国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
RISPERIDONE
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
N05AX08
25 mg/vial
INJECTION, POWDER, FOR SOLUTION
RISPERIDONE 25 mg/vial
INTRAMUSCULAR
Prescription Only
Cilag AG
ACTIVE
2003-07-21
1 NAME OF THE MEDICINAL PRODUCT RISPERDAL CONSTA 25 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION RISPERDAL CONSTA 37.5 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION RISPERDAL CONSTA 50 MG PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION INTERNATIONAL NON-PROPRIETARY NAME RISPERIDONE QUALITATIVE AND QUANTITATIVE COMPOSITION RISPERDAL CONSTA contains 25 mg, 37.5 mg or 50 mg risperidone. RISPERDAL CONSTA is an extended release microspheres formulation of risperidone, composed of risperidone drug substance micro-encapsulated in polylactide-co-glycolide, at a concentration of 381 mg risperidone per gram of microspheres. For excipients, see List of Excipients.. PHARMACEUTICAL FORM Prolonged-release powder and diluent for suspension for injection. _Vial with powder_. White to off-white free flowing powder. _Pre-filled syringe of diluent for reconstitution_. Clear, colorless aqueous solution. 2 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS RISPERDAL CONSTA IS INDICATED FOR THE TREATMENT OF ACUTE AND CHRONIC SCHIZOPHRENIC PSYCHOSES, AND OTHER PSYCHOTIC CONDITION, IN WHICH POSITIVE SYMPTOMS (SUCH AS HALLUCINATIONS, DELUSIONS, THOUGH DISTURBANCES, HOSTILITY, SUSPICIOUSNESS), AND /OR NEGATIVE SYMPTOMS (SUCH AS BLUNTED AFFECT, EMOTIONAL AND SOCIAL WITHDRAWAL, POVERTY OF SPEECH) ARE PROMINENT. RISPERDAL® CONSTA® ALSO ALLEVIATES AFFECTIVE SYMPTOMS (SUCH AS DEPRESSION, GUILT FEELINGS, ANXIETY) ASSOCIATED WITH SCHIZOPHRENIAPOSOLOGY AND METHOD OF ADMINISTRATION For risperidone naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA . RISPERDAL CONSTA should be administered every two weeks by deep intramuscular deltoid or gluteal injection using the appropriate safety needle. For deltoid administration, use the 1-inch needle alte 阅读完整的文件
1 PRODUCT NAME RISPERDAL CONSTA 25 mg Prolonged Release Suspension for Intramuscular Injection RISPERDAL CONSTA 37.5 mg Prolonged Release Suspension for Intramuscular Injection (risperidone) DOSAGE FORMS AND STRENGTHS RISPERDAL CONSTA contains 25 mg or 37.5 mg risperidone. RISPERDAL CONSTA is an extended release microspheres formulation of risperidone, composed of risperidone drug substance micro-encapsulated in polylactide-co-glycolide, at a concentration of 381 mg risperidone per gram of microspheres. Prolonged-release powder and diluent for suspension for injection. _ _ VIAL WITH POWDER White to off-white free flowing powder. PRE-FILLED SYRINGE OF DILUENT FOR RECONSTITUTION Clear, colorless aqueous solution. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS RISPERDAL CONSTA is indicated for the treatment of acute and chronic schizophrenic psychoses, hallucinations and delusions. RISPERDAL ® CONSTA ® also alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia DOSAGE AND ADMINISTRATION For risperidone naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA . _ _ ADULTS (OLDER THAN 18 YEARS OF AGE) The recommended dose is 25 mg intramuscular every two weeks. Some patients may benefit from the higher doses of 37.5 mg or 50 mg. Doses higher than 50 mg every 2 weeks are not recommended. Where patients are not stabilized on oral risperidone the recommended dose is 25 mg RISPERDAL ® CONSTA ® every two weeks. Should a dosage adjustment be required, see two paragraphs down for guidance on dose increments. Patients who have no previous history of risperidone use should be pretreated with oral RISPERDAL ® for several days as clinically feasible, to assess tolerability before the first injection. 2 For those patients stabilized on a fixed dose of oral risperidone for two weeks or more, the following conversion schemes 阅读完整的文件