País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
Somatropin
Novo Nordisk Pharmaceuticals Pty Ltd
Medicine Registered
Norditropin NordiFlex ® Page 1 of 8 NorFlcmi7.doc NORDITROPIN NORDIFLEX ® 5MG, 10MG AND 15MG _Somatropin (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT NORDITROPIN NORDIFLEX ® IS USED FOR...................................... 1 BEFORE USING NORDITROPIN NORDIFLEX ® ................................. 1 USING NORDITROPIN NORDIFLEX ® 2 WHILE YOU OR YOUR CHILD IS USING NORDITROPIN NORDIFLEX ® ........... 3 SIDE EFFECTS................................. 3 STORAGE....................................... 3 PRODUCT DESCRIPTION ................. 4 FURTHER INFORMATION................. 4 INSTRUCTIONS FOR USE................. 5 This leaflet answers some common questions about Norditropin NordiFlex ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child using Norditropin NordiFlex ® against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NORDITROPIN NORDIFLEX ® IS USED FOR Norditropin NordiFlex ® is a pre- filled dial-a-dose pen containing Norditropin ® , a solution of human growth hormone. Norditropin ® [also called somatropin (rbe)], is used to treat: 1. growth failure in children, which may be due to: • a condition called Growth Hormone Deficiency, where the gland at the base of the brain (pituitary gland) does not make enough growth hormone • a condition called either Small for Gestational Age (SGA) or Intrauterine Growth Retardation (IUGR), where growth failure started during the mother’s pregnancy. Children with SGA/IUGR do not lack growth hormone and Llegiu el document complet
Product Information page 1 of 17 Norppi15.docx PRODUCT INFORMATION NORDITROPIN ® SIMPLEXX ® 5 MG, 10 MG AND 15 MG NORDITROPIN NORDIFLEX ® 5 MG, 10 MG AND 15 MG NORDITROPIN ® FLEXPRO ® 5 MG, 10 MG AND 15 MG NAME OF THE MEDICINE Somatropin (rbe). Biosynthetic human growth hormone. DESCRIPTION Norditropin ® (somatropin) 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. 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. ATC: H 01 AC 01. 1 mg of somatropin corresponds to 3 IU (International Units) of somatropin. For excipients, see ‘Presentations and Storage Conditions.’ PHARMACOLOGY PHARMACODYNAMICS Norditropin increases the growth rate in humans by stimulation of protein synthesis and other metabolic processes. _Growth_ The primary and most intensively studied action of somatropin is the stimulation of linear growth. This effect is demonstrated in patients with somatropin deficiency. Skeletal growth - the measurable increase in bone length after administration of somatropin results from its effect on the cartilaginous growth areas of long bones. Studies _in vitro_ have shown that the incorporation of sulphate into proteoglycans is not due to a direct effect of somatropin, but rather is mediated by the somatomedins or insulin-like growth factors (IGF). The somatomedins, among them somatomedin-C (otherwise known as IGF-1), are polypeptide hormones which are synthesised in the liver, kidney and various other tissues. Somatomedin-C (IGF-1) is low in the serum of hypopituitary dwarfs and hypophysectomised humans or animals, but its presence can be demonstrated after tre Llegiu el document complet