국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
HYDROMORPHONE HYDROCHLORIDE
Ethypharm
N02AA; N02AA03
HYDROMORPHONE HYDROCHLORIDE
20 milligram(s)/millilitre
Solution for injection/infusion
Natural opium alkaloids; hydromorphone
Marketed
2005-10-28
PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROMORPHONE HYDROCHLORIDE 20MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION HYDROMORPHONE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION Hydromorphone Hydrochloride (referred to as Hydromorphone Injection in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN HYDROMORPHONE INJECTION 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hydromorphone Injection is and what it is used for 2. What you need to know before you are given Hydromorphone Injection 3. How Hydromorphone Injection is given 4. Possible side effects 5. How to store Hydromorphone Injection 6. Contents of the pack and other information 1. WHAT HYDROMORPHONE INJECTION IS AND WHAT IT IS USED FOR Hydromorphone hydrochloride, the active ingredient in Hydromorphone Injection, is a powerful pain killer. Hydromorphone Injection is used to treat long lasting severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYDROMORPHONE INJECTION YOU SHOULD NOT BE GIVEN HYDROMORPHONE INJECTION IF: • you are allergic to hydromorphone hydrochloride or to any of the other ingredients in this medicine, (listed in section 6) • have severe pain in your abdomen; • have a condition where the small bowel does not work properly(paralytic ileus); • you suffer from any breathing difficulties or problems with your lungs such as severe chronic obstructive pulmonary disease, cor pulmonale (a heart condition caused by lung disease), • you are taking or have recently (in the last two weeks) taken any medicines used to treat depression known as Monoamine Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines’). WARNINGS AND PRECAUTIONS Talk to 전체 문서 읽기
Health Products Regulatory Authority 03 March 2020 CRN009CR4 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml ampoule contains 20mg Hydromorphone Hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Concentrate for solution for infusion A clear colourless solution for injection in Type I glass ampoules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of severe pain in cancer. Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion is indicated in adults and adolescents aged >12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosing of Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion has to be adjusted to the patients' severity of pain and to their individual response. The dose should be titrated until optimum analgesic effect is achieved While the dose to be administered should be sufficient to achieve appropriate analgesia, the aim should also be to keep the dose as small as possible in the individual case. Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion should not be administered longer than absolutely necessary. If long-term treatment is required careful and regular monitoring should control whether and to what degree further treatment is necessary. When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the daily dose gradually to prevent withdrawal symptoms. Hydromorphone Hydrochloride 20 mg/ml Solution for Injection / Concentrate for Solution for Infusion is not suitable for initial opioid therapy. Higher strengths may only be used as individual doses in patients who have no longer sufficiently responded to lower doses of hydromorphone preparations or comparably st 전체 문서 읽기