PIVAINE 0.5% (w/v) ropivacaine hydrochloride (as monohydrate) 100 mg/20 mL solution for injection ampoule

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
28-11-2017

유효 성분:

ropivacaine hydrochloride monohydrate, Quantity: 105.8 mg

제공처:

Medis Pharma Pty Ltd

INN (International Name):

Ropivacaine hydrochloride monohydrate

약제 형태:

Injection, solution

구성:

Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide

관리 경로:

Epidural, Infiltration, Intracutaneous, Intradermal, Intramuscular, Intraneural, Subcutaneous, Mucosal

패키지 단위:

5 ampoules

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Surgical anaesthesia (Adults and children over 12 years of age),? epidural block for surgery including caesarean section,? intrathecal anaesthesia,? field block (minor nerve block and infiltration),? major nerve block,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 post operative pain management,? continuous wound infusion for postoperative pain management (adults only),Analgesia (Children aged 0 - 12 years),? 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.,There are no safety or efficacy data to support the use of ROPIVACAINE ACTAVIS 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).

제품 요약:

Visual Identification: clear colourless solution for injection; Container Type: Ampoule; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2013-02-27