מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 10 mg/mL
Novo Nordisk Pharmaceuticals Pty Ltd
Somatropin
Injection, solution
Excipient Ingredients: histidine; phenol; poloxamer; mannitol; water for injections
Subcutaneous
1 x 1.5mL cartridge
(S4) Prescription Only Medicine
Children:Treatment of growth failure in children due to pituitary growth hormone deficiency. Treatment of growth failure in girls due to gonadal dysgenesis (Turner's Syndrome). Treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. Chronic renal insufficiency is defined as glomerular filtration rate of less than 30 mL/min/1.73 m2. Treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 SD) without spontaneous catch up growth by 2 years of age). Adults: Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/mL. In order to establish Childhood Onset [CO] growth hormone insufficiency, reconfirmation by one provocative test is recommended. In order to establish isolated growth hormone deficiency two provocative tests are recommended. In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.
Visual Identification: Colourless solution for injection in Type I glass cartridge with bromobutyl plunger, aluminium cap, and bromobutyl / polyisoprene rubber cap, pre-sealed into disposable plastic syringes with dial-a-dose metering.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2011-05-09
Norditropin ® FlexPro ® Page 1 of 9 Norditropin FlexPro-15mg-cmi-v3.doc NORDITROPIN ® FLEXPRO ® 15 MG _Somatropin (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET ................ 1 WHAT NORDITROPIN ® FLEXPRO ® IS USED FOR ...................................... 1 BEFORE USING NORDITROPIN ® FLEXPRO ® .................................... 1 USING NORDITROPIN ® FLEXPRO ® .. 2 WHILE YOU OR YOUR CHILD IS USING NORDITROPIN ® FLEXPRO ® ............. 3 SIDE EFFECTS ................................. 3 STORAGE ....................................... 3 PRODUCT DESCRIPTION ................. 4 FURTHER INFORMATION ................. 4 INSTRUCTIONS FOR USE ................. 5 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Norditropin ® FlexPro ® . 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 ® FlexPro ® 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 ® FLEXPRO ® IS USED FOR Norditropin ® FlexPro ® 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 are therefore not treated for growth hormone deficiency. Treatment with Norditropin ® FlexPro ® promotes catch-up growth and increases final height. • Chronic קרא את המסמך השלם
AU-Norditropin ® -PI-VV-LAB-086720 _ _ _ _ Page 1 of 2 AUSTRALIAN PRODUCT INFORMATION Norditropin ® FlexPro ® (somatropin) injection solution 1. NAME OF THE MEDICINE Somatropin (rbe). Biosynthetic human growth hormone. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Somatropin is a polypeptide hormone of recombinant DNA origin. The hormone is synthesised 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. Somatropin 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 FlexPro contains somatropin (rbe) 5 mg, 10 mg or 15 mg in 1.5 mL. 1 mg of somatropin corresponds to 3 IU (International Units) of somatropin. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Children Treatment of growth failure in children due to pituitary growth hormone deficiency. Treatment of growth failure in girls due to gonadal dysgenesis (Turner Syndrome). Treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty- fifth percentile for bone age. Chronic renal insufficiency is defined as a glomerular filtration rate of < 30 mL/min/1.73 m 2 . Treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 SD) without spontaneous catch up growth by 2 years of age). Adults Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/mL. In order to establish Childhood Onset [CO] growth hormone insufficiency, reconfirmation by one provocat קרא את המסמך השלם