Ultiva 1mg. 2mg. 5mg Injection

ULTIVA is indicated as a narcotic analgesic or adjuvant for use during induction and/or maintenance of inhalational anaesthesia during surgical procedures, including cardiac surgery. ULTIVA is indicated for the provision of analgesia and as an aid to sedation (up to 72 hours sedation) in mechanically ventilated intensive care patients. Safety and efficacy beyond 72 hours has not been demonstrated.

As glycine is present in the formulation, ULTIVA is contra-indicated for epidural and intrathecal use. Known hypersensitivity to any component of the preparation and other fentanyl analogues. Safety in pregnancy and lactation has not been established. ULTIVA should not be used with nitrous oxide and oxygen alone at altitudes above sea level. ULTIVA should not be used unless artificial ventilation is planned.

ULTIVA is not recommended for use as the sole agent in general anaesthesia. ULTIVA should be administered only by persons specifically trained in the use of anaesthetic medicines and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation such as the establishment and maintenance of a patent airway and assisted ventilation.

Inadvertent administration: A sufficient amount of ULTIVA may be present in the dead space of the IV line and/or cannula to cause respiratory depression, apnoea and/or muscle rigidity if the line is flushed with IV fluids or other medicines. This may be avoided by administering ULTIVA into a fast-flowing IV line or via a dedicated IV line, which is adequately cleared of residual medicine or which is removed upon discontinuation of ULTIVA. ULTIVA may produce dependency.

ULTIVA is not metabolised by plasma cholinesterase and therefore interactions with medication metabolised by this enzyme are not anticipated. ULTIVA decreases the amounts or doses of inhaled and IV anaesthetics and benzodiazepines required for anaesthesia. If doses of concomitantly administered CNS depressant medicines are not reduced, patients may experience an increased incidence of adverse effects associated with these agents. The cardiovascular effects of ULTIVA (hypotension and bradycardia), may be exacerbated in patients receiving concomitant cardiac depressant medicines, such as beta-blockers and calcium channel blocking agents.

The safety profile of ULTIVA during labour or delivery has not been demonstrated. There are insufficient data to recommend ULTIVA for use during labour and caesarean section. Remifentanil crosses the placental barrier and fentanyl analogues can cause respiratory depression in the child.

If an early discharge is envisaged following treatment using anaesthetic agents, patients should be advised not to drive or operate machinery.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as very common ( u2265 1/10), common ( u2265 1/100 and <1/10), uncommon ( u2265 1/1 000 and <1/100), rare ( u2265 1/10 000 and <1/1 000) and very rare (<1/10 000).

Nervous System Disorders: Very common: skeletal muscle rigidity Rare: sedation (during recovery from general anaesthesia)

Cardiac Disorders: Common: bradycardia

Vascular Disorders: Very common: hypotension Common: post-operative hypertension

Respiratory, Thoracic and Mediastinal Disorders: Common: acute respiratory depression, apnoea Uncommon: hypoxia

Gastrointestinal Disorders: Very common: nausea, vomiting Uncommon: constipation

Skin and Subcutaneous Tissue Disorders: Common: pruritus

General Disorders and Administration Site Conditions: Common: post-operative shivering Uncommon: post-operative aches These adverse events resolve within minutes of discontinuing or decreasing the rate of ULTIVA administration.

Symptoms and signs: Overdose would be manifested by an extension of the pharmacological actions of ULTIVA i.e. respiratory depression, bradycardia, hypotension and skeletal muscle rigidity. Due to the very short duration of action of ULTIVA, the potential for overdose is limited to the immediate time period following administration. Response to discontinuation is rapid with return to baseline within ten minutes.

Treatment: In the event of overdosage, the following actions are to be taken: - discontinue administration of ULTIVA - maintain a patent airway - initiate assisted or controlled ventilation with oxygen - maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressor agents for the treatment of hypotension and other supportive measures may be employed. Intravenous administration of an opioid antagonist such as naloxone may be given to manage severe respiratory depression and muscle rigidity. The duration of respiratory depression following overdose with ULTIVA is unlikely to exceed the duration of action of the opioid antagonist.