Moditen depo solution for i/m injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

fluphenazine (fluphenazine decanoate)

Доступна с:

KRKA d.d.

код АТС:

N05AB02

ИНН (Международная Имя):

fluphenazine (fluphenazine decanoate)

дозировка:

25mg/ml

Фармацевтическая форма:

solution for i/m injection

Штук в упаковке:

(5/1x5/) ampoules 1ml in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-11-24

Характеристики продукта

PI_Text015433_2
– Updated:
Page 1 of 10
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 relapse prevention in schizophrenia and
other psychoses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The most appropriate dose and frequency of administration should be
individualised.
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 short-
acting injections 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, a further 25 mg dose is administered
in 5 to 10 days. The dose is then
individually adjusted.
If a patient is already taking phenothiazines, they may be replaced
with Moditen depo without
previous treatment with short-acting injections or Moditen coated
tablets.
Again, an initial intramuscular dose of 12.5 mg is given to test the
patient’s tolerance of Moditen depo
and then the dose is adjusted according to the course of the disease.
_Elderly patients_
Lower doses are usually sufficient for elderly patients, from 1/3 to
1/4 of the younger adult dose.
_Paediatric population_
_Children and adolescents 12 to 18