Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Pasireotide diaspartate 0.75242mg eqv. Pasireotide
PHARM-D SINGAPORE PRIVATE LIMITED
H01CB05
0.6 mg
INJECTION, SOLUTION
Pasireotide diaspartate 0.75242mg eqv. Pasireotide 0.6 mg
SUBCUTANEOUS
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2013-12-13
SIGNIFOR ® DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Solution for injection ACTIVE SUBSTANCE Each ampule of 1 mL contains: Signifor ® 0.3mg - 0.3 mg pasireotide (as diaspartate). Signifor ® 0.6mg - 0.6 mg pasireotide (as diaspartate). Signifor ® 0.9mg - 0.9 mg pasireotide (as diaspartate). Certain dosage strengths may not be available in all countries. ACTIVE MOIETY Pasireotide EXCIPIENTS Mannitol, tartaric acid, sodium hydroxide, water for injections. INDICATIONS Treatment of patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. DOSAGE AND ADMINISTRATION DOSAGE GENERAL TARGET POPULATION _ _ ADULTS The recommended initial dose of Signifor is 0.6 mg by subcutaneous (s.c.) 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 Novartis Page 2 Singapore-Specific Package Leaflet 04 Sep 2013 Signifor ® 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. SPECIAL POPULATIONS PATIENTS WITH RENAL IMPAIRMENT No dosage adjustment is required in patients with impaired renal function (see section CLINICAL PHARMACOLOGY). PATIENTS WITH HEPATIC IMPAIRMENT Dose adjustment is not required in patients with mildly impaired hepatic f Soma hati kamili
SIGNIFOR ® DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Solution for injection ACTIVE SUBSTANCE Each ampule of 1 mL contains: Signifor ® 0.3mg - 0.3 mg pasireotide (as diaspartate). Signifor ® 0.6mg - 0.6 mg pasireotide (as diaspartate). Signifor ® 0.9mg - 0.9 mg pasireotide (as diaspartate). Certain dosage strengths may not be available in all countries. ACTIVE MOIETY Pasireotide EXCIPIENTS Mannitol, sodium hydroxide, tartaric acid, water for injections. Information might differ in some countries. INDICATIONS Treatment of patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. DOSAGE AND ADMINISTRATION DOSAGE GENERAL TARGET POPULATION ADULT PATIENTS The recommended initial dose of Signifor is 0.6 mg by subcutaneous (s.c.) 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 Novartis Page 2 Singapore Specific Package Leaflet 13 Jan 2020 Signifor ® 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. SPECIAL POPULATIONS PATIENTS WITH RENAL IMPAIRMENT No dose adjustment is required in patients with impaired renal function (see section CLINICAL PHARMACOLOGY). PATIENTS WITH HEPATIC IMPAIRMENT Dose adjustment is not required in patients with mildly impaired hepatic function (Child-Pugh A). For patients Soma hati kamili