RISPERDAL CONSTA Powder and solvent for suspension for injection Ref.[7351] Active ingredients: Risperidone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Product name and form

RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for injection.

Pharmaceutical Form

Powder and solvent for prolonged-release suspension for injection.

Vial with powder: White to off-white free flowing powder.

Prefilled syringe of solvent for reconstitution: Clear, colourless aqueous solution.

Qualitative and quantitative composition

1 vial contains 25 mg risperidone.

1 ml reconstituted suspension contains 12.5 mg of risperidone.

Excipients with known effect: 1 ml reconstituted suspension contains 3 mg sodium.

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

Powder:

[poly-(d, l-lactide-co-glycolide)

Solvent:

Polysorbate 20
Carmellose sodium
Disodium hydrogen phosphate dihydrate
Citric acid anhydrous
Sodium chloride
Sodium hydroxide
Water for injection

Pack sizes and marketing

Needle-free vial access device

  • One vial containing powder.
  • One vial adapter for reconstitution.
  • One prefilled syringe containing the solvent for RISPERDAL CONSTA.
  • Two Terumo SurGuard3 needles for intramuscular injection (a 21G UTW 1-inch (0.8 mm × 25 mm) safety needle with needle protection device for deltoid administration and a 20G TW 2-inch (0.9 mm × 51 mm) safety needle with needle protection device for gluteal administration).

RISPERDAL CONSTA is available in packs containing 1 or 5 (bundled) packs.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0375

Date of first authorisation: 08 August 2002
Date of latest renewal: 30 April 2017

Drugs

Drug Countries
RISPERDAL Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa
 
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