TREVICTA

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

PALIPERIDONE AS PALMITATE

Disponible desde:

J-C HEALTH CARE LTD

Código ATC:

N05AX13

formulario farmacéutico:

EXTENDED RELEASE SUSPENSION FOR INJECTION

Composición:

PALIPERIDONE AS PALMITATE 200 MG / 1 ML

Vía de administración:

I.M

tipo de receta:

Required

Fabricado por:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Área terapéutica:

PALIPERIDONE

indicaciones terapéuticas:

TREVICTA, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product

Fecha de autorización:

2021-10-31

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
TREVICTA
®
Prolonged-release
suspension
for
intramuscular
injection
Composition: The active ingredient and its quantity/concentration:
Paliperidone (as palmitate) 200 mg/ml
Trevicta 175 mg contains: 175 mg paliperidone (as palmitate) in 0.88
ml
Trevicta 263 mg contains: 263 mg paliperidone (as palmitate) in 1.32
ml
Trevicta 350 mg contains: 350 mg paliperidone (as palmitate) in 1.75
ml
Trevicta 525 mg contains: 525 mg paliperidone (as palmitate) in 2.63
ml
Inactive and allergenic ingredients in the preparation – see section
6 – “
Further Information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
The medicine is intended for treatment of adults over the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
-
Trevicta is given as an injection once in 3 months to treat
schizophrenia in adults
whose clinical condition is stable on a once-monthly paliperidone (as
palmitate)
injection.
Therapeutic group: antipsychotic preparations
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
-
You are sensitive (allergic) to the active ingredient paliperidone or
to any of
the additional ingredients contained in the medicine (see section 6
– “Further
Information”).
-
You are sensitive (allergic) to another antipsychotic medicine that
contains
risperidone.
Special warnings regarding use of the medicine
This preparation has not been tested in elderly patients with
dementia, however,
an increased risk of stroke or death has been observed in elderly
patients with
dementia taking medicines similar to Trevicta (see section 4 –
“Side Effects”).
Use of T

Ficha técnica

1
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
TREVICTA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
175 mg extended release suspension for injection
Each pre-filled syringe contains 273 mg paliperidone palmitate in
0.88mL equivalent to 175 mg
paliperidone.
263 mg extended release suspension for injection
Each pre-filled syringe contains 410 mg paliperidone palmitate in 1.32
mL equivalent to 263 mg
paliperidone.
350 mg extended release suspension for injection
Each pre-filled syringe contains 546 mg paliperidone palmitate in 1.75
mL equivalent to 350 mg
paliperidone.
525 mg extended release suspension for injection
Each pre-filled syringe contains 819 mg paliperidone palmitate in 2.63
mL equivalent to 525 mg
paliperidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended release suspension for injection.
The suspension is white to off-white. The suspension is pH neutral
(approximately 7.0).
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
TREVICTA, a 3-monthly injection, is indicated for the maintenance
treatment of schizophrenia in
adult patients who are clinically stable on 1-monthly paliperidone
palmitate injectable product
(see section 5.1).
4.2
Posology and method of administration
Posology
Patients who are adequately treated with 1-monthly paliperidone
palmitate injectable (preferably for
four months or more) and do not require dose adjustment may be
switched to 3-monthly paliperidone
injection.
2
TREVICTA should be initiated in place of the next scheduled dose of
1-monthly paliperidone
palmitate injectable (± 7 days). The TREVICTA dose should be based on
the previous 1-monthly
paliperidone palmitate injectable dose using a 3.5-fold higher dose
shown in the following table:
TREVICTA doses for patients adequately treated with 1-monthly
paliperidone palmitate
injectable
If the last dose of 1-monthly paliperidone
palmitate injectable is
Initiate TREVICTA at the following dose
50 mg
175 mg
75 mg
263 mg
100 mg
350 mg
150 mg
525 mg
There is no equivalent dose of