Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Escitalopram oxalate 6.37mg equivalent to Escitalopram 5 mg;
Ipca Pharma (NZ) Pty Limited
Escitalopram oxalate 6.37 mg (equivalent to Escitalopram 5 mg)
5 mg
Film coated tablet
Active: Escitalopram oxalate 6.37mg equivalent to Escitalopram 5 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Macrogol 400 Magnesium stearate Microcrystalline cellulose Purified talc Purified water Titanium dioxide
Prescription
Neuland Laboratories Limited
In adults: Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.
Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Aluminium - 14 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 28 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 56 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place - Blister pack, PVDC/PVC/Aluminium - 98 tablets - 48 months from date of manufacture stored at or below 30°C. Keep in a dry place
2015-08-03
NEW ZEALAND DATA SHEET IPCA-ESCITALOPRAM Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 1. IPCA-ESCITALOPRAM (5MG, 10MG&20MG FILM COATED TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalopram5mg, 10mg or 20mg (as oxalate) Chemical Structure: Chemistry Escitalopram is the active enantiomer (s-enantiomer) of citalopram. Escitalopram oxalate (CAS no.219861-08-2) is chemically described as S(+)-1-(3-dimethyl-aminopropyl)-1-(4-fluorophenyl)- 1,3dihydroisobenzofuran-5-carbonitrile hydrogen oxalate. Its empirical formula is C 20 H 21 FN 2 O, C 2 H 2 O 4 and molecular weight is 414.42. Escitalopram oxalate is a fine white to yellow, crystalline material and sparingly soluble in water,slightly soluble in acetone, soluble in ethanol and freely soluble in methanol. No polymorphic formshave been detected. EXCIPIENT(S) OF KNOWN EFFECT Ipca-Escitalopram does not contain lactose and gluten. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM IPCA-ESCITALOPRAM 5mg tablets are white to off-white, circular, biconvex film coated tablets with ‘C5’ embossed on one side and plain on other side. IPCA-ESCITALOPRAM 10mg tablets are white to off-white, oval, biconvex film coated tablets with ‘C4’ embossed on one side and a notch break-line on other side. IPCA-ESCITALOPRAM 20mg tablets are white to off-white, oval, biconvex film coated tablets with ‘C3’ embossed on one side and a notch break-line on other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults: Treatment of major depression. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. IPCA-ESCITALOPRAM Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION Escitalopram is administered as a single daily dose and may be taken with or without food. DOSE ADULTS MAJOR DEPRESSION The recommended dose is 10mg once daily. Depending on Lugege kogu dokumenti