Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
OXYCODONE HYDROCHLORIDE
Pinewood Laboratories Ltd
N02AA; N02AA05
OXYCODONE HYDROCHLORIDE
50 milligram(s)/millilitre
Solution for injection/infusion
Natural opium alkaloids; oxycodone
Not marketed
2013-08-09
PACKAGE LEAFLET: INFORMATION FOR THE USER Oxycodone Hydrochloride 50 mg/ml Solution for Injection or Infusion 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. THE NAME OF YOUR MEDICINE IS OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION. IN THE REST OF THIS LEAFLET IT IS CALLED OXYCODONE INJECTION. 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 injection has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which is a strong analgesic (‘painkiller’) which belongs to a group of medicines called opioids. The other ingredients are listed in section 6 of this leaflet. 2. What you need to know before you use Oxycodone Injection DO NOT USE OXYCODONE INJECTION IF YOU: • are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the Injection (listed in section 6) or have previously had an allergic reaction when taking other strong analgesics or painkillers (such as morphine or other opioids); • have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than exp Preberite celoten dokument
Health Products Regulatory Authority 19 March 2024 CRN00DT3X Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxycodone hydrochloride 50mg/ml solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains oxycodone hydrochloride 50 mg (equivalent to 45 mg of oxycodone base). This medicinal product contains less than 1 mmol sodium (23 mg) per dose. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion (injection or infusion). A clear, colourless solution practically free of particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 ROUTE OF ADMINISTRATION: Subcutaneous injection or infusion. Intravenous injection or infusion. POSOLOGY: Prescribers should consider concomitant treatment with antiemetics and laxatives for the prevention of nausea, vomiting and constipation. The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. _Adults over 18 years:_ The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. i.v. (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 one to two minutes in opioid naive patients. Doses should not be administered more frequently than every four hours. i.v. (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 for opioid naive patients. Health Products Regulatory Authority 19 March 2024 CRN00DT3X Page 2 of 11 i.v. (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 l Preberite celoten dokument