Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
PASIREOTIDE AS DIASPARTATE
MEDISON PHARMA LTD
H01CB05
SOLUTION FOR INJECTION
PASIREOTIDE AS DIASPARTATE 0.3 MG/ML
S.C
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
PASIREOTIDE
PASIREOTIDE
Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
2018-07-31
Signifor-0.3 mg-0.6 mg-0.9 mg_1 ml-PIL-ENG-D11-F Page 1 of 8 Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-PIL-1221-V1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only Signifor ® 0.3 mg/1 ml Solution for injection Active ingredient Each ampoule contains: 0.3 mg pasireotide (as pasireotide diaspartate) Signifor ® 0.6 mg/1 ml Solution for injection Active ingredient Each ampoule contains: 0.6 mg pasireotide (as pasireotide diaspartate) Signifor ® 0.9 mg/1 ml Solution for injection Active ingredient Each ampoule contains: 0.9 mg pasireotide (as pasireotide diaspartate) Inactive ingredients and allergens: See section 6 ‘Further information’. Also see “Important information about some of the ingredients of the medicine” section. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is used to treat adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. Therapeutic group: Pasireotide is a synthetic compound derived from somatostatin. The medicine belongs to the group of somatostatin analogs. Cushing’s disease is caused by an enlargement in the pituitary gland (a gland at the base of the brain) called a benign pituitary tumor (adenoma). This condition leads the body to over-produce a hormone called adrenocorticotropic hormone (ACTH), which leads to the 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 similar way to the way somatostatin works. Signifor is thus a Belgenin tamamını okuyun
Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-SPC-1221-V1 - 1 - 1. NAME OF THE MEDICINAL PRODUCT Signifor 0.3 mg/1ml solution for injection Signifor 0.6 mg/1ml solution for injection Signifor 0.9 mg/1ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Signifor 0.3 mg/1ml solution for injection One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate). Signifor 0.6 mg/1ml solution for injection One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate). Signifor 0.9 mg/1ml 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. 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. Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-SPC-1221-V1 - 2 - _Special populations _ _Paediatric population _ The safety and ef Belgenin tamamını okuyun