Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ROPIVACAINE HYDROCHLORIDE
Mercury Pharmaceuticals Ltd
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
2012-02-17
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(s) with known effect: Each 10 ml ampoule contains 1.47 mmol (or 33.9 mg) of sodium. Each 20 ml ampoule contains 2.95 mmol (or 67.8 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless, sterile, isotonic, isobaric aqueous solution for injection with a pH of 4.0 to 6.0. 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 : • 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 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 _ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE_ 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 importance when deciding the dose. INDICATION CONCENTRATION VOLUME DOSE ONSET DURATION 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Läs hela dokumentet