Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
pasireotide diaspartate, Quantity: 752.4 microgram (Equivalent: pasireotide, Qty 600 microgram)
Recordati Rare Diseases Australia Pty Ltd
pasireotide diaspartate
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; tartaric acid; mannitol
Subcutaneous
60 (10 packs of 6) ampoules, 30 (5 packs of 6) ampoules, 6 x 1 mL ampoules
(S4) Prescription Only Medicine
The treatment of adult patients with Cushing?s disease for whom surgery is not an option or for whom surgery has failed.
Visual Identification: Clear colourless solution in a 1 mL colourless glass ampoule with one point cut and two blue coloured rings; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-11-01
SIGNIFOR ® 1 SIGNIFOR ® pasireotide CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Signifor. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. 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 taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SIGNIFOR IS USED FOR Signifor is used to treat Cushing's Disease, a condition caused by an enlargement in the pituitary gland (pituitary adenoma, a benign tumour) which produces too much of a hormone called adrenocorticotropic hormone (ACTH). This overproduction of ACTH causes the body to produce too much of another hormone called cortisol. Too much cortisol leads to a variety of signs and symptoms such as weight gain with abdominal obesity, moon- shaped face, easy bruising, menstrual abnormalities, excessive body and facial hair, muscle wasting with generalized weakness and tiredness, depression and decreased libido. Signifor is designed to block the production of ACTH and therefore cortisol and help to reduce the symptoms caused by excess of cortisol. Signifor contains pasireotide, a synthetic substance that mimics the action of somatostatin, a substance normally found in the human body, which can block the production of certain hormones such as ACTH. The advantage of pasireotide over somatostatin is that its effect is stronger and lasts longer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTI Les hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION – SIGNIFOR ® (PASIREOTIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Pasireotide (as diaspartate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 1 mL contains: 300 microgram pasireotide (as diaspartate) 600 microgram pasireotide (as diaspartate) 900 microgram pasireotide (as diaspartate) Pasireotide 300 micrograms/1 mL, 600 micrograms/1 mL and 900 micrograms/1 mL solution for injection is clear and colourless. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection, solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS The treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSE The recommended dosage range of SIGNIFOR is 300 mcg to 900 mcg by subcutaneous injection, twice a day. The recommended initial dose is 600 mcg or 900 mcg twice a day. Titrate dose based on response and tolerability. For patients who are started on 600 mcg twice a day, a dosage increase to 900 mcg twice a day may be considered based on the response to the treatment as long as the 600 mcg dosage is well tolerated by the patient. Individualised dose reduction may be considered for patients with a stable response at the discretion of the treating physician. Patients should be evaluated for treatment response (clinically meaningful reduction in Urinary Free Cortisol (UFC) levels and/or improvement in signs or symptoms of the disease) and should continue receiving therapy with Signifor as long as benefit is derived. Maximum urinary free cortisol reduction is typically seen by two months of treatment. Patients who do not experience clinical benefit from Signifor should be considered for discontinuation. 2 Management of suspected adverse reactions may require temporary dose reduction of Signifor. Dose reduction by decrements of 300 mcg twice a day is suggested. If a dose of Signifor is missed, the next injection should be admin Les hele dokumentet