Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
hameln pharma gmbh
N02AA05
OXYCODONE HYDROCHLORIDE
10 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
oxycodone
Not marketed
2018-12-21
PACKAGE LEAFLET: INFORMATION FOR THE USER OXYCODONE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION OR INFUSION oxycodone hydrochloride 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 pharmacist. • 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. The name of your medicine is Oxycodone Hydrochloride 10 mg/ml solution for injection or infusion, which will be referred to as Oxycodone Injection throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Oxycodone Injection is and what it is used for 2. What you need to know before you use Oxycodone Injection 3. How to use Oxycodone Injection 4. Possible side effects 5. How to store Oxycodone Injection 6. Contents of the pack and other information 1. WHAT OXYCODONE INJECTION IS AND WHAT IT IS USED FOR This medicine has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or "painkillers". 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXYCODONE INJECTION DO NOT USE OXYCODONE INJECTION: • if you are allergic to oxycodone, or any of the other ingredients of this medicine (listed in section 6); • if you have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; • if you have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen; • if you have a heart problem after long-term lung disease (cor pulmonale); • if you have ongoing problems with constipation; • if you ar read_full_document
Health Products Regulatory Authority 20 March 2024 CRN00F4HR Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxycodone hydrochloride 10mg/ml solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains 10 mg oxycodone hydrochloride (equivalent to 9 mg oxycodone). Each 2 ml ampoule contains 20 mg oxycodone hydrochloride (equivalent to 18 mg oxycodone). Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially 'sodium-free'. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear colourless solution, practically free from visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxycodone is indicated in adults for the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. _Adults _ The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. Intravenous - Bolus Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours. Intravenous - Infusion Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended. Intravenous - Patient Controlled Analgesia (PCA) Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes. Subcutaneous - Bolus Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as re read_full_document