Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
octreotide, Quantity: 100 microgram
Sun Pharma ANZ Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; sodium acetate trihydrate; glacial acetic acid
Subcutaneous
5
(S4) Prescription Only Medicine
For symptomatic control and reduction of growth hormone and IGF-l plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. Octreotide treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,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] Octreotide is not curative in these patients.,For reduction of the incidence of complications following pancreatic surgery.
Visual Identification: Clear colourless solution free from visible particulates; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-04-01
OCTREOTIDE SUN CMI V3 Page 1 of 5 OCTREOTIDE SUN _Octreotide _ CONSUMER HEALTH INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Octreotide SUN. 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 using Octreotide SUN against the benefits they expect it will have for you. 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 OCTREOTIDE SUN IS USED FOR Octreotide SUN has three uses: 1. Octreotide SUN 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. This 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 SUN can relieve many of these symptoms. 2. Octreotide SUN is used to relieve symptoms of certain types of cancer such as carcinoid syndrome and VIPoma. By blocking hormones that are over-produced in these conditions, Octreotide SUN can relieve symptoms such as flushing of the skin and severe diarrhoea. 3. Octreotide SUN is used for people who are having surgery on the pancreas. This medicine helps to lower the chance of complications after the surgery. Octreotide SUN contains octreotide, a man-made medicine derived from somatostatin, a substa Przeczytaj cały dokument
Page 1 of 9 OCTEOTRIDE SUN PI V5 AUSTRALIAN PRODUCT INFORMATION OCTREOTIDE SUN OCTREOTIDE SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Octreotide (as acetate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (as octreotide acetate). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For symptomatic control and reduction of growth hormone and IGF-l plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. Octreotide treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. 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] Octreotide is not curative in these patients. For reduction of the incidence of complications following pancreatic surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION ACROMEGALY Initially 0.05-0.1 mg by subcutaneous injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH <2.5 ng/mL; IGF-1 within normal range) and on clinical symptoms, and on tolerability. In most patients the optimal daily dose will be 0.2 to 0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of octreotide, assessment of biochemical markers should be made periodically. If no relevant reduction of GH levels and no improvement of clinical symptoms have been achieved within three months of starting treatment with octreotide, therapy should be discontinued. GASTRO-ENTERO-PANCREATIC ENDOCRINE TUMOURS Initially 0.05 mg once or twice Przeczytaj cały dokument