0.3 mg, 0.6 mg, 0.9 mg solution <\/p>\n\n\n\n
for injection 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 in whom surgery has failed.<\/p>\n\n\n\n Cushing’s disease is caused by an enlargement of the\u00a0pituitary gland\u00a0(a\u00a0gland\u00a0located on the underside of the brain) called the pituitary adenoma.\u00a0This leads to the body producing too much of a\u00a0hormone\u00a0called adrenocorticotropic\u00a0hormone\u00a0(ACTH), which in turn leads to excessive production of another\u00a0hormone\u00a0called\u00a0cortisol.<\/p>\n\n\n\n The human body naturally produces a substance called somatostatin, which blocks the production of certain\u00a0hormones, including ACTH.\u00a0Pasireotide has an effect very similar to the effect of somatostatin.\u00a0Therefore, Signifor may block the production of ACTH and thereby help regulate the overproduction of\u00a0cortisol\u00a0and improve the symptoms of Cushing’s disease.<\/p>\n\n\n\n Ask your doctor if you are wondering how Signifor works or why you have been prescribed it. Talk to your doctor before using Signifor if you have or have ever had:<\/p>\n\n\n\n During treatment with Signifor<\/strong><\/p>\n\n\n\n Do not give this medicine to children and adolescents under 18 years of age as there are no data available for this age group.<\/a><\/p>\n\n\n\n Signifor may affect the way some other medicines work.\u00a0If you are taking other medicines at the same time as Signifor (including over-the-counter medicines), your doctor may need to check your heart more closely or change the\u00a0dose\u00a0of one of Signifor or the other medicines.\u00a0Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0Tell your doctor in particular if you are using:<\/p>\n\n\n\n You must mention the following medicines:<\/p>\n\n\n\n Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n Signifor may have a minor effect on the ability to drive and use machines as some of the\u00a0side effects\u00a0you may experience while using Signifor, such as dizziness, headache, and fatigue, may impair the ability to drive and use machines safely.<\/p>\n\n\n\n Signifor contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0dose, ie essentially ‘sodium-free’.\u00a0is next to “sodium-free”. Always use this medicine exactly as your doctor has told you.\u00a0Ask your doctor or pharmacist if you are unsure.\u00a0This medicine is in an\u00a0ampoule, ie.\u00a0a small glass container.<\/p>\n\n\n\n How much Signifor to use<\/strong><\/p>\n\n\n\n The recommended dose is one ampoule Signifor 0.6 mg twice a day. If you take Signifor at the same time each day, it will be easier to remember when to take the medicine. Once you have started treatment, your doctor may also want to increase the dose one to one ampoule Signifor 0.9 mg twice a day.<\/p>\n\n\n\n If\u00a0side effects\u00a0occur, the doctor may temporarily reduce the\u00a0dose\u00a0by 0.3 mg per\u00a0injection.<\/p>\n\n\n\n If you have the liver disease before starting treatment with Signifor, your doctor may want you to start treatment with\u00a0a single\u00a0dose of\u00a0Signifor\u00a00.3 mg twice a day.<\/p>\n\n\n\n There are\u00a0ampoules\u00a0of Signifor in different strengths (0.3 mg, 0.6 mg, and 0.9 mg) that are suitable for the\u00a0dose\u00a0prescribed by your doctor.<\/p>\n\n\n\n Your doctor will regularly check how you respond to Signifor treatment and decide which dose is best for you.<\/p>\n\n\n\n How to use Signifor<\/strong><\/p>\n\n\n\n Your doctor or nurse will show you how to inject yourself with Signifor.\u00a0You should also read the instructions at the end of this leaflet.\u00a0If you have any further questions, ask your doctor, nurse, or pharmacist.<\/p>\n\n\n\n Signifor is for\u00a0subcutaneous\u00a0use.\u00a0This means that the medicine is injected with a short needle into the adipose tissue just under the skin.\u00a0The thighs and abdomen are good areas for\u00a0subcutaneous\u00a0injection.\u00a0Avoid soreness and skin irritation by choosing a new injection site with each\u00a0injection.\u00a0You should also avoid injection sites that are sore or where the skin is irritated.<\/p>\n\n\n\n Do not use Signifor if you notice that the liquid is not clear or contains particles.\u00a0The solution for injection should be free of visible particles, clear, and colorless.<\/p>\n\n\n\n How long to use Signifor<\/strong><\/p>\n\n\n\n You should continue to use Signifor for as long as your doctor tells you to.<\/a><\/p>\n\n\n\n If you accidentally use more Signifor than your doctor has prescribed, contact your doctor, nurse or pharmacist immediately.<\/a><\/p>\n\n\n\n Do not inject a double\u00a0dose\u00a0of Signifor to make up for a forgotten\u00a0dose.\u00a0If you forget to inject one\u00a0dose\u00a0of Signifor, only inject the next\u00a0dose\u00a0according to the dosing schedule.<\/p>\n\n\n\n If you stop taking Signifor, your cortisol levels may rise again and your symptoms may return. Therefore, do not stop using Signifor unless your doctor tells you to.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Some side effects can be serious. Tell your doctor if you get any of the following:<\/strong><\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 in 10 people)<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Other side effects of Signifor may be:<\/strong><\/p>\n\n\n\n Very common<\/strong> (affects more than 1 in 10 people)<\/p>\n\n\n\n Common<\/strong> (affects up to 1 in 10 people)<\/p>\n\n\n\n Uncommon<\/strong> (affects up to 1 in 100 people)<\/p>\n\n\n\n
pasireotide<\/a><\/p>\n\n\n\nWhat Signifor is and what it is used for<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before using Signifor<\/h2>\n\n\n\n
Do not use Signifor<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Signifor<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Important information about some of the ingredients of Signifor<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Signifor<\/h2>\n\n\n\n
If you use more Signifor than you should<\/h2>\n\n\n\n
If you forget to use Signifor<\/h2>\n\n\n\n
If you stop using Signifor<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Signifor<\/h2>\n\n\n\n