OKEDI Powder and solvent for suspension for injection Ref.[49627] Active ingredients: Risperidone

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Laboratorios Farmacéuticos Rovi, S.A., Julián Camarillo, 35, 28037 Madrid., Spain

Product name and form

OKEDI 75 mg powder and solvent for prolonged-release suspension for injection.

OKEDI 100 mg powder and solvent for prolonged-release suspension for injection.

Pharmaceutical Form

Powder and solvent for prolonged-release suspension for injection.

Pre-filled syringe of powder: White to white-yellowish non-aggregated powder.

Pre-filled syringe of solvent for reconstitution: Clear solution.

Qualitative and quantitative composition

OKEDI 75 mg powder and solvent for prolonged-release suspension for injection:

1 pre-filled syringe contains 75 mg of risperidone.

OKEDI 100 mg powder and solvent for prolonged-release suspension for injection:

1 pre-filled syringe contains 100 mg risperidone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Risperidone

Risperidone is a selective monoaminergic antagonist with unique properties. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
List of Excipients

Pre-filled syringe of powder:

poly(D,L-lactide-co-glycolide)

Pre-filled syringe of solvent:

Dimethyl sulfoxide

Pack sizes and marketing

Powder prefilled syringe:

Cyclic Olefin Polymer syringe with a nozzle cap and plunger stopper composed of chlorobutyl rubber covered with polytetrafluoroethylene.

Solvent prefilled syringe:

Cyclic Olefin Polymer syringe with a tip cap composed of chlorobutyl rubber, and a plunger stopper composed of bromobutyl rubber covered with ethylene-tetrafluoroethylene copolymer. The doses are differentiated by the colour used in the finger flange of the solvent prefilled syringe, 100mg (blue) and 75 mg (red).

Each kit box of OKEDI contains:

  • An aluminium foil pouch with one pre-filled syringe containing powder and a silica gel desiccant sachet.
  • An aluminium foil pouch with one pre-filled syringe containing the solvent and a silica gel desiccant sachet.
  • One sterile needle for injection 2 inch (0.90 × 51mm [20G]) with safety shield used for gluteus administration.
  • One sterile needle for injection 1 inch (0.80 × 25mm [21G]) with safety shield used for deltoid administration.

Marketing authorization holder

Laboratorios Farmacéuticos Rovi, S.A., Julián Camarillo, 35, 28037 Madrid., Spain

Marketing authorization dates and numbers

OKEDI 75 mg powder and solvent for prolonged-release suspension for injection: EU/1/21/1621/001

OKEDI 100 mg powder and solvent for prolonged-release suspension for injection: EU/1/21/1621/002

Drugs

Drug Countries
OKEDI Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈