Trevicta (previously Paliperidone Janssen)

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

paliperidone palmitate

Tilgængelig fra:

Janssen-Cilag International NV

ATC-kode:

N05AX13

INN (International Name):

paliperidone

Terapeutisk gruppe:

Psycholeptics

Terapeutisk område:

Schizophrenia

Terapeutiske indikationer:

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.

Produkt oversigt:

Revision: 12

Autorisation status:

Authorised

Autorisation dato:

2014-12-05

Indlægsseddel

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREVICTA 175 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
TREVICTA 263 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
TREVICTA 350 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
TREVICTA 525 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
paliperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TREVICTA is and what it is used for
2.
What you need to know before you use TREVICTA
3.
How to use TREVICTA
4.
Possible side effects
5.
How to store TREVICTA
6.
Contents of the pack and other information
1.
WHAT TREVICTA IS AND WHAT IT IS USED FOR
TREVICTA contains the active substance paliperidone which belongs to
the class of antipsychotic
medicines and is used as a maintenance treatment for the symptoms of
schizophrenia in adult patients.
If you have responded well to treatment with paliperidone palmitate
injection given once a month,
your doctor may start treatment with TREVICTA.
Schizophrenia is a disease with “positive” and “negative”
symptoms. Positive means an excess of
symptoms that are not normally present. For example, a person with
schizophrenia may hear voices or
see things that are not there (called hallucinations), believe things
that are not true (called delusions),
or feel unusually suspicious of others. Negative means a lack of
behaviours or feelings that are
normally present. For example, a person with schizophrenia may appear
withdrawn and may not
respond at all emotionally or may have trouble speaking in a clear and
logical way. People with this
disease may also feel depressed, anxious, guilty, or tense.
TREVICTA can help alleviate the symptoms

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TREVICTA 175 mg prolonged release suspension for injection
TREVICTA 263 mg prolonged release suspension for injection
TREVICTA 350 mg prolonged release suspension for injection
TREVICTA 525 mg prolonged release suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
175 mg prolonged release suspension for injection
Each pre-filled syringe contains 273 mg paliperidone palmitate in 0.88
mL equivalent to 175 mg
paliperidone.
263 mg prolonged release suspension for injection
Each pre-filled syringe contains 410 mg paliperidone palmitate in 1.32
mL equivalent to 263 mg
paliperidone.
350 mg prolonged release suspension for injection
Each pre-filled syringe contains 546 mg paliperidone palmitate in 1.75
mL equivalent to 350 mg
paliperidone.
525 mg prolonged 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
Prolonged 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
palmitate injection.
3
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