Sufentanil Hiesi

Leaflet attached to the packaging: information for the user

Sufentanil Chiesi, 50 micrograms/ml, solution for injection

Sufentanil

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

• 1. What Sufentanil Chiesi is and what it is used for
• 2. Important information before using Sufentanil Chiesi
• 3. How to use Sufentanil Chiesi
• 4. Possible side effects
• 5. How to store Sufentanil Chiesi
• 6. Contents of the pack and other information

1. What Sufentanil Chiesi is and what it is used for

Sufentanil Chiesi is a narcotic analgesic from the opioid group, containing sufentanil as the active ingredient. It is used in surgical procedures as an anesthetic and analgesic.

Sufentanil Chiesi is intended for use only in a hospital setting.

2. Important information before using Sufentanil Chiesi

When not to use Sufentanil Chiesi:

• If the patient has been diagnosed with an allergy (hypersensitivity) to sufentanil or any of the other ingredients of Sufentanil Chiesi.
• If the patient has been diagnosed with an allergy to other painkillers from the group of morphine derivatives.
• If the patient has a known intolerance to any of the ingredients of the medicine or other medicines similar to morphine.
• Intravenously during labor or before clamping the umbilical cord during a cesarean section.
• If the patient should avoid the use of drugs that depress the respiratory center.
• If the patient has acute hepatic porphyria.
• If the patient is currently being treated or has been treated in the last 14 days with a drug from the group of MAO inhibitors (used in the treatment of depression).

Warnings and precautions

Before starting treatment, discuss with your doctor or nurse:

• if the patient has lung disease or breathing difficulties;
• if the patient has hypothyroidism;
• if the patient has heart problems;
• if the patient has low blood pressure or too little blood circulating, e.g. due to bleeding;
• if the patient has liver or kidney problems;
• if the patient has abnormal bowel movements;
• if the patient has gallbladder or pancreas disease;
• if the patient has headaches or has had a head injury;
• if the patient has been taking opioids for a long time.

DURING the use of Sufentanil Chiesi, consult a doctor:

• if the patient experiences pain or increased sensitivity to pain (hyperalgesia) and does not respond to a higher dose of the prescribed medicine.

Before starting Sufentanil Chiesi, discuss with your doctor or pharmacist:

• if the patient or any of their relatives have ever abused alcohol, prescription drugs, or narcotics ("addiction");
• if the patient smokes;
• if the patient has ever had mood problems (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental illnesses.

This medicine contains sufentanil, which is an opioid medicine. Repeated use of opioid painkillers can lead to the medicine becoming less effective (the patient gets used to it). This can also lead to addiction and abuse of the medicine, which can result in life-threatening overdose. If the patient is concerned about the possibility of addiction to Sufentanil Chiesi, it is essential to consult a doctor.

Sufentanil can significantly depress the patient's respiratory function. Therefore, medical staff should closely monitor the patient and ensure easy access to life-support equipment, and possibly administer a medicine with an effect opposite to that of opioids (naloxone).

Respiratory disorders associated with sleep

Sufentanil Chiesi may cause respiratory disorders associated with sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms of these disorders may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If these symptoms are observed, a doctor should be consulted. The doctor may consider reducing the dose.

Administration of sufentanil may cause cardiac arrest or cardiac arrhythmias, and may increase muscle tension. To prevent these symptoms, the doctor will take appropriate measures, and if they occur, will provide appropriate treatment.

Rapidly recurring muscle spasms may occur.

In elderly and debilitated patients, it is recommended to reduce the dose of Sufentanil Chiesi, as they may be more sensitive to the effects of the medicine.

Data on intravenous administration of sufentanil in small children are limited, so before using this medicine in newborns and small children, the expected benefits should be carefully weighed against the possible risks.

Due to its properties similar to those of morphine, sufentanil may cause addiction. Addiction will not develop if sufentanil is used only for surgery as an anesthetic. However, it may occur after prolonged use in intensive care units to relieve pain.

Sufentanil Chiesi and other medicines

Tell your doctor or nurse about all medicines you are taking, have recently taken, or plan to take.

Some medicines may affect the way Sufentanil Chiesi works, or increase the risk of side effects.

Tell your doctor or nurse if you are taking:

• Medicines that may cause drowsiness, such as barbiturates, benzodiazepines, neuroleptics, halogenated general anesthetics, and other medicines that act on the central nervous system (e.g., alcohol), as they may increase the risk of respiratory depression.
• Antidepressant medicines called monoamine oxidase inhibitors (MAOIs); these medicines must not be taken within 2 weeks before or at the same time as Sufentanil Chiesi.
• Antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). It is not recommended to take these medicines with Sufentanil Chiesi.
• Medicines used to treat epilepsy, neuralgia, or anxiety (gabapentin and pregabalin), as they may increase the risk of opioid overdose and respiratory depression, which can be life-threatening.
• Ketoconazole and fluconazole (medicines used to prevent and treat skin and fungal infections), as well as ritonavir (a medicine used to treat HIV infection). These medicines may slow down the breakdown of Sufentanil Chiesi.

Concomitant use of sufentanil and muscle relaxants: vecuronium or suxamethonium may cause a decrease in heart rate, especially if the heart rate was already slow (e.g., in patients taking heart medications: calcium channel blockers or beta-blockers).

Concomitant use of high doses of sufentanil and nitrous oxide may lead to a decrease in blood pressure and cardiac arrhythmias, including a decrease in heart rate.

Sufentanil Chiesi with food, drink, or alcohol

Alcohol should be avoided, as it may increase the side effects of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. The doctor will weigh the possible risks and benefits of using Sufentanil Chiesi during pregnancy.

Intravenous administration of sufentanil during labor, as well as before clamping the umbilical cord during a cesarean section, is contraindicated, as it may cause respiratory depression in the newborn.

Sufentanil passes into breast milk. Consult your doctor before breastfeeding.

Driving and using machines

After administration of Sufentanil Chiesi, do not drive or operate machinery after discharge from the hospital for a period determined by your doctor, as the medicine may cause dizziness and drowsiness.

Sufentanil Chiesi contains sodium

Sufentanil Chiesi contains 3.54 mg of sodium (the main component of common salt) per milliliter of solution. The medicine contains 17.7 mg of sodium in a 5 ml ampoule. This corresponds to 0.89% of the maximum recommended daily intake of sodium in the diet for adults.

The medicine contains 70.8 mg of sodium in a 20 ml ampoule. This corresponds to 3.54% of the maximum recommended daily intake of sodium in the diet for adults.

This should be taken into account when administering large volumes of the solution (e.g., more than 6.5 ml, corresponding to more than 1 mmol of sodium) to patients with reduced kidney function or to patients controlling their sodium intake.

The medicine may be diluted in a 0.9% NaCl solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, refer to the product characteristics of the diluent used.

3. How to use Sufentanil Chiesi

This medicine is not intended for self-administration by the patient. The medicine will always be administered to the patient by a qualified and authorized person.

The medicine is administered by slow intravenous injection or continuous intravenous infusion.

The doctor will decide on the amount and frequency of administration of the medicine to the patient, depending on the patient's health condition and response to treatment.

The doctor may decide to discontinue the infusion in case of a mechanical obstruction (e.g., blockage of the tube, needle, or catheter).

It is essential to use this medicine exactly as directed. Using Sufentanil Chiesi may lead to addiction. Do not administer it more frequently or for a longer period than prescribed by your doctor.

Using a higher dose of Sufentanil Chiesi than recommended

Sufentanil is used exclusively in strictly controlled conditions, ensuring its proper use. However, in case of overdose, excessive slowing of respiratory rate or complete respiratory arrest may occur.

4. Possible side effects

Like all medicines, Sufentanil Chiesi can cause side effects, although not everybody gets them.

The following side effects are related to the use of sufentanil, including side effects reported during clinical trials and after the medicine was placed on the market.

Very common side effects (occurring in at least 1 in 10 people):

• excessive sedation,
• itching.

Common side effects (occurring in 1 to 10 in 100 people):

• seizures in infants, dizziness, headache,
• rapid heartbeat,
• increased or decreased blood pressure, pallor,
• cyanosis in newborns,
• vomiting, nausea,
• skin discoloration,
• muscle tremors,
• urination problems (urinary retention, incontinence),
• fever.

Uncommon side effects (occurring in 1 to 10 in 1,000 people):

• rhinitis,
• allergic reactions (hypersensitivity),
• apathy, nervousness,
• coordination disorders (ataxia), involuntary movements of limbs or the whole body (dyskinesia) in newborns, excessive reaction to external stimuli (hyperreflexia), increased muscle tone, decreased movement in newborns (hypokinesia), drowsiness,
• vision disorders,
• heart rhythm disorders (atrioventricular block, bradycardia, arrhythmia, ECG abnormalities),
• bronchospasm, respiratory depression, voice disorders, cough, hiccups, respiratory disorders,
• allergic skin inflammation, excessive sweating, rash, infantile rash, dry skin,
• back pain, decreased muscle tone in infants, muscle stiffness,
• decreased body temperature, increased body temperature, chills, reaction or pain at the injection site, pain.

Frequency not known (cannot be estimated from the available data):

• anaphylactic shock, anaphylactic reaction, pseudoanaphylactic reaction,
• coma, seizures, involuntary muscle contractions,
• pupil constriction,
• cardiac arrest,
• shock,
• respiratory arrest, apnea, respiratory depression, pulmonary edema, laryngospasm,
• skin redness (flushing),
• muscle spasms.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sufentanil Chiesi

Keep the medicine out of sight and reach of children.

Do not use Sufentanil Chiesi after the expiry date stated on the packaging.

The expiry date refers to the last day of the month.

Do not store above 25°C. Protect from light.

Do not use Sufentanil Chiesi if you notice a change in color, if the solution contains visible particles, or if the packaging is damaged.

6. Contents of the pack and other information

What Sufentanil Chiesi contains

• The active substance of the medicine is sufentanil. One milliliter contains 50 micrograms of sufentanil in the form of 75 micrograms of sufentanil citrate. One 5 ml ampoule contains 250 micrograms of sufentanil. One 20 ml ampoule contains 1000 micrograms of sufentanil.
• The other ingredients are sodium chloride, citric acid, and water for injections.

What Sufentanil Chiesi looks like and contents of the pack

Sufentanil Chiesi is available in colorless glass ampoules with white-red-yellow rings, containing a colorless solution without visible particles. One pack contains 5 ampoules of 5 ml of solution or 5 ampoules of 20 ml of solution.

Marketing authorization holder and manufacturer

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Vienna, Austria

For more information, contact the local representative of the marketing authorization holder:

Pharma Business Administration Consultancy

Tel.: +48 22 100 4037

Fax: +48 22 100 4038

Date of last revision of the leaflet:

{Logo Chiesi}

Information intended for healthcare professionals only:

Dosage and administration

Method of administration:

Sufentanil should only be administered by anesthesiologists or other doctors who are familiar with the actions and uses of the medicine, or under their supervision.

The dosage should be determined individually for each patient, depending on their age, weight, and clinical condition (clinical diagnosis, concomitant treatment, type of general anesthesia, duration and type of surgical procedure).

During the administration of supplementary doses, the effect of the initial dose should be taken into account.

To reduce the risk of bradycardia, it is recommended to administer a small dose of one of the anticholinergic drugs immediately before inducing general anesthesia. Nausea and vomiting can be prevented by administering antiemetic drugs.

Dosage:

INTRAVENOUS ADMINISTRATION

Adults and adolescents:

• As an analgesic in general anesthesia induced and maintained with several anesthetics: Initial dose: 0.5 to 2 micrograms/kg body weight - administered by slow intravenous injection or continuous intravenous infusion over 2 to 10 minutes. The duration of action of the medicine depends on the dose. A dose of 0.5 micrograms/kg body weight acts for about 50 minutes. Maintenance dose: 10 to 50 micrograms (about 0.15 to 0.7 micrograms/kg body weight) - administered intravenously when clinical signs of anesthesia wear-off occur.

Children:

The efficacy and safety of sufentanil administered intravenously in children under 2 years of age have been documented in a limited number of cases.

• For induction and maintenance of general anesthesia during cardiac surgery or general surgery, with 100% oxygen administration, the following doses are recommended:
• newborns and children under 3 years: 5 to 15 micrograms/kg body weight
• children under 12 years: 5 to 20 micrograms/kg body weight

Note:Maintenance doses should be individualized based on the patient's condition and the expected time remaining until the end of the operation. Due to the higher clearance of the medicine in children, higher doses or more frequent administration may be required.

Sufentanil administered to patients as monotherapy in injection did not provide sufficient general anesthesia, and patients required additional anesthetics.

Special precautions regarding dosage

Older or debilitated patients usually require smaller doses.

In older patients, the half-life of sufentanil is not prolonged, but there may be an increased risk of cardiovascular disorders.

In patients with impaired compensatory intracranial mechanisms, opioid drugs should be administered with caution. It has been reported that in such patients, a transient decrease in mean arterial pressure was accompanied by a short-term decrease in cerebral perfusion pressure.

In case of renal or hepatic impairment, the possibility of reduced sufentanil elimination should be considered, and the dose should be adjusted accordingly.

Patients who have been taking opioids for a long time or have a history of opioid addiction may require higher doses.

The duration of sufentanil administration depends on the duration of the operation.

The solution for injection can be administered as a single dose or multiple doses. It is recommended to avoid administering sufentanil as a single rapid injection (bolus). If a sedative is administered with sufentanil, it should be given in a separate injection.

Special warnings and precautions for use

The use of sufentanil is subject to intubation and mechanical ventilation of the patient.

As with all potent opioids:

Respiratory depression is dose-dependent and can be reversed by the administration of specific opioid antagonists (naloxone). Since respiratory depression may persist longer than the effect of the antagonist, it may be necessary to repeat the dose. The dose and interval between doses of the antagonist depend on the previously administered dose of sufentanil and the time of its administration.

Deep general anesthesia may be accompanied by significant respiratory depression, which may persist in the postoperative period, and in the case of intravenous administration of sufentanil, may recur. Therefore, patients should be closely monitored. It is necessary to ensure easy access to life-support equipment and the possibility of administering opioid antagonists.

Hyperventilation during anesthesia may change the patient's response to CO2, affecting respiratory function in the postoperative period.

Respiratory disorders associated with sleep

Opioids may cause respiratory disorders associated with sleep, including central sleep apnea (CSA) and sleep-related hypoxemia. The use of opioids increases the risk of CSA in a dose-dependent manner. In patients with CSA, it is recommended to consider reducing the total opioid dose.

Increased muscle tone may occur, including muscle tone in the chest, but this can be prevented by taking the following precautions: slow intravenous injection (for smaller doses, this is usually a sufficient preventive measure), prior administration of benzodiazepines or muscle relaxants.

Opioid-induced hyperalgesia

As with other opioids, if pain control is inadequate in response to an increased dose of sufentanil, the possibility of opioid-induced hyperalgesia should be considered. It may be necessary to reduce the dose of sufentanil, discontinue treatment, or verify treatment.

Non-epileptic myoclonic movements may occur.

Administration of too small a dose of a cholinergic drug or use of sufentanil in combination with muscle relaxants without vagolytic action may cause bradycardia, and even cardiac arrest. Bradycardia can be treated with atropine.

Tachycardia caused by the administration of pancuronium may predominate over bradycardia.

Opioids may cause hypotension, especially in patients with hypovolemia. It is necessary to take measures to maintain blood pressure at a stable level.

In patients with impaired compensatory intracranial mechanisms, opioid drugs should be administered with caution. It has been reported that in such patients, a transient decrease in mean arterial pressure was accompanied by a short-term decrease in cerebral perfusion pressure.

Patients who have been taking opioids for a long time or have a history of opioid addiction may require higher doses.

It is recommended to reduce the dose in elderly or debilitated patients.

Increasing the dose of opioids to establish an optimal dose should be done with caution in patients with uncontrolled hypothyroidism, lung disease, reduced lung capacity, alcoholism, impaired liver or kidney function. Such patients should be monitored for a longer period after surgery.

Effect on the gastrointestinal tract

Sufentanil, as a μ-opioid receptor agonist, may slow down gastrointestinal motility. Therefore, caution should be exercised when using sufentanil in patients at risk of intestinal obstruction.

Sufentanil, as a μ-opioid receptor agonist, may cause spasm of the Oddi sphincter. Therefore, caution should be exercised when using sufentanil in patients with biliary tract disease, including acute pancreatitis.

As with other opioids, it can be expected that the newborn will be particularly sensitive to the respiratory depressant effect of sufentanil. Data on intravenous administration of sufentanil in small children are limited, so before using this medicine in newborns and small children, the expected benefits should be carefully weighed against the possible risks. Due to the high variability of pharmacokinetic parameters in newborns, there is a risk of administering too high or too low a dose of sufentanil in the neonatal period. See also "Dosage and administration".

Tolerance and opioid use disorder (addiction and abuse)

Due to its properties similar to those of morphine, sufentanil may cause addiction.

Addiction will not develop if sufentanil is used only for surgery as an anesthetic. However, it may occur after prolonged use in intensive care units to relieve pain, where increasingly higher doses of sufentanil are administered to achieve a satisfactory analgesic effect. After treatment lasting more than a week, withdrawal symptoms may already occur, and after two weeks of treatment, this is likely.

In this regard, the following recommendations are given:

• 1. Doses should not be higher than necessary.
• 2. Dose reduction should be gradual, over several days.
• 3. If necessary, to combat withdrawal symptoms, clonidine can be used. After repeated administration of opioids, tolerance, physical dependence, and opioid use disorder (OUD) may develop. Abuse or intentional misuse of Sufentanil Chiesi can lead to overdose or death. The risk of developing OUD is increased in patients with a history of substance use disorders (including alcohol use disorders), current smokers, or patients with other mental health disorders (e.g., major depression, anxiety disorders, or personality disorders). Patients will require monitoring for drug-seeking behavior (e.g., requesting prescriptions too early). This includes verifying concomitantly used opioids and psychoactive medicines (such as benzodiazepines). In patients with signs of OUD, it is recommended to consider consultation with an addiction specialist.

Discontinuation of treatment and withdrawal syndrome

Repeated administration over short intervals for a long time may lead to the development of a withdrawal syndrome after discontinuation of treatment. In rare cases, after sudden discontinuation of treatment, especially after prolonged administration for more than three days, cases of sufentanil withdrawal syndrome have been reported, including tachycardia, hypertension, and agitation. In the reported cases, it was beneficial to resume administration of the medicine and gradually reduce the dose administered by infusion. It is not recommended to use Sufentanil Chiesi in mechanically ventilated patients in intensive care units for a treatment period longer than three days.

Sufentanil Chiesi contains 0.15 mmol (3.54 mg) of sodium per milliliter of solution. The medicine contains 17.7 mg of sodium in a 5 ml ampoule, which corresponds to 0.89% of the maximum recommended daily intake of sodium in the diet for adults. The medicine contains 70.8 mg of sodium in a 20 ml ampoule, which corresponds to 3.54% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account when administering large volumes of the solution (e.g., more than 6.5 ml, corresponding to more than 1 mmol of sodium) to patients with reduced kidney function or to patients controlling their sodium intake.

The medicine may be diluted in a 0.9% NaCl solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used for dilution, refer to the product characteristics of the diluent used.

Interactions with other medicines and other types of interactions

Medicines such as barbiturates, etomidate, benzodiazepine derivatives, neuroleptics, opioids, halogenated anesthetics, and other substances that non-selectively depress the central nervous system (e.g., alcohol) may enhance the respiratory depressant effect of opioids. If one of these medicines is administered concomitantly with sufentanil, the dose of one or both medicines should be reduced.

Concomitant administration of sufentanil and benzodiazepines may cause a decrease in blood pressure.

If patients have taken such medicines, it will be necessary to reduce the dose of sufentanil. Similarly, after administration of sufentanil, the dose of other central nervous system depressants should be reduced.

Concomitant use of sufentanil and vecuronium or suxamethonium may cause bradycardia, especially if the heart rate was already slow (e.g., in patients taking heart medications: calcium channel blockers or beta-blockers). It is recommended to reduce the dose of one or both medicines.

Concomitant use of high doses of sufentanil and nitrous oxide may lead to a decrease in blood pressure, a decrease in heart rate, and a decrease in cardiac output.

Sufentanil is primarily metabolized by the cytochrome P450 3A4 isoenzyme, but in vivono inhibition of its action by erythromycin (a known inhibitor of cytochrome P450 3A4) has been observed. Despite the lack of clinical data, in vitrodata indicate the possibility of slowing down the metabolism of sufentanil by other potent cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir). This could increase the risk of prolonged or delayed respiratory depression. Concomitant use of such medicines requires the patient to be under special care and close monitoring. In particular, it may be necessary to reduce the dose of sufentanil.

Concomitant administration of sufentanil with a serotonergic medicine, such as a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI), or a monoamine oxidase inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition. Monoamine oxidase inhibitors should not be taken within 2 weeks before or at the same time as Sufentanil Chiesi.

Gabapentinoids

Concomitant use of opioids and gabapentinoids (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and death.

Effects on fertility, pregnancy, and lactation

Pregnancy

The safety of sufentanil administered intravenously in pregnant women has not been established, although animal studies have not shown the occurrence of serious developmental anomalies. As with other medicines, the risk should be weighed against the benefits for the patient. Sufentanil crosses the placenta. Intravenous administration during labor, as well as before clamping the umbilical cord during a cesarean section, is contraindicated (see "When not to use Sufentanil Chiesi").

Breastfeeding

Sufentanil passes into breast milk. Caution should be exercised when administering sufentanil to a breastfeeding woman.

Overdose

Objective and subjective symptoms

The symptoms of sufentanil overdose are an intensification of its pharmacological effects. Depending on individual sensitivity, the clinical picture is mainly determined by the degree of respiratory depression, which can range from slowed breathing to complete apnea.

Pharmacological effects may cause respiratory depression even at therapeutic doses (i.v.: more than 0.3 micrograms/kg body weight). Sufentanil is used exclusively in strictly controlled conditions, ensuring proper management of these symptoms.

Treatment

In case of decreased respiratory rate or apnea, oxygen should be administered, and assisted or controlled breathing should be used as needed. If necessary, a specific antidote, such as naloxone, should be administered to control respiratory depression. This does not exclude the immediate implementation of other measures. Respiratory depression may persist longer than the effect of the antidote, so it may be necessary to administer repeated doses. In case of concomitant respiratory depression and muscle stiffness, it may be necessary to administer a depolarizing muscle relaxant intravenously to facilitate assisted or controlled breathing. The patient should be closely monitored; it is necessary to maintain a proper body temperature and fluid balance. In case of significant or persistent hypotension, it is necessary to consider the possibility of hypovolemia, and if it is confirmed, countermeasures should be taken by administering an appropriate amount of fluid parenterally.

Incompatibilities

Citrate sufentanil shows physical incompatibility with diazepam, lorazepam, sodium phenobarbital, phenytoin, and thiopental.

Shelf life

Shelf life before opening the packaging

3 years.

Shelf life after dilution

It has been demonstrated that diluted solutions remain chemically and physically stable for 72 hours at 25°C (see "Special precautions for disposal and preparation of the medicine for administration").

From a microbiological point of view, diluted solutions should be used immediately.

If the solution is not used immediately, the user is responsible for the storage conditions and storage time, which should not normally exceed 24 hours at 2 to 8°C, unless dilution took place in controlled, approved aseptic conditions.

Special precautions for disposal and preparation of the medicine for administration

Sufentanil Chiesi can be diluted with Ringer's solution, 0.9% sodium chloride solution, or 5% glucose solution. The diluted solution should be used within 72 hours of preparation.

Before administering Sufentanil Chiesi, carefully inspect the contents of the ampoules to assess whether there has been any precipitation of particles, damage to the container, or any visible signs of deterioration.

If such defects are found, the solution should be discarded.