Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
pasireotide
Recordati Rare Diseases
H01CB05
pasireotide
Pituitary and hypothalamic hormones and analogues
Acromegaly; Pituitary ACTH Hypersecretion
Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.Signifor is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Revision: 14
Authorised
2012-04-24
89 B. PACKAGE LEAFLET 90 PACKAGE LEAFLET: INFORMATION FOR THE USER SIGNIFOR 0.3 MG SOLUTION FOR INJECTION SIGNIFOR 0.6 MG SOLUTION FOR INJECTION SIGNIFOR 0.9 MG SOLUTION FOR INJECTION pasireotide 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Signifor is and what it is used for 2. What you need to know before you use Signifor 3. How to use Signifor 4. Possible side effects 5. How to store Signifor 6. Contents of the pack and other information 1. WHAT SIGNIFOR IS AND WHAT IT IS USED FOR Signifor is a medicine that contains the active substance pasireotide. It is used to treat Cushing’s disease in adult patients for whom surgery is not an option or for whom surgery has failed. Cushing’s disease is caused by an enlargement in the pituitary gland (a gland at the base of the brain) called a pituitary adenoma. This leads the body to over-produce a hormone called adrenocorticotropic hormone (ACTH), which in turn results in over-production of another hormone called cortisol. The human body naturally produces a substance called somatostatin, which blocks the production of certain hormones, including ACTH. Pasireotide works in a very similar way to somatostatin. Signifor is thus able to block the production of ACTH, helping to control the over-production of cortisol and improve the symptoms of Cushing’s disease. If you have any questions about how Signifor works or why this medicine has been prescribed for you, ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SIGNIFOR DO NOT US Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Signifor 0.3 mg solution for injection One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate). Signifor 0.6 mg solution for injection One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate). Signifor 0.9 mg solution for injection One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide diaspartate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day. Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit. Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived. A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient. Patients who have not responded to Signifor after two months of treatment should be considered for discontinuation. Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor. Dose reduction by decrements of 0.3 mg twice a day is suggested. If a dose of Signifor is missed, the next injection should be administered at the scheduled time. Doses should not be doubled to make up for a missed dose. _Switch from intramuscular to subcutaneous formulation _ There are no clinical data available on switching from the intramuscular to the subcuta Pročitajte cijeli dokument