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Country of origin : Switzerland

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remifentanil

Vials, lyophilized injection 1 mg, 2 mg, 5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Switzerland
GMP approvals
EU GMP
Unavailable markets
Austria , Brazil , Canada , Chile , Colombia , Denmark , Finland , France , Germany , Greece , Ireland , Israel , Italy , Jordan , Kuwait , Lebanon , Mexico , Netherlands , Norway , Panama , Portugal , Saudi Arabia , Spain , Sweden , Switzerland , Turkey , United Arab Emirates , United Kingdom , Venezuela , Yemen
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Worldwide excluding the below mentioned countries:Yemen, Bahrain, Oman, Hong Kong, Indonesia, Malaysia, Pakistan, Singapore, Sri Lanka, Vietnam, New Zealand, Australia, Thailand, Taiwan, Philippines Libya, Kenya, Egypt, South Africa
Manufacturer #8501

A pharmaceutical manufacturer based in Europe that has been active in 10+ countries selling its products in Europe, North America, and Asia for 100+ years. The company's production lines are cGMP-compliant. The main dosage forms include injectable and oral solid. The company possesses manufacturing facilities in Europe, North America, and Asia.

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Remifentanil

Remifentanil is short-acting and a potent synthetic opioid analgesic. It is used in surgeries to relieve pain and as an adjunct to an Anaesthetic. It is used to sedate and combined with other medications in inducing general anesthesia. Remifentanil potentiates the use of high-dose opioids and low-dose hypnotic anesthesia, using the synergy between itself and other hypnotic drugs and volatile anesthetics. Remifentanil was meant to be a strong anesthetic with the shortest and predictable duration, without causing accumulation issues. As a specific mu-type- opioid receptor agonist, it reduces sympathetic nervous system tone and leads to respiratory depression and analgesia. Remifentanil is sold under the brand Names Ultiva among others. Glaxo Wellcome Inc. filed its Remifentanil patent and was FDA approved in 1996.

Dosage and administration

Remifentanil is sold as Injection, powder, lyophilized, for the solution of 1mg, 2mg & 5mg vials. For inducing Anesthesia, the adult is given a dose of 0.5-1 mcg per kg per minute, through an IV until after intubation, and could be given an initial dose of 1 mcg per kg if intubation is needed less than 8 min after the start of infusion. This is followed by a maintenance dose of 0.25-0.5 mcg per kg per minute through an IV and if using bolus with 0.5-1 mcg per kg over 2-5 minutes for inducing light anesthesia or transient episodes of intense surgical stress. For inducing Conscious Analgesia, the dose is 1 mcg per kg, through an IV bolus, followed by a maintenance dose of 0.05-0.2 mcg per kg per min and for Analgesia in the Immediate Post-Op Period, the dose is 0.025-0.2 mcg per kg per min, through an IV.

The Price of Remifentanil

In the USA, the consumer has to pay around $550 for a supply of 10 powder for injection of 1 mg. the average price of Remifentanil API is around $187,211per kilogram of the powder.

How does it work?

Remifentanil is the fastest acting, rapid onset, and peak effect µ-opioid agonist with a short duration of action. The µ-opioid activity antagonized by opioid antagonists like naloxone. However, the analgesic effects, results, and side effects are dependent on the dose and similar to other opioids. Remifentanil rapid blood-brain equilibration of half-time of 1 ± 1 minutes with a rapid onset of action.

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