Sufentanil chiesi: detailed information

Package leaflet: Information for the user

Sufentanil Chiesi, 50 micrograms/ml, solution for injection
Sufentanilum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What Sufentanil Chiesi is and what it is used for
Important information before using Sufentanil Chiesi
How to use Sufentanil Chiesi
Possible side effects
How to store Sufentanil Chiesi
Contents of the pack and other information

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

Sufentanil Chiesi is a narcotic analgesic belonging to the opioid group, containing sufentanil as the active substance. It is used during surgical procedures as an anaesthetic and analgesic agent.
Sufentanil Chiesi is intended for hospital use only.

2. Important information before using Sufentanil Chiesi

When not to use Sufentanil Chiesi:

If the patient has a known allergy (hypersensitivity) to sufentanil or any of the other ingredients of Sufentanil Chiesi.
If the patient has a known allergy to other pain-relieving medicines of the morphine-type.
If the patient has intolerance to any of the ingredients of the medicine or to other morphine-like drugs.
Intravenous administration during labour or before clamping of the umbilical cord during caesarean section.
If the patient must avoid medicines that depress the respiratory centre.
If the patient has acute hepatic porphyria.
If the patient is currently being treated or has been treated within the last 14 days with a medicine from the group of MAO inhibitors (used in the treatment of depression).

Warnings and precautions
Before starting treatment, discuss the following with your doctor or nurse:

if the patient has a lung disease or experiences difficulty breathing;
if the patient has hypothyroidism;
if the patient has heart disorders;
if the patient has hypotension or reduced blood volume, e.g. due to bleeding;
if the patient has liver or kidney disorders;
if the patient has abnormally slowed intestinal peristalsis;
if the patient has gallbladder or pancreatic disorders;
if the patient experiences headaches or has a history of head injury;
if the patient has been using opioids long-term.

DURING treatment with Sufentanil Chiesi, consult your doctor:

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

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

if the patient or any of their relatives have ever misused alcohol, prescription medicines or drugs ("addiction");
if the patient smokes tobacco;
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 may result in reduced effectiveness (the patient may become tolerant). This may also lead to dependence and abuse of the medicine, which could result in life-threatening overdose. If the patient is concerned about the possibility of becoming addicted to Sufentanil Chiesi, it is important to discuss this with the doctor.
Sufentanil may significantly depress the patient's respiratory function. Therefore, medical staff should closely monitor the patient, ensure immediate access to resuscitation equipment, and, if necessary, administer an opioid antagonist (naloxone).
Sleep-related breathing disorders
Sufentanil Chiesi may cause sleep-related breathing disorders, such as sleep apnoea (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, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If these symptoms are observed, contact your doctor. The doctor may consider reducing the dose.
Administration of sufentanil may cause bradycardia or cardiac arrest and may lead to increased muscle tone. To prevent these effects, the doctor will take appropriate preventive measures and, if they occur, will initiate appropriate treatment.
Rapidly successive muscle spasms may occur.
In elderly and debilitated patients, a reduced dose of Sufentanil Chiesi is recommended, as they may be more sensitive to the effects of the medicine.
Data on intravenous administration of sufentanil in young children are limited; therefore, the benefit-risk ratio should be carefully evaluated before using this medicine in neonates and young children.
Due to its morphine-like properties, sufentanil may cause dependence. Dependence will not develop if sufentanil is used only during surgery as an anaesthetic. However, it may occur after prolonged use in intensive care units for pain relief.

Sufentanil Chiesi and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the way Sufentanil Chiesi works or increase the likelihood of adverse effects.
Inform your doctor or nurse if the patient is taking:

Medicines that may cause drowsiness, such as: barbiturates, benzodiazepines, neuroleptics, halogenated general anaesthetics, and other central nervous system depressants (e.g. alcohol), as they may intensify respiratory depression caused by opioids; benzodiazepines together with Sufentanil Chiesi may also cause a drop in blood pressure.
Antidepressant medicines known as monoamine oxidase inhibitors (MAOIs); these medicines must not be taken within 2 weeks before or concurrently with Sufentanil Chiesi.
Antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Concomitant use of these medicines with Sufentanil Chiesi is not recommended.
Medicines used to treat epilepsy, neuropathic pain, or anxiety (gabapentin and pregabalin), as they may increase the risk of opioid overdose and respiratory depression, which may be life-threatening.
Ketoconazole and fluconazole (medicines used to prevent and treat skin and fungal infections), and ritonavir (a medicine used to treat HIV infection). These medicines may inhibit the metabolism of Sufentanil Chiesi.

Concomitant use of sufentanil and muscle relaxants: vecuronium or suxamethonium may cause bradycardia, especially if the heart rate is already slow (e.g. in patients receiving medicines for heart conditions: calcium channel blockers or beta-blockers).
Concomitant use of high doses of sufentanil and nitrous oxide may lead to hypotension and cardiac rhythm disturbances, including bradycardia.

Sufentanil Chiesi with food, drink or alcohol
Alcohol consumption should be avoided, as it may intensify the adverse effects of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. The doctor will assess the potential risks and benefits of using Sufentanil Chiesi during pregnancy.
Intravenous administration of sufentanil during labour, as well as before clamping of the umbilical cord during caesarean section, is contraindicated, as it may cause respiratory depression in the newborn.
Sufentanil passes into human milk. Consult your doctor before starting breastfeeding.

Driving and operating machinery
After administration of Sufentanil Chiesi, the patient must not drive or operate machinery after leaving the hospital for the period specified by the doctor, as this medicine may cause dizziness and drowsiness.

Sufentanil Chiesi contains sodium
Sufentanil Chiesi contains 3.54 mg of sodium (the main component of table salt) per millilitre 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 sodium intake in the diet of adults.
The medicine contains 70.8 mg of sodium in a 20 ml ampoule. This corresponds to 3.54% of the maximum recommended daily sodium intake in the diet of adults.
This should be taken into account when administering large volumes of the solution to patients with impaired kidney function and to patients on a controlled sodium diet (e.g. more than 6.5 ml, equivalent to more than 1 mmol of sodium).
The medicine may be diluted in 0.9% NaCl solution. The sodium content from the diluent should be considered when calculating the total sodium content in the prepared diluted solution. For accurate information on the sodium content of the diluent used, refer to the patient leaflet of the diluent.

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 suitably qualified and authorized person.
This medicine is given as a slow intravenous injection or as a continuous intravenous infusion.
The doctor will decide the dose and frequency of administration depending on the patient's health condition and response to treatment.
The doctor may decide to interrupt the infusion in case of a mechanical obstruction (e.g. blockage of tubing, needle, or catheter).
It is very important to always use this medicine exactly as recommended. Use of Sufentanil Chiesi may lead to dependence. Do not administer it more frequently or for a longer duration than prescribed by the doctor.
Administration of a higher than recommended dose of Sufentanil Chiesi
Sufentanil is used only under strictly controlled conditions, which ensures its proper use. However, in case of overdose, excessive respiratory depression or complete respiratory arrest may occur.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions associated with the use of sufentanil, including those reported during clinical trials and after the medicine was placed on the market.

Very common adverse reactions (occur in at least 1 in 10 people):

excessive sedation,
itching.

Common adverse reactions (occur in 1 to 10 in 100 people):

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

Uncommon adverse reactions (occur in 1 to 10 in 1,000 people):

rhinitis,
allergic reactions (hypersensitivity),
apathy, nervousness,
movement coordination disorders (ataxia), involuntary movements of limbs or entire body (dyskinesia) in newborns, exaggerated response to external stimuli (hyperreflexia), increased muscle tone, reduced motor activity in newborns (hypokinesia), somnolence,
visual disturbances,
heart rhythm disorders (atrioventricular block, bradycardia, arrhythmia, ECG abnormalities),
bronchospasm, respiratory depression, voice disturbances, cough, hiccough, breathing disorders,
allergic dermatitis, 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 available data):

anaphylactic shock, anaphylactic reaction, pseudoanaphylactic reaction,
coma, convulsions, involuntary muscle contractions,
miosis (pupillary constriction),
cardiac arrest,
shock,
respiratory arrest, apnoea, respiratory depression, pulmonary oedema, laryngospasm,
skin redness (flushing),
muscle spasms.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sufentanil Chiesi

Keep this medicine out of the sight and reach of children.
Do not use Sufentanil Chiesi after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Protect from light.
Do not use Sufentanil Chiesi if a change in colour is observed, if the solution contains visible particles, or if the packaging is damaged or leaking.

6. Contents of the pack and other information

What Sufentanil Chiesi contains

The active substance is sufentanil. One millilitre contains 50 micrograms of sufentanil as 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 ampoules made of colourless glass, with white-red-yellow
bands, containing a colourless solution free from visible particles. One pack contains
5 ampoules of 5 ml solution or 5 ampoules of 20 ml solution.
Marketing Authorisation Holder and Manufacturer
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna, Austria
For further information, please contact the local representative of the Marketing Authorisation Holder:
Pharma Business Administration Consultancy,
Tel.: +48221004037
Fax: +48221004038
{Chiesi Logo}

Information intended exclusively for healthcare professionals:

Dosage and administration
Route of administration:
Sufentanil should be administered only by anaesthesiologists or other physicians familiar with its effects and use, or under their supervision.
Dosage must be individualized for each patient depending on age, body weight, and clinical condition (clinical diagnosis, concomitant therapy, type of general anaesthesia, duration and type of surgical procedure). When administering supplemental 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 an anticholinergic agent intravenously immediately before induction of general anaesthesia. Nausea and vomiting may be prevented by administering antiemetic agents.

Dosage:
INTRAVENOUS ADMINISTRATION
Adults and adolescents:

As an analgesic in multi-agent general anaesthesia (induction and maintenance): Initial dose: 0.5 to 2 micrograms/kg body weight – administered as a slow intravenous injection or continuous intravenous infusion over 2 to 10 minutes. Duration of action depends on the dose. A dose of 0.5 micrograms/kg body weight provides an effect lasting approximately 50 minutes. Maintenance dose: 10 to 50 micrograms (approximately 0.15 to 0.7 micrograms/kg body weight) – administered intravenously when clinical signs of waning anaesthesia occur.
Weaning phase – during this phase, the dose should be reduced very gradually.
As an anaesthetic agent for induction and maintenance of general anaesthesia: Initial dose: 7 to 20 micrograms/kg body weight – administered as a slow intravenous injection or short-term intravenous infusion over 2 to 10 minutes. Maintenance dose: 25 to 50 micrograms (approximately 0.36 to 0.7 micrograms/kg body weight) – administered intravenously when clinical signs of waning general anaesthesia occur. Maintenance doses of 25 to 50 micrograms of sufentanil are usually sufficient to maintain haemodynamic stability during general anaesthesia. Note: Maintenance doses should be individually adjusted according to the patient's condition and the anticipated time remaining until the end of surgery.

Children:
The efficacy and safety of intravenous sufentanil in children under 2 years of age have been documented only in a limited number of cases.

For induction and maintenance of general anaesthesia during cardiac or vascular surgery or general surgical procedures, when administered with 100% oxygen, the following doses are recommended:
- newborns and children up to 3 years: 5 to 15 micrograms/kg body weight
- children up to 12 years: 5 to 20 micrograms/kg body weight

Note: Maintenance doses should be individually adjusted according to the patient's condition and the anticipated time remaining until the end of surgery. Due to higher drug clearance in children, higher doses or increased dosing frequency may be required.
Sufentanil administered as monotherapy via intravenous injection has not been sufficient to achieve adequate general anaesthesia, and patients required additional anaesthetic agents.

Special dosage precautions
Elderly or debilitated patients generally require lower doses.
In elderly patients, the half-life of sufentanil is not prolonged, but there may be an increased risk of cardiovascular abnormalities.
The selected total dose should be administered cautiously in patients with any of the following conditions: uncorrected hypothyroidism, lung disease (particularly with reduced vital capacity), obesity, or alcoholism. In such cases, prolonged postoperative observation is recommended.
In cases of renal or hepatic impairment, reduced elimination of sufentanil should be considered, and the dose should be appropriately reduced.
Chronically ill patients receiving opioids or with a history of opioid dependence may require higher doses.
The duration of sufentanil administration depends on the length of the surgical procedure.
The injection solution may be administered once or repeatedly. Avoid administering sufentanil as a single rapid intravenous bolus. If a sedative is co-administered with sufentanil, it should be given in a separate injection.

Special warnings and precautions for use
Sufentanil must be used under conditions that include endotracheal intubation and mechanical ventilation.
As with all potent opioids:
Respiratory depression is dose-dependent and can be reversed by administration of specific opioid antagonists (e.g., naloxone). Because respiratory depression may persist longer than the effect of the antagonist, repeated doses may be necessary. The dose and interval between doses of the opioid antagonist depend on the previously administered dose and timing of sufentanil.
Profound general anaesthesia may be associated with significant respiratory depression. This may persist into the postoperative period, and when sufentanil has been administered intravenously, respiratory depression may recur. Therefore, appropriate patient monitoring is essential. Immediate access to resuscitation equipment and opioid antagonists must be ensured. Hyperventilation during anaesthesia may alter the patient's response to CO₂ and affect respiratory function in the postoperative period.

Sleep-related breathing disorders
Opioids may cause sleep-related breathing disorders, including central sleep apnoea (CSA) and sleep-related hypoxaemia. Opioid use increases the risk of CSA in a dose-dependent manner. In patients with CSA, consider reducing the total opioid dose.

Muscle rigidity, including of the chest wall muscles, may occur, but can be avoided by the following precautions: slow intravenous injection (which is usually sufficient for smaller doses), pre-treatment with benzodiazepines or muscle relaxants.

Opioid-induced hyperalgesia
As with other opioids, if inadequate pain control occurs despite increasing the sufentanil dose, opioid-induced hyperalgesia should be considered. Reduction of the sufentanil dose, discontinuation of treatment, or re-evaluation of therapy may be indicated. Non-epileptic myoclonic movements may occur.

Insufficient anticholinergic premedication or the use of sufentanil in combination with non-anticholinergic muscle relaxants may lead to bradycardia or even cardiac arrest. Bradycardia can be treated with atropine. Tachycardia induced by pancuronium may mask bradycardia.

Opioids may cause hypotension, particularly in patients with hypovolaemia. Appropriate measures should be taken to maintain stable arterial pressure.

In patients with impaired intracranial pressure compensation mechanisms, rapid intravenous injection of opioids should be avoided. In such patients, a transient decrease in mean arterial pressure may be associated with a short-term reduction in cerebral perfusion pressure.

Patients on long-term opioid therapy or with a history of opioid dependence may require higher doses.

Dosage reduction is recommended in elderly or debilitated patients.

Increasing opioid dosage to determine the optimal dose should be done cautiously in patients with: uncorrected hypothyroidism, lung disease, reduced pulmonary reserve capacity, alcoholism, impaired liver or kidney function. Such patients should be observed for a longer period after surgery.

Gastrointestinal effects
Sufentanil, as a μ-opioid receptor agonist, may slow gastrointestinal motility. Therefore, caution is advised when administering sufentanil to patients at risk of intestinal obstruction.

Sufentanil, as a μ-opioid receptor agonist, may cause spasm of the sphincter of Oddi. Therefore, caution is advised when administering sufentanil to patients with biliary tract diseases, including acute pancreatitis.

As with other opioids, neonates may be particularly sensitive to the respiratory depressant effects of sufentanil. Data on intravenous sufentanil administration in young children are limited; therefore, the benefit-risk ratio should be carefully evaluated before using this drug in neonates and young children. Due to high variability in pharmacokinetic parameters in neonates, there is a risk of administering too high or too low a dose intravenously. See also "Dosage and administration".

Tolerance and opioid use disorder (abuse and dependence)
Due to its morphine-like properties, sufentanil may cause dependence. Dependence does not develop when sufentanil is used solely for surgery as an anaesthetic agent. However, dependence may occur after prolonged use in intensive care units, where increasingly higher doses of sufentanil are administered to achieve satisfactory analgesia. Withdrawal symptoms may appear after treatment lasting more than one week, and are likely after two weeks of therapy.

Therefore, the following recommendations are given:

Doses should not exceed what is necessary.
Dose reduction should be gradual over several days.
In case of need, clonidine may be used to manage withdrawal symptoms. Repeated opioid administration may lead to tolerance, physical and psychological dependence, and opioid use disorder (OUD). Abuse or intentional misuse of Sufentanil Chiesi may lead to overdose or death. The risk of OUD is increased in patients with a personal or family history (parents or siblings) of substance use disorders (including alcohol use disorders), active smokers, or patients with other psychiatric disorders (e.g., major depression, anxiety disorders, personality disorders). Patients should be monitored for drug-seeking behaviours (e.g., early requests for repeat prescriptions). This includes verifying concomitant use of opioids and psychoactive drugs (e.g., benzodiazepines). In patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

Discontinuation and withdrawal syndrome
Repeated administration at short intervals over a prolonged period may lead to withdrawal syndrome upon discontinuation. Rarely, after abrupt discontinuation, particularly after prolonged administration exceeding three days, withdrawal symptoms such as tachycardia, hypertension, and agitation have been reported. In reported cases, resumption of drug administration and gradual dose reduction in infusion were beneficial. Sufentanil Chiesi is not recommended for use in mechanically ventilated intensive care unit patients for treatment periods longer than three days.

Sufentanil Chiesi contains 0.15 mmol (3.54 mg) of sodium per millilitre of solution. The 5 ml ampoule contains 17.7 mg of sodium, equivalent to 0.89% of the WHO-recommended maximum daily intake of 2 g sodium for adults. The 20 ml ampoule contains 70.8 mg of sodium, equivalent to 3.54% of the WHO-recommended maximum daily intake of 2 g sodium for adults. This should be taken into account when administering large volumes of solution (e.g., more than 6.5 ml, corresponding to more than 1 mmol of sodium) to patients with impaired renal function or those on a sodium-restricted diet.
The drug may be diluted with 0.9% sodium chloride solution. The sodium content from the diluent should be considered when calculating the total sodium content in the prepared diluted solution. For accurate information on sodium content in the diluent used, refer to the product characteristics of the diluent.

Interactions with other medicinal products and other forms of interaction
Drugs such as barbiturates, etomidate, benzodiazepine derivatives, neuroleptics, opioids, halogenated anaesthetic agents, and other substances that non-selectively depress the central nervous system (e.g., alcohol) may potentiate respiratory depression caused by narcotic agents. When any of these drugs are used concomitantly with sufentanil, the doses of one or both drugs should be reduced.

Concomitant administration of sufentanil and benzodiazepines may cause a decrease in arterial pressure.
If patients have received such drugs, the sufentanil dose should be reduced. Similarly, after administering sufentanil, the dose of other central nervous system depressants should be reduced.

Concomitant use of sufentanil and vecuronium or succinylcholine may cause bradycardia, especially if heart rate was already reduced (e.g., in patients receiving calcium channel blockers or β-blockers). Dose reduction of one or both drugs is recommended.

Concomitant use of high-dose sufentanil infusion solution and nitrous oxide may lead to decreased arterial pressure, reduced heart rate, and reduced cardiac output.

Sufentanil is metabolized primarily by the cytochrome P450 3A4 isoenzyme. However, in vivo studies have not shown inhibition of its metabolism by erythromycin (a known inhibitor of CYP3A4). Despite lack of clinical data, in vitro studies suggest that other strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may slow sufentanil metabolism, potentially increasing the risk of prolonged or delayed respiratory depression. Concomitant use of such drugs requires special patient care and close monitoring. Dose reduction of sufentanil may be particularly necessary.

Concomitant administration of sufentanil with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs) may increase the risk of serotonin syndrome, a potentially life-threatening condition. MAOIs must not be administered within 2 weeks before or concurrently with 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 intravenous sufentanil in pregnant women has not been established, although animal studies have not shown teratogenic effects. As with any drug, the risk should be weighed against the benefit for the patient. Sufentanil crosses the placenta. Intravenous administration during labour and before clamping of the umbilical cord during caesarean section is contraindicated (see When not to use Sufentanil Chiesi).

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

Overdose
Symptoms
Symptoms of sufentanil overdose are exaggerated effects of its pharmacological action. Depending on individual sensitivity, the clinical picture is primarily defined by the degree of respiratory depression, which may range from slowed respiration to complete apnoea.
Pharmacological effects of the drug may cause respiratory depression even after therapeutic doses (iv: >0.3 micrograms/kg body weight). Sufentanil is used exclusively under strictly controlled conditions, ensuring proper management of these symptoms.

Treatment
In case of reduced respiratory rate or apnoea, oxygen should be administered and assisted or controlled ventilation initiated as indicated. If appropriate, a specific opioid antagonist (e.g., naloxone) should be administered to reverse respiratory depression. This does not preclude immediate initiation of other supportive measures. Respiratory depression may persist longer than the antagonist effect, so repeated doses of the antagonist may be necessary. If respiratory depression and muscle rigidity occur simultaneously, intravenous administration of a depolarizing muscle relaxant may be required to facilitate assisted or controlled ventilation. The patient should be carefully monitored; body temperature and fluid balance should be maintained. In case of significant or persistent hypotension, hypovolaemia should be considered and treated with appropriate parenteral fluid administration.

Pharmaceutical incompatibilities
Sufentanil citrate shows physical incompatibility with diazepam, lorazepam, sodium phenobarbital, phenytoin sodium, and thiopental.

Shelf life
Shelf life before first opening of the container:
3 years.
Shelf life after dilution:
Diluted solutions have been shown to maintain chemical and physical stability for 72 hours at 25°C (see Special precautions for disposal and preparation for use).

From a microbiological point of view, diluted solutions should be used immediately.
If not used immediately, the user is responsible for storage conditions and duration, which should generally not exceed 24 hours at 2–8°C, unless dilution was performed under controlled, validated aseptic conditions.

Special precautions for disposal and preparation for use
For infusions, Sufentanil Chiesi may 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 administration, the contents of the ampoules should be carefully inspected for particulate matter, container damage, or any visible signs of deterioration.
If such defects are observed, the solution should be discarded.