RISVAN Suspension fon injection Ref.[109545] Active ingredients: Risperidone

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

RISVAN contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9- tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol.

The structural formula is:

Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl.

RISVAN is available as a sterile two-syringe mixing system; a solvent syringe prefilled with the solvent dimethyl sulfoxide, a transparent and colorless solution. The powder syringe is prefilled with risperidone and poly (lactide-coglycolide) acid co-polymer. The powder is white to white-yellowish in color.

RISVAN is available as an extended-release injectable suspension, for intramuscular use, in the following strengths of risperidone: 75 mg and 100 mg.

Table 5. RISVAN Constituted Product Delivered Mass:

ComponentRISVAN 75 mgRISVAN 100 mg
Risperidone75 mg100 mg
PLGA150 mg200 mg
Dimethylsulfoxide350 mg466.7 mg

PLGA Poly (D,L-lactide-co-glycolide) 50:50

Dosage Forms and Strengths

RISVAN (risperidone) for extended-release suspension is available in strengths of 75 mg and 100 mg.

Each strength is provided as a kit which includes: one pre-filled syringe containing a white to white-yellowish powder in a sealed pouch with a desiccant, one pre-filled syringe containing transparent and colorless solvent in a sealed pouch with a desiccant, one 20-gauge, 2-inch needle for gluteal administration and one 21-gauge, 1 inch needle for deltoid administration.
How Supplied

RISVAN (risperidone) for extended-release injectable suspension is available in dosage strengths of 75 mg and 100 mg that is an off-white to off-white-yellowish, uniform suspension when fully mixed.

RISVAN 75 mg is supplied in a single-dose kit, packaged in a carton (NDC 82090-001-01), containing the following:

  • One pouch with a desiccant and a sterile syringe (labelled ‘R’) prefilled with white to white-yellowish powder of risperidone and poly (lactide-co-glycolide) acid co- polymer.
  • One pouch with a desiccant and a sterile syringe (labelled ‘S’) prefilled with dimethyl sulfoxide solvent (transparent and colorless).
  • Two administration needles, one 21G, 1 inch for deltoid and another 20G, 2 inch for gluteal administration.

RISVAN 100 mg is supplied in a single-dose kit, packaged in a carton (NDC 82090-003-01), containing the following:

  • One pouch with a desiccant and a sterile syringe (labelled ‘R’) prefilled with a white to white-yellowish powder of risperidone and poly (lactide-co-glycolide) acid co- polymer.
  • One pouch with a desiccant and a sterile syringe (labelled ‘S’) prefilled with dimethyl sulfoxide solvent (transparent and colorless).
  • Two administration needles, one 21G, 1 inch for deltoid and another 20G, 2 inch for gluteal administration.

Manufactured for:

Laboratorios Farmacéuticos Rovi S.A. Madrid, Spain

Powder syringe manufactured by Laboratorios Farmacéuticos Rovi S.A. Madrid, Spain

Solvent syringe manufactured by Rovi Pharma Industrial Services S.A.U. Madrid, Spain

Drugs

Drug Countries
RISVAN United States
 
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