RISPERDAL CONSTA 37.5 MG VIAL 2 ML

* Prolonged release suspension for intramuscular injection:
& & – Vial with risperidone, powder for suspension for injection.
& & – Pre-filled syringe containing 2mL of diluent for reconstitution.
& & – Needle-free vial access device for reconstitution.
& & – Safety needle for administration.
* Vial with risperidone, powder for suspension for injection: Formula: Risperidone 37.5 mg,
& & 7525 DL JN1 [poly-(d, l-lactide-co-glycolide)] polymer.
* Pre-filled syringe containing 2ml of diluent for reconstitution: Formula: polysorbate 20, carmellose sodium 40 mPa.s,
& & sodium hydrogen phosphate dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide and water for injections.
* INDICATIONS AND USAGE: RISPERDAL® CONSTA® (risperidone) is indicated for the treatment of schizophrenia.
* DOSAGE AND ADMINISTRATION:
& & – RISPERDAL® CONSTA® should be administered every 2 weeks by deep intramuscular (IM) gluteal injection.
& & – Each injection should be administered by a health care professional using the enclosed safety needle.
& & – Injections should alternate between the two buttocks. Do not administer intravenously.
& & – The recommended dose is 25 mg IM every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose
& & of 37.5 mg or 50 mg.
& & – The maximum dose should not exceed 50 mg RISPERDAL® CONSTA® every 2 weeks.
& & – A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients
& & with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations,
& & or in patients who have a history of poor tolerability to psychotropic medications.
& & – Oral RISPERDAL® (or another antipsychotic medication) should be given with the first injection of RISPERDAL® CONSTA®
& & and continued for 3 weeks (and then discontinued) to ensure that adequate therapeutic plasma concentrations
& & are maintained prior to the main release phase of risperidone from the injection site.
& & – RISPERDAL® CONSTA® has not been studied in children younger than 18 years old.
* For immediate intramuscular (IM) use after reconstitution with diluent.
* Store at 2 degrees – 8 degrees C. Keep container in the outer carton.
* Manufactured by: CILAG AG, Switzerland, for: Janssen Pharmaceutica N.V., Belgium, استيراد: سوفيكوفارم للأدوية