Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 3.3 mg/mL
Sandoz Pty Ltd
Somatropin
Injection
Excipient Ingredients: poloxamer; dibasic sodium phosphate heptahydrate; benzyl alcohol; sodium hydroxide; monobasic sodium phosphate; mannitol; water for injections; phosphoric acid
Subcutaneous
1 cartridge of solution for injection, 5 cartridges of solution for injection, 10 cartridges of solution for injection.
(S4) Prescription Only Medicine
OMNITROPE 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; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-10-28
OMNITROPE ® 1 OMNITROPE ® _Somatropin (rbe) (recombinant human growth hormone, r-hGH) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Omnitrope. 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 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 need to read it again. WHAT OMNITROPE 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. Omnitrope 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 YOU USE OMNITROPE _WHEN YOU MUST NOT USE IT _ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • somatropin, the active ingredient • any of the 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 intensive care • read_full_document
210803-Omnitrope-pi Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION OMNITROPE ® (SOMATROPIN (RBE)) SOLUTION FOR INJECTION AND POWDER FOR SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Somatropin (rbe) (recombinant human growth hormone, r-hGH) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Omnitrope 5 mg/1.5 mL solution for injection contains 3.33 mg/mL somatropin. Omnitrope 5 mg/1.5 mL solution for injection for SurePal 5 contains 3.33 mg/mL somatropin. Omnitrope 10 mg/1.5 mL solution for injection contains 6.67 mg/mL somatropin (rbe). Omnitrope 10 mg/1.5 mL solution for injection for SurePal 10 contains 6.67 mg/mL somatropin (rbe). Omnitrope 15 mg/1.5 mL solution for injection for SurePal 15 contains 10 mg/mL somatropin (rbe). Omnitrope 1.33 mg powder for injection contains 1.33 mg/mL somatropin (rbe) on reconstitution. Omnitrope 5 mg powder for injection contains 5 mg/mL somatropin (rbe) on reconstitution. _List of excipients with known effect_ : mannitol (Omnitrope 5 mg/1.5 mL solution for injection preparations) Omnitrope ® 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 Omnitrope solution for injection is a clear, colourless solution. Omnitrope powder for injection is a white to off-white powder. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Omnitrope 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 diagnos read_full_document