Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OCTREOTIDE ACETATE
Hospira UK Limited
H01CB02
OCTREOTIDE ACETATE
0.1 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Somatostatin and analogues
Authorised
2007-06-22
Commercial-in-Confidence PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OCTREOTIDE 50 MICROGRAMS/1ML SOLUTION FOR INJECTION OCTREOTIDE 100 MICROGRAMS/1ML SOLUTION FOR INJECTION OCTREOTIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION OCTREOTIDE 500 MICROGRAMS/1 ML SOLUTION FOR INJECTION 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 Octreotide is and what it is used for 2. What you need to know before you use Octreotide 3. How to use Octreotide 4. Possible side effects 5. How to store Octreotide 6. Contents of the pack and other information 1. WHAT OCTREOTIDE IS AND WHAT IT IS USED FOR Octreotide 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 Octreotide over somatostatin are that it is stronger and its effects last longer. Octreotide 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. Octreotide marke Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octreotide 100 micrograms/1 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is octreotide acetate. Each 1 ml of solution for injection contains 100 micrograms of Octreotide as octreotide acetate. Octreotide solutions for injection contain less than 1 mmol (23 mg) of sodium per 1 ml of solution (i.e. essentially "sodium-free"). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless. 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. Octreotide 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). Octreotide 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. Octreotide is to be used in association with specific treatment such as endoscopic sclerotherapy. Treatment of TSH-secreting pituitary adenomas: • When secretion has not normalised after surgery and/or radiotherapy; • In patients in whom surgery is inappropriate; • In irradiated patients, until radiotherapy is effective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Acromegaly_ Initially 0.05 to 0.1 mg by subcutaneous (s.c.) Read the complete document