देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
RISPERIDONE
J-C HEALTH CARE LTD
N05AX08
SOLUTION
RISPERIDONE 1 MG / 1 ML
PER OS
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
RISPERIDONE
RISPERIDONE
Risperdal is indicated for the management of schizophrenia and manifestation of psychotic disorders. The antipsychotic efficacy of Risperdal was established in short-term (6 to 8-weeks) controlled trials of schizophrenic inpatients. Risperdal is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Risperdal is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Conduct and other disruptive disorders: Treatment of behavioral disorders expressed by impulse control disorders or self-alienated-aggressive or treatment-requiring behavioral disorders with reduced or substandard intelligence. Treatment should not be given to children under the age of 5 years.Risperdal is indicated for the treatment of mania in bipolar disorder. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviors
2014-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Risperdal ® 1 mg, Film-coated Tablets Risperdal ® 2 mg, Film-coated Tablets Risperdal ® 3 mg, Film-coated Tablets Risperdal ® 4 mg, Film-coated Tablets Risperdal ® 1 mg/ml Oral Solution Active ingredient and its amount: Risperdal 1 mg film-coated tablets contain: Risperidone 1 mg Risperdal 2 mg film-coated tablets contain: Risperidone 2 mg Risperdal 3 mg film-coated tablets contain: Risperidone 3 mg Risperdal 4 mg film-coated tablets contain: Risperidone 4 mg Each 1 ml oral solution contains: Risperidone 1 mg Inactive ingredients and allergens in the preparation – see section 2 Important information regarding some of the ingredients of the medicine and 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 your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? - Risperdal is intended for the treatment of schizophrenia and symptoms of psychotic disorders. - Risperdal is also effective in maintaining the clinical improvement in long-term treatment in patients who have exhibited an initial response to treatment. - Risperdal is intended for the treatment of psychotic manifestations of moderate to severe Alzheimer’s dementia (short-term treatment up to six weeks in cases of consistent aggression) in patients who are not responding to non-pharmacological treatments and in whom there is concern that they will harm themselves or others. Additional behavioral disorders: - For the treatment of behavioral disorders such as violence, impulsiveness and self- aggression in children over 5 years of age and in adolescents who are intellectually disable पूरा दस्तावेज़ पढ़ें
Risperdal tabs&sol IL-SPC 06-2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT RISPERDAL 1 mg film-coated tablets RISPERDAL 2 mg film coated tablets RISPERDAL 3 mg film coated tablets RISPERDAL 4 mg film coated tablets RISPERDAL 1 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Film coated Tablets: Each 1 mg film-coated tablet contains 1 mg of risperidone Each 2 mg film-coated tablet contains 2 mg of risperidone Each 3 mg film-coated tablet contains 3 mg of risperidone Each 4 mg film-coated tablet contains 4 mg of risperidone Excipients with known effect Each 1 mg film-coated tablet contains 131 mg lactose monohydrate. Each 2 mg film-coated tablet contains 130 mg lactose monohydrate and 0.05 mg orange yellow S aluminium lake (sunset yellow) E110. Each 3 mg film-coated tablet contains 195 mg lactose monohydrate. Each 4 mg film-coated tablet contains 260 mg lactose monohydrate. _ _ _Oral Solution: _ _ _ 1 ml oral solution contains 1 mg of risperidone Excipients with known effect 1 ml oral solution contains 2 mg benzoic acid (E210). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated _Tablets: _ Film-coated tablets for oral use: Risperdal tabs&sol IL-SPC 06-2023 • 1 mg risperidone as white, half-scored, oblong, biconvex tablets • 2 mg risperidone as slightly orange, half-scored, oblong, biconvex tablets; • 3 mg risperidone as yellow, half-scored, oblong, biconvex tablets; • 4 mg risperidone as green, half-scored, oblong, biconvex tablets; The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Film-coated tablets are etched on one side with RIS|1, RIS|2, RIS|3, and RIS|4 respectively. _ _ _Oral Solution: _ _ _ The Oral solution 1 mg/ml is clear and colorless. 4. CLINICAL PARTICULARS 4.1 CLINICAL PARTICULARS Therapeutic Indications RISPERDAL is indicated for the management of schizophrenia, and the manifestations of psychotic disorders. The antipsychotic efficacy of पूरा दस्तावेज़ पढ़ें