Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - remifentanil hydrochloride - powder for concentrate for solution for injection/infusion - 1 milligram(s) - opioid anesthetics; remifentanil

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - remifentanil hydrochloride - powder for concentrate for solution for injection/infusion - 2 milligram(s) - opioid anesthetics; remifentanil

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - remifentanil hydrochloride - powder for concentrate for solution for injection/infusion - 5 milligram(s) - opioid anesthetics; remifentanil

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 1.097 mg - injection, powder for - excipient ingredients: glycine; hydrochloric acid - 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.

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 5.485 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - 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.

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 2.194 mg - injection, powder for - excipient ingredients: glycine; hydrochloric acid - 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.

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 1.097 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - 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.

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 2.194 mg - injection, powder for - excipient ingredients: glycine; hydrochloric acid - 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.

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

arrotex pharmaceuticals pty ltd - remifentanil hydrochloride, quantity: 5.485 mg - injection, powder for - excipient ingredients: glycine; hydrochloric acid - 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.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - remifentanil hydrochloride (unii: 5v444h5wic) (remifentanil - unii:p10582jyyk) - remifentanil 1 mg in 1 ml - remifentanil hydrochloride (hcl) for injection is indicated for intravenous (iv) administration: - as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. - for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. - as an analgesic component of monitored anesthesia care in adult patients. remifentanil hcl is contraindicated: - for epidural or intrathecal administration due to the presence of glycine in the formulation [see nonclinical toxicology (13)] . - in patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see adverse reactions (6.2)] . risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with remifentanil hydrochloride in pregnant women are insufficient to