Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DROPERIDOL
Kyowa Kirin Ltd
N05AD08
DROPERIDOL
2.5 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
droperidol
Marketed
2008-02-29
PACKAGE LEAFLET: INFORMATION FOR THE USER XOMOLIX 2.5 MG/ML SOLUTION FOR INJECTION Droperidol 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 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 Xomolix is and what it is used for 2. What you need to know before you are given Xomolix 3. How you will be given Xomolix 4. Possible side effects 5. How to store Xomolix 6. Contents of the pack and other information 1. WHAT XOMOLIX IS AND WHAT IT IS USED FOR Xomolix is a solution for injection containing the active substance droperidol, which belongs to a group of antipsychotics called butyrophenone derivatives. Xomolix is used to prevent you feeling sick (nausea) or vomiting when you wake up after an operation or when you receive morphine based painkillers after an operation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN XOMOLIX YOU SHOULD NOT BE GIVEN XOMOLIX IF YOU: are allergic to droperidol, or any of the other ingredients of this medicine (listed in section 6). are allergic to a group of medicines used to treat psychiatric disorders, called butyrophenones (e.g. haloperidol, triperidol, benperidol, melperone, domperidone) or anyone in your family have an abnormal electrocardiogram (ECG) heart tracing have low levels of potassium or magnesium in your blood have a pulse rate of less than 55 beats per minute (the doctor or nurse will check this), or are taking any medicines that could cause this to happen have a tumour in your adrenal gland (phaeochromocytoma) are in a coma have Parkinson’s disease have severe depression WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Xomolix: if you have epilepsy, or a history of epilepsy if you Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xomolix 2.5 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of the solution contains 2.5 mg droperidol. Excipient with known effect: sodium < 23 mg per ml (see section 4.4 for further details). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution, free from visible particles. The pH of droperidol solution for injection is 3.0 – 3.8 and has an osmolarity of approximately 300 millimosmol /kg water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xomolix is indicated in: Prevention and treatment of post-operative nausea and vomiting (PONV) in adults and, as second line, in children (2 to 11 years) and adolescents (12 to 18 years). Prevention of nausea and vomiting induced by morphine and derivatives during post-operative patient controlled analgesia (PCA) in adults. Certain precautions are required when administering droperidol: see sections 4.2, 4.3, and 4.4. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prevention and treatment of post-operative nausea and vomiting (PONV). _Adults_: 0.625 mg to 1.25 mg (0.25 to 0.5 ml). _Elderly (over 65 years):_ 0.625 mg (0.25 ml) _Renal/hepatic impairment:_ 0.625 mg (0.25 ml) _Paediatric population_ _Children (2 to 11 years) and adolescents (12 to 18 years):_ 10 to 50 microgram/kg (up to a maximum of 1.25 mg). _Children (below the age of 2 years):_ not recommended. Administration of droperidol is recommended 30 minutes before the anticipated end of surgery. Repeat doses may be given every 6 hours as required. The dosage should be adapted to each individual case. The factors to be considered here include age, body weight, use H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Prečítajte si celý dokument