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Norditropin
Overview
What is Norditropin?
Norditropin is a registered trademark of Novo Nordisk Health Care AG for somatropin, a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.
Norditropin cartridges are supplied as sterile solutions for subcutaneous injection in ready-to-administer cartridges or prefilled pens with a volume of 1.5 mL or 3 mL.
Each contains the following (see Table 2):
What does Norditropin look like?































































What are the available doses of Norditropin?
Norditropin is preloaded in the Norditropin FlexPro or Norditropin NordiFlex pens, or cartridges for use with the corresponding NordiPens ():
What should I talk to my health care provider before I take Norditropin?
How should I use Norditropin?
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Noonan syndrome.
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature associated with Turner syndrome.
Norditropin [somatropin (rDNA origin) injection] is indicated for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years.
For subcutaneous injection.
Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.
What interacts with Norditropin?
Sorry No Records found
What are the warnings of Norditropin?
Sorry No Records found
What are the precautions of Norditropin?
Sorry No Records found
What are the side effects of Norditropin?
Sorry No records found
What should I look out for while using Norditropin?
Acute Critical Illness (, )
Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment - reports of sudden death (, )
Active Malignancy ()
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()
Children with closed epiphyses ()
Known hypersensitivity to somatropin or excipients ()
What might happen if I take too much Norditropin?
Short-Term
Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose with somatropin is likely to cause fluid retention.
Long-Term
Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [].
How should I store and handle Norditropin?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F). [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion. [somatropin (rDNA origin) injection] 5 mg/1.5 mL:Norditropin NordiFlex is individually cartoned in 5 mg/1.5 mL prefilled pensUnused Norditropin NordiFlex pens must be stored at 2-8°C/36-46°F (refrigerator). Do not freeze. Avoid direct light. 5 mg/1.5 mL (orange) prefilled pens:After the initial injection, a Norditropin NordiFlex (5 mg/1.5 mL) prefilled pen may be stored in the refrigerator (2-8ºC/36-46ºF) and used within 4 weeks stored for up to 3 weeks at not more than 25ºC (77ºF). Discard unused portion.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Somatropin (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-I produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis) [].
Non-Clinical Toxicology
Acute Critical Illness (, )Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment - reports of sudden death (, )
Active Malignancy ()
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()
Children with closed epiphyses ()
Known hypersensitivity to somatropin or excipients ()
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with amounts of somatropin []. The safety of continuing somatropin treatment in patients receiving doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Professional
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Tips
Interactions
Interactions
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