מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Ropivacaine Hydrochloride
Fresenius Kabi Deutschland GmbH
N01BB; N01BB09
Ropivacaine Hydrochloride
2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Amides; ropivacaine
Not marketed
2010-08-06
PACKAGE LEAFLET: INFORMATION FOR THE USER Ropivacaine 2 mg/ml solution for injection Ropivacaine 7.5 mg/ml solution for injection Ropivacaine 10 mg/ml solution for injection Ropivacaine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or any other healthcare professional. - If you get any side effects, talk to your doctor, nurse or any other healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. The full names of the medicines covered by this leaflet are: Ropivacaine 2 mg/ml solution for injection Ropivacaine 7.5 mg/ml solution for injection Ropivacaine 10 mg/ml solution for injection In this leaflet they are jointly referred to as Ropivacaine. WHAT IS IN THIS LEAFLET 1. What Ropivacaine is and what it is used for 2. What you need to know before you are given Ropivacaine 3. How to use Ropivacaine 4. Possible side effects 5. How to store Ropivacaine 6. Contents of the pack and other information 1. WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR • Ropivacaine contains a medicine called ropivacaine hydrochloride. • It belongs to a group of medicines called local anaesthetics. Ropivacaine 2 mg/ml solution for injection is used in adults and children of all ages for acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery. Ropivacaine 7.5 mg/ml solution for injection is used in adults and children above 12 years to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to: - Numb parts of the body during surgery, including having a baby by Caesarean section. - Relieve pain during childbirth, after surgery, or after an accident. Ropivacaine 10 mg/ml solution for injection is used in adults and children above 12 years to numb (anaesthetise) parts of the body during surgery. 2. WHAT YOU N קרא את המסמך השלם
Health Products Regulatory Authority 05 October 2023 CRN00DTJ1 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ropivacaine 2 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution for injection contains 2 mg ropivacaine hydrochloride. Each 10 ml ampoule contains 20 mg ropivacaine hydrochloride. Each 20 ml ampoule contains 40 mg ropivacaine hydrochloride. Excipient with known effect: Each 10 ml ampoule contains 1.48 mmol (or 34 mg) of sodium. Each 20 ml ampoule contains 2.96 mmol (or 68 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution with a pH of 4.0 to 6.0 and an osmolality between 255 and 305 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ropivacaine 2 mg/ml solution for injection is indicated for acute pain management: In adults and children above 12 years of age for - Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain - Field blocks - Continuous peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management In infants from 1 year and children up to and including 12 years of age for: - Single and continuous peripheral nerve block In neonates, infants and children up to and including 12 years for (per- and postoperative) - Caudal epidural block - Continuous epidural infusion 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia. POSOLOGY _ROPIVACAINE 2 MG/ML SOLUTION FOR INJECTION_ _ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE _ Health Products Regulatory Authority 05 October 2023 CRN00DTJ1 Page 2 of 12 The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician's experience and knowledge of the patient's physical status are of impo קרא את המסמך השלם