Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 6 mg (Equivalent: Somatropin, Qty 18 IU)
Eli Lilly Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; glycerol; hydrochloric acid; metacresol
Intramuscular, Subcutaneous
1 syringe with diluent 3.17mL, 1 cartridge of powder - 18IU (6mg)
Not scheduled. Not considered by committee, (S4) Prescription Only Medicine
HUMATROPE is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.,HUMATROPE is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (Turner syndrome).,HUMATROPE is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranal irradiation), two dynamic tests should be recommended, except for those having low IGF-I concentrations less than or equal to 2 SDS who may be considered for one test. The cut-off point of the dynamic test should be strict.,HUMATROPE is also indicated for the treatment of growth retardation in prepubertal children with 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.,HUMATROPE is also indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years (see CLINICAL TRIALS). Humatrope is also indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years. (See Clinical Trials)
Visual Identification: Clear liquid.; Container Type: Cartridge; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1995-10-24
HUMATROPE ® _Somatropin (rbe)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about HUMATROPE and its use that you should be aware of. All medicines have risks and benefits. Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR HEALTH CARE PROFESSIONAL. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT HUMATROPE IS USED FOR HUMATROPE is a biosynthetic human growth hormone. It is used in children who do not produce enough natural growth hormone, in girls who have Turner syndrome, in children with chronic renal insufficiency, and children born small for gestational age. HUMATROPE helps these children to grow at a natural rate. HUMATROPE is also used in adults who do not produce enough natural growth hormone. In adults, HUMATROPE helps to decrease body fat, in growth hormone deficient adults only. Your doctor may have prescribed HUMATROPE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY HUMATROPE HAS BEEN PRESCRIBED FOR YOU. BEFORE USING HUMATROPE A doctor who is experienced in the diagnosis and management of patients who do not produce enough natural growth hormone should direct your treatment with HUMA Les hele dokumentet
AUSTRALIAN PRODUCT INFORMATION vA11-0_2Jan19 SUPERSEDES: vA10-0_09Oct15 Page 1 of 16 HUMATROPE ® (SOMATROPIN, RBE) POWDER FOR INJECTION 1. NAME OF THE MEDICINE HUMATROPE ® (somatropin). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HUMATROPE is a highly purified preparation and is available in cartridges containing 6 mg (18 IU ), 12 mg (36 IU*), or 24 mg (72 IU*) somatropin and when reconstituted with the diluent provided the cartridge contains 2.07 mg/mL, 4.17 mg/mL or 8.46 mg/mL somatropin respectively. Each cartridge also contains the inactive ingredients: mannitol, glycine and dibasic sodium phosphate heptahydrate and is supplied with an accompanying diluent. The diluent contains water for injections, metacresol and glycerol (see section 6.5 NATURE AND CONTENTS OF CONTAINER and section 6.4 SPECIAL PRECAUTIONS FOR STORAGE). The glycerol in the diluent ensures the tonicity of the reconstituted product is within acceptable ranges. Reconstituted solutions have a pH of approximately 7.5. 3. PHARMACEUTICAL FORM HUMATROPE is a sterile, white, lyophilised powder intended for subcutaneous or intramuscular administration after reconstitution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HUMATROPE is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone. HUMATROPE is also indicated for the treatment of growth disturbances associated with gonadal dysgenesis (Turner syndrome). HUMATROPE is also indicated for the treatment of adults with severe growth hormone deficiency defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. The specific activity of the International Standard for somatropin is defined as 3 International Units per mg of protein. HUMATROPE is now labelled based on a specific activity of 3 IU/mg and was formerly labelled bas Les hele dokumentet