País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
octreotide, Quantity: 100 microgram
Generic Health Pty Ltd
Octreotide
Injection, solution
Excipient Ingredients: glycine; dilute hydrochloric acid; mannitol; water for injections
Subcutaneous
5 ampoules
(S4) Prescription Only Medicine
For 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. 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 an antitumour therapy and 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: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2009-10-28
Octreotide GH v3.0 Page 1 of 4 (octreotide acetate) solution for injection CONSUMER MEDICINE INFORMATION OCTREOTIDE GH (OCTREOTIDE ACETATE) SOLUTION FOR INJECTION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Octreotide GH. 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 GH 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 GH IS USED FOR Octreotide GH has three uses: 1. OCTREOTIDE GH 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 GH can relieve many of these symptoms. 2. OCTREOTIDE GH 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 GH can relieve symptoms such as flushing of the skin and severe diarrhoea. 3. OCTREOTIDE GH IS USED FOR PEOPLE WHO ARE HAVING SURGERY ON THE PANCREAS. THIS MEDICINE HELPS TO LOWER THE CHANCE OF COMPLICATIONS AFTER THE SURGERY. Octreotide GH contains octreotide, a man-made medicine derived from somatostatin, a substance found in the human body. Octreotide is used instead of somatostatin because its effects are stronger and last longer so that it needs to be given only 2 or 3 times a day. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY OCTREOTIDE GH HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine f Llegiu el document complet
Octreotide GH v5.0 Page 1 of 14 (octreotide as acetate) solution for injection AUSTRALIAN PRODUCT INFORMATION – OCTREOTIDE GH (OCTREOTIDE AS ACETATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Octreotide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (present as acetate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • For 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. 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. Octreotide GH v5.0 Page 2 of 14 (octreotide as Llegiu el document complet