Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Haloperidol
Essential Pharma Limited
N05AD; N05AD01
Haloperidol
Solution for injection
Butyrophenone derivatives; haloperidol
Marketed
1993-10-10
HalD50-100mgAmp-PL-IE-2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HALDOL ® DECANOATE 50 MG/ML SOLUTION FOR INJECTION HALDOL ® DECANOATE 100 MG/ML SOLUTION FOR INJECTION haloperidol 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Haldol Decanoate is and what it is used for 2. What you need to know before you are given Haldol Decanoate 3. How to use Haldol Decanoate 4. Possible side effects 5. How to store Haldol Decanoate 6. Contents of the pack and other information 1. WHAT HALDOL DECANOATE IS AND WHAT IT IS USED FOR The name of your medicine is Haldol Decanoate. Haldol Decanoate contains the active substance haloperidol (as haloperidol decanoate). This belongs to a group of medicines called ‘antipsychotics’. Haldol Decanoate is used in adults whose condition has previously been treated with haloperidol taken by mouth. It is used for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia). These illnesses may make you: • Feel confused (delirium) • See, hear, feel or smell things that are not there (hallucinations) • Believe things that are not true (delusions) • Feel unusually suspicious (paranoia) • Feel very excited, agitated, enthusiastic, impulsive or hyperactive • Feel very aggressive, hostile or violent. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HALDOL DECANOATE DO NOT USE HALDOL DECANOATE IF: • You are allergic to haloperidol or any of the other ingredients of this medicine (listed in secti Preberite celoten dokument
Health Products Regulatory Authority 03 November 2023 CRN00DK2N Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Haldol Decanoate 50mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 70.52 mg of haloperidol decanoate, equivalent to 50 mg of haloperidol base. Excipients with known effect: Each ml of solution contains 15 mg of benzyl alcohol and up to 1 ml of sesame oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Slightly amber, slightly viscous solution, free from visible foreign material. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HALDOL Decanoate is indicated for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment initiation and dose titration must be carried out under close clinical supervision. Posology The individual dose will depend on both the severity of the symptoms and the current oral haloperidol dose. Patients must always be maintained on the lowest effective dose. As the initial dose of haloperidol decanoate is based on a multiple of the daily oral haloperidol dose, specific guidance on switching from other antipsychotics cannot be provided (see section 5.1). _Adults aged 18 years and above_ TABLE 1: HALOPERIDOL DECANOATE DOSE RECOMMENDATIONS FOR ADULTS AGED 18 YEARS AND ABOVE TRANSITION FROM ORAL HALOPERIDOL A haloperidol decanoate dose of 10 to 15 times the previous daily dose of oral haloperidol is recommended. Based on this conversion, the haloperidol decanoate dose will be 25 to150 mg for most patients. CONTINUATION OF TREATMENT It is recommended to adjust the haloperidol decanoate dose by up to 50 mg every 4 weeks (based on individual patient response) until an optimal therapeutic effect is obtained. The most effective dose is expected to range between 50 and 200 mg. It is recommended to Preberite celoten dokument