Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
RISPERIDONE
J-C HEALTH CARE LTD
N05AX08
POWDER FOR SUSPENSION FOR INJECTION
RISPERIDONE 37.5 MG/VIAL
I.M
Required
CILAG AG, SWITZERLAND
RISPERIDONE
RISPERIDONE
Risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.Risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar I disorder to delay occurrence of mood episodes.Risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.
2012-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor s prescription only Risperdal Consta ® 25 mg Risperdal Consta ® 37.5 mg Risperdal Consta ® 50 mg Powder for preparation of suspension for injection Active ingredient Risperdal Consta 25 mg contains: Risperidone 25 mg/vial Risperdal Consta 37.5 mg contains: Risperidone 37.5 mg/vial Risperdal Consta 50 mg contains: Risperidone 50 mg/vial Inactive ingredients and allergens in the preparation – see section 6 Further Information . Read this 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 to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. WARNING: Increased mortality in elderly patients with psychosis-related dementia. Elderly patients with psychosis-related dementia treated with antipsychotic medicines are at an increased risk of death. Risperdal Consta is not approved for the treatment of patients with psychosis-related dementia. 1. WHAT IS THE MEDICINE INTENDED FOR? Risperdal Consta is indicated for the treatment of schizophrenia and schizoaffective disorders. Risperdal Consta is indicated as monotherapy for the maintenance treatment of bipolar disorder to delay occurrence of mood episodes. Risperdal Consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder. Therapeutic group: atypical antipsychotics. 2. BEFORE USING THE MEDICINE Do not use the preparation if: You are sensitive (allergic) to the active ingredient (risperidone) or its metabolite (paliperidone) or to any of the additional ingredients contained in the medicine (see section 6 Further Information ). Hypersensitivity reactions, including anaphylactic reaction and angioedema, have be Διαβάστε το πλήρες έγγραφο
1 RISPERDAL CONSTA ® 25 MG, 37.5 MG AND 50 MG POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION 1 THERAPEUTIC INDICATION 1.1 SCHIZOPHRENIA RISPERDAL CONSTA ® (risperidone) is indicated for the treatment of schizophrenia and schizoaffective disorders.( _see Clinical _ s _tudies (14_ )) 1.2 BIPOLAR DISORDER RISPERDAL CONSTA ® is indicated as monotherapy for the maintenance treatment of bipolar I disorder to delay occurrence of mood episodes. RISPERDAL CONSTA® is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder. 2 DOSAGE AND ADMINISTRATION For patients who have never taken oral RISPERDAL ® , it is recommended to establish tolerability with oral RISPERDAL ® prior to initiating treatment with RISPERDAL CONSTA ® . RISPERDAL CONSTA ® should be administered every 2 weeks by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle _[see Dosage and Administration_ (2.8) _]_ . For deltoid administration, use the 1-inch needle alternating injections between the two arms. For gluteal administration, use the 2-inch needle alternating injections between the two buttocks. Do not administer intravenously. 2.1 SCHIZOPHRENIA The recommended dose for the treatment of schizophrenia is 25 mg IM every 2 weeks. Although dose response for effectiveness has not been established for RISPERDAL CONSTA ® , some patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA- RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. RISPERDAL ® CONSTA ® (RISPERIDONE) IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. [_SEE WARNINGS AND PRECAUTIONS (5.1)_] 2 maximum dose should not exceed 50 mg RISPERDAL CONSTA ® ever Διαβάστε το πλήρες έγγραφο