Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pasireotide pamoate
Novartis Pharmaceuticals UK Ltd
H01CB05
Pasireotide pamoate
60mg
Powder and solvent for suspension for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5010678919318
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SIGNIFOR ® 10 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION SIGNIFOR ® 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION SIGNIFOR ® 30 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION SIGNIFOR ® 40 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION SIGNIFOR ® 60 MG POWDER AND SOLVENT FOR SUSPENSION 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 acromegaly in adult patients. It is also used to treat Cushing’s disease in adult patients for whom surgery is not an option or for whom surgery has failed. Acromegaly Acromegaly is caused by a type of tumour called a pituitary adenoma which develops in the pituitary gland at the base of the brain. The adenoma leads the body to over-produce hormones that control growth of tissues, organs and bones, resulting in an increase in the size of bones and tissues, especially in the hands and feet. Signifor reduces the production of these hormones and possibly also the size of the adenoma. As a result, it reduces the symptoms of acromegaly, which include headache, increased sweating, numbness of the hands and feet, tiredness and jo Прочитайте повний документ
OBJECT 1 SIGNIFOR 60 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION Summary of Product Characteristics Updated 01-May-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Signifor ® 10 mg powder and solvent for suspension for injection Signifor ® 20 mg powder and solvent for suspension for injection Signifor ® 30 mg powder and solvent for suspension for injection Signifor ® 40 mg powder and solvent for suspension for injection Signifor ® 60 mg powder and solvent for suspension for injection 2. Qualitative and quantitative composition Signifor 10 mg powder and solvent for suspension for injection One vial contains 10 mg pasireotide (as pasireotide pamoate). Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate). Signifor 30 mg powder and solvent for suspension for injection One vial contains 30 mg pasireotide (as pasireotide pamoate). Signifor 40 mg powder and solvent for suspension for injection One vial contains 40 mg pasireotide (as pasireotide pamoate). Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder and solvent for suspension for injection (powder for injection). Powder: slightly yellowish to yellowish powder. Solvent: clear, colourless to slightly yellow or slightly brown solution. 4. Clinical particulars 4.1 Therapeutic indications 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. Treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. The 60 mg strength is only to be used in the treatment of acromegaly. 4.2 Posology and method of administration Posology _Acromegaly _ The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 wee Прочитайте повний документ