Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
paliperidone palmitate
Janssen-Cilag International N.V.
N05AX13
paliperidone
Psycholeptics
Schizophrenia
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).
Revision: 3
Authorised
2020-06-18
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 For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.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 read_full_document
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 read_full_document