Solian 50

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Amisulpride 50mg;  ;  ; Amisulpride 50mg

Verfügbar ab:

sanofi-aventis new zealand limited

INN (Internationale Bezeichnung):

Amisulpride 50 mg

Dosierung:

50 mg

Darreichungsform:

Tablet

Zusammensetzung:

Active: Amisulpride 50mg     Excipient: Hydrated silica Lactose monohydrate Magnesium stearate Methylcellulose Potato starch Active: Amisulpride 50mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Einheiten im Paket:

Blister pack, PVC-Al, 2 tablets

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Sanofi Chimie

Anwendungsgebiete:

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.

Produktbesonderheiten:

Package - Contents - Shelf Life: Blister pack, PVC-Al - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 5 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 90 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC-Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Berechtigungsdatum:

2000-01-11

Fachinformation

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