国家: 以色列
语言: 英文
来源: Ministry of Health
PALIPERIDONE
J-C HEALTH CARE LTD
N05AX13
TABLETS EXTENDED RELEASE
PALIPERIDONE 6 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
PALIPERIDONE
PALIPERIDONE
Invega is indicated for :-treatment of schizophrenia in adults and adolescents (12-17 years).-treatment of schizoaffective disorder in adults.
2023-07-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only INVEGA ® 3 MG, INVEGA ® 6 MG, INVEGA ® 9 MG EXTENDED-RELEASE TABLETS ,ג״מ 3 TM הגווניא ,ג״מ 6 TM הגווניא ג״מ 9 TM הגווניא ךשוממ רורחשב תוילבט غلم 9 ،غلم 6 ،غلم 3 ﺎﭽﻴﭭﻨﻳإ دتمم رﻳرحت تاذ صارقأ INVEGA 3 MG CONTAINS PALIPERIDONE 3 MG INVEGA 6 MG CONTAINS PALIPERIDONE 6 MG INVEGA 9 MG CONTAINS PALIPERIDONE 9 MG Inactive and allergenic ingredients in the preparation – see chapter 2 section “Important information about some of the ingredients of the medicine” and chapter 6 – “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is used to treat schizophrenia in adults and adolescents aged 12 years and above, and schizoaffective disorder in adults. THERAPEUTIC GROUP: Antipsychotic medicines Schizophrenia is a disorder with symptoms characterized by hearing, seeing or sensing things that are not there, false beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, behavioral and emotional flatness (lack of emotional expression). Patients with schizophrenia may also feel depressed, anxious, guilty, or tense. Schizoaffective disorder is a mental condition in which patients experience a mix of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (very elated mood, sadness, feeling nervous, distracted, sleeplessness, talkativeness, loss of interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurren 阅读完整的文件
1. NAME OF THE MEDICINAL PRODUCT INVEGA 3 mg INVEGA 6 mg INVEGA 9 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each extended-release tablet contains 3 mg of paliperidone. Each extended-release tablet contains 6 mg of paliperidone. Each extended-release tablet contains 9 mg of paliperidone. For the 3mg tablets: Excipient with known effect: Each 3 mg tablet contains 13.2 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended-release tablet Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3” Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6” Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INVEGA is indicated for the treatment of schizophrenia in adults and in adolescents (12-17 years). INVEGA is indicated for the treatment of schizoaffective disorder in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Schizophrenia (adults)_ The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of more than 5 days. _Schizoaffective disorder (adults)_ The recommended dose of INVEGA for the treatment of schizoaffective disorder in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some patients may benefit from higher doses within the recommended range of 6 mg to 12 mg once daily. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increments of 3 mg/day are recomm 阅读完整的文件