Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Paliperidone
Norton Waterford
N05AX13
Paliperidone
25 milligram(s)
Prolonged-release suspension for injection
paliperidone
Not marketed
2021-12-03
2 PACKAGE LEAFLET: INFORMATION FOR THE USER PALIPERIDONE TEVA 25 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION PALIPERIDONE TEVA 50 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION PALIPERIDONE TEVA 75 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION PALIPERIDONE TEVA 100 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION PALIPERIDONE TEVA 150 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION _TREATMENT INITIATION PACK _ PALIPERIDONE TEVA 150 MG AND PALIPERIDONE TEVA 100 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 Paliperidone Teva is and what it is used for 2. What you need to know before you use Paliperidone Teva 3. How to use Paliperidone Teva 4. Possible side effects 5. How to store Paliperidone Teva 6. Contents of the pack and other information 1. WHAT PALIPERIDONE TEVA IS AND WHAT IT IS USED FOR Paliperidone Teva 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 Paliperidone Teva 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), o Perskaitykite visą dokumentą
Health Products Regulatory Authority 23 February 2024 CRN00F113 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paliperidone Teva 25 mg prolonged-release suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Paliperidone Teva 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release suspension for injection (prolonged-release injection). The suspension is white to off-white. The suspension is pH neutral (approximately 7.0). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paliperidone Teva 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, paliperidone may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended initiation of Paliperidone Teva is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2). The third dose should be administered one month after the second initiation dose. The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy. Patients who are overweight or obese may require doses in the upper range (see section 5.2). Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged release characteristics of Perskaitykite visą dokumentą