Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Amisulpride 100 mg/mL;
sanofi-aventis new zealand limited
Amisulpride 100 mg/mL
100 mg/mL
Oral solution
Active: Amisulpride 100 mg/mL Excipient: Caramel Hydrochloric acid Methyl hydroxybenzoate Potassium sorbate Propyl hydroxybenzoate Purified water Sweetener Gesweet 01002023
Bottle, glass, + graduated dose syringe, child proof cap, 60 mL
Prescription
Prescription
Sanofi Chimie
Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
Package - Contents - Shelf Life: Bottle, glass, + graduated dose syringe, child proof cap - 60 mL - 36 months from date of manufacture stored at or below 25°C 2 months opened stored at or below 25°C
2003-02-27
SOLIAN ® 1 SOLIAN ® _amisulpride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet is designed to provide answers to some common questions about this medicine. It does not contain all the available information. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Solian 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 THIS MEDICINE. You may need to read it again. WHAT SOLIAN IS USED FOR The name of your medicine is Solian. It contains the active ingredient called amisulpride. Solian belongs to a group of medicines called antipsychotics. Solian is used to treat symptoms of schizophrenia. Schizophrenia is a condition which affects the way you think, feel and/or act. Schizophrenia may cause symptoms such as hallucinations (eg hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness, emotional and social withdrawal. People with schizophrenia may also feel depressed, anxious or tense. Your doctor may have prescribed Solian for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SOLIAN HAS BEEN PRESCRIBED FOR YOU. BEFORE TAKING IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SOLIAN IF: • YOU HAVE AN ALLERGIC REACTION TO SOLIAN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Signs of an allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue. • YOU ARE BREASTFEEDING OR PLAN TO BREASTFEED. • YOU ARE TAKING THE FOLLOWING MEDICINES − medicines used to treat irregular heart rhythm such as quinidine, disopyramide, amiodarone and sotalol − cisapride − antibiotics such as erythromycin and pentamidine, given as an injection into the veins − levodopa, a medicine used in Parkinson's disease − thioridazone, an antipsychotic − methadone, medicine used to treat pain or addiction • THE PACKAGING IS TORN OR SHOWS SIGNS OF T Lesen Sie das vollständige Dokument
solian-ccdsv14-dsv17-27nov20 Page 1 DATA SHEET 1 PRODUCT NAME SOLIAN 50 50mg Tablets* SOLIAN 100 100mg Tablets* SOLIAN 200 200mg Tablets* SOLIAN 400 400mg Tablets* SOLIAN 100mg/mL Solution, oral *Not marketed 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SOLIAN 50 50mg Tablets*: Each tablet contains 50mg of amisulpride SOLIAN 100 100mg Tablets*: Each tablet contains 100g of amisulpride SOLIAN 200 200mg Tablets*: Each tablet contains 200mg of amisulpride SOLIAN 400 400mg Tablets*: Each tablet contains 400mg of amisulpride SOLIAN 100mg/mL Solution, oral: Each mL contains 100mg of amisulpride For the full list of excipients, see Section 6.1. *Not marketed 3 PHARMACEUTICAL FORM SOLIAN 50* white to off white, flat-faced breakable tablet, engraved “AMI 50”. SOLIAN 100* white to off white, flat-faced breakable tablet, engraved “AMI 100”. solian-ccdsv14-dsv17-27nov20 Page 2 SOLIAN 200* white to off white, flat-faced breakable tablet, engraved “AMI 200”. SOLIAN 400* white, film-coated, breakable, oblong tablet, engraved “AMI 400”. SOLIAN SOLUTION 100mg/mL a clear, yellow to yellowish coloured liquid *Not marketed 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. 4.2 DOSE AND METHOD OF ADMINISTRATION For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with amisulpride. Doses should be adjusted Lesen Sie das vollständige Dokument