Country: Israel
Language: English
Source: Ministry of Health
ROPIVACAINE AS HYDROCHLORIDE
NEOPHARM (ISRAEL) 1996 LTD
N01BB09
SOLUTION FOR INJECTION
ROPIVACAINE AS HYDROCHLORIDE 2 MG/ML
PERINEURAL, EPIDURAL
Required
FRESENIUS KABI NORGE AS, NORWAY
ROPIVACAINE
Acute pain management :In adults and adolescents above 12 years of age for:- Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain.- Field blocks.- Peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management.
2022-05-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ropivacaine Fresenius 2 mg/ml solution for infusion Ropivacaine Fresenius 2 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ropivacaine Fresenius 2 mg/ml solution for infusion: 1 ml solution for infusion contains ropivacaine hydrochloride (as ropivacaine base) 2 mg (1.77mg). 1 bag of 100 ml contains ropivacaine hydrochloride 200 mg. 1 bag of 200 ml contains ropivacaine hydrochloride 400 mg. 1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg. Excipients: 1 ml contains 3.4 mg sodium. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ropivacaine Fresenius 2 mg/ml solution for infusion for epidural and perineural administration Ropivacaine Fresenius 2 mg/ml solution for injection for epidural and perineural administration Solution for injection/infusion - Clear , colorless and free from visible particles 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ropivacaine Fresenius 2 mg/ml solution for injection or infusion is indicated for: acute pain management: In adults and adolescents above 12 years of age for: Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain. Field blocks. Peripheral nerve block via continuous infusion or intermittent bolus injections, e.g: postoperative Ropivacaine Fresenius 2 mg/ml solution for injection: 1 ml solution for injection contains ropivacaine hydrochloride (as ropivacaine base)2 mg(1.77mg). 1 ampoule of 10 ml contains ropivacaine hydrochloride 20 mg. 1 ampoule of 20 ml contains ropivacaine hydrochloride 40 mg. 2 pain management. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For epidural and perineural use. Ropivacaine Hydrochloride should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia. ADULTS AND ADOLESCENT ABOVE 12 YEARS OF AGE POSOLOGY The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block sho Read the complete document