Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 1 mg/mL
Janssen-Cilag Pty Ltd
Oral Liquid, solution
Excipient Ingredients: purified water; benzoic acid; tartaric acid; sodium hydroxide
Oral
1 x 100mL, 30 mL bottle
(S4) Prescription Only Medicine
RISPERDAL is indicated for the treatment of schizophrenia and related psychoses. RISPERDAL is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. RISPERDAL is also indicated for the treatment of behavioural disturbances in dementia. RISPERDAL 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 (see Clinical Trials for maintenance data). RISPERDAL is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Clinical Trials).
Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1996-09-13
RISPERDAL® 1 RISPERDAL ® _TABLETS; ORAL SOLUTION _ _Risperidone _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about RISPERDAL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT USING RISPERDAL, ASK YOUR DOCTOR OR PHARMACIST. Your doctor and pharmacist have more information. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT RISPERDAL IS USED FOR RISPERDAL belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. It 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 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 old), adolescents and adults who are intellectually disabled, • treatment of behavioural symptoms of autism in children and adolescent. RISPERDAL helps to correct a chemical imbalance in the brain associated with these conditions. This medicine has been approved for the uses mentioned above. However, your doctor may prescribe it for another use. It is only available with a doctor's prescription. IF YOU WANT MORE INFORMATION, ASK YOUR DOCTOR. RISPERDAL is not addictive. BEFORE YOU USE Lestu allt skjalið
CCDS200407ver21 Page 1 of 18 RISPERDAL(210811) API AUSTRALIAN PRODUCT INFORMATION RISPERDAL ® RISPERIDONE FILM COATED TABLETS ORAL SOLUTION 1 NAME OF THE MEDICINE Risperidone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RISPERDAL contains risperidone as the active ingredient, and is available as 0.5, 1, 2, 3 and 4 mg oral film-coated tablets or as a 1 mg/mL oral solution. Excipients of known effect: Tablets: Sugars as lactose Oral solution: Benzoates. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM RISPERDAL Tablets: 0.5 mg brownish-red, film-coated, biconvex, half-scored oblong tablets, “Ris 0.5” on the scored side and “JANSSEN” on the other side. 1 mg white, film-coated, half-scored oblong tablets, "Ris 1" on the scored side. 2 mg orange, film-coated, half-scored oblong tablets, "Ris 2" on the scored side. 3 mg yellow, film-coated, half-scored oblong tablets, "Ris 3" on the scored side. 4 mg green, film-coated, half-scored oblong tablets, "Ris 4" on the scored side. RISPERDAL Oral Solution: 1mg/mL clear, colourless oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for the treatment of schizophrenia and related psychoses. RISPERDAL 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). Product Information - Australia CCDS200407ver21 Page 2 of 34 RISPERDAL(210811)API RISPERDAL 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) RISPERDAL 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. Lestu allt skjalið