APO-Remifentanil remifentanil (as hydrochloride) 5 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

remifentanil hydrochloride, Quantity: 5.485 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Remifentanil hydrochloride

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: glycine; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

5 x 5 mg

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.

Product summary:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-01-06