Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 1 mg/mL
Boucher & Muir Pty Ltd
Oral Liquid, solution
Excipient Ingredients: tartaric acid; benzoic acid; purified water; hydrochloric acid
Oral
30 mL, 100 mL
(S4) Prescription Only Medicine
Rixadone is indicated for the treatment of schizophrenia and related psychoses.,Rixadone is indicated for the short-term treatment of acute mania associated with Bipolar 1 Disorder.,Rixadone is indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type.,Rixadone is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.,Rixadone is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.
Visual Identification: Clear, colourless solution.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2018-12-06
1 RIXADONE Consumer Medicine Information RIXADONE _RISPERIDONE _ Oral solution 1 mg/mL WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Rixadone. This leaflet answers some common questions about Rixadone. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rixadone against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT RIXADONE IS USED FOR Rixadone contains risperidone. Risperidone belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. It works by helping to correct a chemical imbalance in the brain associated with these conditions. Rixadone is used for: treatment of sudden (acute) and long-term (chronic) schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action. short term treatment of sudden (acute) mania associated with bipolar 1 disorder. This condition is characterised by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility or poor judgement including disruptive or aggressive behaviours. treatment of behavioural problems in patients with a decline in mental ability (dementia) caused by Alzheimer's disease. These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering. treatment of conduct and other disruptive behaviours such as aggression, impulsiveness and self-injury in children (over 5 years), adolescents and adults who are intellectually disabled. 2 RIXADONE treat Lue koko asiakirja
1 RIXADONE AUSTRALIAN PRODUCT INFORMATION RIXADONE (RISPERIDONE) ORAL SOLUTION 1 NAME OF THE MEDICINE Risperidone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rixadone oral solution contains 1 mg risperidone per 1 mL. Excipients with known effect: benzoic acid. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Rixadone is a clear, colourless oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rixadone is indicated for the treatment of schizophrenia and related psychoses. Rixadone is indicated for the short-term treatment of acute mania associated with Bipolar 1 Disorder (see Section 4.2 Dose and method of administration: Bipolar mania) _. _ Rixadone is indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type (see Section 4.2 Dose and method of administration: Behavioural disturbances in dementia). Rixadone is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self- 2 RIXADONE injurious behaviours) are prominent (see Section 5.1 Pharmacodynamic properties: Clinical trials for maintenance data). Rixadone is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Section 5.1 Pharmacodynamic properties: Clinical trials). 4.2 DOSE AND METHOD OF ADMINISTRATION _ _ _SCHIZOPHRENIA _ Studies on the efficacy and safety of risperidone have been performed predominantly in patients with schizophrenia. The pivotal studies lasted up to 8 weeks, but more than 600 patients have been treated for at least 12 months. _ _ _Switching from other antipsychotics: _ When medically appropriate, gradual discontinuation of the previous treatment is recommended while Rixadon Lue koko asiakirja