Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 3.3 mg/mL
SciGen Australia Pty Ltd
Somatropin
Injection
Excipient Ingredients: mannitol; benzyl alcohol; poloxamer; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate dihydrate; sodium hydroxide; phosphoric acid
Subcutaneous
5 cartridges of solution for injection, 1 cartridge of solution for injection, 10 cartridges of solution for injection., 2 x 1.5m l Cartridges
Medicine Registered
(S4) Prescription Only Medicine
SCITROPIN A is intended for long term treatment of children (above three years of age with growth disturbance due to insufficient secretion of pituitary growth hormone; growth disturbance associated with gonadal dysgenesis (Turner's syndrome); & growth disturbance associated with chronic renal insufficiency.
Visual Identification: Clear to turbid, colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2007-10-31
Page 1 of 4 SCITROPIN A ™ SOMATROPIN (RBE) (RECOMBINANT HUMAN GROWTH HORMONE, R-HGH) CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SciTropin A. It does not contain all of 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 using this medicine against the benefits they expect it will have for you or your child. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT SCITROPIN A IS USED FOR This medicine is used to treat: • short stature in children due to growth hormone deficiency • girls with growth disturbance associated with Turner Syndrome • growth disturbance in children with chronic renal insufficiency. It contains the active ingredient somatropin. Somatropin is a biosynthetic human growth hormone which is a protein molecule occurring naturally in humans. SciTropin A is identical to the body's own growth hormone. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE USING SCITROPIN A _ _ _WHEN YOU MUST NOT USE IT _ _ _ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: _ _ • somatropin, the active ingredient • any of other ingredients listed at the end of this leaflet under Product description. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE THIS MEDICINE IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • active tumours or evidence of tumour growth. • serious injury or illness, or surgical procedures, requiring in Olvassa el a teljes dokumentumot
Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION SCITROPIN A™ (SOMATROPIN (RBE)) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Somatropin (rbe) (recombinant human growth hormone, r-hGH) _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SciTropin A 5 mg/1.5 mL Solution for Injection contains 3.33 mg/mL somatropin (rbe). SciTropin A 10 mg/1.5 mL Solution for Injection contains 6.67 mg/mL somatropin (rbe). _List of excipients with known effect: mannitol (SciTropin A 5 mg/1.5 mL solution for injection _ _preparations) _ _ _ SciTropin A™ is produced using recombinant DNA technology. The active substance somatropin (biosynthetic human growth hormone, rDNA-derived human growth hormone [ r-hGH ] ) is produced in cell culture by _Escherichia coli_ cells bearing the gene for human growth hormone. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM SciTropin A Solution for Injection is a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 T HERAPEUTIC I NDICATIONS SciTropin A is intended for the long term treatment of children (above three years of age) with: • growth disturbance due to insufficient secretion of pituitary growth hormone • growth disturbance associated with gonadal dysgenesis (Turner syndrome) • growth disturbance associated with chronic renal insufficiency 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Therapy with somatropin should be initiated and monitored by physicians who are experienced in the diagnosis and management of patients with growth hormone deficiency. The dose is based on body weight and must always be adjusted individually in accordance with the response to therapy. Daily administration by subcutaneous injection in the evening is recommended. The injection sites have to be rotated to minimise the risk of local lipoatrophy. Patients and caregivers have to receive appropriate training and instruction on the proper use of the SciTropin A vials and the pen, from their physician or other suitably qualified health professionals. Page 2 of 15 _GROWTH Olvassa el a teljes dokumentumot