Country: Israel
Language: English
Source: Ministry of Health
ROPIVACAINE HYDROCHLORIDE
BIOAVENIR LTD, ISRAEL
N01BB09
SOLUTION FOR INFUSION
ROPIVACAINE HYDROCHLORIDE 2 MG/ML
EPIDURAL, PERINEURAL
Required
L.MOLTENI & C. DEI F.LLI ALITTI,ITALY
ROPIVACAINE
In adults and adolescents above 12 years of age for: - Continuous epidural infusion or intermittent bolus administration during post-operative or labour pain. - Field blocks. - Peripheral nerve blocks via continuous infusion or intermittent bolus injections, e.g. postoperative pain management.
2020-03-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ropivacaine BioAvenir 2 mg/ml solution for infusion Ropivacaine BioAvenir 2 mg/ml solution for injection Ropivacaine BioAvenir 7.5 mg/ml solution for injection Ropivacaine BioAvenir 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ropivacaine BioAvenir 2 mg/ml solution for infusion: 1 ml solution for infusion contains ropivacaine hydrochloride 2 mg. 1 bag of 100 ml contains ropivacaine hydrochloride 200 mg. 1 bag of 200 ml contains ropivacaine hydrochloride 400 mg. Ropivacaine BioAvenir 2 mg/ml solution for injection: 1 ml solution for injection contains ropivacaine hydrochloride 2 mg. 1 ampoule of 10 ml contains ropivacaine hydrochloride 20 mg. 1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg. Ropivacaine BioAvenir 7.5 mg/ml solution for injection: 1 ml solution for injection contains ropivacaine hydrochloride 7.5 mg. 1 ampoule of 10 ml contains ropivacaine hydrochloride 75 mg. 1 ampoule of 20 ml contains ropivacaine hydrochloride 150 mg. Ropivacaine BioAvenir 10 mg/ml solution for injection: 1 ml solution for injection contains ropivacaine hydrochloride 10 mg. 1 ampoule of 10 ml contains ropivacaine hydrochloride 100 mg. 1 ampoule of 20 ml contains ropivacaine hydrochloride 200 mg. Excipients: 1 ml contains 3 mg sodium. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ropivacaine BioAvenir 2 mg/ml solution for infusion 2 Ropivacaine Bioavenir 2 mg/ml, 7.5 mg/ml, 10 mg/ml solution for injection for epidural and perineural administration Solution for injection - Sterile, clear, colourless, isotonic, aqueous solution with pH between 4.0-6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ropivacaine BioAvenir 2mg/ml solution for injection is indicated for acute pain management: In adults and adolescents above 12 years of age for: Continuous epidural infusion or intermittent bolus administration during post operative or labour pain. Field blocks. Peripheral nerve block via continuous Read the complete document