Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Octreotide acetate
Novartis Pharmaceuticals UK Ltd
H01CB02
Octreotide acetate
100microgram/1ml
Solution for injection
Intravenous; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030403; GTIN: 5013054190257
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SANDOSTATIN ® 50 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION SANDOSTATIN ® 100 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION SANDOSTATIN ® 500 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION SANDOSTATIN ® 1000 MICROGRAM/5 ML, SOLUTION FOR INJECTION/INFUSION octreotide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sandostatin is and what it is used for 2. What you need to know before you use Sandostatin 3. How to use Sandostatin 4. Possible side effects 5. How to store Sandostatin 6. Contents of the pack and other information 1. WHAT SANDOSTATIN IS AND WHAT IT IS USED FOR Sandostatin is a synthetic compound derived from somatostatin, a substance normally found in the human body which inhibits the effects of certain hormones such as growth hormone. The advantages of Sandostatin over somatostatin are that it is stronger and its effects last longer. SANDOSTATIN IS USED in 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. 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 tumours, VIPomas, glucagonomas, gastrinom Read the complete document
OBJECT 1 SANDOSTATIN 50 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 20-Mar-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Sandostatin ® 50 microgram/1 ml, solution for injection/infusion Sandostatin ® 100 microgram/1 ml, solution for injection/infusion Sandostatin ® 500 microgram/1 ml, solution for injection/infusion Octreotide ® 50 microgram /1 ml, solution for injection/infusion Octreotide ® 100 microgram/1 ml, solution for injection/infusion Octreotide ® 500 microgram/1 ml, solution for injection/ infusion 2. Qualitative and quantitative composition Sandostatin ® 50 microgram/1 ml, solution for injection/infusion One ampoule of 1 ml contains 50 microgram octreotide (as octreotide acetate) Sandostatin ® 100 microgram/1 ml, solution for injection/infusion One ampoule of 1 ml contains100 microgram octreotide (as octreotide acetate) Sandostatin ® 500 microgram/1 ml, solution for injection/infusion One ampoule of 1 ml contains 500 microgram octreotide (as octreotide acetate) Excipient(s) with known effect Contains less than 1 mmol (23 mg) sodium per dose, i.e. is essentially “sodium-free”. For the full list of excipients see section 6.1. 3. Pharmaceutical form Solution for injection/infusion. Clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic 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 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, e.g. carcinoid tumours with features of the carcinoid syndrome (see section 5.1). Sandostatin is not an anti-tumour therapy and is not curative in these patients. Prevention of complications following pancreatic surgery. Emergency management to Read the complete document