Source: Health Products and Food Branch (CA) Revision Year: 2020
SIGNIFOR LAR – Pasireotide for Injectable Suspension.
10 mg, 20 mg, 30 mg, 40 mg, and 60 mg pasireotide (as pasireotide pamoate) per vial.
| Route of Administration | Dosage Form/Strength | Clinically Relevant Nonmedicinal Ingredients |
|---|---|---|
| Intramuscular (i.m.) | Each vial contains: SIGNIFOR LAR 10 mg – 10 mg pasireotide (as pamoate) SIGNIFOR LAR 20 mg – 20 mg pasireotide (as pamoate) SIGNIFOR LAR 30 mg – 30 mg pasireotide (as pamoate) SIGNIFOR LAR 40 mg – 40 mg pasireotide (as pamoate) SIGNIFOR LAR 60 mg – 60 mg pasireotide (as pamoate) | Vial: Poly (D,L-lactide-co-glycolide) (50-60:40-50), Poly (D,L-lactide-co-glycolide) (50:50). Pre-filled syringe: Carmellose sodium, mannitol, poloxamer 188, water for injections. For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING |
SIGNIFOR LAR is a long-acting depot injection form of pasireotide, powder for suspension for injection to be suspended in a solvent immediately prior to intramuscular (i.m.) injection.
Powder: Slightly yellowish to yellowish powder in vial.
Solvent for suspension for injection (solution for reconstitution): clear, colorless to slightly yellow or slightly brown solution in pre-filled syringe
SIGNIFOR LAR is supplied in kits containing:
containing 10, 20, 30, 40 or 60 mg of pasireotide (as pamoate) slow release
Each vial contains:
SIGNIFOR LAR 10 mg – 10 mg pasireotide (as pamoate)
SIGNIFOR LAR 20 mg – 20 mg pasireotide (as pamoate)
SIGNIFOR LAR 30 mg – 30 mg pasireotide (as pamoate)
SIGNIFOR LAR 40 mg – 40 mg pasireotide (as pamoate)
SIGNIFOR LAR 60 mg – 60 mg pasireotide (as pamoate)
Excipients:
Vial: Poly (D,L-lactide-co-glycolide) (50-60:40-50), Poly (D,L-lactide-co-glycolide) (50:50).
Pre-filled syringe: Carmellose sodium, mannitol, poloxamer 188, water for injections.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Recordati Rare Diseases Canada Inc., Toronto, Ontario, Canada, M4N 3N1 237292 |
Date of approval:
February 10, 2015 May 19, 2020 |
| Drug | Countries | |
|---|---|---|
| SIGNIFOR LAR | Australia, Canada, Ecuador, Hong Kong, Israel, Japan, New Zealand, Singapore, South Africa |
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