Moditen depo solution for i/m injection

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

fluphenazine (fluphenazine decanoate)

Dostopno od:

KRKA d.d.

Koda artikla:

N05AB02

INN (mednarodno ime):

fluphenazine (fluphenazine decanoate)

Odmerek:

25mg/ml

Farmacevtska oblika:

solution for i/m injection

Enote v paketu:

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

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2016-11-23

Lastnosti izdelka

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