DEXISUN Concentrated solution for infusion Ref.[50700] Active ingredients: Dexmedetomidine

NOTE: DEXISUN should be administered only by healthcare professionals skilled in the management of patients in the intensive care setting. Continuous monitoring of vital signs, in particular blood pressure, heart rate and oxygen saturation is mandatory during infusion of DEXISUN.

In order to minimise undesirable pharmacologic side effects, bolus injection of DEXISUN should not be used.

Clinically significant events of bradycardia and sinus arrest have been associated with dexmedetomidine hydrochloride administration in young healthy volunteers with high vagal tone, or with different routes of administration including rapid intravenous or bolus administration of dexmedetomidine hydrochloride.

DEXISUN should be administered by continuous intravenous infusion not to exceed 24 hours. Fluid supplementation should be administered prior to and during administration of DEXISUN to ensure normovolaemia.

DEXISUN has been administered to patients requiring mechanical ventilation as well as to patients breathing spontaneously after extubation. There is no respiratory depression associated with the administration of DEXISUN. Patients receiving DEXISUN have been observed to be arousable and alert when stimulated. This is an expected component of dexmedetomidine sedation and should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms. DEXISUN has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post extubation. It is not necessary to discontinue DEXISUN prior to extubation.

Posology

Adults

ICU Sedation

DEXISUN dosage should be individualised and titrated to the desired clinical effect.

Initiation:

For adult patients, it is recommended to initiate DEXISUN with a loading dose of 1,0 microgram/kg over ten minutes.

Maintenance of ICU Sedation:

Adult patients will generally require a maintenance infusion in the range of 0,2 to 0,7 micrograms/kg/h. The rate of the maintenance infusion can be adjusted in order to achieve the desired clinical effect. Dosages as low as 0,05 micrograms/kg/h have been used in clinical studies.

A dose reduction for both the loading and maintenance infusions should be considered in patients with impaired hepatic or renal function and in patients over 65 years of age (see sections 4.3, 4.4 and 5.2).

Conscious Sedation

Monitored anaesthesia care (MAC) with an adequate nerve block and awake fibreoptic intubation (AFI).

DEXISUN dosing should be individualised and titrated to the desired clinical effect.

Initiation:

For adult patients, DEXISUN is generally initiated with a loading infusion of 1 (one) mcg/kg over 10 minutes.

For patients over 65 years of age or those undergoing less invasive procedures such as ophthalmic surgery, a loading infusion of 0,5 mcg/kg over 10 minutes may be suitable.

Maintenance of Conscious Sedation:

MAC – Following the load, maintenance dosing of DEXISUN should generally be initiated at 0,6 mcg/kg/h and titrated to achieve desired clinical effect with doses ranging from 0,2 to 1 mcg/kg/h for all procedures. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.

AFI – Following the load in awake fibreoptic intubation, a fixed maintenance dose of 0,7 mcg/kg/h should be used.

Special populations

Elderly

Since the elderly are more sensitive to the effects of DEXISUN dosage reductions may need to be considered (see section 5.2).

Impaired Hepatic Function

Dosage reductions may need to be considered for patients with hepatic impairment, as DEXISUN is metabolised primarily in the liver (see section 4.4 and 5.2).

Impaired Renal Function

Since the majority of metabolites are excreted in the urine, dosage reductions may need to be considered for patients with renal impairment (see section 5.2).

Paediatric population

Safety and efficacy of DEXISUN has not been studied in children and adolescents and is therefore not recommended for patients under 18 years of age (see section 5.2).

Dosage Adjustment

Due to possible pharmacodynamics interactions a reduction in dosage of DEXISUN or other concomitant anaesthetics, sedatives, hypnotics or opioids may be required when coadministered (see section 4.5).

Method of administration

For IV infusion only.

A controlled infusion device should be used to administer DEXISUN.

Parenteral products should be inspected visually for particulate matter and discolouration prior to administration.

Vials are intended for single patient use only.

For information on instructions for preparation or reconstitution see section 6.6.

DEXISUN must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.

First-degree AV block and second-degree heart block may occur. Bradycardia, with or without hypotension, and cardiac arrest may occur. Because DEXISUN has the potential to augment bradycardia induced by vagal stimuli, medical practitioners should be prepared to intervene. In clinical trials, atropine and glycopyrrolate were effective in the treatment of DEXISUN-induced bradycardia (see section 4.8).

24 Months.

Store at or below 25°C in the original container.

Do not refrigerate.

Once diluted, the diluted solution should be used immediately. If not used immediately, the diluted solution may be stored at 2–8°C during the 24 hour “in use” period. Discard any unused diluted solution after 24 hours.

Keep out of reach of children.

DEXISUN is packed in a 2 ml tubular, USP type 1 flint glass vial, with a 13 mm Teflon coated grey rubber stopper and a 13 mm pink aluminium flip-off seal, in a outer carton. Each carton contains 1 or 5 vials.

Preparation of Solution

Strict aseptic technique must always be maintained during handling of DEXISUN infusion.

Preparation of infusion solutions is the same, whether for the loading dose or for the maintenance dose.

To prepare the infusion, withdraw 2 ml of DEXISUN concentrate and add to 48 ml of 0,9% sodium chloride solution to total 50 ml. Shake gently to mix well.

After dilution, DEXISUN is intended for immediate use and should be discarded after 24 hours.

Administration with other fluids

DEXISUN has been shown to be compatible when administered with the following intravenous fluids and medicines:

Lactated Ringers, 5% Dextrose in Water, 0,9% Sodium Chloride in Water, 20% Mannitol, thiopental sodium, etomidate, vercuronium, bromide, succinylcholine, atracurium besylate, mivacurium chloride, glycopyrrolate bromide, phenylephrine HCL, atropine sulphate, midazolam, morphine sulphate, fentanyl citrate and a plasma-substitute (i.e. Haemacel).

Compatability studies have shown potential for adsorption of DEXISUN to some types of natural rubber. Although DEXISUN is dosed to effect, it is advisable to use components with synthetic or coated natural rubber gaskets.

DEXISUN must not be mixed with other medicinal products or diluents except those mentioned above.