Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
paliperidone palmitate
Janssen-Cilag International N.V.
N05AX13
paliperidone
Psycholeptics
Schizophrenia
Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Revision: 16
Authorised
2011-03-04
67 B. PACKAGE LEAFLET 68 PACKAGE LEAFLET: INFORMATION FOR THE USER XEPLION 25 MG PROLONGED RELEASE SUSPENSION FOR INJECTION XEPLION 50 MG PROLONGED RELEASE SUSPENSION FOR INJECTION XEPLION 75 MG PROLONGED RELEASE SUSPENSION FOR INJECTION XEPLION 100 MG PROLONGED RELEASE SUSPENSION FOR INJECTION XEPLION 150 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 Xeplion is and what it is used for 2. What you need to know before you use Xeplion 3. How to use Xeplion 4. Possible side effects 5. How to store Xeplion 6. Contents of the pack and other information 1. WHAT XEPLION IS AND WHAT IT IS USED FOR Xeplion 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 stabilised on paliperidone or risperidone. If you have shown responsiveness to paliperidone or risperidone in the past and have mild to moderate symptoms your doctor may start treatment with Xeplion without prior stabilisation with paliperidone or risperidone. 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 t Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 25 mg prolonged release suspension for injection Each pre-filled syringe contains 39 mg paliperidone palmitate in 0.25 mL equivalent to 25 mg paliperidone. 50 mg prolonged release suspension for injection Each pre-filled syringe contains 78 mg paliperidone palmitate in 0.5 mL equivalent to 50 mg paliperidone. 75 mg prolonged release suspension for injection Each pre-filled syringe contains 117 mg paliperidone palmitate in 0.75 mL equivalent to 75 mg paliperidone. 100 mg prolonged release suspension for injection Each pre-filled syringe contains 156 mg paliperidone palmitate in 1 mL equivalent to 100 mg paliperidone. 150 mg prolonged release suspension for injection Each pre-filled syringe contains 234 mg paliperidone palmitate in 1.5 mL equivalent to 150 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 Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended initiation of Xeplion is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid Aqra d-dokument sħiħ