Description

Norditropin is a prescription medicine that contains human growth hormone and is used to treat:

• Children who are not growing because of low or no growth hormone from the pituitary gland
• Adults who have growth hormone deficiency

Norditropin NordiFlex 5 mg/1.5 ml is a multidose disposable pre-filled pen that delivers a maximum of 1.5 mg somatropin (the active ingredient) per dose, in increments of 0.025 mg somatropin.Some key information about Norditropin NordiFlex 5 mg/1.5 ml:

• It is a solution for injection in a pre-filled pen
• One ml of the solution contains 3.3 mg of somatropin
• It should only be used with the matching color-coded NordiPen (orange) to ensure proper dosing
• Patients should wash their hands thoroughly before use and avoid shaking the pen vigorously
• Common side effects include common cold, headache, fever, pain in extremity, and reaction at the injection site

Norditropin NordiFlex 5 mg/1.5 ml is an approved treatment option for growth hormone deficiency in both children and adults.

Composition

• One pre-filled pen contains 5 mg somatropin in 1.5 ml solution
• 1 ml of the solution contains 3.3 mg of somatropin

Indications

• Treatment of children with growth failure due to inadequate secretion of endogenous growth hormone
• Replacement of endogenous growth hormone in adults with growth hormone deficiency

Dosage and Administration

• Norditropin NordiFlex 5 mg/1.5 ml is a multidose disposable pre-filled pen
• Delivers a maximum of 1.5 mg somatropin per dose, in increments of 0.025 mg somatropin
• Should only be used with the matching color-coded NordiPen (orange)
• Patients should wash their hands thoroughly before use and avoid shaking the pen vigorously

Safety Information

• Common side effects include common cold, headache, fever, pain in extremity, and reaction at the injection site
• Contraindicated in patients with acute critical illness, active malignancy, hypersensitivity to somatropin or excipients

Unique Features

• Pre-filled pen for easy and accurate dosing
• Delivers precise doses in small increments
• Matching color-coded pen ensures proper administration
• Disposable design for convenience and sterility
  

  Key Benefits of Norditropin NordiFlex 5 mg/1.5 ml

  • Treats growth failure in children due to growth hormone deficiency
  • Promotes catch-up growth and increases final height in children born small for gestational age
  • Treats growth hormone deficiency in adults
  • Pre-filled pen for easy and accurate dosing
  • Delivers precise doses in small increments of 0.025 mg somatropin

  Key Ingredients

  The active ingredient in Norditropin NordiFlex 5 mg/1.5 ml is:

  • Somatropin (rbe) – biosynthetic human growth hormone identical to that produced in the human body

  The other ingredients are:

  • Mannitol
  • Histidine
  • Poloxamer
  • Phenol
  • Water for injections

  Mechanism of Action of Norditropin

  Norditropin contains somatropin, which is a recombinant human growth hormone (r-hGH) that is identical to the natural growth hormone produced by the human pituitary gland.The key mechanisms of action of somatropin (the active ingredient in Norditropin) include:Growth Stimulation

  • Somatropin stimulates the production of insulin-like growth factor-1 (IGF-1) in the liver and other tissues
  • IGF-1 is the primary mediator of the growth-promoting effects of somatropin, stimulating skeletal growth, cell multiplication, and protein synthesis

  Metabolic Effects

  • Somatropin has anabolic effects, promoting the conversion of protein, fat, and carbohydrates
  • It increases nitrogen retention, fat mobilization, and glucose metabolism

  Other Effects

  • Somatropin has beneficial effects on body composition, increasing lean body mass and decreasing fat mass
  • It also has positive effects on cardiovascular function, bone mineral density, and psychological well-being
    

    Chemical Structure of Norditropin

    Norditropin contains the active ingredient somatropin, which is a recombinant human growth hormone (r-hGH). The key details about the chemical structure of somatropin are:Molecular Formula
    The molecular formula of somatropin is C990H1528N262O300S7, with a molecular weight of approximately 22,125 Daltons.Structural Formula
    Somatropin is a polypeptide hormone consisting of a single chain of 191 amino acids. It has the identical sequence of amino acids as the naturally occurring human growth hormone produced by the pituitary gland.The somatropin molecule contains two disulfide bridges that help stabilize its structure.Physicochemical Properties
    Somatropin is a white to off-white, crystalline powder that is freely soluble in water. It is produced by a special strain of E. coli bacteria that has been genetically modified to express the human growth hormone gene.

  Dosage

  • Norditropin NordiFlex 5 mg/1.5 ml is a multidose disposable pre-filled pen
  • It delivers a maximum of 1.5 mg somatropin per dose, in increments of 0.025 mg somatropin
  • The dosage varies by indication:
    • For pediatric growth hormone deficiency: 0.17 to 0.24 mg/kg per week (0.024 to 0.034 mg/kg per day)
    • For Prader-Willi syndrome: 0.24 mg/kg per week (0.034 mg/kg per day)
    • For Noonan syndrome, Turner syndrome, and idiopathic short stature: up to 0.47 mg/kg per week (up to 0.067 mg/kg per day)
    • For small for gestational age (SGA): up to 0.47 mg/kg per week (up to 0.067 mg/kg per day)

  Storage

  • Before first use, Norditropin NordiFlex 5 mg/1.5 ml must be stored in a refrigerator at 2-8°C (36-46°F)
  • After the first injection, it can be stored:
    • In the refrigerator at 2-8°C (36-46°F) for up to 4 weeks
    • At room temperature up to 25°C (77°F) for up to 3 weeks

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