Manufacturer: Novo Nordisk
Pharmaceutical name: Human Growth Hormone 191aa
Pack: 1 cartridge (45 iu (15mg/1,5 ml))
Norditropin Simplexx 45IU
15 mg in a 1.5 ml of solution in a cartridge (Type I glass) closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a laminated rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The aluminium cap is sealed with a coloured cap (green). Pack sizes of 1, 3 and 5. The cartridges are blister packed in a carton.
Norditropin Simplexx 45IU is a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone.
Therapy with Norditropin Simplexx 45IU 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.
The Norditropin dosage and administration schedule should be individualized based on the growth response of each patient. Serum insulin-like growth factor I (IGF-I) levels may be useful during dose titration.
Norditropin Simplexx Pen 45IU injection is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes. It is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome. It is a form of human growth hormone. Common side effects include headache, nausea, vomiting, fatigue, muscle pain, or weakness.
Norditropin Simplexx 45IU may interact with insulin or oral diabetes medicine, steroids, cyclosporine, seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women. Tell your doctor all medications you use. Norditropin should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.
Norditropin Simplexx 45IU and 10mg (30IU)
Norditropin Simplexx Pen 45IU and 10mg (30IU) solution for injection cartridges are indicated in children with growth problems, Turner’s syndrome, in people with certain kidney problems and in children who are too small for their age.
Norditropin is supplied by Novo Nordisk Limited and contains:
hydrochloric acid for pH adjustment
sodium hydroxide for pH adjustment
water for injections
Norditropin Simplexx is manufactured using recombinant DNA technology in E. coli secretion expression system.
Caution must be taken if the patient:
is a child who has stopped growing completely
is over 60 years old
is allergic or sensitive to any ingredients
is suffering from complications caused by surgery, trauma, or other medical conditions
has a respiratory infection, tumour, or kidney problems
has diabetes or is at risk for developing diabetes e.g. family history of diabetes, has certain skin problems or is obese
has or have had brain or central nervous system problems
has pituitary problems
has Prader-Willi syndrome
has Silver-Russell syndrome
has sleep apnoea
Norditropin SimpleXx is contraindicated in children under the age of four and in those who are having a kidney transplant.
The following drugs may interact with Norditropin SimpleXx:
The following types of drugs may also interact with Norditropin SimpleXx:
medicines that are metabolised by the cytochrome P450 system
Doctor must be informed if the patients is taking any of the above, or is undergoing treatment with any alternative medicaments, including vitamins, herbal supplements, and non-prescription drugs.
For the best result from Norditropin SimpleXx it should be taken in the evening.
Do not use Norditropin SimpleXx if the packaging has been tampered with, or if it shows any signs of damage. If you started a cartridge, leave it in the pen. Once opened, store it in a fridge at 2-8°C, and dispose no later than 28 days after opening. You can also store it at the room temperature; however, you must dispose of it 21 days after opening. Store it in the carton box (it is light sensitive), out of the sight and reach of children and pets. Do not freeze, or use after the expiry date shown on the packaging.
In children, side-effects are usually uncommon or rare.