Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Haloperidol
Janssen Sciences Ireland UC
N05AD; N05AD01
Haloperidol
50 milligram(s)/millilitre
Solution for injection
Butyrophenone derivatives; haloperidol
Marketed
1993-10-10
. . . READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 eff ects, talk to your doctor, pharmacist or nurse. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET 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 EFF ECTS 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 aff ecting 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 section 6) • You are allergic to sesame oil. Haldol Decanoate contains sesame oil. See ‘Haldol Decanoate contains’ below • You are less aware of things around you or Leggi il documento completo
HealthProductsRegulatoryAuthority 10June2019 CRN008JQQ Page1of15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT HaldolDecanoate50mg/mlSolutionforInjection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachmlofsolutioncontains70.52 mgofhaloperidoldecanoate,equivalentto50 mgofhaloperidolbase. Excipientswithknowneffect: Eachmlofsolutioncontains15 mgofbenzylalcoholandupto1 mlofsesameoil. Forthefulllistofexcipients,seesection 6.1. 3 PHARMACEUTICAL FORM Solutionforinjection. Slightlyamber,slightlyviscoussolution,freefromvisibleforeignmaterial. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HALDOLDecanoateisindicatedforthemaintenancetreatmentofschizophreniaandschizoaffectivedisorderinadultpatients currentlystabilisedwithoralhaloperidol(seesection 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatmentinitiationanddosetitrationmustbecarriedoutundercloseclinicalsupervision. Posology Theindividualdosewilldependonboththeseverityofthesymptomsandthecurrentoralhaloperidoldose.Patientsmust alwaysbemaintainedonthelowesteffectivedose. Astheinitialdoseofhaloperidoldecanoateisbasedonamultipleofthedailyoralhaloperidoldose,specificguidanceon switchingfromotherantipsychoticscannotbeprovided(seesection 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 Ahaloperidoldecanoatedoseof10to15 timesthepreviousdailydoseoforalhaloperidolisrecommended. Basedonthisconversion,thehaloperidol Leggi il documento completo