Norditropin Pen

Norditropin Pen Flexpro, Nordilet, etc uses:

Norditropin-nordilet-flexpro-pen

  • Deficient children with somatropin secretion of endogenous growth retardation: Long-term treatment of children with growth retardation or absence due to deficit somatropin. The diagnosis must be verified investigating pituitary function before administering the product.
  • Turner syndrome: NORDITROPIN is useful in Turner syndrome, which is a chromosomal abnormality associated in slow growth and short stature affecting only girls, in which typically a chromosome “??? XA does not exist, or, another variant in which only part of one chromosome “Xa ??? does not appear. NORDITROPIN is only effective while the epiphyseal function has not taken place.
  • Prepubertal children with chronic renal insufficiency and growth retardation: In children with chronic renal failure and stunted due to lack of somatropin. Children with gestational short stature (SGA).
  • Adults with endogenous somatropin deficiency In patients deficient adults with somatropin start from childhood or adulthood failure or pituitary tumor by surgery.
  • Description: NORDITROPIN proved indistinguishable from pituitary growth hormone (hGH). NORDITROPIN is a preparation of high purity, with extremely low levels of pollutants. This has been confirmed in clinical trials have demonstrated the efficacy and safety of treatment with patients with NORDITROPIN growth hormone deficiency.

Is very low frequency of antibodies against hGH after Norditropin.

Posology

The dose is individual. Generally, a daily subcutaneous injection at night is recommended. The injection site will vary to prevent lipoatrophy.

Patients should remember to wash your hands thoroughly with soap and water and / or disinfected before any contact with NORDITROPIN. NORDITROPIN should not be shaken vigorously at any time.

NORDITROPIN NordiLet and NORDITROPIN NodiFlex are prefilled pens, which are designed to be used with NovoFine and NovoFine S respectively. Only for prescribing.

To NORDITROPIN NordiLet, the dose is released by click, from 1-29 clicks in 1 click per injection. The dose per click is 0.0667 mg (5 mg / 1.5 ml) of 0.1333 mg (10 mg / 1.5 ml) and 0.2000 mg (15 mg / 1.5 ml). In the instructions for use for each concentration give a range of doses in mg per number of clicks in a conversion table.

For the injection procedure:

  • NORDITROPIN SimpleXx, please see the manual for NordiPen 5.10 or 15.
  • NORDITROPIN NordiLet, please see the manual for NORDITROPIN NordiLet 5, 10 or 15 mg.
  • NORDITROPIN NordiFlex, please see the manual for NORDITROPIN NordiFlex 5, 10 or 15 mg.

Below general dosage recommendations:

Children:

  • Deficient in growth hormone secretion: 25-35 mg / kg / day or 0.7 to 1.0 mg / m2 / day.
  • With chronic renal failure or Turner syndrome: 50 mg / kg / day or 1.4 mg / m2 / day.
  • Short stature in children gestational (SGA): 33-67 mg / kg / day or 1-2 mg / m2 / day.

Adults:

  • Replacement therapy: It is recommended to start treatment with a low dose of 0.1 to 0.3 mg / day and the dose increased gradually at monthly intervals to ensure the individual needs of the patient.
  • The FCI-I serum can be used as a guide for dose titration.
  • The dosage requirements vary from person to person, but seldom exceed 1.0 mg / day (equal to 3 IU / day).

Contraindications

Norditropin should not be used:

  • Patients with evidence of tumor activity, neoplasms must be inactivated and antitumor therapy should be completed prior to instituting therapy.
  • Pregnancy and lactation.
  • Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, respiratory complications or similar conditions.
  • Hypersensitivity to some components in the formula.
  • In children with chronic renal disease, treatment should be discontinued NORDITROPIN in kidney transplantation.

Adverse effects of Norditropin

Side effects in children are rare. Children may experience:

  • Swollen hands and feet due to fluid retention.
  • Redness, itching and pain at the injection site.
  • Muscle and joint pain.

Adults may experience the following:

  • Swollen hands and feet due to fluid retention.
  • Itching, numbness or pain perhaps mainly on the fingers due to the pressure on the nerves.
  • Muscle and joint stiffness.
  • Muscle and joint pain.
  • Itching and pain at the injection site.
  • Because the effects of the somatropin in glucose metabolism, can produce enough glucose intolerance to meet the diagnostic criteria for type 2 diabetes mellitus.

In rare cases, the following side effects may occur:

  • Development of antibodies to growth hormone.
  • High pressure in the brain.
  • Very rare cases have been reported from hypersensitivity reactions.

Norditropin presentations

Norditropin Cartridges (SimpleXx) for use in NordiPen device 5, 10 or 15:

  • Box of 1 or 3 cartridges with 5 mg / 1.5 ml for use in NordiPen device 5.
  • Box of 1 or 3 cartridges with 10 mg / 1.5 mL for use in device 10 NordiPen.
  • Box of 1 or 3 cartridges with 15 mg / 1.5 mL for use in device 15 NordiPen.
  • Prefilled pen NordiLet 5, 10 or 15:
  • Box with a prefilled pen NORDITROPIN NordiLet 5 mg / 1.5 ml.
  • Box with a prefilled pen NORDITROPIN NordiLet 10 mg / 1.5 ml.
  • Box with a prefilled pen NORDITROPIN NordiLet 15 mg / 1.5 ml.
  • Prefilled pen NordiFlet 5, 10 or 15:
  • Box with a prefilled pen NORDITROPIN NordiFlet 5 mg / 1.5 ml.
  • Box with a prefilled pen NORDITROPIN NordiFlet 10 mg / 1.5 ml.
  • Box with a prefilled pen NORDITROPIN NordiFlet 15 mg / 1.5 ml.

Active ingredients of Norditropin

Each prefilled pen cartridge and each containing:

Solution 5 mg / 1.5 ml:

……………….. 3.3 mg somatropin

Vehicle cbp 1 ml ……………….

Solution 10 mg / 1.5 ml:

……………….. 6.7 mg somatropin

Vehicle cbp ……………… 1 ml

Solution 15 mg / 1.5 ml:

………………. 10 mg somatropin

Vehicle cbp 1 ml ……………..

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