Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Octreotide acetate 0.56 mg/mL equivalent to 0.5 mg/mL octreotide base
Novartis New Zealand Ltd
Octreotide acetate 0.56 mg/mL (equivalent to 0.5 mg/mL octreotide base)
0.5 mg/mL
Solution for injection
Active: Octreotide acetate 0.56 mg/mL equivalent to 0.5 mg/mL octreotide base Excipient: Lactic acid Mannitol Sodium bicarbonate Water for injection
Ampoule, glass, 5x1ml, 5 mL
Prescription
Prescription
Novartis Ringaskiddy Ltd
Package - Contents - Shelf Life: Ampoule, glass, 5x1ml - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1987-12-17
__________________________________________________________________________________________________ Sandostatin 1 SANDOSTATIN _0.05, 0.1 and 0.5mg/ml injection _ _octreotide_ _____________________________________________________________________________________ CONSUMER MEDICINE INFORMATION __________________ WHAT IS IN THIS LEAFLET _________________________________ This leaflet answers some common questions about Sandostatin. 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. You can also download the most up to date leaflet from www.medsafe.govt.nz. 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 SANDOSTATIN IS USED FOR ________________________ Sandostatin has 4 uses: 1. Sandostatin 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, Sandostatin can relieve many of these symptoms. 2. Sandostatin is used to relieve symptoms of certain types of cancer such as carcinoid syndrome, VIPomas, glucagonomas, gastrinomas, insulinomas and GRFomas Baca dokumen lengkap
NEW ZEALAND DATA SHEET SANDOSTATIN ® 0.05 MG/1 ML, 0.1 MG/1 ML, 0.5 MG/1 ML SOLUTION FOR INJECTION DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Solution for injection (s.c). The solution is clear and colourless. ACTIVE SUBSTANCE The active substance is octreotide acetate. 1 mL ampoules containing 0.05, 0.1 or 0.5 mg octreotide (as free peptide). EXCIPIENTS Lactic acid, mannitol, sodium hydrogen carbonate, water for injections. INDICATIONS Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours: Carcinoid tumours with features of the carcinoid syndrome. VIPomas. Glucagonomas. Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with proton pump inhibitors, or H 2 -antagonist therapy. Insulinomas, for pre-operative control of hypoglycaemia and for maintenance therapy. GRFomas. Sandostatin is not an anti-tumour therapy and is not curative in these patients. Prevention of complications following pancreatic surgery. Emergency management to stop bleeding and to protect from re-bleeding owing to gastro- oesophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy. DOSAGE AND ADMINISTRATION DOSAGE GENERAL TARGET POPULATION ACROMEGALY Initially 0.05 to 0.1 mg by s.c. 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 clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of Sandostatin, Baca dokumen lengkap