Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
octreotide, Quantity: 10 mg
Teva Pharma Australia Pty Ltd
Injection, modified release
Excipient Ingredients: polyglactin; mannitol
Intramuscular
1 x 8 mL vial of powder with 1 x 3 mL pre-filled syringe of diluent
(S4) Prescription Only Medicine
Acromegaly For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide. Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,Gastro-entero-pancreatic tumours For the relief of symptoms associated with the following functional tumours of the gastro-enteropancreatic endocrine system: ? Carcinoid tumours with features of the carcinoid syndrome ? Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide Octreotide Depot is not curative in these patients.,Advanced Neuroendocrine Tumours of the Midgut Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.
Visual Identification: The powder is a white to white with yellowish tint.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-11-25
OCTREOTIDE DEPOT ® _Octreotide (as acetate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Octreotide Depot. 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 Octreotide Depot against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OCTREOTIDE DEPOT IS USED FOR Octreotide Depot is a long acting form of octreotide injection. It is injected into the buttocks once every 4 weeks, instead of having frequent injections of the octreotide under the skin. • Octreotide Depot is used to treat acromegaly In people with acromegaly the body makes too much growth hormone which controls the growth of tissues, organs and bones. Too much growth hormone leads to enlargement of the bones, especially of the hands and feet. Other symptoms include headaches, increased sweating, tiredness, numbness of the hands and feet, pain and stiffness in the joints and loss of sexual function. By blocking the excess growth hormone, Octreotide Depot can relieve many of these symptoms. • Octreotide Depot is used to relieve symptoms of certain types of cancer such as carcinoid tumour and VIPoma. By blocking hormones that are over- produced in these conditions, Octreotide Depot can relieve symptoms such as flushing of the skin and severe diarrhoea. Octreotide Depot contains octreotide, a man- made medicine derived from somatostatin. Somatostatin is a substance found in the human body which controls the effects of certain hormones such as insulin and growth hormone. Octreotide Depot is used instead of somatostatin because its effects are stronger and last longer. • Octreotide Depot is used to treat advanced neuroendocrine tumours located in the gut (eg appendix, small intestine or colo Citiți documentul complet
Teva Pharma Australia Pty Limited Version 2 1 AUSTRALIAN PRODUCT INFORMATION – OCTREOTIDE DEPOT (OCTREOTIDE) MODIFIED RELEASE INJECTION 1 NAME OF THE MEDICINE Octreotide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection plus diluent OCTREOTIDE DEPOT octreotide (as acetate) 20 mg modified release injection plus diluent OCTREOTIDE DEPOT octreotide (as acetate) 30 mg modified release injection plus diluent For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Modified release, injection Octreotide Depot is a modified release injection of octreotide. The octreotide is distributed within polymer microspheres. The powder is a white to white with yellowish tint. Diluent The vehicle is a clear, colourless to slightly yellow or brown solution. The pH of the reconstituted suspension is 5-8. Single glass vials of 10, 20 or 30 mg octreotide modified release injection to be suspended in 2 mL diluent prior to injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Acromegaly For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide. Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. Gastro-entero-pancreatic tumours For the relief of symptoms associated with the following functional tumours of the gastro-entero- pancreatic endocrine system: • Carcinoid tumours with features of the carcinoid syndrome • Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide Teva Pharma Australia Pty Limited Version 2 2 Octreotide Depot is not curative in these patients. Advanced Neuroendocrine Tumours of the Citiți documentul complet