Byannli (previously Paliperidone Janssen-Cilag International)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

paliperidone palmitate

Saatavilla:

Janssen-Cilag International N.V.  

ATC-koodi:

N05AX13

INN (Kansainvälinen yleisnimi):

paliperidone

Terapeuttinen ryhmä:

Psycholeptics

Terapeuttinen alue:

Schizophrenia

Käyttöaiheet:

Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).

Tuoteyhteenveto:

Revision: 3

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2020-06-18

Pakkausseloste

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
BYANNLI 700 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
BYANNLI 1 000 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
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 BYANNLI is and what it is used for
2.
What you need to know before you use BYANNLI
3.
How to use BYANNLI
4.
Possible side effects
5.
How to store BYANNLI
6.
Contents of the pack and other information
1.
WHAT BYANNLI IS AND WHAT IT IS USED FOR
BYANNLI contains the active substance paliperidone which belongs to
the class of antipsychotic
medicines.
BYANNLI 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 or
once every three months, your doctor may start treatment with BYANNLI.
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.
BYANNLI can help alleviate the symptoms of your disease and reduce the
risk of your sympto

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BYANNLI 700 mg prolonged-release suspension for injection in
pre-filled syringe
BYANNLI 1 000 mg prolonged-release suspension for injection in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
700 mg prolonged-release suspension for injection
Each pre-filled syringe contains 1 092 mg paliperidone palmitate in
3.5 mL equivalent to 700 mg
paliperidone
1 000 mg prolonged-release suspension for injection
Each pre-filled syringe contains 1 560 mg paliperidone palmitate in 5
mL equivalent to 1 000 mg
paliperidone
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release suspension for injection (injection).
The suspension is white to off-white. The suspension is pH neutral
(approximately 7.0).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BYANNLI, a 6-monthly injection, is indicated for the maintenance
treatment of schizophrenia in adult
patients who are clinically stable on 1-monthly or 3-monthly
paliperidone palmitate injectable
products (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients who are adequately treated with 1-monthly paliperidone
palmitate injection at doses of
100 mg or 150 mg (preferably for four months or more) or 3-monthly
paliperidone palmitate injection
at doses of 350 mg or 525 mg (for at least one injection cycle) and do
not require dose adjustment may
be transitioned to 6-monthly paliperidone palmitate injection.
_BYANNLI for patients adequately treated with 1-monthly paliperidone
palmitate injection_
BYANNLI should be initiated in place of the next scheduled dose of
1-monthly paliperidone palmitate
injection (± 7 days). To establish a consistent maintenance dose, it
is recommended that the last two
doses of 1-monthly paliperidone palmitate injection be the same dose
strength before starting
BYANNLI. The BYANNLI dose should be based on the previous 1-monthly
paliperidone palmitate
injectable dose shown in the following table:
TRANSITIONIN