Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluphenazine (fluphenazine decanoate)
KRKA d.d.
N05AB02
fluphenazine (fluphenazine decanoate)
25mg/ml
solution for i/m injection
(5/1x5/) ampoules 1ml, in blister
Prescription
Registered
2016-11-23
1.3.1 Fluphenazine decanoate SPC, Labeling and Package Leaflet SmPCPIL139350_1 10.10.2019 – Updated: 10.10.2019 Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT Moditen depo 25 mg/1 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection (1 ampoule) contains 25 mg fluphenazine decanoate, which is equivalent to 18.48 mg fluphenazine. Excipients: benzyl alcohol (12 mg/ml), sesame oil. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution for injection is a clear, yellowish, oily solution, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Maintenance treatment and prophylaxis of the relapse of schizophrenia, paranoid psychosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The most appropriate dose and frequency of administration should be made by the doctor. The medicine is released slowly; therefore, a constant amount of the medicine passes into your blood between two injections. The injections will be given deep into a muscle. The usual initial dose is 12.5 mg to 25 mg of Moditen depo. Subsequent doses and dosing intervals are determined individually. The usual dosing interval is 15 to 35 days. If doses higher than 50 mg are required, they are gradually increased by 12.5 mg. A single dose should not exceed 100 mg. Patients who have not received previous phenothiazine therapy should initially be treated with injections with short-term action or Moditen coated tablets. When patients are found to tolerate Moditen well, they can be switched to Moditen depo. An initial dose of 12.5 mg Moditen depo is given intramuscularly. If no severe undesirable effects occur, 5 to 10 days later a further 25 mg dose can be administered. The dose is then individually adjusted. If a patient is already taking phenothiazines, they may be replaced with Moditen depo without previous treatment with injections with short-term action or Moditen coated tablets. _Elderly patients_ Lower doses are usually sufficient for e Прочитать полный документ