Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risperidone
Rosemont Pharmaceuticals Ltd
N05AX08
Risperidone
1mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5016119325298
0 10 20 30 40 50 60 70 80 90 100 JOB INFORMATION Product Name: Strength: Keyline Ref: Font Type: Font Size: Pharmacode: Dimensions: EAN Code: Folded Size: No. of Colours: Tabbed: Pack Size: Bottle Size: Design Icon: Print Colours: Non-print Colours: New Item Code: Previous Item Code: Supplier Code: Page Number: COLOURS ARTWORK VERSION: Date: Date: Operator: Operator: PREFLIGHT VERSION: JOB SPECIFICATION MAIN BODY TEXT Univers Roman UNIVERS BOLD 1mg/ml BLACK CUTTER UKL472 376 300 x 400mm N/A 150 x 37mm 1 8pt Yes 100ml N/A N/A J2A98RBJ1 P0794 N/A 1 of 2 Risperidone 1mg/ml Oral Solution 15/12/17 - DH - 2 - APPROVALS THIRD PARTY APPROVAL REQUIRED Name: Name: Signature: Signature: Date: Date: AUTHORITY APPROVAL SUPPLIED REGULATORY SIGN-OFF YES YES NO N/A TICK APPLICABLE BOX TICK APPLICABLE BOX RARE (AFFECTS 1 TO 10 USERS IN 10,000): n infection n inappropriate secretion of a hormone that controls urine volume n sugar in the urine, low blood sugar, high blood triglycerides (a fat) n lack of emotion, inability to reach orgasm n neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness) n blood vessel problems in the brain n coma due to uncontrolled diabetes n shaking of the head n glaucoma (increased pressure within the eyeball), problems with movement of your eyes, eye rolling, eyelid margin crusting n eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine n dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood n severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure n dangerously excessive intake of water n irregular heart beat n blood clot in the legs, blood clot in the lungs n tro Прочитать полный документ
OBJECT 1 RISPERIDONE 1MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 16-Jan-2018 | Rosemont Pharmaceuticals Limited 1. Name of the medicinal product Risperidone 1mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of oral solution contains 1mg Risperidone For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution A clear colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Risperidone is indicated for the treatment of schizophrenia. Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone 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. Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents. 4.2 Posology and method of administration Risperidone should be diluted with water or orange juice. When diluted in this way, the product should be used immediately. This liquid should not be mixed with coffee and tea (see section 6 Pharmaceutical Particulars). Schizophrenia _Adults_ Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased Прочитать полный документ