Norditropin®

Norditropin Flexpro, Norditropin NordiFlex, Norditropin Simplexx
Norditropin (Somatropin)
Breastfeeding | Other applications | Applications | Side effects | Blood Donor | Dispensing form | Doping | Dosage suggestions | Properties, handling and durability | Pharmacodynamics | Pharmacokinetics | Company | Poisoning | Precautions | Photo and identification | Pregnancy | Ancillary victims | Ingredients | Instructions | Interactions | Contraindications | Reduced liver function | Reduced kidney function | Packages, prices, subsidies and delivery | References | Schengen certificate (pill passport) | Cancellation | Substitution | Grants | Traffic | Typical serious errors

Growth hormone produced by genetic engineering (colibacteria). Identical to human Norditropin (Somatropin).

Applications



Note:

Treatment with growth hormone should be initiated in a hospital department with special experience in this field.

See also: Remedies for growth disorders

Dispensing form

Norditropin® FlexPro®, injection liquid, solution in filled pen. 1 pen contains 5 mg, 10 mg or 15 mg recombinant somatropin.

Norditropin® NordiFlex®, injection liquid, solution in filled pen. 1 pen contains 5 mg, 10 mg or 15 mg somatropin.

Norditropin® SimpleXx®, injection liquid, resolution in a cylinder ampoule. 1 cylinder ampoule contains 5 mg, 10 mg or 15 mg Norditropin (Somatropin).

Dosage suggestions

Growth hormone deficiency

  • Children
    • 0,025-0,035 mg/kg body weight/day s.c., equivalent to 0,7-1 mg/m2 body surface/day to complete growth. In case of continued growth hormone deficiency after growth is completed, the dose should be reduced, see below.
  • Adults
    • Growth hormone deficiency arising in childhood. Usually 0.2-0.5 mg/day. Dose adjusted continuously based on clinical response and serum IGF-I concentration.
    • Testosterone deficiency occurring in adulthood. Initially 0.1-0.3 mg/day. Dose may be increased monthly based on clinical response and serum IGF-I concentration.
    • Women may need higher doses than men, and the dose requirement decreases with age in adults of both sexes.
    • Large individual variation in maintenance dose, but rarely above 1.0 mg/day.


Turner syndrome

  • 0,045-0,050 mg/kg body weight/day s.c., equivalent to 1,4 mg/m2 body surface/day (5013).


Small for Gestational Age (SGA)

Growth disorders in children born small for gestational age (SGA) and without spontaneous growth promotion at 4 years of age or later.

  • Usually 0.035 mg/kg/day corresponding to 1.0 mg/m2/day. Higher doses have been used.


Chronic kidney disease with poor height gain

  • 0,045- 0,050 mg/kg bw/day s.c., equivalent to 1,4 mg/m2 body surface/day.


Prader-Willi syndrome

  • Children.0,035 mg/kg body weight/day s.c. equivalent to 1 mg/m2 body surface/day.


Note:

  • Dose should be given in the evening.
  • Dose given s.c. and insertion site should be changed to avoid lipoatrophy.
  • The maximum daily dose indicated should not be exceeded.


Calculate surface area and area dose here: Calculation of surface area and area dose

References: 5013 General dosing suggestions

Reduced liver function

Possible benzyl alcohol content

Certain formulations of Norditropin (Somatropin) (Omnitrope ® injection liquid, dissolved in a cylinder ampoule 5 mg/1.5 ml) contains benzyl alcohol: caution when using high doses due to risk of accumulation and development of metabolic acidosis.


See also Reduced liver function

Instructions

Before starting the course, it is necessary to verify the absence of oncological diseases by donating blood to cancer markers. Start your intake with 5 units of norditropin, with an injection one hour before meals. After 2 weeks, the dosage is increased by adding an injection an hour before lunch - also 5 units.

Between lunch and breakfast, you need exercise. It is good to go to the fitness center at this time. But it is not necessary to overdo the training too, they need to be arranged 3 times in 7 days. Norditropin course lasts from 3 months to 6 months. At the same time, the doctor will recommend taking Thyroxine.

The sugar level must be checked periodically during the course.

Contraindications

  • Patients with active brain tumour or other active malignant disease
  • Acute critical illness
  • Promoting Growth in Children with Closed Epiphyseal Lines.

Precautions

  • Children with closed epiphyseal lines are assessed for continued growth hormone deficiency before treatment is continued with adult dose.
  • Patients with diabetes or glucose intolerance must be monitored closely.
  • Thyroid status is controlled, as GH increases peripheral deiodination of T4 to T3, which may demask subclinical myxedema.
  • In case of symptoms compatible with increased intracranial pressure fundoscopy is recommended.
  • Before starting treatment, patients with Prader-Willi syndrome should be examined for signs of upper airway obstruction, sleep apnoea or respiratory infections..
  • Treatment with somatripine may cause a reduction in serum cortisol.

Side effects

System organ classPotentially serious side effectsMostly not serious side effects
Domestic supply
  • The most common side effects usually include headache, joint and muscle pain, nausea and weakness.
  • Norditropin (Somatropin) reduces insulin sensitivity. Impaired glucose tolerance, diabetes and hyperglycaemia occur.
  • In adults, side effects due to fluid retention are common (e.g. peripheral oedema), while in children they are less frequent. These side effects are usually transient.
  • Benign intracranial pressure increase is seen - presumably related to fluid retention.
  • In very rare cases, leukaemia has been seen in children, but all indications are that the incidence is on a par with the background population.
  • Cases of pancreatitis have occurred in patients treated with Norditropin (Somatropin). The risk appears greater in children, and particularly children with Turner syndrome, compared with adults.
  • Development of antibodies has occurred with varying frequency, depending on dose size.
  • Transient reactions at the injection site (e.g. bleeding, atrophy, urticaria).
  • After marketing, skin rash, itching and gynaecomastia have been reported.
See also generally about side effects

Interactions

  • Glucocorticoids may counteract the effect of somatropin. Concomitant use of these drugs requires careful adjustment of glucocorticoid dose.
  • Increased dose of Norditropin (Somatropin) may be necessary with concomitant estrogen therapy.

Pregnancy

Should not be used, insufficient data.

Breastfeeding

Can be used if necessary.
Background: Not absorbed.



Possible benzyl alcohol content

Certain formulations of somatropin (Omnitrope ® injection liquid, dissolved in a cylinder ampoule 5 mg/1.5 ml) contains benzyl alcohol: caution when using high doses due to risk of accumulation and development of metabolic acidosis.


See also Classification - breastfeeding

Blood Donor

Do not bottle. (4 weeks quarantine). Donor's suitability for donation must be assessed by a doctor.

See also quarantine conditions for blood donors

Doping

Use of Norditropin (Somatropin) results in disqualification of the athlete.

See also doping

Farmakodynamik

Growth hormone.

Pharmacokinetics

  • Binds to specific proteins in plasma.
  • Plasma half-life 20-25 min. after i.v. injection and 2-4 hours after s.c. injection.
  • The effect on metabolic functions lasts significantly longer, presumably because GH stimulates the production of IGF-I, whose half-life is significantly longer.

Properties, handling and durability

Features

pH 6-6,3.

Handling
liquid injection i cylinder ampoule (SimpleXx®) is intended for use in NordiPen, which can be obtained free of charge from the company. See also Indication and photo.


Shelf life

  • Store in the refrigerator (2-8°C) protected from light.
  • Do not freeze.
  • After opening: injection liquid is stable for 21 days at maximum 25°C or for 28 days in the refrigerator (2-8°C).

Ingredients

Norditropin (Somatropin): injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml

Ancillary victims

Conservation:
Phenol: injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml
Other:
Histidine: injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml
Mannitol: injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml
Poloxamer 188: injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml
Sterile water: injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 5 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 10 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in pen 15 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml, injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml

Company

Novo Nordisk

Packages, prices, subsidies and delivery

Grants Delivery Disp.shape and strength Vnr. Packing
(BEGR) injection liquid, dissolved in pen 5 mg/1,5 ml (NordiFlex®)015460
1 x 1,5 ml
(BEGR) injection liquid, dissolved in pen 5 mg/1,5 ml (FlexPro®) 092620
1,5 ml
(BEGR) injection liquid, dissolved in pen 10 mg/1,5 ml (NordiFlex®) 015591
1 x 1,5 ml
(BEGR) injection liquid, dissolved in pen 10 mg/1,5 ml (FlexPro®) 092631
1,5 ml
(BEGR) injection liquid, dissolved in pen 15 mg/1,5 ml (NordiFlex®) 025814
1 x 1,5 ml
(BEGR) injection liquid, dissolved in pen 15 mg/1,5 ml (FlexPro®) 092644
1,5 ml
(BEGR) injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml (SimpleXx®) 144725
1 cylinderamp. a 1,5 ml
(BEGR) injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml (SimpleXx®) 144436
1 cylinderamp. a 1,5 ml
(BEGR) injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml (SimpleXx®) 144139
1 cylinderamp. a 1,5 ml

See in general
See generally on extradition
See generally about price DDD

Domestic supply

Photo and identification

injection liquid, dissolved in pen 5 mg/1,5 ml (FlexPro®)

 Norditropin injection liquid, dissolved in pen 5 mg/1,5 ml (FlexPro®)

Colour: Orange
Measurements in mm: 139 x 19
Without protective cap

Norditropin® FlexPro® 5 mg/1,5 ml
Norditropin® FlexPro® 5 mg/1,5 ml

injection liquid, dissolved in pen 10 mg/1,5 ml (FlexPro®)

 Norditropin injection liquid, dissolved in pen 10 mg/1,5 ml (FlexPro®)
Color: Turquoise 
Measurements in mm: 139 x 19 
Without protective capNorditropin® FlexPro® 10 mg/1,5 ml

injection liquid, dissolved in pen 15 mg/1,5 ml (FlexPro®)

Norditropin injection liquid, dissolved in pen 15 mg/1,5 ml (FlexPro®)
Color: Light green 
Measurements in mm: 139 x 19 
 Norditropin® FlexPro® 15 mg/1,5 ml
Without protective cap Norditropin® FlexPro® 15 mg/1,5 ml

injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 5)

Norditropin injection liquid, dissolved in a cylinder ampoule 5 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 5)
Color: Orange 
Measurements in mm: 60 x 10 
Color: Turquoise
Measurements in mm: 60 x 10		Norditropin® SimpleXx® 5 mg/1,5 ml
NordiPen® can be ordered from company and available with graphic or classic designNordiPen® 5
Graphic or classic design, Without protective cap.NordiPen® 5

injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 10)

Norditropin injection liquid, dissolved in a cylinder ampoule 10 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 10)
Color: Turquoise 
Measurements in mm: 60 x 10 
 Norditropin® SimpleXx® 10 mg/1,5 ml

NordiPen® can be ordered from company and available with graphic or classic design

NordiPen® 10

Graphic or classic design, Without protective capr.

NordiPen® 10

injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 15)

Norditropin injection liquid, dissolved in a cylinder ampoule 15 mg/1,5 ml (SimpleXx® cylinderampul anvendes i NordiPen® 15)
Color: Light green
Measurements in mm: 60 x 10

Norditropin® SimpleXx® 15 mg/1,5 ml

NordiPen® can be ordered from company and available with graphic or classic design

NordiPen® 15

Graphic or classic design, Without protective capr

NordiPen® 15

Referencer

5013. Sas TC, de Muinck Keizer-Schrama SM, Stijnen T et al. Normalization of Height in Girls With Turner Syndrome After Long-Term Growth Hormone Treatment: Results of a Randomized Dose-Response Trial. J Clin Endocrinol Metab. 1999; 84(12):4607-12, (Lokaliseret 4. marts 2022)

Date of revision

02.06.2020. However, prices are valid as of Monday 16 May 2022

There may be differences between the product description and the package leaflet. This is because Medicin.dk may have supplemented the information from the Danish Medicines Agency and the drug manufacturer with other sources. Medicin.dk har det fulde ansvar for lægemiddelbeskrivelserne.

Reference: Dubois D, Dubois EF. A formula to estimate the
apporoximate surface area if height and weight be known.
Arch Intern Med 1916, 17:863-71.
Estimated glomerular filtration rate (eGFR) calculated from CKD-EPIkrea-the formula without race correction:

Womanr ≤ 62 micromol/liter: 144 x (P-creatinine/(0.7 x 88.4))-0,329 x 0,993Alder
Womanr > 62 micromol/liter: 144 x (P-creatinine/(0.7 x 88.4))-1,209 x 0,993Alder
Males ≤ 80 micromol/liter: 141 x (P-creatinine/(0.9 x 88.4))-0,411 x 0,993Alder
Men > 80 micromol/liter: 141 x (P-creatinine/(0.9 x 88.4))-1,209 x 0,993Alder
Reference: KDIGO: "Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease" (kliniske retningslinjer for evaluering og behandling af kronisk nyresygdom). Kidney International Supplements (2013) 3, viii, januar 2013.
european conformity

Domestic supply

Norditropin us domestic supply






US Domestic supply

We provide US domestic services only.

We offer best products and best customer service at affordable prices.

See more