国: マルタ
言語: 英語
ソース: Medicines Authority
ZUCLOPENTHIXOL ACETATE
Lundbeck Limited 2nd Floor, Building 3 Abbey View, Everard Close, St Albans ALI 2PS, United Kingdom
N05AF05
ZUCLOPENTHIXOL ACETATE 50 mg/ml
SOLUTION FOR INJECTION
ZUCLOPENTHIXOL ACETATE 50 mg/ml
POM
PSYCHOLEPTICS
Withdrawn
2006-02-14
Page 1 of 9 Package leaflet: Information for the patient CLOPIXOL-ACUPHASE® 50 MG/ML SOLUTION FOR INJECTION ZUCLOPENTHIXOL ACETATE 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 • f 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 CLOPIXOL-ACUPHASE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE CLOPIXOL-ACUPHASE IS GIVEN 3. HOW CLOPIXOL-ACUPHASE IS GIVEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLOPIXOL-ACUPHASE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CLOPIXOL-ACUPHASE IS AND WHAT IT IS USED FOR THE NAME OF YOUR MEDICINE IS CLOPIXOL-ACUPHASE 50 MG/ML SOLUTION FOR INJECTION (CALLED CLOPIXOL-ACUPHASE IN THIS LEAFLET). CLOPIXOL-ACUPHASE CONTAINS THE ACTIVE SUBSTANCE ZUCLOPENTHIXOL. CLOPIXOL-ACUPHASE BELONGS TO A GROUP OF MEDICINES KNOWN AS ANTIPSYCHOTICS (ALSO CALLED NEUROLEPTICS). These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness. Clopixol-Acuphase is used for the initial treatment of short-term psychoses including mania or increases in the severity of existing psychoses. 2. WHAT YOU NEED TO KNOW BEFORE CLOPIXOL-ACUPHASE IS GIVEN CLOPIXOL-ACUPHASE IS NOT GIVEN • If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthene drugs or antipsychotic drugs or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you think you might be • If you are feeling less alert than usual, or are drowsy or sleepy or have serious problems with your blood circulation WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before Clopixol-Acuphase is given to you: Page 2 of 9 • If you hav 完全なドキュメントを読む
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopixol-Acuphase 50 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zuclopenthixol acetate 50 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellowish oil, practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the initial treatment of acute psychoses including mania and exacerbation of chronic psychoses, particularly where a duration of effect of 2-3 days is desirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults _ Dosage should be adjusted according to the severity of the patient's illness. The usual dosage is 50-150 mg (1-3 ml), repeated if necessary after 2 or 3 days. Some patients may need an additional injection between 1 and 2 days after the first injection. Clopixol-Acuphase is not intended for long-term use and duration of treatment should not be more than two weeks. The maximum accumulated dosage should not exceed 400 mg and the number of injections should not exceed four. _Older patients _ The dosage may need to be reduced in older patients owing to reduced rates of metabolism and elimination. Maximum dosage per injection should be 100 mg. _Paediatric population _ Clopixol-Acuphase is not recommended for use in children due to lack of clinical experience. _Patients with renal impairment _ Page 2 of 10 Clopixol-Acuphase can be given in usual doses to patients with reduced renal function. Where there is renal failure, dosage should be reduced to half the normal dosage. _Patients with hepatic impairment _ Use with caution in patients with hepatic disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised. Maintenance Therapy Clopixol-Acuphase is not intended for long-term use. A single injection of Clopixol-Acuphase has an onset of sedative action shortly after injection and an antipsychotic action persist 完全なドキュメントを読む