Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 5 mg/mL
Pfizer Australia Pty Ltd
Somatropin
Injection, powder for
Excipient Ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate
Subcutaneous
1's, 5's
(S4) Prescription Only Medicine
Short stature due to decreased or failed secretion of pituitary growth hormone. 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. Growth disturbances associated with gonadal dysgenesis (Turner's syndrome). Improvement of body composition and treatment of short stature associated with Prader-Willi syndrome (PWS) in paediatric patients. For treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. Chronic renal insufficiency is defined as glomerular filtration rate of less than 50 mL/min/1.73m2.
Visual Identification: Unreconstituted: White lyophilised powder.; Container Type: Cartridge; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2010-03-05
GENOTROPIN ® _somatropin (rbe), recombinant human growth hormone_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions that you may have about GENOTROPIN. It does not contain all the available information. It does not take the place of talking with your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using GENOTROPIN against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GENOTROPIN IS USED FOR GENOTROPIN is a growth hormone. GENOTROPIN is used to treat: • Short stature caused by the lack of growth hormone. GENOTROPIN promotes the growth of the long bones (for example, upper legs) in children with reduced height due to lower than normal levels of growth hormone. • Reduced growth in girls with Turner syndrome. Turner syndrome is a genetic disorder found in females. The condition may cause short stature and ovaries to not fully develop. • Children with Prader-Willi syndrome. Prader-Willi syndrome is a genetic disorder that may cause short stature, low muscle tone and a constant feeling of hunger. GENOTROPIN helps to improve growth and body composition. It also helps to reduce excessive fat and improve muscle mass. Diet restrictions may still be necessary during treatment with GENOTROPIN. • Children with kidney disease, to help them grow at a normal rate. • Adults who do not produce enough natural growth hormone. However, your doctor may prescribe GENOTROPIN for another purpose. Ask your doctor if you have any questions about why GENOTROPIN has been prescribed for you. BEFORE YOU USE GENOTROPIN _WHEN YOU MUST NOT USE_ _GENOTROPIN (DISCUSS WITH_ _YOUR DOCTOR)_ YOUR DOCTOR WILL NOT PRESCRIBE GENOTROPIN IF YOU: • are a child and have closed epiphyses (this means that your bones have finished growing). • have an active tumour or evidence of canc Διαβάστε το πλήρες έγγραφο
Version: pfpgenov10220 Supersedes: pfpgenov10619 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION GENOTROPIN AND GENOTROPIN _ GOQUICK_ POWDER FOR INJECTION WITH DILUENT (WITH PRESERVATIVE) GENOTROPIN MINIQUICK POWDER FOR INJECTION WITH DILUENT (SINGLE DOSE SYRINGES) 1. NAME OF THE MEDICINE Somatropin (rbe). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 5 mg with preservative, two- compartment cartridge contains somatropin (rbe) 5 mg/mL. After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 5.3 mg with preservative, two- compartment cartridge contains somatropin (rbe) 5.3 mg/mL. After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 12 mg with preservative, two- compartment cartridge contains somatropin (rbe) 12 mg/mL. After reconstitution, GENOTROPIN MiniQuick, two-compartment cartridge contains somatropin (rbe) 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg or 2.0 mg in 0.25 mL. Reconstituted solution has an osmolality of approximately 300 mOsm/kg and pH approximately 6.7. EXCIPIENT(S) WITH KNOWN EFFECT • Mannitol For the full list of excipients, see Section 6.1 - List of excipients. 3. PHARMACEUTICAL FORM Powder for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short stature due to decreased or failed secretion of pituitary growth hormone. 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. Growth disturbances associated with gonadal dysgenesis (Turner syndrome). Version: pfpgenov10220 Supersedes: pfpgenov10619 Page 2 of 17 Improvement of body composition and treatment of short stature associated with Prader-Willi syndrome (PWS) in paediatric patients. For treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percen Διαβάστε το πλήρες έγγραφο