Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
OCTREOTIDE
Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom
H01CB02
OCTREOTIDE 100 µg/ml
SOLUTION FOR INJECTION
OCTREOTIDE 100 µg/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Withdrawn
2013-03-13
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION OCTREOTIDE 100 MICROGRAMS/ML SOLUTION FOR INJECTION OCTREOTIDE 500 MICROGRAMS/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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. 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 hormone-containing medicinal product that inhibits the secretion of other hormones, in a similar way to somatostatin, a hormone that occurs naturally in the body. As a result, the symptoms of diseases in which hormones play a role can be reduced or resolved. OCTREOTIDE IS USED: A. To treat excessive growth of bones and soft tissues, particularly of the nose, lower jaw and ears, once puberty has passed. This condition is known as ACROMEGALY. Excessive release of specific hormones cause acromegaly and in most cases, the excessive hormone production is due to an enlargement of the pituitary gland (adenoma of the pituitary gland). Symptoms include: an excessive increase in height, tiredness, pigmented spots on the skin, joint pain and sweating. Octreotide can be helpful to treat patients with acromegaly who: have no benefit from surgery or Citiți documentul complet
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octreotide 100 micrograms/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of 1 ml solution for injection contains octreotide acetate equivalent to 100 micrograms octreotide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to slightly brownish solution. pH of the solution: 3.9 – 4.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • GEP tumours For the relief of symptoms associated with functional gastro enteropancreatic endocrine tumours including: • carcinoid tumours with features of carcinoid syndrome • VIPomas • glucagonomas Octreotide is not an anticancer agent and is not curative in the above-mentioned patients. • Acromegaly Symptomatic treatment and reduction of plasma levels of growth hormone (GH) and IGF-1 in patients with acromegaly who respond inadequately to treatment with surgery or radiotherapy. Octreotide may also be administered to patients with acromegaly who are not able or willing to undergo surgery, or in the initial stage of radiotherapy treatment until it becomes effective. • Prevention of complications following pancreatic surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GEP tumours Initially 50 micrograms subcutaneously once or twice daily. Page 2 of 14 Depending on the clinical response, the effect on the concentrations of hormones produced by the tumour (in carcinoid tumours on the excretion of 5-hydroxy-indolacetic acid in urine) and on the tolerability, the dose may be gradually increased to 100 – 200 micrograms three times daily. In exceptional circumstances, higher doses may be required. The maintenance doses should be determined individually. The recommended route of administration is subcutaneous. However, in instances where a rapid response is require Citiți documentul complet