국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OCTREOTIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
OCTREOTIDE
5Units Units
DELPHARM DIJON
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SANDOSTATIN ® SOLUTION FOR INJECTION/ INFUSION Octreotide Acetate (0.05mg/1ml, 0.1 mg/1ml) 1 WHAT IS IN THIS LEAFLET 1. What Sandostatin is used for 2. How Sandostatin works 3. Before you use Sandostatin 4. How to use Sandostatin 5. While you are using Sandostatin 6. Side effects 7. Storage and Disposal of Sandostatin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SANDOSTATIN IS USED FOR Sandostatin is used • to treat acromegaly, a condition where the body produces too much growth hormone. Normally, growth hormone controls growth of tissues, organs, and bones. Too much growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. By decreasing the growth hormone levels, Sandostatin markedly reduces the symptoms of acromegaly, which include headache, excessive perspiration, numbness of the hands and feet, tiredness, and joint pain. • to relieve symptoms associated with some tumours of the gastrointestinal tract (e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas, GRFomas). In these conditions, there is overproduction of some specific hormones and other related substances by the stomach, bowels, or pancreas. This overproduction upsets the natural hormonal balance of the body, and results in a variety of symptoms, such as flushing, diarrhoea, low blood pressure, rash, and weight loss. Treatment with Sandostatin helps to control these symptoms. • to prevent complications following surgery of the pancreas gland. Treatment with Sandostatin helps to lower the chance of complications (e.g. abscess in the abdomen, inflammation of the pancreas gland) after the surgery. • to stop bleeding and to protect from re-bleeding from ruptured gastro-oesophageal varices in individual suffering from cirrhosis (chronic liver disease). Treatment with Sandostatin helps to control bleeding and reduce transfusion requirements. HOW SANDOSTATIN WORKS Sandostatin is a synth 전체 문서 읽기
Novartis Page 2 Malaysian Package Leaflet 14-Feb-2023 Sandostatin SANDOSTATIN ® Antigrowth hormone. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion). The solution is clear and colourless. ACTIVE SUBSTANCE(S) The active substance is octreotide acetate. 1 mL ampoules containing 0.05, 0.1 or 0.5 mg octreotide (as free peptide). Certain dosage strengths and dosage forms may not be available in all countries. 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 tumors: • Carcinoid tumors 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 hypoglycemia and for maintenance therapy. • GRFomas. Sandostatin is not an anti-tumor 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- esophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy. Novartis Page 3 Malaysian Package Leaflet 14-Feb-2023 Sandostatin DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN 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 withi 전체 문서 읽기