Put the cap on the syringe pen again, setting "O" opposite the dose indicator.

G Set the correct number of clicks

While holding NordiLet horizontally, rotate the cap of the syringe-pen in the direction of the arrow shown in the figure and set the desired dose.

Be careful that your hand is not above the button for pressing while you are measuring the dose. If the button for pressing fails to rise freely, the growth hormone will be ejected from the needle.

The scale on the cap of the syringe-pen shows the number of clicks (0, 1, 2, 3, 4 clicks). When the cap of the syringe-pen is turned, the button for pressing rises.

The scale of the button for pressing shows the number of clicks (5, 10, 15, 20 and 25 clicks). Each time you make a full turn of the cap of the syringe pen, 5 clicks will be set.

Always check the cap scale of the pen syringe and the scale of the push-button to verify the correct dose.

H Dose control

Examples of dosage (see figure H)

- How to set four clicks:

Turn the cap so that the number "4" is in front of the dose indicator.

How to install eight clicks:

Turn the cap of the syringe pen so that it makes a full turn and the digit "O" is again opposite the dose indicator. Now you have installed five clicks.Continue to rotate the scale of the cap of the syringe pen until the figure "3" is opposite the dose indicator. The scale with the number 5 will be shown on the scale of the button for pressing.

Adding "3" to display the scale of the cap pen to "5" on the scale buttons to press, you will see that scored eight clicks.

To check the dose setting, add a digit on the cap scale of the pen syringe to the largest digit shown on the scale of the button to be pressed. If you have set the dose incorrectly, simply turn the cap of the syringe pen forward or backward until the desired number of clicks is set. The maximum dose is given by 29 clicks.

If you try to set a higher dose, the growth hormone will flow out of the needle, and the dose will be wrong.

If you did this by mistake, turn the cap of the syringe-pen back until the button for pressing fully sinks and you feel resistance.

If "D" is not set in front of the dosing indicator, remove the cap of the syringe handle and replace it, as shown in the figure F.

Then start again, remembering that the maximum dose is 29 clicks. After setting the dose, remove the cap of the syringe-pen to make an injection.

How to inject growth hormone

I Press the button to enter.

The introduction procedure consists of two stages:

The first step is to insert the needle into the skin. The second step is to press the button to enter the dose.

Use the recommended route of administration by your doctor.
After the injection of growth hormone, the needle should remain under the skin for a minimum of 6 seconds. Keep the button fully depressed until the needle is removed from the skin. This will ensure the introduction of a full dose.
After the injection, put on the outer cap of the needle, unscrew the needle and, carefully, discard it. Again, put the cap on the syringe handle so that the dose indicator points to "O".
When removing and eliminating needles, health care workers, relatives and other persons who inject and care for patients should follow general precautions to avoid the risk of unintentional needle damage.

Subsequent injections

Always check to see if the button is to be pressed to the lowest position. If not, rotate the cap of the syringe pen until the push button is in the lowest position. Then proceed to the steps outlined in sections 1-3.

Do not use the sound of clicks as a definition or confirmation of your dose. Always check both scales to make sure the correct dose is set.

Remember, please, that

- At a time when you are not using your NordiLet, its cover should be

keep tightly closed.

Always use a new needle for each injection.
Do not leave NordiLet with a needle on when you do not use it.
You can use the indicator of the level of growth hormone to estimate the number of remaining clicks of growth hormone. You can not use the HGH indicator to set a dose.
You can not set a dose that exceeds the number of clicks left.
After full use, discard carefully NordiLet,

previously free of the needle.

5. Storage

NordiLet is designed for accurate and safe use. Norditropin NordiLet should not be shaken vigorously. It should be handled with care. It is necessary to avoid situations in which NordiLet can be damaged. Protect NordiLet from dust, dirt and direct sunlight. Do not use Norditropin NordiLet if the drug solution in the pre-filled syringe pen has ceased to be transparent, as water, and colorless.The outer surface of the NordiLet device can be cleaned by wiping with cotton wool soaked with alcohol.

Do not immerse it in alcohol, do not wash or lubricate it, as this may damage the mechanism.

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Side effects:

There may be fluid retention with the development of peripheral edema. Mostly, adults can have a "tunnel" (carpal tunnel) syndrome. Symptoms, as a rule, are transitory, dose-dependent, may require a dose reduction. In addition, adults can develop joint pain, muscle pain and paresthesia (they are usually short-lived and pass on their own).

Side effects are rare in children. The integrated database contains information on children who received Norditropine treatment for up to 8 years. The incidence of headaches is 0.04 cases per patient per year.

Antibodies to somatropin are rarely observed with a decrease in its effectiveness.

In the course of therapy with the drug Norditropin NordiLet, local reactions in the injection area may occur: soreness, numbness, hyperemia, swelling, lipoatrophy, pruritus.It is rare to develop benign intracranial hypertension (severe and frequent headache, nausea, vomiting).

Attention!: The following side effects are described in the literature when the drug is used somatropin, however, they were not observed on the present day with Norditropin NordiLet: weakness, fatigue, epiphysis of the head of the femur, gynecomastia, edema of the optic nerve (usually observed during the first 8 (abdominal pain, nausea, vomiting), otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome), subluxation of the hip in children (limping, pain in the thigh), pancreatitis (abdominal pain, nausea, vomiting), most often in patients with Shereshevsky- Turner syndrome and knee), gynecomastia, leukemoid reactions, acceleration of the growth of the previously existing nevus (malignancy is possible). Progression of scoliosis (in patients with excessively rapid growth).

Allergic reactions: skin rash, itching.

Increase in the content in the blood of inorganic phosphate, parathyroid hormone and activity of alkaline phosphatase.

Overdose:

Acute overdose can lead in the beginning to hypoglycemia and, subsequently,to hyperglycemia. Such fluctuations in glucose concentration were determined only biochemically without clinical manifestations. With prolonged overdose, signs and symptoms characteristic of excess human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the level of cortisol in the serum may appear. Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

Concomitant glucocorticosteroid therapy can suppress growth and, thus, inhibit the growth effect of Norditropin NordiLet. The effectiveness of the drug (in terms of final growth) may also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.

Special instructions:

Norditropin NordiLet is supplied ready for use and is a pre-filled syringe for multiple injections, consisting of a 1.5 ml cartridge (colorless glass type 1), fixedly fixed in a plastic handle-injector.From the bottom, the cartridge is sealed with a plastic stopper in the form of a plunger, and above is a laminated plastic stopper in the form of a disc sealed with an aluminum cover.

Do not use Norditropin NordiLet if the solution has ceased to be colorless and transparent as water.

You can not use Norditropin NordiLet, if before the first injection you had to do more than 6 idle strokes, in which air is released from the syringe handle.

The specialist in pathology of growth should regularly monitor the condition of children receiving Norditropin NordiLet. The treatment with Norditropin NordiLet should always be started by a doctor who has special knowledge in the field of growth hormone deficiency and its treatment. This also applies to the treatment of growth retardation in the Shereshevsky-Turner syndrome and chronic renal failure.

Dysplasia in children with chronic renal failure should be accurately established before the Norditropin NordiLet treatment begins by monitoring the growth in optimal therapy for chronic kidney disease within one year.During therapy with Norditropin NordiLet, conservative treatment of uremia with traditional medicines and, if necessary, with dialysis, should be continued. In children suffering from chronic renal failure, treatment with Norditropin NordiLet should be discontinued in a kidney transplant operation.

During treatment with Norditropin NordiLet, patients with chronic renal failure should be monitored for renal function with a marked decrease or increased glomerular filtration rate (which may indicate hyperfiltration).

The effect of somatropin on carbohydrate metabolism has been established, so patients should also be examined for glucose tolerance impairment.

In patients receiving insulin treatment, the appointment of Norditropin NordiLet may need to adjust its dose.

When treating Norditropin NordiLet, the serum thyroxine level may decrease due to increased peripheral deiodination T4 in T3. In patients with progressive pituitary pathology hypothyroidism can develop. Patients with Shereshevsky-Turner syndrome

have an increased risk of developing primary hypothyroidism associated with antithyroid antibodies. Since hypothyroidism is an obstacle to an adequate growth effect when treated with Norditropin NordiLet, in patients receiving this therapy, thyroid function should be regularly monitored and thyroid hormone replacement therapy should be performed if there is a decrease in thyroid function.

With secondary deficiency of growth hormone due to the presence of intracranial neoplasm, regular patient examinations should be performed to identify signs of progression or recurrence of the primary disease. A small number of patients with growth hormone deficiency, some of whom were treated with somatropin, reported on the development of leukemia. Based on current data, it seems unlikely that the treatment with somatropin was the cause. In patients with complete remission of tumors or malignant diseases, growth hormone therapy was not associated with an increased rate of relapse. Nevertheless, after the start of treatment with Norditropin NordiLet, patients who achieved complete remission of malignant diseases should be carefully monitored for their relapse.

In patients with endocrine diseases, subluxation of the femoral head may be more common, and Legg-Calvet-Perthes disease may be more common in low-growth patients. These diseases can be manifested by lameness or pain in the femoral or knee joint. Doctors and patients should be warned about this.

In the presence of severe or repeated headaches, visual impairment, nausea and / or vomiting, it is recommended that the eye fundus (fundoscopy) be inspected to detect edema of the optic nerve disc. If edema is confirmed, there should be a suggestion of benign intracranial hypertension and, if necessary, treatment with growth hormone should be discontinued. Currently, there is insufficient data to guide only the clinical criteria for deciding patients with intracranial hypertension in the resolution stage. When resuming treatment with growth hormone, careful monitoring of the symptoms of intracranial hypertension is necessary.

Adult drug Norditropin NordiLet is prescribed for insufficiency of growth hormone, developed in childhood and confirmed again in during two provocative tests, as well as with a significant decrease in output growth hormone in the established disease of the hypothalamic-pituitary region (insufficiency of yet another hormone other than prolactin), confirmed during two provocative tests after the initiation of adequate replacement therapy for the deficiency of any other hormone.

Adults with growth hormone deficiency undergoing substitution therapy with Norditropin NordiLet should be monitored by an endocrinologist with experience in treating pituitary diseases.

Adult growth hormone deficiency persists throughout life and requires appropriate treatment, but currently experience in treating patients older than 60 years, as well as the results of therapy lasting more than 5 years, are insufficient.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and work with mechanisms.

Form release / dosage:

A solution for subcutaneous administration of 5, 10 or 15 mg in 1.5 ml cartridges in a syringe pen.

Packaging:

For 1.5 ml of the drug in a cartridge of colorless glass I hydrolytic class.The cartridge is installed in a plastic multi-dose disposable syringe pen for multiple injections, sealed on one side with a rubber "piston" ~ on the other hand laminated with a rubber disc "for

aluminum rolling. For 1 multi-dose plastic disposable syringe for multiple injections with instructions for medical use in - - cardboard pack .--

Storage conditions:

List B. Keep out of reach of children For a dosage of 5 mg / 1.5 ml and 10 mg / 1.5 ml: at a temperature of 2 ° C to 8 ° C (in the refrigerator) in a cardboard bundle.

For the syringe pen in use: store for 4 weeks at a temperature of 2 ° C to 8 ° C (in the refrigerator) or for 3 weeks at a temperature of no higher than 25 ° C. Do not freeze

For a dosage of 15 mg / 1.5 ml: at a temperature of 2 ° C to 8 ° C (in the refrigerator) in a cardboard bundle.

For the syringe pen in use: store for 4 weeks at a temperature of 2 ° C to 8 ° C (in the refrigerator). Do not freeze

Shelf life:2 years. Do not use the product after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015447 / 01

Date of registration:16.03.2009

The owner of the registration certificate:Novo Nordisk A / SNovo Nordisk A / S Denmark

Manufacturer: & nbsp

NOVO NORDISK, A / S Denmark

Representation: & nbspNOVO NORDISK TOVNOVO NORDISK TOVDenmark

Information update date: & nbsp16.08.2015

Illustrated instructions

Instructions

use a pen syringe

Norditropin® NordiLet® (Norditropin® NordiLet®)