Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
octreotide 0.5 mg/ml
Novartis Pharmaceuticals UK Limited
H01CB02
octreotide
solution for infusion or injection
Authorised
2005-10-27
SANDOSTATIN® AMPOULES 500 MICROGRAMS IN 1 ML, SANDOSTATIN® MULTIDOSE VIAL 1 MG IN 5 ML, SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION (OCTREOTIDE) PATIENT INFORMATION LEAFLET This medicine will be referred to as Sandostatin in this leaflet. WHAT YOU NEED TO KNOW ABOUT SANDOSTATIN Your doctor has decided that you need this medicine to help treat your condition. PLEASE read this leaflet carefully before you start to have your medicine. It contains important information. KEEP THE LEAFLET IN A SAFE PLACE BECAUSE YOU MAY WANT TO READ IT AGAIN. IF YOU HAVE ANY OTHER QUESTIONS, OR IF THERE IS SOMETHING YOU DON’T UNDERSTAND, PLEASE ASK YOUR DOCTOR OR PHARMACIST. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.. If any of the side effects gets serious, or if you notice any effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 What Sandostatin is and what it's used for 2 Things to consider before you start to take Sandostatin 3 How to take Sandostatin 4 Possible side effects 5 How to store Sandostatin 6 Further information 1. WHAT SANDOSTATIN IS AND WHAT IT’S USED FOR Sandostatin is an injection. Sandostatin injections contain the active ingredient octreotide (as the acetate). Octreotide is a synthetic form of a hormone called somatostatin, which occurs naturally in the human body. It helps stop the release of some hormones, including growth hormone, in the body. Sandostatin can be used 1. To treat acromegaly Acromegaly is a condition where the body produces too much growth hormone. The level Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT 0.5 MG/1 ML AMPOULES SANDOSTATIN ® 0.5 mg/1 mL ampoules, solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion). 1 MG/5 ML (0.2 MG/ML) MULTIDOSE VIALS SANDOSTATIN ® multidose vials 1 mg/5 mL (0.2 mg/mL), solution for injection (s.c.) or concentrate for solution for infusion (i.v. infusion). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is octreotide acetate. 1-mL ampoules containing 0.5 mg octreotide (as free peptide). 5-mL multidose vials containing 1 mg octreotide (as free peptide). Sandostatin ® solution for injection contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’. For a full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORMS Solution for injection (s.c) or concentrate for solution for infusion (i.v.infusion). The solution is clear and 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. 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. • Lesen Sie das vollständige Dokument