Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Pasireotide diaspartate
FTA Healthcare Sdn. Bhd.
Pasireotide diaspartate
6ampoule Ampoules; 30ampoule Ampoules; 60ampoule Ampoules
NOVARTIS PHARMA STEIN AG
_Consumer Medication Information Leaflet (RiMUP) _ SIGNIFOR SOLUTION FOR INJECTION Pasireotide (0.3mg/1ml, 0.6mg/1ml and 0.9mg/1ml) 1 WHAT IS IN THIS LEAFLET 1. WHAT SIGNIFOR IS USED FOR 2. HOW SIGNIFOR WORKS 3. BEFORE YOU USE SIGNIFOR 4. HOW TO USE SIGNIFOR 5. WHILE YOU ARE USING SIGNIFOR 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF SIGNIFOR 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT SIGNIFOR 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. HOW SIGNIFOR WORKS Signifor is able to block the production of ACTH, helping to control the over-production of cortisol and improve the symptoms of Cushing’s disease. BEFORE YOU USE SIGNIFOR _Do not use Signifor _ - if you are allergic to pasireotide or any of the other ingredients of this medicine. - if you have severe liver problems. _PREGNANCY, BREAST-FEEDING AND _ _FERTILITY _ Ask your doctor or pharmacist for advice before using any medicine. - You should not use Signifor during pregnancy unless clearly necessary. If you are pregnant or think that you may be, it is important to tell your doctor who will discuss with you whether you can use Signifor during your pregnancy. - You should not breast-feed while using Signifor. It is not known whether Signifor passes into breast milk. - If you are a sexually active woman, you should use an effective method of contraception during treatment. Ask your doctor about the need for contraception before taking this medicine. _Before you start to use it _ Talk to your doctor before using Signifor if you currently have or have ever had: - problems with your blood sugar levels, whether too high (as in diabetes) or too low (hypoglycaemia) - heart problems such as a recent heart attack, congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or sudden and oppressive chest pain (usu Leggi il documento completo
Novartis Malaysia Package Insert 13 Jan 2020 Signifor ® 1 NAME OF THE MEDICINAL PRODUCT Signifor 0.3mg solution for injection Signifor 0.6mg solution for injection Signifor 0.9mg 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 RECORDATI RARE DISEASES Novartis Malaysia Package Insert 13 Jan 2020 Signifor ® 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 _ The Leggi il documento completo