ROCAN 0.75% (w/v) ropivacaine hydrochloride (as monohydrate) 150 mg/20 mL solution for injection ampoule

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
28-11-2017

有効成分:

ropivacaine hydrochloride monohydrate, Quantity: 158.7 mg

から入手可能:

Medis Pharma Pty Ltd

INN(国際名):

Ropivacaine hydrochloride monohydrate

医薬品形態:

Injection, solution

構図:

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

投与経路:

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

パッケージ内のユニット:

5 ampoules

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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).

製品概要:

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

認証ステータス:

Registered

承認日:

2013-02-27