Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
paliperidone palmitate
Janssen-Cilag International NV
N05AX13
paliperidone
Psycholeptics
Schizophrenia
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.
Revision: 12
Authorised
2014-12-05
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 For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.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 Soma hati kamili
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 Soma hati kamili