Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - ropivacaine hydrochloride - solution for injection - ropivacaine hydrochloride 7.5 mg/ml - anesthetics

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - ropivacaine hydrochloride - solution for injection - ropivacaine hydrochloride 10 mg/ml - anesthetics

Israel - English - Ministry of Health

mbi pharma ltd., israel - bupivacaine as hydrochloride anhydrous - solution for injection - bupivacaine as hydrochloride anhydrous 5 mg / 1 ml - bupivacaine - long acting local anaesthetic

Australia - English - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - bupivacaine hydrochloride monohydrate, quantity: 105.54 mg (equivalent: bupivacaine hydrochloride, qty 100 mg); adrenaline (epinephrine) acid tartrate, quantity: 182 microgram (equivalent: adrenaline (epinephrine), qty 100 microgram) - injection, solution - excipient ingredients: sodium metabisulfite; hydrochloric acid; sodium chloride; water for injections - bupivacaine 0.5% with adrenaline 1:200,000 phebra is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows:,surgical anaesthesia ? epidural block for surgery ? field block (minor and major nerve blocks and infiltration) analgesia ? intermittent bolus epidural administration for analgesia in postoperative pain or labour pain ? field block (minor nerve block and infiltration)

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - ropivacaine hydrochloride 10 mg/ml equivalent to ropivacaine 8.85 mg/ml;   - solution for injection - 10 mg/ml - active: ropivacaine hydrochloride 10 mg/ml equivalent to ropivacaine 8.85 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - analgesia (adults and children over 12 years of age) · continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain · field block (minor nerve block and infiltration) · continuous peripheral nerve block infusion or intermittent injections for postoperative pain management · continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0-12 years of age) · caudal epidural block in neonates (>37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years · continuous epidural infusion in infants (>30 days and over 2500 g weight) and children up to and including 12 years · peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - ropivacaine hydrochloride 2 mg/ml equivalent to ropivacaine 1.77 mg/ml;   - solution for injection - 2 mg/ml - active: ropivacaine hydrochloride 2 mg/ml equivalent to ropivacaine 1.77 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - analgesia (adults and children over 12 years of age) · continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain · field block (minor nerve block and infiltration) · continuous peripheral nerve block infusion or intermittent injections for postoperative pain management · continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0-12 years of age) · caudal epidural block in neonates (>37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years · continuous epidural infusion in infants (>30 days and over 2500 g weight) and children up to and including 12 years · peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - ropivacaine hydrochloride 5 mg/ml equivalent to ropivacaine 4.43 mg/ml;   - solution for injection - 5 mg/ml - active: ropivacaine hydrochloride 5 mg/ml equivalent to ropivacaine 4.43 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - analgesia (adults and children over 12 years of age) · continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain · field block (minor nerve block and infiltration) · continuous peripheral nerve block infusion or intermittent injections for postoperative pain management · continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0-12 years of age) · caudal epidural block in neonates (>37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years · continuous epidural infusion in infants (>30 days and over 2500 g weight) and children up to and including 12 years · peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - ropivacaine hydrochloride 7.5 mg/ml equivalent to ropivacaine 6.64 mg/ml;   - solution for injection - 7.5 mg/ml - active: ropivacaine hydrochloride 7.5 mg/ml equivalent to ropivacaine 6.64 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - analgesia (adults and children over 12 years of age) · continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain · field block (minor nerve block and infiltration) · continuous peripheral nerve block infusion or intermittent injections for postoperative pain management · continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0-12 years of age) · caudal epidural block in neonates (>37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years · continuous epidural infusion in infants (>30 days and over 2500 g weight) and children up to and including 12 years · peripheral nerve block in children aged 1 up to and including 12 years for peri- and postoperative pain management