Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
PIPOTIAZINE PALMITATE
May & Baker Limited
PIPOTIAZINE PALMITATE
50 Mg/Ml
Solution for Injection
Withdrawn
2007-02-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piportil Depot 5% w/v Injection (1 ml Ampoule) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pipotiazine Palmitate 5% w/v (50 mg/ml). Each 1ml ampoule contains 50 mg Pipotiazine palmitate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection A bright or slightly dim yellow coloured sterile liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of psychotic disorders, particularly for maintenance therapy in patients with chronic schizophrenia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intramuscular injection. Adults only: The usual initial dose is 25mg. Subsequent doses should be increased by increments of 25mg or 50mg monthly until a satisfactory response is obtained. The usual dosage is 50 to 100mg once every four weeks but doses of up to 200mg every four weeks may be needed. The Elderly: The usual initial dosage is 5 to 10 mg with subsequent slow increments as necessary. 4.3 CONTRAINDICATIONS 1. Use in patients hypersensitive to the active ingredient, or other phenothiazines. 2. Use in patients with marked cerebral atherosclerosis or coronary artery or cardiac insufficiency, in coma, or renal or hepatic failure. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Phenothiazines should only be used with great caution in patients with a history of jaundice or with existent liver dysfunction or blood dyscrasias, epilepsy or myasthenia gravis. Patients receiving phenothiazines over a prolonged period require regular and careful surveillance with particular IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/10/2006_ _CRN 2029178_ _page number: 1_ attention to potential for inducing eye changes, effec Baca dokumen lengkapnya