SOFENTIL Solution for injection / infusion Ref.[50941] Active ingredients: Sufentanil

Adults

Combination anesthesia and analgesia:

Analgesia: 0.5-5 micrograms/kg i.v.

Anesthetic: 25-50 micrograms/kg i.v.

Epidural analgesia in the treatment of postoperative pain: 25-50 micrograms.

Analgesic supplement at birth: 5-20 micrograms epidural.

Intravenous administration

To avoid bradycardia, it is recommended to administer a small intravenous dose of anticholinergic just prior to induction (see section 4.4).

Epidural administration

Proper placement of the needle or catheter in the epidural should be checked before Sofentil is injected.

Pediatric population

Intravenous administration

Children ≤1 month (neonates):

Due to the high variability of pharmacokinetic parameters in neonates, no reliable dose recommendations can be given. See also sections 4.4 and 5.2.

Children >1 month:

For all doses, to avoid bradycardia, premedication with an anticholinergic (such as atropine) is recommended, unless contraindicated.

Induction of anaesthesia:

Sofentil can be administered as a slow bolus injection of 0.2-0.5micrograms/kg over 30 seconds or longer in combination with an anaesthetic induction agent. In major surgery (e.g. cardiac surgery) doses up to 1 micrograms/kg can be administered.

Maintenance of anaesthesia in ventilated patients:

Sofentil can be administered as part of combined anaesthesia. Dosage depends on the dose of concomitant anaesthetic agents, type and duration of surgery. An initial dose of 0.3-2 micrograms/kg administered by slow bolus injection over at least 30 seconds may be followed by additional bolus injections of 0.1-1 micrograms/kg as required up to a total maximum of 5 micrograms/kg total for cardiac surgery.

Epidural administration

Sofentil must be administered to children epidurally only by anaesthesiologists who are specially trained in paediatric epidural anaesthesia and in the management of the respiratory depressant effects of opioids. Access to resuscitation equipment and opioid antagonists must be immediately available.

After epidural administration of Sofentil, paediatric patients must be monitored for signs of respiratory depression for at least 2 hours. The use of epidural administered sufentanil in paediatric patients has been documented in only a limited number of cases.

Children <1 year:

The safety and efficacy of sufentanil in children below 1 year have not yet been established (see also section 4.4 and 5.1).

Currently available data for children over 3 months are described in section 5.1 but no dosage recommendations on can be made. For newborns and infants below 3 months no data are available.

Children >1 year:

A single intra-operatively administered bolus dose of 0.25-0.75 micrograms/kg body weight sufentanil results in pain relief for a period of 1 to 12 hours. The duration of effective analgesia is influenced by the surgical procedure and concomitant administration of epidural amide-type local anaesthetics.

Elderly (65 years and over) and debilitated patients

As with other opioids, elderly and debilitated patients will require lower doses.

The intended total dose should be carefully titrated in patients with any of the following disorders:

• Non-compensated hypothyroidism
• Pulmonary disorders, particularly if vital capacity is reduced
• Alcoholism or hepatic and renal insufficiency (see also section 4.4).

Prolonged postoperative monitoring of these patients is also advisable.

Patients on chronic opioid treatment or with a history of opiate abuse may require higher doses.

Signs and symptoms

Overdose appears to be an extension of the pharmacological effects of sufentanil. Depending on individual sensitivity, the most serious significant effect of overdose is respiratory depression, which may be manifested at all grades, from bradypnoea to apnoea.

Treatment

In hypoventilation or apnoea, oxygen should be administered and respiration should be assisted or controlled as indicated. A specific opioid antagonist may be used to control respiratory depression. At the same time, immediate symptomatic countermeasures should also be taken. Because the duration of respiratory depression induced by sufentanil may last longer than the duration of the antagonist action, repeated doses of the antagonist may be necessary.

If respiratory depression is associated with muscle rigidity, administration of an intravenous neuromuscular blocking agent may be required to facilitate assisted or controlled respiration.

The patient should be closely monitored, and body warmth and fluid intake maintained. Hypovolaemia should be considered as a possible cause of severe or persistent hypotension. In this case, it should be controlled with appropriate parenteral fluid administration.

Shelf life prior to first opening:

30 months.

Shelf-life after first opening:

After first opening the medicinal product should be used immediately.

Shelf-life after dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C and at 2-8°C.

From a microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special temperature storage conditions.

Keep the ampoules in the outer carton, in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

Clear glass ampoules of 10 ml and 5 ml filling capacity respectively, Type I.

The ampoules are presented with an adhesive label and are secondarily packed in molded PVC trays (each tray contains 5 ampoules), sealed with PE foil.

The peel able membrane on PVC blisters is used only in the case of ampoules of 5 ml filling capacity.

Not all pack sizes may be marketed.

May be mixed with sodium chloride isotonic solution for infusion, glucose 5% solution for infusion and Ringer-lactate solution for infusion.

Wear gloves when opening the vial. Accidental exposure of the skin should be treated by rinsing the affected area with water. Avoid using soap, alcohol and other cleansers that may cause chemical or physical damage to the skin.